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AUGUST 2009 Volume 5, Number 8
www.drugdiscoverynews.com
what’s inside
Global News
6
Informatics
14
automation & instrumentation
19
genomics & proteomics
24
research & development
30
finance....................................................... 3
Markets..................................................... 4
Editorial/commentary............................ 12
new products.......................................... 36
Stats . ...................................................... 38
J&J’s spending spree continues
Johnson & Johnson buys $1
billion stake in Elan to acquire
Alzheimer’s program
By Amy Swinderman
NEW BRUNSWICK, N.J.—On July 2, Johnson &
Johnson announced its second billion-dollar
purchase in as many months: The acquisition of Dublin, Ireland-based neuroscience biotechnology firm Elan Corp. PLC’s
Alzheimer’s disease program for $1 billion
follows J&J’s May announcement that it will
acquire Cougar Biotechnology for the same
price tag. The deal gives J&J access to a market where it had almost no presence and
gives Elan a much-needed cash infusion and
Alzheimer’s program investment.
Under the agreement, J&J will invest $1
billion in new Elan equity in exchange for an
18.4 percent stake. J&J will also acquire all of
the assets and rights of Elan’s Alzheimer’s
Immunotherapy Program (AIP Program)
through a newly formed company. The AIP
program is a 50/50 joint venture with Wyeth
to research, develop and commercialize
selective products for the treatment and/or
prevention of neurodegenerative conditions,
including Alzheimer’s disease.
Elan will receive a 49.9 percent equity
interest in the new company and is entitled
to the same percentage share of profits and
certain royalty payments upon the commercialization of products under the collabora-
Geron to provide stem
cells to GE Healthcare
Companies to develop and commercialize
cellular assay products derived from
human embryonic stem cells
By DAVID HUTTON
MENLO PARK, Calif.—Geron Corp. has reached an agreement to provide stem cells to GE Healthcare for use in tools that will test for the
toxic effects of drug treatments, a move that takes GE further into
stem cell research.
GE Healthcare and Geron have established a multi-year alliance
program under which scientists from the two companies will work
closely together to develop hESC-based products for drug discovery.
Under terms of the agreement, the partners will develop and commercialize cellular assay products derived from human embryonic
stem cells (hESCs) for use in drug discovery, development and toxicity screening. The program will use stem cells derived from hESC
lines listed on the National Institutes of Health’s Human Pluripotent
Stem Cell Registry.
Stem cell research series
Our ongoing coverage of business developments in the
stem cell research arena continues on page 10
According to Konstantin Fiedler, general manager of cell technologies and life sciences at GE Healthcare, the goals of the agreement are to develop and commercialize cellular assay products
derived from human embryonic stem cells for use in drug discovery,
development and toxicity screening. Working with Geron gives GE
Healthcare “access to NIH-approved hESC lines, strong IP and
ge continued on page 10
tion with Wyeth. J&J, through its affiliate,
will assume and continue Elan’s activities
with Wyeth under the AIP program and
initially commit up to $500 million to continue the development and launch activities
of bapineuzumab, a potential first-in-class
treatment that is being evaluated for slowing the progression of Alzheimer’s disease,
as well as other compounds. The agreement
provides for additional funding obligations
of the parties if needed.
The AIP program includes multiple compounds being evaluated for slowing the progression of Alzheimer’s disease. The lead
compound, bapineuzumab, administered
intravenously once every three months, is
currently in Phase III clinical trials. A sub-
J&J’s latest large-figure deal gives it access to
one of Elan Corp.’s most promising Alzheimer’s
disease programs.
cutaneous formulation, administered once
a week, is currently in Phase II trials. In
addition, a vaccine for Alzheimer’s disease
elan continued on page 33
Blood test for Alzheimer’s disease
likely within 12 to 18 months
Millipore and Proteome
Sciences sign licensing
agreement to detect
the disease in
pre-symptomatic stage
Under its deal
with Proteome
Sciences,
Millipore will
develop and sell
Luminex beadbased panels for
research related
to Alzheimer’s
disease and other
cognitive function
disorders.
By Lloyd Dunlap
BILLERICA, Mass.—I n w h a t
Proteome Sciences’ Dr. Ian Pike
describes as the “perfect combination,” the company he
serves as chief business officer,
Millipore Corp., and the Institute
of Psychiatry at King’s College,
London, are working together to
develop multiplex immunoassays
to measure Proteome Sciences’
proprietary Alzheimer’s disease
biomarkers. The ongoing collaboration has been formalized by an
exclusive license agreement by the
two companies to develop new
products that will help to advance
the study of the disease.
“We contribute the biomarkers,”
Pike says, “Millipore develops the
Luminex bead-based assays and
Dr. Simon Lovestone’s group contributes the clinical expertise. The
ability to quickly test for these biomarkers will enable researchers to
develop new drugs and diagnostics to treat and monitor patients
with Alzheimer’s.”
Proteome Sciences is a publicly
held company that began life running in “virtual mode,” according
to Pike, sponsoring research in
academia that focused on oncology, organ transplant rejection,
stroke, diabetes and obesity. In
millipore continued on page 21
SWISS SUCCESS
Medidata makes important deals with two
different Swiss pharmas in a two-week period
By Jeffrey Bouley
NEW YORK— If you hear any yodeling coming from New York City, it
might be because Medidata Solutions, a global provider of hosted clinical
development solutions, rang in the first day of July with the announcement that Basel, Switzerland-based Roche has selected Medidata Rave
as its enterprise-wide electronic data capture (EDC) solution. That was
followed two weeks later by the news that another Swiss company,
NovImmune, had added Medidata’s Trial Planning product suite its
lineup, after already enjoying the fruits of Medidata’s Grants Manager,
CRO Contractor and Designer products.
Looking at the Roche deal, Medidata CEO Tarek Sherif sees the willingness of Roche to invest in Medidata Rave on a global, enterprise-level
medidata continued on page 16
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finance
AUGUST 2009 • Drug Discovery News 3
NanoBio announces closing of $22M Series B financing round
ANN ARBOR, Mich.—NanoBio Corp.,
a biopharmaceutical company
developing dermatological products, anti-infective treatments and
intranasal vaccines, announced
in July that it closed a $22 million
Series B financing round after
recently securing an additional
$ 10 million investment from
NanoBio’s majority shareholder
Perseus LLC, based in New York,
and Venture Investors of Madison,
Wis., and Ann Arbor, Mich.
The $10 million is in addition to
the $12 million Series B funding
announced in February. To date,
NanoBio has received more than
$90 million in equity and grant
funding to support the development of the company’s anti-infective products and nanoemulsionbased vaccines.
According to NanoBio, the
funds will support clinical trials
and ongoing operations through
early 2011 and the advancement of numerous clinical and
preclinical programs, including
the development of products for
herpes labialis, onychomycosis,
acne and cystic fibrosis, as well
as intranasal vaccines for season-
al influenza and other diseases.
The company will begin a Phase
I clinical study in acne this summer and is planning to initiate a
Phase III study in herpes labialis.
In addition, the company is currently conducting a Phase I clinical study in NB-1008, a seasonal
influenza vaccine administered
via a nasal dropper.
NB-1008 uses a novel nanoemulsion-based adjuvant to achieve
a robust immune response using
only a small fraction of the antigen
required by currently available
injectable vaccines. In numerous
animal studies, NB-1008 has demonstrated robust mucosal, systemic and cellular immunity without
inflammation or safety concerns.
According to Dr. James R. Baker
Jr., NanoBio’s CEO and founder,
investors are finding value in the
company’s platform technology
from both a medical and commercial perspective.
“There is a clear need for novel
topical anti-infective therapies and
new vaccine-adjuvant approaches
that offer safety, ease-of-use and
enhanced efficacy,” Baker said in
a statement.
George Arida, managing director for Venture Investors’ healthcare practice, added that NanoBio
is a compelling investment choice
because it offers a strong scientific basis supported by promising
ongoing trial results.
“At a time when investors have
a multitude of good companies
seeking financing, we are selectively backing those with strong
management teams and novel
technology that have the potential to create significant change in
the healthcare landscape,” Arida
stated. DDN
Profectus BioSciences
secures $5M in
Series C venture
financing round
BALTIMORE, Md.— Profectus
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Sciences Inc., a clinical-stage biop
harmaceutical company focused on
the development of novel vaccine
candidates for chronic viral infections,
announced in July that the company
closed on a $5 million Series C venture
financing round.
Current investor Cross Atlantic
Capital Partners led the round, which
brings the total venture investment in
Profectus to $19 million to date.
In addition to the equity financing,
Profectus also announced that it has
entered into a $1 million equipment
leasing line of credit with Fountain
Partners of San Francisco. The equip
ment leasing will primarily be used for
the purchase of laboratory equipment
for Profectus’ new vaccine innovation
center in Tarrytown, N.Y.
According to Don Caldwell, chairman
of Profectus’ board and CEO of Cross
Atlantic Capital Partners, Profectus’
broad vaccine and therapeutic pipe
line focuses on key markets with major,
unmet medical needs. Each of these
markets represents a $2 billion oppor
tunity, Caldwell said in a statement
released by Profectus.
“From a partnering perspective, the
vaccine market has re-emerged as a
key revenue generator for large pharma
as pipelines have dried and favorable
legislation has been implemented,”
Caldwell stated. “We look forward to this
very important transition to the clinic
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markets
4 Drug Discovery News • AUGUST 2009
Pharmaceutical and Biotech Market Indices
Amex Pharmaceutical Index
Burrill Select
Source: Yahoo Finance
Source: Burrill & Co.
Burrill Mid-Cap Biotech and Small-Cap Biotech
T
he Burrill Report recorded a significant 25 percent increase in total
financings and partnering in the second quarter of this year compared
to the first quarter. While financings were down quarter over quarter, the
amount U.S. biotech firms raised in partnering deals was up 68 percent,
Burrill said. The firm also noted that it has become increasingly difficult to attract
venture capital as the amount raised by biotechs in the U.S. in the second quarter
was down 43 percent down from the total raised in the first quarter.
“While it is still going to take many more months before biotech starts on the road
to full recovery, it is encouraging to see companies are still raising capital despite
the tough economic conditions,” Burrill said. “This increase reflects the fact that in
a tight fiscal environment companies are devoting their energies on finding pharmaceutical and biotech partners to help build value of their lead product programs.”
Source: Burrill & Co.
Biotech buoyed by strong capital market performance in Q2
By Burrill & Co.
SAN FRANCISCO—Despite the fact that stocks
moved lower on the last day of June after
the Conference Board said its Consumer
Confidence Index fell in the month, the market still had a stellar quarter, with the Dow
Jones industrials up 12 percent and Nasdaq
up 20 percent compared with a 3 percent
uptick for the Burrill Biotech Select Index.
“The general markets have experienced
three excellent months of gains as investors
are betting that the worst of the economic woes are now behind us. This positive
market trend has certainly spilled over to
biotech,” said G. Steven Burrill, CEO of the
San Francisco-based venture capital firm.
“While biotech is not out of the woods yet,
and we will not return to ‘business as usual,’
investors still recognize that there are a lot
of good biotech companies out there with
excellent late-stage product candidates.”
Shares of Human Genome Sciences, for
example, jumped a whopping 246 percent in
the quarter after the company said its drug
candidate Benlysta reduced lupus symptoms over a four-year period, Burrill noted.
I nve s t o r s a l s o r e w a r d e d S av i e nt
Pharmaceuticals, whose shares soared
119 percent in June (180 percent in the
second quarter) after the U.S. Food and
Drug Administration (FDA) said its drug
Krystexxa appears to successfully relieve
swollen joints and pain flare-ups associated with gout, despite evidence of a series
of safety concerns seen in clinical trials
of the drug, including heart problems
and allergic reactions. The FDA has been
reviewing the company’s drug application
since December and has already delayed a
decision on the drug once.
In addition, shares of Dendreon increased
by a whopping 500 percent in the second quarter following the company’s first
announcement of positive Phase III data that
showed its lead product Provenge extended
the lives of men with advanced prostate cancer by an average of 4.1 months.
Cougar Biotechnology’s share value also
closed up 33 percent in the second quarter
P
u
b
l
i
c
Illumina’s second-quarter
revenue misses estimates
SAN DIEGO—Genetic analysis instrument maker
Illumina Inc. last month said its second-quarter
revenue fell short of its own forecast and Wall
Street estimates. The company said Q2 rev
enues were about $161 million, well below its
prior forecast range of $168 million to $173
million, and below analysts’ average estimate
of $172 million. The company attributed the
reduction in outlook to a shortfall in sales of
its DNA arrays due to customers delaying the
start of new genome-wide association studies in
anticipation of new, rare variant content arrays;
the impact of reduced foundation funding in
a few key accounts; and order delays directly
related to stimulus funding under the American
Recovery & Reinvestment Act (ARRA). Illumina
added that customer uncertainty about stimu
lus funding could hurt its third-quarter revenue
as well. Because of that, the company reverted
from the $700 million to $720 million revenue
forecast for 2009 offered in April to a January
range of $690 million to $720 million.
increasingly difficult to attract venture capital as the amount raised by biotechs in the
U.S. in the second quarter was down 43 percent down from the total raised in the first
quarter.
“While it is still going to take many more
months before biotech starts on the road to
full recovery, it is encouraging to see companies are still raising capital despite the tough
economic conditions,” Burrill said. DDN
thanks to Johnson & Johnson’s $970 million
cash bid to acquire the company.
The Burrill Report also recorded a significant 25 percent increase in total financings
and partnering in the second quarter of this
year compared to the first quarter. While
financings were down quarter over quarter, the amount U.S. biotech firms raised in
partnering deals was up 68 percent, Burrill
said. The firm also noted that it has become
C
o
m
pan
Novartis reports 10 percent
drop in second-quarter profits,
lifts drug sales target
BASEL, Switzerland—Swiss drugmaker Novartis
AG reported a 10 percent drop in second-quar
ter profit as a stronger U.S. dollar wiped away
increased sales of its medications. Q2 profit
fell to $2.04 billion, or 89 cents a share, from
$2.27 billion, or 98 cents a share, in Q2 2008.
In local currencies, sales improved 8 percent,
but because Novartis reports its results in U.S.
dollars, a strong dollar resulted in a 2 percent
drop in sales to $10.55 billion. The company’s
vaccines and diagnostics unit showed a 15 per
cent drop after year-earlier government orders of
H5N1 pandemic flu vaccine. The company said it
is making “good progress” on a vaccine against
the H1N1 flu pandemic and raised its pharma
ceutical sales forecast. For the year, Novartis
said it sees group sales rising mid-single-digits
in local currencies, but warned that currencyrelated losses could wipe out profit growth. It
increased its view for pharmaceutical-division
sales, seeing high-single-digit percentage
y
N
e
w
s
growth. The previous Novartis pharmaceutical
unit forecast was for mid- to high-single-digit
percentage growth.
Biogen’s second-quarter
earnings down 31 percent
on Acorda payment
CAMBRIDGE, Mass.—Despite strong sales of its
multiple sclerosis drug Tysabri and better-thanexpected revenues, Biogen Idec Inc. reported
in July that its second-quarter profit fell 31
percent on a $110 million payment regarding
its partnership and licensing pact with Acorda
Therapeutics Inc. Revenues rose 10 percent to
$1.1 billion, compared to $993 million the same
period last year. Biogen Idec reported earnings
of $142.9 million, or 49 cents a share, down
from $206.6 million, or 70 cents a share, a year
earlier. Excluding acquisition and other costs but
including the Acorda payment, earnings fell to
75 cents from 91 cents. The payment also made
Biogen cut its full-year earnings outlook to at
least $3.85, including a 38-cent impact from
the payment.
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Global News
b r i e f s
GSK, Chroma Therapeutics
form alliance
LONDON—GlaxoSmithKline
PLC and British
compatriot Chroma Therapeutics Ltd.
announced in July that they will co-develop
macrophage-targeted compounds using
Chroma’s proprietary esterase-sensitive motif
(ESM) technology, which adds amino acid
esters to compounds, with the aim of targeting the compounds to specific cells in the
inflammatory disease process. Chroma will
be responsible for four discovery and development programs to identify small-molecule
therapeutics, including its macrophage-targeted HDAC inhibitor program for inflammatory disorders such as rheumatoid arthritis,
through completion of clinical proof-of-concept studies. Chroma will retain full rights to
further develop and commercialize its product candidates in any program GSK chooses
not to license. Chroma will receive an upfront
cash payment, milestone payments, option
fees and tiered royalties that could exceed
$1 billion.
Novavax licenses VLP
technology to ROVI
Pharmaceuticals
ROCKVILLE, Md.—Novavax
Inc. has agreed
to license its proprietary, recombinant viruslike-particle (VLP) vaccine technology to ROVI
Pharmaceuticals of Spain, the companies
announced last month. ROVI will use the VLP
technology to create a comprehensive influenza vaccine solution for the Spanish government under a new $84 million program
sponsored and led by the Spanish Ministry
of Health and other government groups to
develop pandemic and seasonal flu vaccines
and establish its only in-border facility. Under
agreements being negotiated by both companies, ROVI will receive exclusive licenses
to Novavax’s portable VLP vaccine technology
to commercialize flu vaccines in Spain and
Portugal and non-exclusive licenses in Europe,
Latin America and Africa. ROVI will also make
a $3 million equity investment in Novavax.
Evotec signs high-throughput
screening deal with
Alios Biopharma
HAMBURG, Germany—Evotec
AG, a provider
in the discovery and development of novel
small-molecule drugs, announced in July a
collaboration with Alios Biopharma Inc. in
which Evotec will use its proprietary ultrahigh-throughput platform and technology to
screen a priority biological target for Alios. In
addition, Alios will access Evotec’s high quality small molecule screening library for the
screen. No financial details or specific information on Alios’ target were disclosed.
Failed drugs reincarnated
Israel’s Optimata,
Teva join forces
to develop
salvaged
cancer drugs
By Lori Lesko
RAMAT GAN, Israel—Biopharma
ceutical company Optimata
Ltd. and generic giant Teva
Pharmaceutical Industries Ltd.
have teamed up to fast-track the
development of cancer drugs by
using bio-stimulation technol
ogy aimed at salvaging drugs
that failed clinical tests.
The linchpin of the process—
and the collaboration—is the
Optimata Virtual Patient (OVP),
which allows companies to res
cue and redirect the clinical
development of discontinued
drug candidates, shelved by
originator pharmaceutical firms.
Under the terms of the part
nership, announced June 30,
Optimata will receive upfront
payments, development mile
stones and royalty payments.
In addition, partner Teva, head
quartered in Tikya, Israel, has
made an undisclosed equity
investment in Optimata.
Both companies are keeping
the specific financials confiden
tial and close to the vest.
Dr. Pini Orbach, chief oper
ating officer of Optimata, says
the company “seeks arrested
oncology compounds. Then, by
applying our OVP technology,
we ascertain that under certain
regimens, in given populations,
there is a safer way to use the
drugs in question.
“We shall utilize available
preclinical or clinical data, as
well as the PK/PD profile of the
drug in question, and the safety
profile of the drug in order to
run virtual clinical trials using
our OVP technology,” Orbach
adds. “Based on results from
the virtual trials, recommend
ed optimal regimens and the
Optimata continued on page 7
Dr. Pini Orbach, chief operating officer of Optimata, says his company seeks
“arrested oncology compounds” for which the company will run virtual clinical
trials using its Optimata Virtual Patient technology.
A flurry of activity
Shifting its focus
to neurological
conditions, Lundbeck
acquires Danish
biotech NeuronIcon
and U.K.-based
drugmaker LifeHealth
Mylan chooses
Bangalore’s
Biocon as global
generic biologics
partner
By Lloyd Dunlap
By David Hutton
drug
maker H. Lundbeck A/S has
been busy in recent weeks,
buying Danish company
NeuronIcon for an undisclosed
sum and striking a research deal
with scientists specializing in
neurology at the University of
Aarhus, where NeuronIcon was
conceived, and forging a deal to
buy U.K.-based LifeHealth Ltd.
for $147 million, expanding its
interest in Xenazine, a new treat
ment for Huntington’s disease.
The flurry of activity spot
COPENHAGEN —Danish
lundbeck continued on page 11
Bolus of
growth
Danish drugmaker H. Lundbeck A/S has purchased NeuronIcon and also reached a
research deal with scientists specializing in neurology.
BANGALORE, India— Based
on the expectation that
generic biologics, espe
cially monoclonal antibod
ies, will become the next
great “bolus of growth” in
the generic pharmaceutical
industry, Biocon Ltd. and
Mylan Inc. have formed an
alliance that promises to
provide “all four corners
of what any organization
would want or need to
offer a highly competitive
and distinct generic biolog
ics product portfolio with
tremendous growth poten
GROWTH continued on page 8
global news
optimata
continued from page 6
patient population for the specific
solid tumor indication should be
identified. This is our first step in
the drug rescue proof-of-concept
in the clinic.”
Optimata’s Virtual Patient
monitors the interaction of drugs
in patients and permits drug
developers to carry out clinical
trials and predict optimal treat
ments, according to the company.
This technology should allow
Teva to “fix” drugs that failed
advanced clinical development
tests by monitoring changes in
dosing and timing.
Optimata further states that its
Virtual Patient applies the tech
nology to recommend improved
treatment, including improved
schedules, combination thera
pies, safety profiles and optimal
pairing of clinical indications
and patient-populations for given
drug candidates.
Virtual Patient has been suc
cessfully validated in a series of
clinical trials in breast cancer
patients undergoing chemothera
py, the company says.
Shir Altay, a Teva spokesman,
says the largest benefit to Teva that
the collaboration with Optimata
brings is “the ability to potential
ly license in, and then develop,
clinical-stage products that have
failed development by the innova
tor but, following analysis using
Optimata’’ Virtual Patient tech
nology, have potential for further
development and commercial
ization.” Salvaging failed cancer
drugs provides Teva with an easy
entry to the cancer drug market,
where it hopes to expand.
Orbach told Drug Discovery News
that the choice of a partner for the
project was clear. Having Teva as
a partner “is clearly a transform
ing event in the history of our com
pany,” he says.
“The initiative was ours, and
Teva was receptive from the start.
We had known Teva for quite some
time and previously discussed
potential future projects based
on our OVP technology. Recently,
these talks materialized to an actu
al business deal,” he says.
The largest benefit to Optimata
in this endeavor is the “partner
ing and working experience with
a world class pharma partner, as
well as the opportunity to prove
the concept of our technology in
perspective clinical trials,” Orbach
says. “With this new collaboration,
we continue to fulfill Optimata’s
goal of accelerating the oncology
drug development process.”
Optimata has been in the cancer
field since it was created in 2000,
he says, adding, “the various mod
els the company has developed for
solid tumor cancer indications are
innovative and are central to our
proprietary IP.”
From the start, Optimata vali
dated its technology both in clini
cal trials and in preclinical projects
with leading pharmas such as Eli
Lilly & Co., Orbach says.
Additionally, the company
obtained validations in retrospec
tive clinical trials in two medical
centers, one in Israel and the other
in the United Kingdom.
“Each of our projects under
taken to date was an additional
validation step on our route,” he
says. “Our goals are to strengthen
our cooperation and experience
with leading pharmaceutical com
panies, to bring back oncology
shelved drugs into clinical trials
and to prove that our technology
and business model could attain
market significance.”
Optimata’s collaboration with
Teva “is focusing currently on
the oncolog y dr ugs market,”
Orbach says.
“We already have a technologi
cal potential in other therapeutic
areas which we hope to further
develop in the near future,” he
adds.
Founded in 2000 by Prof. Zvia
Agur, a biomathematician and
pioneer in the field of disease
control modeling, Optimata has
developed a family of proprietary
mathematical algorithms, which
simulate the dynamics of key bio
logical and pathological processes
in patients undergoing drug treat
ment, according to the company
Web site.
These simulations facilitate
quantitative assessment of drug
effects on the disease, in conjunc
tion with different aspects of its
side effects. DDN
editconnect: e080905
We have known Teva for
quite some time and
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global news
Survive to thrive
CombinatoRx, Neuromed to merge in all-stock transaction
By Lori Lesko
CAMBRIDGE, Mass. —In
a move
targeted toward creating one sus
tainable drug development com
pany, financially-strapped biotech
CombinatoRx and Neuromed
Pharmaceuticals Inc., a privately
held biopharmaceutical headquar
tered in Vancouver, stand poised to
merge in an all-stock transaction.
Under the terms of the merg
er agreement, announced June
3 0, C a mb r i d ge, Ma s s . - b a s e d
CombinatoRx will issue approxi
mately 36 million new shares of its
common stock to Neuromed stock
holders, with each party owning
approximately 50 percent of the
voting power of the merged orga
nization upon closing.
Relative ownership of
CombinatoRx will then be adjust
ed based upon the outcome of the
FDA’s review of product candidate,
Exalgo. The company will have the
CombinatoRx name and is expect
ed to trade under the stock sym
bol CRXX on the NASDAQ global
market.
Robert Forrester, CombinatoRx
interim president and CEO, tells
Drug Discovery News that the
impetus to merge was the need to
“survive to thrive.”
In December 2008, the Boston
Globe reported that CombinatoRx
was planning to cut 80 jobs, or twothirds of its workforce, as a way to
enable the company to operate for
at least four more years without
raising additional cash.
Forrester says the merger with
Neuromed “will leverage the
operational efficiencies created by
CombinatoRx`s recent restruc
turing—including workforce
reductions—and divestiture of our
Singapore subsidiary, to focus on
our core technology, simplification of
our balance sheet and reduced cash
burn going forward. As a result, we
expect to have sufficient cash to con
tinue operations into 2012.”
The opportunity to forge a
merger “germinated in late 2008
at a biotech conference in San
Francisco when I met with an
investment banker friend who
mentioned Neuromed to me,”
Forrester says. “The idea reso
nated immediately and grew from
that chance meeting.”
The partnership brings major
benefits to CombinatoRx, Forrester
says. This includes the potential
for significant non-diluted capital
when Neuromed’s drug, Exalgo, is
approved by the FDA; Neuromed’s
experienced drug development
expertise, its ion channel discov
ery engine; and the product candi
dates Neuromed has generated in
pain and epilepsy. The combined
company will serve the markets for
pain, inflammation, Parkinsons,
diabetes and epilepsy.
The merger, expected to close
in the fourth quarter, is an all-
“With closed IPO markets, royalty finance
markets and a general decrease of available
investment capital, Neuromed needed
a significant amount of capital in order
to carry Exalgo through registration and
commercialization to the point of profitability.”
— Christopher Gallen, president and CEO, Neuromed
growth
tial for the coming decade,” says
Biocon chairman and managing
director Dr. Kiran MazumdarShaw.
The agreement with Mylan
maps out an exclusive collabora
tion on the development, manufac
turing, supply and commercializa
tion of multiple, high-value generic
biologic compounds for the global
marketplace. Through this part
nership, “Mylan and Biocon bring
together highly complementary
capabilities that will significantly
advance their efforts to secure a
leading position in the emerging
generic biologics industry,” their
announcement states.
Biocon’s Mazumdar-Shaw sum
marizes the partners’ strength
this way: “Biocon offers scientific
expertise; an excellent product
development track record and
state-of-the-art, cost-efficient and
scalable manufacturing of highquality protein therapeutics,
including both novel biologics and
bio-generics, with an appreciation
of complex regulatory require
ments. Mylan brings a global com
mercial footprint and significant
regulatory expertise around the
world. Together, this creates a costeffective model to address a large,
emerging opportunity for generic
biologics recently supported by
the Obama administration. Biocon
also has a unique corporate culture
that is very similar to Mylan’s. All
of these attributes will provide a
critical synergy and create a strong
and effective long-term partner
ship, addressing a critical need to
stock merger of equals, Forrester
s ay s . H owe ve r, i f E x a l go i s
approved before the end of 2009,
CombinatoRx shareholders will
own 30 percent of the combined
company. If the approval occurs
during the first three quarters of
2010, CombinatoRx shareholders
will own 40 percent; if approval
comes in the fourth quarter of
will own 60 percent. And if there
is no approval before the end of
will own 70 percent of the com
bined company.
Christopher Gallen, Neuromed
p r e s i d e nt a n d C E O, s ays
CombinatoRx’s unique discovery
approach and the multiple midand early-stage product candidates
in the CombinatoRx pipeline, com
bined with Neuromed`s clinical
development experience, project
management driven culture and
ion channel inhibitor programs,
will enable the potential creation
of new therapeutics. Gallen says
the current global economic crisis
prompted the merger.
“The global capital crunch has
made it very difficult to raise sig
nificant amounts of money,” Gallen
says. “With closed IPO markets,
royalty finance markets and a gen
eral decrease of available invest
ment capital, Neuromed needed
a significant amount of capital in
order to carry Exalgo through reg
istration and commercialization to
the point of profitability.
“This capital was simply not
available,” Gallen continues. “As
a consequence, Neuromed had to
divest the Exalgo product to an
excellent partner, Covidien Ltd.
This created a situation where we
no longer had a late stage pipeline,
only pre-clinical assets. The obvi
ous solution was to find a merger
partner with a later stage pipeline
lower spiraling healthcare costs in
both the developed and emerging
economies.”
Myl a n ch a i r m a n a n d C E O
Robert J. Coury adds: “Biocon is a
first-class, highly respected organi
zation, and I am extremely excited
to be able to announce what I con
sider to be one of the more compre
hensive and high quality biolog
ics initiatives reported within the
industry to date. After conducting
extensive due diligence, I can tell
you that Biocon is truly an ideal
partner for Mylan.”
“Monoclonal antibodies are
emerging as the most dominant
class in biologics,” MazumdarShaw notes. “Through this part
nership, we hope to deliver highquality, affordable biogeneric anti
bodies and biologics. We would
anticipate launching in ‘outside the
CombinatoRx interim president and CEO Robert Forrester.
for our clinical group to continue
advancing while our discovery
group advanced their compounds
into the clinic.”
Gallen calls the merger “an excel
lent match. The new combined
company will have a strong Phase
I, Phase II and clinical pipeline, an
enhanced discovery capacity and a
significant amount of cash ... This
cash will be important in advanc
ing the current CombinatoRx
Phase I and II pipeline.”
Neuromed’s clinical expertise
is very broad and encompasses
multiple therapeutic areas, but is
particularly deep in central ner
vous systems (CNS) development,
Gallen says. The Neuromed pipe
line is currently oriented toward
acute and chronic pain, hyper
tension, epilepsy, addiction and
oncology.
“C o mb i n at o R x ’s d i s c ove r y
capacity has very broad implica
tions touching on many therapeu
tic areas,” Gallen says. “The most
advanced compounds appear rel
evant to inflammation, diabetes,
and Parkinson’s disease. We are
very excited as well about their
oncology screening capacity.”
Neuromed had looked at a wide
variety of merger partners, “and
CombinatoRx stood out head
and shoulders as the best overall
match,” Gallen says. “The com
bined company will have stronger
financial resources, a discovery
platform and a better pipeline than
either company has separately. In
these trying times for biotech, we
believe such strength is essential to
survive and to thrive,” he says. DDN
U.S.’ major markets before launch
ing in the U.S., with opportunities
to launch the same products in
less regulated markets potentially
even sooner. This will depend on a
number of factors including adop
tion of legislation and the expiry
of relevant patents. We do believe,
however, that our first launch in a
regulated market will likely occur
outside the U.S.”
As part of the collaboration,
Mylan and Biocon will share
development, capital and certain
other costs to bring products to
market. Mylan will have exclu
sive commercialization rights in
the U.S., Canada, Japan, Australia,
New Zealand and in the European
Union and European Free Trade
Association countries through a
profit sharing arrangement with
Biocon. Mylan will have co-exclu
sive commercialization rights with
Biocon in all other markets around
the world. Financial terms and
product details remain confiden
tial.
Established in 1978, Biocon,
together with its group companies,
forms a fully integrated biotech
nology enterprise, specializing
in biopharmaceuticals, custom
research and clinical research.
The company launched the world’s
first recombinant human insulin,
INSUGEN, in November 2004
using Pichia expression and India’s
first indigenously produced mono
clonal antibody BIOMAb-EGFR.
Focusing on unmet medical needs
in cancer, diabetes and inflamma
tory diseases, Biocon offers novel
therapies with an emphasis on
affordable innovation. DDN
DDN
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Editconnect code, like the one
in the CombinatoRX-Neuromed
story above: E080908.
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global news
Let it bleed
CDI reprograms blood
cells into stem cells using
a small volume of human
blood; expands drug testing
agreement with Roche
By David Hutton
M A D I S O N, Wi s . — C e l l u l a r D y n a m i c s
International Inc. (CDI) has announced that
its researchers have generated pluripotent
stem cells which have the ability to generate all tissue types in the body, from very
small volumes of ordinary human blood
samples. This significant provides a readily
obtainable source of pluripotent stem cells
from the millions of samples in storage at
blood repositories and healthcare institutions worldwide. CDI is the first company to
say it can make stem cells from something
as readily available, and so representative of
human diversity, as blood.
“Industry’s challenge was to reliably create iPS cells from a commonly available
and easily accessible tissue source and we
focused on stored human peripheral blood
samples,” says Chris Kendrick-Parker, chief
commercial officer of CDI. “Generating
pluripotent stem cells from small volumes of
blood, either freshly collected from a patient
or accessed from blood storage repositories,
provides a convenient source for generating
patient-specific stem cells that are valuable
research tools and may one day be used as a
cellular therapy to treat disease.”
According to Emile Nuwaysir, CDI’s chief
operations officer, the breakthrough allows
researchers to use existing banked blood
samples and standard procedures utilized in
clinical trials to derive iPS cells.
“Utilizing standard tissue repositories
and protocols make iPS cell technology easier to employ in clinical development as well
as leverages banked samples, where going
back to the individual or patient would be
impossible,” Nuwaysir says. “In addition,
this new method will dramatically expand
the utility of iPS cell technology by making
it more accessible. Fifty years of intensive
biomedical research has demonstrated that
there is no single definition of human biology.”
Nuwaysir points out that we are all individuals with different risk factors and predispositions to disease.
“In order to properly represent ‘human’
biology, our research models need to represent this diversity,” he says. “iPS cell technology allows you to represent the diversity
of human biology in an in vitro test by making individualized pluripotent stem cells
from anyone. Previous methods to derive
iPS cells required that the patient donate a
skin biopsy to obtain the necessary tissue
sample.”
Nuwaysir points out that this is “the first
step in paving the way for large-scale processing and industrialization of iPS cells.”
To generate the induced pluripotent stem
(iPS) cells, CDI scientists isolated T-cells, a
type of white blood cell, from a 3 ml donor
blood sample. The cells were stimulated,
expanded and exposed to documented
reprogramming factors. iPS cell colonies
were observed after three weeks. Analysis
revealed that the iPS cells are function-
Stem cell research series
The stories you see on this page are part of DDN’s ongoing coverage of
trends in stem cell research. Look for more business news developments in
this burgeoning area of drug discovery research throughout the year.
CDI continued on page 11
GE
a wealth of expertise in hESC expansion and
differentiation,” he says.
Dr. David J. Earp, Geron’s senior vice
president of business development and chief
patent counsel, points out that the company
is focused on developing hESC-based cell
therapies.
“The expertise that we have developed
in scalable manufacturing and differentiation of hESCs to specific cell types is directly
applicable to the production of these cells for
drug discovery,” Earp says.
Earp says GE Healthcare and Geron would
not disclose the financial terms of their alliance, which will involve some upfront payments by GE Healthcare, as well as milestones and royalties for successful development and sale of the products. According
to Earp, GE Healthcare has been granted
an exclusive license under Geron’s extensive intellectual property portfolio covering
the growth and differentiation of hESCs, as
well as a sublicense under Geron’s rights to
the foundational hESC patents held by the
Wisconsin Alumni Research Foundation.
The program will use stem cells derived
from hESC lines listed on the NIH Human
P lu r ip o t e nt St e m C e l l Re g i st r y. G E
Healthcare will fund the R&D program
and will be responsible for manufacturing,
sales and distribution of products developed
under the agreement.
Up to three quarters of toxicity problems
U.K.-based GE Healthcare recently reached an agreement to receive stem cells from Geron Corp.
are not detected until preclinical or later
stages of drug development and this significantly increases the cost of developing new
drugs. Earlier detection of toxicity problems
could reduce both overall drug development
costs and potentially harmful patient exposure in clinical trials, Earp says.
The combination of GE Healthcare’s Cell
Factory capability for cell reproduction and
manufacturing with Geron’s hESC technology will make it possible to generate a large
scale supply of hESC-derived cells which
retain normal cellular functions and could
address bottlenecks in new drug research
and accelerate the drug development process. The first products developed in the GE
Healthcare and Geron alliance are expected
to be available by early 2010, with a pipeline
of products to follow.
Under the agreement, intellectual property rights arising from the alliance program
research will be shared, with GE Healthcare
receiving rights for the development of drug
discovery technologies, and Geron receiving
rights for cell therapy applications.
Fielder says the deal is designed to add
another breakthrough technology to GE
Healthcare’s already strong portfolio of
enabling technology in drug discovery and
pharmaceutical development.
“ Th i s m a rks a f u r t h e r st e p i n G E
Healthcare’s cell technology strategy aimed
at addressing the potential of stem cell applications in the drug discovery and therapy
markets,” he says.
The initial tests of experimental drugs
developed by the two companies for launch
next year will help identify any effects on the
heart, and a second test will look at effects on
the liver—two vital organs studied closely by
pharmaceutical companies and regulators.
According to Earp, the first products
developed under this deal should be available by early 2010, with a pipeline of products to follow.
For GE Healthcare, success will be measured by acceptance, Fiedler says.
“Through strong collaboration with our
pharma customers, we hope to establish
widespread acceptance and use of this technology in the drug discovery and development market,” Fiedler says.
Selecting GE Healthcare was done
through a process in which several companies were first considered. Earp said Geron
had a short list of five companies and GE
Healthcare rose to the head of the class.
For Geron, the Obama administration’s
decision in March to lift certain restrictions
on government funding of stem cell research
has had minimal impact on its efforts. Earp
points out that the company has never relied
on federal funding.
“The only impact it had on us was the
ability to find academic collaborators,” he
says. DDN
LUNDBECK CDI
lights Lundbeck’s strategic shift
toward neurological conditions
as the patent expiration date for
the company’s depression drug
Lexapro approaches in 2012. The
company’s new technology centers
on brain disorders that trigger the
elimination of nerve cells.
Through the acquisition of
Ne u r o n I c o n , L u n d b e c k w i l l
gain ownership of technologies
that may lead to a breakthrough
in the treatment of brain damage following strokes or similar
events. NeuronIcon was founded
by scientists at the University of
Aarhus and is based on research
conducted there and at the
University of Berlin.
According to Kasper Riis, a
Lundbeck spokesman, the acquisition of NeuronIcon provides
Lundbeck with opportunities to
develop new therapies for acute
brain damage after strokes or skull
fractures, areas in which there is
presently a great need for effective
treatment options.
“Due to this lack of treatment
options, patients often have to
live with serious disabilities and
strongly reduced quality of life,
but new pharmaceuticals would
change this situation,” Riis adds.
Jan Egebjerg, divisional director of Lundbeck’s biologic research
unit, points out that by accessing
NeuronIcon’s know-how and technology, Lundbeck will get a better
understanding of what it will take
to avoid cell death.
“The trick is to avoid the activation of Sortilin, and Lundbeck
has special expertise in controlling
the interaction of molecules in the
body,” says Egebjerg. “We will now
need to identify compounds that
can prevent such activation, and
in the course of a few years we will
hopefully have the first pharmaceutical candidate in this area.”
According to Riis, the acquisition is the result of Lundbeck’s
intensified collaboration with universities in Denmark and abroad.
He said it was the appropriate time
to secure rights to the technologies
on a longer-term basis.
Riis adds Lundbeck hasn’t
disclosed financial terms of its
deal for NeuronIcon, but adds
that the terms of the deal with
the University of Aarhus give
Lundbeck certain rights to any
new discoveries made over the
next three years.
However, Lundbeck isn’t necessarily measuring success in dollars
and cents, though that would follow. Ultimately, it comes down to
helping patients suffering with the
effects of stroke, Alzheimer’s and
Parkinson’s diseases, Riis says.
“If we can one day provide new
effective medicines for patients
based on these technologies, then
clearly the agreements will have
been a success,” says Riis. DDN
ally identical to embryonic stem
cells and iPS cells generated from
other human tissue sources, that
they carry the same genetic background as the source blood sample, and that they have the pluripotent ability to differentiate into
any cell type.
Ke n d r i ck-Pa rke r s ays t h i s
method now can be “employed
in clinical development, as well
as be added to existing genetic
eDiTcoNNecT: e080907
global news
analysis sample banks as a way
of establishing starting materials
to understand individual biology
without the need to start with
materials like a skin punch or
even a hair follicle.”
Moving forward, Nuwaysir says
CDI’s next step will be to continue to perfect the iPS process and
industrialize it.
“In addition, we will need to
compare to other tissues of origin to make sure that this starting
material (blood) will demonstrate
the full pluripotency of other tis-
AUGUST 2009 • Drug Discovery News
sues that had previously been utilized for iPS generation,” Nuwaysir
points out.
Kendrick-Parker also adds
t h at it i s C D I ’s i nt e nt i o n t o
engage its pharma partners to
determine how this method can
aid in better understanding of
individual response to drugs in a
clinical setting.
“We are engaged with many
different groups to make largescale panels of pluripotent stem
cell lines for use in basic research,
drug discovery and development,
11
and drug toxicity testing,” he says.
“These panels will better represent the basic diversity of human
biology and are better model systems for scientists to study human
biology.”
CDI was formed in 2004 by
stem cell pioneer James Thomson
and three other University of
Wisconsin researchers.
The company currently has 65
employees and finished ramping
up its stem cell production facility
in June. DDN
eDiTcoNNecT: e080926
editorial
Foreign governments feed biotechnology venture
capital firms as U.S. appetite for bailouts wanes
W
By Amy Swinderman
hile the suggestion that the
United States government bail out
venture capital firms has failed to
attract support from government
leaders—and would surely raise taxpayer ire—
the mood is quite different overseas, according
to recent media reports.
In late June, the U.K. government announced
that it will invest $248 million in a new venture capital “fund of funds,” according to a
Venture Capital Dispatch report. Predicted by
First Secretary of State Lord Mandelson to be
a “real shot in the arm for the British venture
capital industry,” the U.K. Innovation Fund
aims to attract investment from pension funds
and the private sector to create a $1.6 billion
fund within 10 years.
Last year, venture capital investment in U.K.
start-ups fell 28 percent to nearly $2 billion,
while the number of deals dropped 26 percent to 324, the lowest total on record in this
decade, according to research firm Dow Jones
VentureSource. In particular, the U.K’s biotechnology industry has suffered badly during
the last 18 months because many investors lost
their appetite for high-risk investments, according to Venture Capital Dispatch. The Bioindustry
Association (BIA) told the publication that a
third of its small drug developer members had
less than six months’ worth of cash left. The
BIA and other trade organizations have reportedly lobbied hard for government financial support, arguing that venture capital is essential for
economic recovery and to maintain the U.K’s
competitiveness in the sector.
“We need the Google or Genentech of the
future, and they will only be created if there
is the capital to back them,” Lord Drayson,
minister for Science and Innovation, told the
publication.
T h e U. K . gove r nment will appo int a
manager to run the U.K.
Innovation Fund and
hopes to make its first
investment by the end
of the year.
Elsewhere overseas,
Israel is also setting
Amy Swinderman,
up a $63 million capiDDN Chief Editor
tal fund to specifically
finance biotech start-ups, according to a recent
Reuters report.
The government hopes the fund, expected
to rise to $253 million using loans from private
investors, will encourage and advance growth
in Israel’s biotech sector. The government will
split profits from activities in the fund between
itself and private investors.
“There’s great importance to the fact that
250 million shekels ($63 million) of government
money is allocated to the development of an
industry whose workforce is of great value and
whose development and prosperity are crucial
to the economy,” Eli Ofer, chief scientist at the
Industry and Trade Ministry, told Reuters.
Back on home soil, however, our appetites for
government aid of the venture capital industry
aren’t quite as robust. According to a recent
Wired report, during the first three months of
2009, biotech firms brought in only $576 million
of venture capital, the worst quarter since fall
2001, after the Sept. 11, 2001, terrorist attacks.
Although some biotech leaders have lobbied
Congress for a bail-out since last fall, they have
yet to gain widespread approval for it.
Amidst the seemingly never-ending economic gloom and doom, there does seem to be a light
at the end of this tunnel: U.S. biotech start-ups
may be taking matters into their own hands.
San Francisco venture capital firm Burrill &
Co. recorded a significant 25 percent increase
in total financings and partnering in the second
quarter of this year compared to the first quarter. While financings were down quarter over
quarter, the amount U.S. biotech firms raised
in partnering deals was up 68 percent, Burrill
said. The firm also noted that it has become
increasingly difficult to attract venture capital
as the amount raised by biotechs in the U.S. in
the second quarter was down 43 percent down
from the total raised in the first quarter.
“While it is still going to take many more
months before biotech starts on the road to full
recovery, it is encouraging to see companies are
still raising capital despite the tough economic
conditions,” Burrill said. “This increase reflects
the fact that in a tight fiscal environment companies are devoting their energies on finding pharmaceutical and biotech partners to help build
value of their lead product programs.” DDN
www.drugdiscoverynews.com
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Laurence Doyle
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Senate committee: 12 years of data exclusivity is cool
T
By Stephen Albainy-Jenei
o amend the public health service
act to establish a pathway for the
licensure of biosimilar biologic products, to promote innovation in the life
sciences.” Amendment No. 297.
The U.S. Senate Health, Education, Labor,
and Pensions (HELP) Committee voted last
month in favor of a proposal by Sens. Kay Hagan
(D-N.C.), Michael Enzi (R-WY) and Orrin Hatch
(R-UT) to create a follow-on biologics (FOB)
pathway that provides 12 years of data exclusivity for brand-name biologic drugs.
In looking for a way to create an abbreviated
pathway for the Food and Drug Administration
(FDA) to approve generic biologic therapies
(aka biogenerics or follow-on biologics), there
are lots of questions about how to achieve
the proper balance between innovation and
competition.
The sticking point (in general) has been that
the brand name drugmakers and generics can’t
agree on how long a biotech drug should be
on the market before a generic drugmaker can
market a generic.
Under the proposed law, if FDA approves
a biological product on the grounds that it is
interchangeable to a reference product, the
Department of Health and Human Services
(HHS) is prohibited from making a determination that a second or subsequent biological product is interchangeable to that same
reference product until one year after the first
commercial marketing of the first interchangeable product.
The act also authorizes HHS to issue guidance with respect to the licensure of biological products under this new pathway, and it
includes provisions governing patent infringe-
ment concerns such as the exchange of information, good faith negotiations and initiation of
infringement actions.
The Biotech Industry Organization (BIO)
has called for 14 years of market exclusivity,
while generic makers want the period limited to
no more than five years
of protection. Not to be
confused with patents,
data exclusivity is the
period after the FDA
approves a product during which an imitator
can’t rely on the innovator’s clinical data for
safety and effectiveness.
It can run during and
Stephen Albainy-Jenei,
longer than the period Frost Brown Todd LLC
of patent protection.
The current measure for 12 years passed 16
to 7, despite an earlier decree by the Obama
administration that a seven-year exclusivity
limit sounded good. The Obama administration had sent out an earlier warning shot that it
considered seven years enough time to protect
brand-name biotechnology medicines from
generic competitors. In a letter to Rep. Henry
Waxman (D-CA), the White House said seven
years “strikes the appropriate balance between
innovation and competition by providing for
seven years of exclusivity.”
The posturing by the current administration
is not a surprise given that the U.S. government is the largest consumer of medical care
via Medicare and Medicaid and the fact that
sales of biotech drugs were $40.3 billion last
year. With creating a governmental healthcare
system at the top of its priority list, ways to cut
costs are critical to any reform.
After considering at least four proposals
all titled the “Biologics Price Competition and
Innovation Act of 2009,” the HELP committee
declined several other proposals including voting down one by Sen. Sherrod Brown (D-OH),
which would have provided only seven years of
exclusivity for brand name biologics.
Sen. Barbara Mikulski (D-MD) proposed a
10-year exclusivity period, which could be extendable by one year if a supplemental application
was approved for one or more new therapeutic
indications. Sen. John McCain’s (R-AZ) proposal
would have provided a 10-year period of exclusivity that could be extended by two years “if there
has been significant therapeutic advancements
with respect to the reference product.”
The vote was at least a small victory for major
biotech drugmakers, which have been lobbying for a period of 12 to 14 years before generic
equivalents could be approved. Biotech companies have been pushing for a longer period
of data exclusivity, saying that it can take 15
years and a $1 billion to develop and market a
biotech drug, so they need the longer period to
make back their investment. Generic drugmakers, not surprising, would like the exclusivity
period to be as little as possible.
This is just as small step, since the Senate
plan could change when the healthcare bill goes
to the floor for a vote. It also must be approved
by the House.
So, what will the final number be for exclusivity? We’ll have to wait to see. DDN
Stephen Albainy-Jenei is a patent attorney at Frost
Brown Todd LLC, serving up chat at PatentBaristas.
com. Write him with comments or questions at
[email protected]. Albainy-Jenei doesn’t
own shares of companies mentioned in this article.
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editorial
Guest commentary: American pathway to
generic biologics approval remains undefined
A
By J. Michael Nicholas
s we stand at the fore-
front of major changes
across the healthcare
industry, a pathway for
the approval of generic
biologics will be one of
the major initiatives in the government’s
efforts to achieve reduced costs. Worldwide,
biologic drugs—now a common treatment
option for people with conditions such as
multiple sclerosis, diabetes, cancer and
rheumatoid arthritis—account for about
one of every eight prescriptions. By 2015,
an estimated $20 billion worth of biologic
drugs are expected to come off patent, providing a lucrative incentive for companies to
develop and manufacture generic biologics.
The American pathway to generic biologics
approval, however, remains undefined.
In 1984, the United States passed the
Waxman-Hatch Act, a hard-fought piece of
legislation allowing companies five years of
exclusivity for new drugs and three additional years for new-generation products.
Under the act, an applicant must demonstrate its generic drug product is “bioequivalent,” or show safety and efficacy equivalence, to the branded drug product. The
influential act, in its efforts to balance
interests of the brand name pharmaceutical and generic drug industries, substantially reduced prescription drug prices and
expenditures, provided increased patient
access to therapeutics drugs and accelerated the pace of drug innovation.
Fast-forward 25 years: Biogenerics have
been approved and used in the European
Union, India and several other countries
over the last few years. In fact, since 2004,
the European Medicines Agency (EMEA)
has approved the sale of six biosimilar
drugs, with several more pending regulatory review. Meanwhile, the U.S. is still
formulating a comprehensive biogeneric
approval process.
Congress has now entered the debate, and
two competing bills are guiding discussions
on what will likely detail the final regulatory
framework for approval of generic biologics
in the U.S.
The bill, proposed by Rep. Henry A.
Waxman (D-CA), “Promoting Innovation
and Access to Life-saving Medicines Act,”
would allow the determination of acceptable therapeutic equivalence and interchangeability of a generic biologic to be
determined by the U.S. Food and Drug
Administration (FDA), as it currently does
for brand biologics. The agency would
have full discretion in determining whether additional data are necessary to prove
similarity, interchangeability, efficacy and/
or safety and would also be authorized to
require post-marketing studies.
The second bill, introduced by Reps.
Anna Eshoo (D-CA), Joe Barton (R-TX),
et al., “The Pathway for Biosimilars Act,”
includes a complex process unlike current drug and biologic approvals. The bill
has a specific requirement for clinical trials of generic biologic candidates to prove
acceptable therapeutic equivalence and
interchangeability, but gives the FDA the
power to waive any trials other than those
designed to assess immunogenicity.
However, under this bill, the FDA could
waive the requirement of immunogenicity
trials, but only after the agency undergoes
an extensive notice and comment period
resulting in a published guidance advising
that such a waiver is scientifically feasible
and explaining the data surrounding the
decision. What remains to be seen is how
the differences between small-molecule
and complex, or biologic, drugs will affect
efforts to develop a straightforward approval process for generic biologics.
As exact copies of branded drugs, generic
small-molecule products are identical to the
innovator drug in terms of dosage, safety,
strength, administration, quality, performance and
intended use.
A biologic
drug, however,
i s m ade o f a
protein made
by a living
organism and
is difficult or
impossible to
precisely replicate.
There is also
a diverse range
of drugs that Dr. J. Michael Nicholas, senior
director of Strategic Regulatory
do not fit comAffairs and Post-Marketing
fortably in the Labeling/Compliance,
“ b i o l o g i c o r Teva Neuroscience
non-biologic”
paradigm for generic drug approval. While
some biologics are relatively well characterized and can be verified as bioequivalent to
each other, some synthesized, non-biologic, complex drugs derived from nonliving
sources share some of the same attributes as
biologics, specifically:
■■ cannot be characterized;
■■ are not amenable to pharmacodynamics
(PD) or pharmacokinetics (PK) bioequivalence studies; and
■■ pose significant immunogenicity risks if
manufactured even slightly differently from
the innovator’s process.
These complex products are already
posing a number of challenges to regulatory agencies evaluating follow-on versions
of these agents. In accordance with the
Waxman-Hatch Act, chemical and physical characterization of a generic drug must
be performed to appropriate levels. Thus,
requirements for safety and efficacy testing and determination of the appropriate
approval pathway for follow-on complex
and biogeneric drugs will likely depend on
the extent to which a drug can be characterized in order to ensure comparability
between the generic and the reference listed
product (RLP).
It is important the final legislation recognizes and supports FDA authority and
discretion to make generic drug approvals
on a case-by-case basis, considering drug
complexity and drug efficacy and safety
in patients.
For example, low-molecular-weight
heparin (LMWH) enoxaparin is a complex
heterogeneous mixture of polysaccharides
obtained by fractionation or depolymer-
ization of polymeric heparin derived from
natural sources (e.g., porcine intestine). The
intrinsic order of saccharides in LMWHs is,
and can be, identified. Moreover, pharmacologically active sequences within enoxaparin
have not only been described by the manufacturer, but can be replicated and tested in
PD studies.
Immunogenicity testing, too, shows generic enoxaparin has comparable immunogenic
effects to those of the RLP, Lovenox (within the margin of error). For these reasons,
generic preparation of enoxaparin is appropriate for approval via the ANDA process.
However, many other complex drugs cannot
be fully characterized using state-of-theart multidimensional analyses. Even small
Obviously, clinical trials will be needed to
obtain approval of drugs in the glatiramoid
class, including follow-on GA products.
With complex products like GA, it is currently impossible to predict how potentially
unobservable differences in follow-on products will be translated into unwanted immunogenicity, and what will be the resulting efficacy and safety ramifications. As such, it is
very important to devise an appropriate testing strategy, including a range of complementary assays for the detection and characterization of antibodies induced against followon complex drugs and biologics. Moreover,
correlation studies should be planned to
assess the relationship between immunogenicity and efficacy and safety results over
The U.S. is still formulating a comprehensive
biogeneric approval process. Congress has
now entered the debate, and two competing
bills are guiding discussions on what will
likely detail the final regulatory framework
for approval of generic biologics in the U.S.
It is important the final legislation recognizes
and supports FDA authority and discretion to
make generic drug approvals on a case-bycase basis, considering drug complexity and
drug efficacy and safety in patients.”
differences in the composition of complex
drugs and substances can lead to significant
differences in safety, such as immunogenicity, and efficacy. In some cases, the materiality of the differences is not well understood,
and even the differences themselves cannot
necessarily be recognized or characterized.
Take, for example, glatiramer acetate
(GA), a treatment for relapsing-remitting
multiple sclerosis, a chronic and degenerative disease. This drug, comprising a
complex mixture of polypeptides containing a huge, perhaps incalculable, number
of active amino acid sequences, is part of
the glatiramoid class. Called a “biologic
on steroids” by Dr. Andrew Myers, chairman of the Department of Chemistry and
Chemical Biology at Harvard University,
the scientific community has yet to identify
the pharmacologically active sequences in
GA; therefore it is difficult, if not impossible, to show that two glatiramoids, made
by different manufacturers, have the same
active ingredients.
Furthermore, research by Teva, who
discovered and manufactures GA, showed
long-term treatment in animals with another glatiramoid, TV-5010 (protiramer), led
to systemic toxicity and caused extensive
fibrosis, organ damage and eosinophilia—
signs never observed in similar preclinical studies involving GA. This experience
demonstrated that very minor differences
among glatiramoids can have very serious
implications for drug safety and efficacy.
time, using different methodologies.
For complex drugs like GA and for many
generic biologics, which present similar
issues in terms of the inability to prove
immunogenicity, science should dictate
the requirements for approval of generic versions. The appropriate regulatory
pathway must be examined on a case-bycase basis, as should the requirement for
clinical trials, in order to maintain and
ensure patient safety.
With billions of dollars at stake and multiple major issues up for debate in the pursuit
of a viable generic biologic approval pathway, access to safe and effective medicines
is key. DDN
Dr. J. Michael Nicholas is senior director of Strategic
Regulatory Affairs and Post-Marketing Labeling/
Compliance for Teva Neuroscience, where he is
responsible for all post-marketing aspects of regulatory affairs. Nicholas received his PhD in pharmacology from the University of Tennessee Center for
Health Sciences in 1982. After postdoctoral work
at the University of Mississippi, he joined Mylan
Pharmaceuticals in Morgantown, W.Va., as director of Scientific Affairs. He has also held positions
at Marion Laboratories, Marion Merrell Dow and
Hoechst Marion Roussel, where he was involved with
all aspects of regulatory matters, including product
development and approval. Prior to his current position, he was vice president of U.S. Regulatory Affairs
and Compliance, Marketed Products for Aventis
Pharmaceuticals and was responsible for regulatory
matters for approved products.
informatics
b r i e f s
Perceptive Informatics forges
alliance with Biospective
BOSTON—Perceptive Informatics, an e-clinical solutions provider and subsidiary of
PAREXEL International Corp., (Nasdaq: PRXL),
announced in July that it has partnered with
Biospective Inc., a medical imaging process
and analysis software provider, to enhance
its capabilities with respect to processing and
analysis of medical images for central nervous
system- (CNS) and oncology-related clinical trials. Biospective will provide software solutions
tailored for CNS and oncology studies, including specialized Magnetic Resonance Imaging
(MRI) and Positron Emission Tomography
(PET) techniques. This will enable Perceptive
Informatics to support independent reviews of
imaging data for both exploratory and largescale, multi-center studies. Financial terms of
the deal were not disclosed.
Optibrium acquires software
platform from BioFocus DPI
CAMBRIDGE, England— Optibrium
Ltd. is
pleased to announce its acquisition of the
StarDrop business from BioFocus DPI, a subsidiary of Galapagos NV. StarDrop is a software
platform used by pharmaceutical and biotech
companies and research establishments to
guide compound selection and design decisions in drug discovery. Optibrium was founded
in 2009 as a spin-out of BioFocus. The founding group was responsible for the development
of StarDrop from 2003. Optibrium has a global
customer base ranging from top-10 pharmaceutical companies to small biotechs and academic groups.
NIH expands clinical and
translational science awards
BETHESDA, Md.—The National Center for
Research Resources (NCRR), part of the
National Institutes of Health (NIH), announced
in July that Clinical and Translational Science
Awards (CTSAs) will be made to seven more
academic health centers, bringing the consortium to 46 member institutions. The institutions receiving new CTSA funding include
the Medical University of South Carolina, the
Mount Sinai School of Medicine, the New York
University School of Medicine, the University of
Arkansas for Medical Sciences, the University
of Florida, the University of Illinois at Chicago
and the University of Texas Medical Branch.
Launched in 2006, this network now includes
awardees in 26 states that are working to
accelerate the process that develops laboratory discoveries into treatments for patients, to
engage communities in clinical research and
to train a new generation of clinical and translational researchers. When the program is fully
implemented, it will support approximately 60
CTSAs across the nation.
Search for pathway-level biomarkers
Agilent Foundation
awards grant to
UCSD to develop
system for analyzing
proteomics data and
identifying proteinnetwork cancer
biomarkers
By Amy Swinderman
LA JOLLA, Calif.—In a collaboration that will produce a system
for analyzing proteomics data
to map pathways, the Agilent
Foundation, the philanthropic
arm of Agilent Technologies
Inc., announced in July that it
will support leukemia research
efforts at the University of
California, San Diego’s (UCSD)
Ideker Laboratory, a unit in the
school’s medicine and bioengineering departments that uses
genome-scale measurements
to construct computer-aided
models of cellular processes
and disease.
Under the agreement, Agilent
will provide scientific and financial support to the lab, led by
prinicipal investigator Dr. Trey
Ideker, associate professor of
bioengineering, adjunct professor of computer science and
member of the Moores UCSD
Cancer Center. Agilent’s sponsorship will give the lab the
resources it needs to investigate the relationships between
genetic variations and proteins
in the search for better methods
of analyzing cancer, including a
new approach for recognizing
the mechanism that triggers leukemia using multiple scientific
disciplines.
Ultimately, the lab hopes to
develop a system for analyzing
proteomics data to map path-
Allan Kuchinsky, principal project scientist at Agilent, says Trey Ideker’s lab at
UCSD is doing a lot of biomedical research in addition to applying software
analysis techniques to the study of chronic lymphocytic leukemia.
ways, and for finding proteinnetwork biomarkers of cancer.
Specific financial details on the
grant were not disclosed, but
the project is expected to last
TGen tapped for ‘biobank’
Luxembourg selects TGen to create
biobank for storage of blood and
tissue samples for scientists
By David Hutton
PHOENIX— A
partnership between Luxembourg
and the Translational Genomics Research Institute
(TGen) is shifting into high gear with the arrival of
a new CEO and the construction of a new building
for the Integrated Biobank of Luxembourg (IBBL).
Luxembourg has tapped Phoenix-based TGen to
create a “biobank” that will store blood and tissue
samples for scientists to access as they research
diseases such as lung cancer and heart disease.
The partnership marks TGen’s first major project
overseas, and TGen executives are optimistic that
the pact can generate more jobs in Arizona and
potentially start up businesses in the state as well.
This project helps Luxembourg with
their long-term goals, while providing
Arizona with significant investments.
At the same time, it holds the
promise of furthering scientific
investigations on a global basis.”
—Dr. Jeffrey Trent, TGen president
and research director
According to Tess Burleson, TGen’s chief operating officer, the company will provide “expertise
in developing the infrastructure and collaborative
network to encourage transatlantic research.”
The IBBL is seen as an international collection, repository, analysis and distribution point
By Lloyd Dunlap
BASEL, Switzerland— In the continuation of a string of successes that has seen the company
become the putative market
leader, Genedata has added
Chugai Pharmaceuticals to its
customer list.
According to Dr. Othmar
Pf annes, CEO of Genedata,
in approximately three years,
Genedata has won eight of the
top 10 Japanese pharmas as
customers for its Expressionist
system to streamline their
internal R&D process for biomarker discovery and person-
AGILENT continued on page 16
A new
home for
SQL*LIMS
Seeking new
strategic direction,
Life Technologies
sells laboratory
information
management
software business
to LabVantage
By Jeffrey Bouley
alized medicine.
Gl o b a l l y, P f a n n e s a d d s ,
Genedata now serves 30 of the
top 50 pharmas.
“Many claims are made,”
Pfannes says, making one of his
own, “but there are not many
enterprise systems out there
that are organization-wide and
where all can participate from
many sites.”
CARLSBAD, Calif.— The end
of June saw the announcement by Life Technologies
Corp. that it had signed a
definitive agreement to sell
its SQL*LIMS business to
LabVantage Solutions Inc.
for an undisclosed amount.
Under the terms of the
agreement, LabVantage
will continue to support
the SQL*LIMS product
and customers will receive,
according to a news release
about the sale, “the same
level of support to which
genedata continued on page 17
life continued on page 18
tgen continued on page 15
A ‘CROSSOMICS’ COLLABORATION
Genedata AG signs
bioinformatics deal
with Roche subsidiary
Chugai
Pharmaceuticals
nearly a year.
Agilent and UCSD are no
strangers to each other, as the
two parties have a longstanding
informatics
tgen
$190 million will be captured by
Arizona researchers.
“We are under confidentiality
regarding this matter, but we can say
that this is one of TGen’s largest contracts to date and portions of it span
over five years,” Burleson notes.
TGen officials likely will be able
to see tangible results of the partnership much sooner than that,
making it easy to gauge success,
she adds.
“We have milestones and timelines that the project is evaluated
against, but ultimately, in this field
of work, success occurs when we
impact the lives of patients through
our work,” notes Burleson.
According to Hewitt, there also
will be a number of ways to gauge
the success of the TGen-IBBL
pairing.
“IBBL will generate ‘spin off ’
projects and companies in the
same way as TGen; and IBBL will
continue to exist long-term as key
infrastructure supporting biomedical research in Luxembourg and
beyond,” he says. DDN
“We have milestones
and timelines that the
project is evaluated
against, but ultimately,
in this field of work,
success occurs
when we impact
the lives of patients
through our work.”
—Tess Burleson, TGen COO
September 15-16 Woodbridge
September 29-30 Princeton
October 13-14 Somerset
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for blood, serum, saliva, tumors
and other biospecimen samples to
assist investigators worldwide in
scientific research.
“I think it’s fantastic,” adds Dr.
Jeffrey Trent, TGen’s president
and research director. “This project helps Luxembourg with their
long-term goals, while providing
Arizona with significant investments. At the same time, it holds
the promise of furthering scientific investigations on a global
basis. We’ve already made a lot
of progress.”
Announced more than a year
ago, the IBBL is beginning to take
shape with a new building under
construction there and the hiring
of Dr. Robert Hewitt as chief executive officer. Over the next several
months, Hewitt will hire a staff of
nearly 70. In April, ground was
broken for the IBBL’s new building. The new facility is set for completion in October.
“Thanks to generous government funding, careful planning
and expert guidance from partners at TGen, we have all the right
ingredients to develop a worldclass biobank, biorefinery and
advanced technology center in
Luxembourg,” Hewitt says.
Hewitt adds that the success
TGen has experienced since its
launch in 2002 made it an attractive partner for IBBL.
“It has been very appealing for
IBBL to develop a trans-Atlantic
collaboration with such a renowned
partner as TGen,” he says.
TGen developed computer software that will track tissue samples and the genetic information
that those samples yield. The data
will be made available to scientists worldwide who are researching diseases such as cancer and
heart disease.
The Luxembourg project already
has expanded in scope since it was
announced last year. For example,
while initial plans focused on collecting tissues for cancer research,
the IBBL is studying an international project involving the collection of biospecimens across
Europe and Africa in an investigation of cardiovascular disease.
Burleson points out that the
information technology needed
to process tissue samples has
resulted in new computer software
developed jointly by TGen and
Luxembourg investigators at the
Institute Henri Tudor that could
have commercial uses.
Burleson says the partner marketing new discoveries that stem
from the agreement will depend on
exactly who licenses the technology.
“Both TGen and Luxembourg
will promote any intellectual
property to interested parties,”
Burleson notes.
The entire project will last five
years, but TGen officials could not
immediately say how much of the
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in Medicinal Chemistry
Keynote Speakers:
Stephen H. Friend, M.D., Ph.D.
Co-founder, President,
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President and CEO,
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medidata
basis as continuing evidence that drug developers are “looking for EDC solutions that
not only offer access to data that will drive
critical clinical research decisions across all
phases, but also provide key efficiencies for
all members of the research team.”
As to why he thinks Medidata Rave will
serve a company like Roche well, Sherif
points to the product suite’s usability, flexibility, scalability and accessibility. Medidata
touts how well data managers, investigators, monitors and other clinical team members can use Rave to work collaboratively
through easy-to-learn, easy-to-use Webbased interfaces.
Sherif adds that because Rave’s data management tools are built directly into the EDC
system, this broaden the capabilities of the
product compared to many EDC systems by
better enabling management of mid-study
changes and providing a single platform
that offers greater efficiencies across multiple trials, multiple languages and multiple
development programs.
“Designed to more efficiently capture and
manage data collection, Medidata Rave will
enable global access of clinical trial data
to all relevant Roche stakeholders, while
also enhancing the company’s overall drug
development process,” Medidata noted in
the news release about the deal.
Roche reports that it will make use of
Medidata Rave as the core enterprise-wide
EDC system in its clinical trials as part of
a phased, multi-year approach across its
five disease biology areas, which are oncol-
ogy, inflammation, virology, metabolism
and central nervous system disorders. The
company will begin with data collection for
early stage, exploratory trials, but plans to
ultimately encompass all phases of development, even up through registration, in the
Medidata Rave effort.
Roche had no further comment on the
deal, however.
Swiss company NovImmune, for its part,
has already used Medidata Grants Manager
and CRO Contractor for a Phase II type I
diabetes trial involving 160 patients and 75
sites in 12 countries, and it is in the process
of incorporating Medidata Designer into its
clinical development process. NovImmune
selected Medidata’s Trial Planning product
suite to support the development of its biologics for immune-related disorders, and
to “streamline all phases of clinical trials
across [its] diverse portfolio,” according to
Jack Barbut, the company’s CEO.
“Specializing in both immunology and
biologics, we’re working within two of the
fastest-growing areas of drug development,”
Barbut says. “Medidata’s trial planning tools
are key to our ability to prioritize and make
critical decisions about our strategy for multiple clinical development programs—from
size to locations to cost to timing—so that
we’re better equipped to manage and drive
our pipeline.”
NovImmune reportedly has already
experienced the benefits of Medidata’s trial
planning products in developing a task and
activity plan, using CRO Contractor for an
important study where a CRO was engaged.
This facilitated clearer understanding and
consensus on tasks that needed to be con-
“Medidata’s trial planning
products will enable
NovImmune to continue to
make informed and strategic
decisions about the therapies
the company choses to pursue
and the varying resources they
will need to be successful in
clinical development.”
—Tarek Sherif, CEO of Medidata
ducted and aided in agreements on pricing,
based on the CRO Contractor benchmark
costs.
In the ongoing effort to incorporate
Medidata Designer, NovImmune is looking toward the ability to better standardize
development of study protocols and simultaneous capture of all protocol metadata in
a structured, CDISC ODM certified XML file
that can be reused to rapidly set-up downstream systems, such as EDC.
As study protocols are developed, data
extracted from Grants Manager’s PICAS
repository will enable ongoing evaluation of
trial cost, and because of this, NovImmune
will better be able to understand sites’ costs
of executing the protocol as it is being developed.
All of this is important to NovImmune,
Barbut says, because the company is currently working with seven compounds
agilent
in several stages of development that are
expected to have applications in multiple
therapeutic areas. So, NovImmune’s clinical
trials range in size, complexity and patient
population and often require engagement
with multiple contract research organizations with varying and highly specialized
areas of expertise.
“NovImmune is working to meet a critical market need with its focus on biologics and immunology, and we are pleased to
support its efforts to improve the efficiency
of its clinical development processes,” said
Medidata’s Sherif in a news release about
the deal. “Medidata’s trial planning products
will enable NovImmune to continue to make
informed and strategic decisions about the
therapies the company chooses to pursue
and the varying resources they will need to
be successful in clinical development.” DDN
“There are numerous technical issues
and challenges involved with figuring out
how to aggregate proteins together into a
pathway-level biomarker. It’s these issues
that are going to have to be worked out.”
collaboration in the network biology space. In 2002, Agilent
and Ideker, among many other collaborators, co-developed
and released Cytoscape, an open-source bioinformatics
software platform for visualizing molecular interaction
networks and biological pathways and integrating these
networks with annotations, gene expression profiles and
other state data.
Although Cytoscape was originally designed for biological research, now it is a general platform for complex
network analysis and visualization. The project was funded
by a federal grant from the National Institute of General
Medical Sciences (NIGMS) of the National Institutes of
Health (NIH) and the National Science Foundation (NSF).
Corporate funding was provided through a contract from
Unilever PLC.
According to Allan Kuchinksy, principal project scientist at Agilent, “Trey Ideker’s lab is a lot bigger than just
Cytoscape,” which led Agilent to help the Ideker lab to
develop a protein network visualization application for
Cytoscape to study leukemia. Considered a pioneer in using
genome-scale measurements to construct network models
of cellular processes and disease, Ideker has developed software and algorithms for protein network analysis, networklevel comparison of pathogens and genome-scale models of
the response to DNA-damaging agents. His work has been
featured recently in The Scientist, Technology Review, the San
Diego Union Tribune and Forbes magazine. Ideker is also the
recipient of the 2009 Overton Prize, awarded each year to an
early-to-mid-career scientist making a significant contribution to the field of computational biology.
Ideker’s lab has received funding to study protein interaction networks from the NIGMS, the NSF, the National
Institute of Environmental Health Sciences (NIEHS), the
National Institute of Mental Health (NIMH), Microsoft,
Pfizer and Unilever.
“Trey Ideker’s lab is doing a lot of biomedical research
in addition to applying the software’s analysis techniques
to chronic lymphocytic leukemia (CLL),” Kuchinsky says.
—Dr. Trey Ideker, associate professor of
bioengineering and adjunct professor of computer
science, University of California, San Diego
“We saw that as very strategic to Agilent’s direction, and
we wanted to fund that research as a separate collaboration
from the Cytoscape project, although we will use some of
those analysis techniques as Cytoscape plug-ins.”
Cytoscape’s plug-ins are available for network and molecular profiling analyses, new layouts, additional file format
support, scripting and connection with databases. Plug-ins
may be developed by anyone using the Cytoscape open API
based on Java technology, and plug-in community development is encouraged. Most are freely available.
The new plug-ins planned for Cytoscape will modularize the visualization platform, allowing it to be accessed
through scripting languages and reorganizing all libraries
and plug-ins so users can more easily locate them.
“This is an important strategic area for Agilent because
we see open-source software as something that enables
people to interpret their data,” Kuchinsky says. “We’re providers of measurement equipment, reagents and consumables, but people aren’t really interested in our instruments
as much as the information that comes out of them and how
it answers biological questions. One of the big challenges
in this area is how to analyze different types of data across
different platforms in concert and manage it. The challenge
is not so much how you are storing and retrieving the data,
but how you are interpreting it. These tools are a start for us
in helping people use our different platforms in concert to
solve a problem.”
Ideker says his lab’s research efforts, coupled with the
data analysis capabilities created by Cytoscape, represent a
new paradigm shift in genomics research.
“I think the field needs to stop thinking about biomarkers
as individual markers,” Ideker says. “It’s like saying, ‘my
engine died, and I think it is this screw,’ when the problem is
actually the alternator. All the little parts form bigger parts,
and it’s the bigger parts that are the problem. If you look at
the 1990s, it was all about genomics—how do you sequence
the genome, process DNA, etc. But in the 2000s, we haven’t
really done much to build on that. It is all well and good to
know that we have 30,000 genes, but we need to know how
proteins interact with those genes.”
The goal of this collaboration is to try to elevate biomarkers from individual proteins to entire pathways of proteins,
Ideker says.
“There is currently no tool out there for discovering
pathway-level biomarkers,” he says. “How you aggregate
proteins into pathways and show how predictive a disease
or drug toxicity is going to be has always been a bottleneck. What is exciting and daunting at the same time is
that we have no clue how to analyze that data. There are
numerous technical issues and challenges involved with
figuring out how to aggregate proteins together into a
pathway-level biomarker. It’s these issues that are going to
have to be worked out.”
The Agilent Foundation recently announced $1.3 million
in new grants for the second half of its fiscal year 2009. DDN
INFORMATICS
GENEDATA
CONTINUED FROM PAGE 14
Company officials also are
keeping a keen eye on their competitors. Pfannes notes that the
c o mp a ny h e c o n s i de r s t o b e
Genedata’s biggest competitor,
Rosetta Biosoftware, was recently
acquired by Microsoft’s Amalga
Life Sciences unit.
As part of their work in oncology
and chronic diseases, researchers
at Chugai have used Expressionist
to perform a one-step, enterprisewide normalization on their entire
microarray data pool.
Expressionist was also used to
standardize the workflow-based
microarray quality control process
and obtain fully comparable data
for subsequent data analysis.
agricultural R&D processes,”
Pfannes adds. The software-based
system is installed on customers’
computers with different levels
of programming for end users
and experts. The system is “userfriendly” and low maintenance,
Pfannes says.
In addition to Expressionist,
the company provides Genedata
Phylosopher for target discovery and integrative biological
data management and Genedata
Screener for automated highthroughput screening and high-
content screening.
The company is privately held,
with offices in cities around the
world, including Boston and San
Francisco; Konstanz and Munich,
Germany; and Tokyo.
“Our goal is to continue our
growth pattern of 30 percent
per year,” he says, and adds that
Genedata will have a new product
to release in six months.
In addition to personalized
medicine, which he notes is a “big
target,” the company is also aiming for growth in the agricultural
AUGUST 2009 • Drug Discovery News
space, cosmetics and biofuels, all
areas where profiling compounds
to enhance yields and the effect of
active ingredients offer attractive
potential.
Since October 2002, Chugai has
pursued prescription pharmaceutical R&D activities in Japan
and abroad as a member of the
Roche Group.
Specifically, Chugai is focusing
on the oncology and chronic disease areas. Outside Japan, Chugai
Pharma USA and Chugai Pharma
Europe are engaged in clini-
cal development activities in the
United States and Europe.
The consolidated sales in 2008
of Chugai totaled $3.5 billion and
the operating profit was $5 5 3
million.
In March, the company’s shares
fell as much as 11 percent after
Chugai reported 15 deaths among
people who had used its Actemra
drug for rheumatoid arthritis.
Actemra won approval in Europe
in January, but has not been
approved in the U.S. DDN
EDITCONNECT: E080912
SIMPLIFY YOUR SCIENCE
FROM DISCOVERY
TO CLINICAL
“Many claims are made, but there are
not many enterprise systems out there
that are organization-wide and where all
[researchers] can participate from many
sites,” says Dr. Othmar Pfannes, CEO of
Genedata. The company now serves 30
of the top 50 pharmas worldwide, and
eight of Japan’s top 10 pharmas use
Expressionist.
“We are working with tens
of thousands of GeneChip data
sets. In the past, we were limited
to normalizing small batches at
a time. With Expressionist, we
can normalize the entire data set
in one go,” says Junichi Muroya,
member of the bioinformatics
team at Chugai. “This has greatly
increased processing speed, facilitated sophisticated software analysis and improved the quality of our
results significantly.”
Genedata Expressionist is an
enterprise solution that was 12
years in development, Pfannes
notes. According to Pf annes,
Expressionist integrates, stores
and analyzes transcriptomics, proteomics and metabolomics data as
well as a wide variety of phenotypic data.
“From a scientific viewpoint,” he
adds, “it also supports ‘crossomics,’ the ability to look at proteins
and metabolites at the same time,
for example.”
Expressionist consists of several modules that support highthroughput, standardized and
workflow-based data processing
and statistical analysis.
“It fits to a large variety of pharmaceutical, biotechnological and
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“While the LIMS business
is an important asset for a
segment of our customers,
it was not a perfect fit with
our strategic direction. This
agreement will allow us to
better focus on our strengths,
while ensuring continued
access to a key solution in the
laboratory worfkow.”
—Mark Stevenson, president and
CEO of Life Technologies
LIFE
they have been accustomed.”
The SQL*LIMS business from
Applied Biosystems, a part of Life
Technologies, is an enterprise laboratory information management
system (LIMS) provider.
The system also manages the
laboratory process lifecycle and
is used for tracking raw materials and samples as they enter and
travel through the laboratory
workflow, for sample analysis, for
data collection and for communication of this information to corporate systems.
“The SQL*LIMS business was
a successful and viable business, but it was clearly orthogonal to our core business, so the
feeling here was that we and our
customers would benefit best by
SQL*LIMS moving to a softwareonly, LIMS-only company,” says
Pat Pijanowski, general manager
of the SQL*LIMS business unit for
Life Technologies.
“While the LIMS business is an
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important asset for a segment of
our customers, it was not a perfect fit with our strategic direction,” adds Mark Stevenson, Life
Technologies’ president and CEO.
“This agreement will allow us
to better focus on our strengths,
while ensuring continued access
to a key solution in the laboratory
workflow.”
Pijanowski also says that he
believes the combination of these
t wo l e ad i n g L I M S b u s i n e s ses—the SQL*LIMS product and
LabVantage’s thin-client LIMS
product, SAPPHIRE—will “allow
for expanded and strengthened
product offerings to meet the needs
of this market.”
Another reason the sale makes
such good sense is that it makes
for a more seamless, almost endto-end solution, according to
Pijanowski and Ronald S. Kasner,
vice president of corporate development for LabVantage.
SQL*LIMS has fared best in
the field of late-stage research and
early-stage development, whereas
SAPPHIRE has had more play
in the areas of later-stage develo p m e nt , m a nu f ac t u r i n g a n d
quality operations, according to
Pijanowski.
“LabVantage was the best company to take over our SQL*LIMS
business because the two products
cater to different parts of the value
chain,” Pijanowski says.
But it’s more than just the technology that LabVantage is getting,
the companies note.
“ This transaction creates a
powerful combination of technology and people,” points out Jim
Aurelio, president and CEO of
LabVantage.
Aurelio also points out that
with more than 250 dedicated
L I M S e mp l oye e s a r o u n d t h e
world, plus an extensive partner network, “LabVantage will
be even better equipped to meet
the needs of customers seeking to
deploy LIMS across their global
enterprise.”
Reportedly, the vast majority of those 250 employees come
to LabVantage directly from Life
Technologies’ SQL*LIMS business, though neither company
offered a precise breakdown when
asked.
“We will continue to support the
SQL*LIMS product and customers with the same high level of care
and attention that they receive currently,” says Aurelio.
“These customers—indeed, all of
our customers—will gain access to
a broader portfolio of world-class
software products and services,”
he adds.
The transaction is subject to
customary closing conditions and
is expected to close in the third
quarter of 2009.
Life Technologies says the company does not expect this transaction to have a material affect on its
financials in fiscal year 2009. DDN
automation &
instrumentation
b r i e f s
PerkinElmer expands presence
in India with new technical
center in Hyderabad
HYDERABAD —PerkinElmer
Inc. announced
in July that it plans to establish a state-ofthe-art biopharma Center of Excellence here.
The center will provide regional PerkinElmer
clients and partners in India with access to
established and emerging drug discovery and
pharmaceutical quality assurance and control
applications and technologies, training facilities and expertise.
The facility will also support focused
research efforts in screening and profiling
technologies. PerkinElmer India customers will
have early access to new applications as they
are developed, as well as the opportunity to
help guide development of future technologies
based on their current and emerging research
requirements.
Applied Biosystems and
Chromsystems team up to
simplify mass spectrometry
for clinical research
CARLSBAD, Calif.—Applied
Biosystems, part
of Life Technologies Corp., and Chromsystems
Instruments & Chemicals GmbH announced
last month that they will co-develop complete,
integrated workflows to simplify mass spectrometry technology for a variety of clinical
research applications, such as therapeutic
drug monitoring.
The agreement involves the integration of
Chromsystems’ validated reagent kits, calibrators and controls with Applied Biosystems’
AB SCIEX mass spectrometers and software.
Applied Biosystems will also expand its offerings
of application-specific iMethod Tests, which are
pre-configured methods for laboratory use and
designed to optimize Chromsystems’ specialized chemistries on AB SCIEX triple quadrupole
and QTRAP LC/MS/MS systems.
The solutions are expected to accelerate the
adoption of new validated diagnostic tests for
medically relevant research, including vitamin
D, amino acids, acylcarnitines, immunosuppressants, antidepressants and neuroleptics.
Financial terms of the deal were not disclosed.
Syrris, Chemglass sign
agreement to distribute
batch reactor products
ROYSTON, England—Last month, Syrris and
Chemglass Life Sciences signed an exclusive
distribution agreement in the United States
covering all Syrris batch reactor products. A network of 15 account managers will supply customer service across the Syrris product portfolio, which includes the Reactor Master product
line and the Atlas syringe pump. Financial
details were not released.
AN ARRAY OF ADVANTAGES
Aushon’s 2470 microarray printer to provide
customized solution for small-molecule
screening at the Broad Institute
Researchers
at the Broad
Institute will
use Aushon’s
2470 Arrayer in
their mission
to “transform
medicine
with new
genome-based
knowledge”
by seeking to
describe all
the molecular
components of
life and their
connections;
discover the
molecular
basis of major
human diseases;
develop
effective new
approaches to
diagnostics and
therapeutics;
and openly
disseminate
discoveries,
tools, methods
and data.
By Jeffrey Bouley
BILLERICA, Mass. —The
2470 Arrayer technology from Aushon
BioSystems Inc.—a provider of advanced microarray instrumentation and laboratory services for biomarker discovery, development
and analysis—will now play a key role at the Cambridge, Mass.based Eli and Edythe L. Broad Institute of MIT and Harvard in the
institute’s small-molecule microarray research.
It’s a win for Aushon that’s been a couple years in the making.
“We contacted the Broad initially to understand their potential
microarray instrumentation needs approximately two years ago,
and maintained an ongoing relationship with them,” recalls Peter
Honkanen, CEO of Aushon. “As a result of our ongoing contact, they
were already aware of our 2470 microarray printing platform and its
many advantages, and set out to explore how our multiplexing technology could contribute to their small-molecule research.”
The 2470 Arrayer has been installed in leading research institutions throughout North America, Europe and Asia to provide rapid,
accurate, high-density microarray printing for both genomic and
proteomic applications, notes Aushon. According to the company,
the 2470 Arrayer is able to print virtually any sample—including cell
lysates and blood—onto substrates with unique shapes and chemistries, as well as the most delicate of substrates such as nitrocellulose
and silicon chips which, along with other features, making it “the
most flexible and reliable microarray printing platform available,”
according to the company’s news release about the Broad’s selection
of the 2470 Arrayer.
It wasn’t just the existing flexibility of the technology that won
the Broad Institute over, Honkanen notes, but his own company’s willingness to work with the institute and adapt the 2470
Arrayer beyond its base capabilities to accommodate the Broad’s
Nanos from the bottom up
Particle Sciences and
Microfluidics combine to advance
pharmaceutical nanotechnology
BETHLEHEM, Pa. —Particle
nano continued on page 22
Analytical
team-up
RTS Life Science
is partnering with
Hall Analytical
Laboratories to
provide analytical
services and
consultancy in
automation,
inhaler testing
By Lloyd Dunlap
Sciences Inc.—a selfdescribed boutique contract research organization—has formed a strategic alliance with
Microfluidics to share formulation and nanotechnology expertise for drug development, analysis
and commercialization.
Particle Sciences was founded in 1991 with a
specialization in formulation and delivery, analytic services and clinical trial material production.
With more than 35 scientists holding more than 100
patents, a comprehensive formulations laboratory,
cGMP production suites and cGMP analytical/bioanalytical capabilities, Particle Sciences claims a
solid track record of developing commercializable
technologies for companies ranging from start-ups
to large pharma.
“Clients come to us with tough formulation
problems,” says Dr. Robert W. Lee, vice president of pharmaceutical development at Particle
Sciences. “We like to tinker, come up with new
process twists. Our model is to offer our cli-
ARRAYER continued on page 22
By David Hutton
MANCHESTER, U.K. —RTS
Robert W. Lee, vice president of pharmacuetical development
for Particle Sciences Inc., says his company is interested in
adding the Microfluidizer processor to existing approaches
for particle size reduction to the submicron range of poorly
water-soluble APIs.
Life Science, a worldwide
supplier of automated sample management and drug
delivery testing systems,
is partnering with Hall
Analytical Laboratories
to provide analytical services and consultancy in
the area of automation and
inhaler testing.
rts continued on page 20
Aiming to create the ‘disposable factory’
Sartorius Stedim Biotech partners with
SAFC Biosciences to integrate filtration
and liquid handling systems with cell
culture media manufacturing services
“For us, every
partner is an
integral part of our
organization. We
have a philosophy
when it comes to
partnerships: they
are not just hot air,
they are absolutely
essential in order
to live—and for
us, living the
partnership
is extremely
important. We
will make sure
that SAFC is
successful, and
they are committed
to supporting our
success,” says Maik
W. Jornitz, group
V.P. of marketing
and product
management,
filtration and
fermentation
technologies at
Sartorius Stedim
Biotech.
By Amy Swinderman
GOETTINGEN, Germany—In an agreement that could bring bio-
pharma one step closer to the reality of a “totally disposable
factory” with integrated technologies and control systems,
Sartorius Stedim Biotech (SSB) and SAFC Biosciences, both
leading suppliers to the biopharma industry, announced last
month a global partnership that marries SSB’s expertise in
filtration and liquid handling systems with SAFC’s proficiency in development and manufacturing of cell culture
media and downstream purification products.
The combination of the two companies’ expertise in generating application data on filter and mixing performance
with critical purification buffers and cell culture media is
expected to provide more robust and comprehensive solutions to biopharma manufacturers. Similarly, extractable
and leachable data will be generated with buffers and media,
and filters and biobag combinations. In addition, SAFC will
use SSB’s technology for storage and mixing of cell culture
media to optimize its fluid/powder handling systems.
Financial terms of the collaboration were not disclosed,
but the integrated solution will be co-marketed globally
to customers of SSB, which is headquartered in Aubagne,
France, and has manufacturing and R&D sites in Europe,
North America and Asia, and SAFC Biosciences, a member
of the Sigma-Aldrich group that has manufacturing facilities
worldwide. The companies will also offer their customers
validation support, process improvement, technical support
and problem solving.
According to Maik W. Jornitz, group vice president of mar-
RTS
Initially focused on inhaled drug
delivery devices, the companies
will share facilities, technology and
resources to provide a range of services to help organizations improve
efficiency in the development,
adoption and use of automation.
According to Mark Fish, director of drug delivery automation for
RTS Life Science, the company’s
experience of inhaler testing automation means it understands how
devices work and appreciate factors that can introduce variability
keting and product management, filtration and fermentation
technologies at SSB, the agreement gives both companies’
customers a fully integrated cell culture media storage and
mixing solution, yielding a powerful combination of fluid
management and liquid/powder systems and help them to
enhance the efficiency of their cell culture processes. SAFC
was the right partner for integration, Jornitz says, because
in analytical testing.
“We have proven experience
validating automation systems in
accordance with the latest regulatory guidance,” Fish says. “By
offering these services, customers will benefit from this knowledge and have new options to help
improve laboratory efficiency.”
Fish points out the combination of RTS Life Science’s device
testing expertise and automated
inhaler testing technology with
Hall Analytical Laboratories’ analytical problem solving expertise
and GxP accredited facilities offers
The initial focus will be on inhaled drug delivery devices, but RTS and Hall will share
facilities, technology and resources to provide a range of services to help organizations
improve efficiency in the development, adoption and use of automation.
clients confidence that their analytical and automation needs for
inhaled product testing will be
understood and approached with a
refreshing new depth of insight.
As pharmaceutical companies
continue to recognize both the
financial and quality benefits of
outsourcing specialized scientific
applications, Susan Jones, marketing manager with RTS Life Science,
points out that suppliers of such
services need to able to respond in
a positive and prompt manner.
“It is very doubtful that one service company has all of the expertise in-house to adequately meet
the stringent requirements and
hence one logical action is to form
partnerships between companies
with complimentary specialized
skills,” she says. “This partnership
is then able to react to the individual needs of their clients.”
Jones says that the RTS and Hall
Analytical partnership in the area
of inhalation testing is a prime
example of such a partnership.
“RTS is a recognized leader in
the manufacture of automation
devices for the pharmaceutical
industry, whilst Hall has been
providing high quality analytical
data to the same market for many
years,” she notes. “The logical
combination of such skills and
expertise gives pharmaceutical
confidence that the problem can
be resolved by experts who fully
understand the issues and challenges and are capable in providing the necessary solutions and
its service philosophy and portfolio paralleled that of SSB.
“When you supply the entire process from upstream to
downstream, including filtration, fermentation and disposal, it is absolutely essential that you acquire an experienced
parner to supply the cell culture media,” Jornitz says. “SAFC
is a world-class cell culture media company with a lot of
safc continued on page 22
“[The combination of our]
skills and expertise gives
pharmaceutical confidence that
the problem can be resolved by
experts who fully understand
the issues and challenges and
are capable in providing the
necessary solutions and data
quality required.”
— Susan Jones, marketing manager, RTS Life Science
data quality required.”
Services to be provided in consultation with clients include method development for both manual
and automated applications; equipment and analytical validation services; performance qualification
of automation systems; laboratory
and analytical consultancy for
OINDP products; canister content
testing; plus emitted and delivered
dose uniformity testing.
M a l c o l m K i m b e r, m a n a ging director of Hall Analytical
Laboratories, points out that
this collaboration will help his
company continue its customeroriented focus.
“This partnership with RTS
allows us to offer a more com-
prehensive range of services for
inhaled devices, building on our
experience working with pharmaceutical clients and our excellent
reputation for regulatory compliance and analytical problem solving,” Kimber says.
Under the agreement, Jones also
notes that RTS will produce the
automated testing instrumentation
while Hall will provide the analytical testing and validation for the
devices that are being tested to each
client’s individual requirements. In
effect a complete tailored solution.
“The success of the venture will
be measured by the uptake of the
technology and the associated analytical work,” she notes. DDN
millipore
2001, the company started its own
wet lab and formed a relationship
with King’s College. Their early
work centered on cutting edge
proteomics using tandem mass tag
technology—a novel quantification
strategy for comparative analysis
of complex protein mixtures by
MS/MS.
The way the pair hooked up with
Millipore was “non-linear,” notes
Jonathan DiVincenzo, president of
Millipore’s bioscience division.
“We were working on a project with Pfizer to develop assays
related to neurodegeneration
when we were contacted by King’s
College to develop assays for proteins it had identified. We worked
with them to put together panels
to detect circulating proteins,”
DiVincenzo says.
Working in collaboration with
Lovestone’s group, Proteome
Sciences has established a strong
portfolio of patent-protected
blood biomarkers of Alzheimer’s
disease. A number of these biomarkers have been independently
Alzheimer’s disease
is the fifth leading
cause of death in
persons over the age
of 65 in the U.S.
identified and their relationship to
Alzheimer’s disease confirmed by
researchers at GlaxoSmithKline.
Millipore’s expertise is making
multi-analyte panels that don’t
conflict (see sidebar).
“Before Luminex,”DiVincenzo
notes, you had to proceed one protein at a time. With Luminex, you
can use 100 different plastic beads
to detect the presence and concentration of circulating proteins.”
Because the beads are conjugated
with specific labels and antibodies,
it’s possible to monitor a different
analyte on each bead, he adds.
“This collaboration will help
us achieve our broader goal of
advancing the study of neurobiology and neurodegenerative diseases,” says DiVincenzo. “This is the
start of a long-term relationship. A
joint development committee will
work to refine the catalog of assays
that we have available. We’ve earmarked a good portion of our R&D
budget to work on this project.”
According to DiVincenzo, 12
months is the target for reaching
the clinic with as many as 20 diagnostic panels.
“We’re very optimistic that
changes we are seeing in very early
Alzheimer’s will be detected in
the pre-symptomatic stage,” Pike
says. Asked if screening is likely
to be acceptable, he points out
mammography, the test for prostate specific antigen (PSA), the
PAP test and others as evidence
that such screening is acceptable,
and says that indeed, screening is
“the mainstay of good preventive
medicine. Our goal is to have the
tools to assay at the pre-symptomatic stage—the earlier the better.
Proteome Sciences is keen to see
the management of individual
health maximized.”
Mi l l ip o r e w i l l ac qu i r e t h e
exclusive right to develop and
sell Luminex bead-based panels
for research related to the study
of Alzheimer’s disease and other
cognitive function disorders.
Proteome Sciences retains all
rights to clinical applications of
these biomarkers. Financial terms
of the license agreement were not
disclosed.
Alzheimer’s disease is the fifth
leading cause of death in persons
over the age of 65 in the U.S. with
5.3 million Americans afflicted
by the disease. A suspected new
case is identified every 70 seconds.
The disease results in an economic
burden that is estimated at more
than $142 billion for 2005 with $112
billion in direct medical costs. DDN
Millipore will acquire the right to develop and sell Luminex bead-based panels for
research on the study of Alzheimer’s disease and other cognitive function disorders.
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nano
arrayer
unique small molecule applications.
“Aushon offers a balance of advanced, proven
technology with a core corporate philosophy of
building long-term, mutually rewarding relationships with our customers and partners. That was
evident in our willingness to work with the Broad
Institute from the beginning, giving them access to
our instruments and scientists to help them understand the technology and its solutions, and how they
could be adapted to meet their needs,” Honkanen
says. “Certainly, our close physical proximity to the
Broad helped facilitate this high level of support,
but that commitment to service is fundamental to
our success and provided to every customer.”
“The ability and willingness of Aushon to customize the capabilities of the 2470 Arrayer for our
specific small-molecule microarray application
was critical,” echoes Dr. Angela Koehler, Institute
Fellow of Chemical Biology at the Broad Institute,
who believes the technology will significantly
enhance the success of the Broad’s research efforts.
“Through our collaboration with Aushon, we were
able to exploit the advanced capabilities of the 2470
microarray printing platform while adapting it to
meet the stringent criteria of our own applications.”
The benefits have been mutual, Honkanen
indicates, as the customization work and interactions with the Broad Institute have provided “vital
insights into new applications for our printing plat-
The Eli and Edythe L. Broad Institute of MIT and Harvard
safc
experience in media preparation
in development, so their service
queue fit very well with ours.”
“For us, every partner is an
integral part of our organization,”
Jornitz adds. “We have a philosophy when it comes to partnerships: they are not just hot air, they
are absolutely essential in order to
live—and for us, living the partnership is extremely important.
We will make sure that SAFC is
successful, and they are committed to supporting our success.”
Bruce Lehr, SAFC’s director of
global marketing, says the deal
also has many benefits for SAFC.
Most notable among them is the
opportunity SAFC has to partner
with a market leader in process
and single-use technologies devel-
Aushon customized its 2470 Arrayer to the needs of the Broad
Institute, which was key to the company landing the deal.
form, and enhanced the reach and scope of our
microarray technology.”
The Broad Institute was founded in 2003 to
“transform medicine with new genome-based
knowledge,” and it seeks to describe all the molecular components of life and their connections; discover the molecular basis of major human diseases;
develop effective new approaches to diagnostics
and therapeutics; and disseminate discoveries,
tools, methods and data openly to the entire scientific community. The Broad not only taps the talents
within MIT, Harvard and their affiliated hospitals
but also has collaborations spanning over a hundred private and public institutions in more than
40 countries.
Aushon BioSystems provides a comprehensive
suite of microarray instruments, consumables and
services to pharmaceutical, biotechnology, academic and diagnostic clients worldwide. The company’s
signature combination of advanced microarray
printing technology, robust biomarker content and
innovative multiplex immunoassay development
and detection systems is said to delivers exceptional
performance, quality and reliability that accelerates
preclinical and clinical biomarker research. DDN
opment. The capabilities created
by the agreement will enable the
cell culture specialist to offer its
customers a wide range of highly
customized products and services, Lehr says.
“So far, we have received very
positive feedback from our customers, who use both of us as
primary suppliers in their facilities and see the benefit of having us work together,” he says.
“Both of us have the desire to
add as much value to the process
for our customers as we can. We
each have different strengths
within our existing product and
service portfolios, so it turns out
that we complement each other
quite well. Working together creates shared savings, but it also
enables us to create solutions
that are not available right now.
We expect to be able to offer a lot
more value to our customers.”
Ultimately, the availability of
integrated technologies and control systems may bring the biopharma industry closer to achieving
the creation of a “totally disposable
factory,” especially as productivity
rates rise and create manufacturing demands, Jornitz says.
“The concept of a ‘disposable
factory’ is becoming somewhat of
a buzz word in the industry,” he
says. “Whether there will ever be
a completely disposable factory
is questionable. I foresee a hybrid
solution that largely involves
disposable equipment working
together with disposable unit
operations. In particular, when
you look at the vaccine industry,
which is dealing with the pandemic flu virus, we could build a
production facility with a disposable factory and equipment much
ents a number of state-of-the-art
approaches using best-of-breed,
reproducible and scalable technologies. For high-shear fluid processing, we chose the Microfluidizer
a f t e r a t h o r o u gh eva lu at i o n
of the competing alternatives.
One area of interest to us is adding the Microfluidizer processor
to our existing approaches for
particle size reduction to the
submicron range of poorly
water-soluble APIs, which is an
increasingly important formulation approach for pharmaceutical
API development.”
As part of the non-exclusive
agreement, Particle Sciences has
installed an M-110EH-30 Basic
BioPharma Microfluidizer processor to produce nanoemulsions and
nanosuspensions, and for cell disruption and nanoencapsulation in
pilot and production volumes.
“We believe Microfluidizer processors are the undisputed gold
standard in the pharmaceutical
industry, from the lab to clinical research and production,”
says Bill Kober, vice president of
Americas sales at Microfluidics.
“Through this relationship, our
users now have access to our technology combined with the scientific ingenuity and experience of
Particle Sciences.”
Microfluidics, a wholly owned
subsidiary of Microfluidics Inter
national Corp., has been a worldwide supplier of Microfluidizer
high shear fluid processing systems to the biotechnology, pharmaceutical, chemical and cosmetics
industries since 1984.
It s Mi c r o flu i d i c s Re ac t i o n
Technology (MRT) is a continuous
and scalable microreactor system
used for efficient, large-scale production of nanoparticles with high
purity at low cost. MRT is particularly well-suited to pharmaceutical applications where the trend
is to go to very small particles that
faster and more affordably than a
stainless steel facility.”
Lehr agrees, observing that the
industry is seeing more and more
of these trends as they envision
where they can use more modular units in their manufacturing
processes.
“As productivity rates have risen
with cell culture systems, it has
enabled some of the bioreactor
requirements to be smaller than
in the past and is driving them to
the stage where disposables might
be an option,” Lehr says. “There
are also obvious issues about flexibility, cutting validation costs
and eliminating the large capital
requirements involved with building a large stainless steel facility.
The idea of people going to disposable solutions is part of a strong
trend in market.” DDN
have precise polymorph control.
Microfluidics has demonstrated
MRT by creating nanosuspensions of a variety of injectable or
inhalable drugs, including cancer
therapies, antibiotics, antihistamines and nonsteroidal antiinflammatories.
M RT s o lve s a n i s s u e t h at
conventional mixers/reactors
have been unable to overcome.
Conventional processes utilize a
“top-down” method to grind particle sizes to the nano-level through
a process of wet-milling, homogenization, micronization and other
techniques. This top-down process
does not allow for optimal and consistent sizing of the particles and is
often unable to produce particles
sizes small enough to be effective.
MRT utilizes a “bottom-up”
proprietary approach whereby
the particle is built up molecule
by molecule in seconds, allowing
not only for optimal and consistent sizing of the particles, but also
for the creation of smaller particle
sizes not previously achievable.
The process is both continuous
and results in extreme phase purity of products.
MRT was presented during a
poster presentation at the Nano
Science and Technology Institute
(NSTI) Nanotech 2007 Conference
and won a Nano50 Award as one
of the most innovative ideas in
nanotechnology. The core of this
technology is a continuous microreactor (reaction chamber) based
on impinging jet design. Two
opposing jets form as fluids flow
through two microchannels within the chamber. The jets collide
inside a microliter volume where
the fluids mix at the nanometer
scale. Average fluid velocities
inside the channels may exceed
400 m/s, which is orders of magnitude higher than existing impinging jet reactors. A planar array of
opposed pairs of such channels
ensures effective scaling up of the
technology. DDN
“Working together
creates shared
savings, but it also
enables us to create
solutions that are not
available right now.”
— Bruce Lehr, director of
global marketing, SAFC
SBS Symposia
Join us in these topic-focused environments designed to
bring together great science and great business.
Participate in quality scientific sessions;
meet face-to-face with your peers and share best practices;
and talk with technologies and service providers in the exhibit hall.
Screening Stem Cells:
Advances & Challenges in
September 2 - 3, 2009 • Boston, MA, USA
November 2 - 3, 2009 • San Diego, CA, USA
From Reprogramming to Regenerative Medicine
Program Overview:
Stem cells and regenerative medicine is an emerging field of
drug-discovery research. Reprogramming somatic cells to a
pluripotent state could generate a rich supply of patient-specific
stem cells and mature cells for regenerative medicine and
compound screening. It has been shown that viral-mediated gene
delivery of four transcription factors, including two potential oncogenes, can directly reprogram somatic cells to induced pluripotent
stem (iPS) cells. Unfortunately, the resulting iPS cells are unsuitable for many therapeutic applications because the viral transgenes
can spontaneously reactivate a process that has led to tumor
formation. Therefore, discovering small molecules through highthroughput technologies capable of reprogramming cells-- without
relying on viruses or oncogenes--would be extremely valuable to
therapeutic applications. Furthermore, using stepwise differentiations of pluripotent cells and/or embryonic stem cells to terminally
differentiated functional cells via small molecule treatment would
be useful for transplantation therapy, identifying targets for drug
discovery and for toxicology testing. High-throughput screening
(HTS) and high-content screening (HCS) technologies against stem
cells offer great potential for identifying novel small molecules to
reprogram cells and to induce formation of terminally differentiated
functional cells.
Scientific sessions will encompass these core topics:
• Promise of Stem Cells
• Stem Cell Screening Systems
• Access, Distribution & Quality Control
• Therapeutic Applications
Learn from research innovators in keynote presentations
delivered by:
• Michael Clarke, MD – Stanford Institute for Stem Cell
& Regenerative Medicine, USA
• Douglas Melton, PhD – Harvard Stem Cell Institute
(HSCI) & Harvard University, USA
Label-Free Technologies for Drug Discovery
Program Overview:
Label-free technologies in drug discovery are allowing
scientists to address some of the outstanding fundamental
questions of productivity that contemporary Pharma R&D is
struggling with. Label-free technologies present the opportunity to
address issues such as limited access to tractable therapeutic
targets, early exploitation of chemical genomics, poor predictability
of the therapeutic action of chemical compounds in biological
assays, and inadequate selection of candidate molecules that fulfill
the right biological and physicochemical profile of a drug. Label-free
methodologies positively impact assay development by enabling
the direct monitoring of molecular and cellular interactions on native
systems of biological relevance in a non-destructive and generic
manner.
The symposium will showcase the latest scientific and technological advances where label-free technologies have proven their value
in the discovery and characterization of new drugs and therapeutic
targets. Case studies from formation of multi-component biomolecular complexes to phenotypic alterations in native cells, from the
detection of the interaction between small organic molecules and
isolated proteins to the redistribution of mass within a cell upon
activation of a particular receptor, from screening of compound
libraries to hit (in)validation or elucidation of the mode of action of
lead compounds, from agonist trafficking to receptor panning will
draw the interest of the meeting participants. The technological
challenges and uncertainties that drive the wide adoption of
label-free by the drug-discovery community will be also presented.
Learn from research innovators in keynote presentations
delivered by:
• Manfred Auer, PhD – University of Edinburgh, Scotland
• Michael I. Recht, PhD – Palo Alto Research Center, USA
Explore the program by visiting www.sbsonline.org/labelfree/
Explore the program by visiting www.sbsonline.org/stemcells/
Advancing the Science of Drug Discovery
Society for Biomolecular Sciences · 36 Tamarack Avenue, #348 · Danbury, CT 06811, USA
Phone: +1 (203) 743-1336 · Fax: +1 (203) 748-7557 · www.sbsonline.org
MORE INFO @ adv-connect.com
Genomics &
Proteomics
b r i e f s
Roche NimbleGen CNV arrays
selected for landmark Korean
copy number variation study
MADISON, Wis.—Roche
NimbleGen has partnered with the Korea Centers for Disease
Control and Prevention and Macrogen Inc. to
conduct an eight-month intensive copy number
variation (CNV) study of Koreans. The new, twophased CNV study is an extension of the Korean
Association Resource (KARE) project that is
focused on identifying single nucleotide polymorphism associations with diabetes and other
diseases. This study will include large-scale
characterization of CNVs in Korean populations
and analysis of common CNVs in genome-wide
association studies for complex diseases like
diabetes. According to the companies, the
study could broaden the population spectrum
of CNV data in existing databases and provide
new insights into the contribution of CNVs to
normal phenotypic variation, disease susceptibility and response to drug therapies.
Thermo and Institute of
Cancer Research create stateof-the-art proteomics lab
HEMEL HEMPSTEAD, England—Thermo Fisher
Scientific Inc. announced in July a collaboration
with the integrative network biology initiative at
The Institute of Cancer Research (ICR). The collaboration involves a number of Thermo Fisher
Scientific solutions, including laboratory equipment, silencing RNA, protein reagents, mass
spectrometry and related services. The ICR’s
new, state-of-the-art proteomics laboratory
has been equipped with a complete Thermo
Scientific proteomics workflow meant to provide
powerful capabilities to meet ICR’s demanding
research goals, including the assessment of
how networks of cancer cells interact with each
other and surrounding tissues to metastasize
throughout the body, the companies said.
Archemix and Dicerna to
collaborate RNAi therapeutics
CAMBRIDGE, Mass.—Archemix
Corp., a biotechnology company focused on discovering,
developing and commercializing aptamer therapeutics, and Dicerna Pharmaceuticals Inc.,
a second-generation RNA interference (RNAi)
company developing novel therapeutics utilizing its proprietary Dicer Substrate Technology
and dicer substrate RNA (DsiRNA) molecules,
announced in July that the two companies will
collaborate on aptamer-DsiRNA therapeutics
that leverage both the intracellular delivery
capabilities of Archemix’s aptamers and the
gene silencing of Dicerna’s DsiRNA molecules.
The agreement includes an option for Dicerna
to obtain exclusive rights to further develop and
commercialize aptamer-DsiRNA therapeutics
generated during the collaboration.
DE NOVO GENE GENESIS
Researchers identify primatespecific sequences in the
human genome in comparative
genomics study
Dr. Leonard
Lipovich of
Wayne State
University
notes that
much is said
about using
genome and
transcriptome
data to look
at conserved
genes, but he
also points
out that
investigators
too often
will ignore
genomic
intervals
outside of
those known
genes, leaving
a large
untapped
area for
discovering
more about
genomics.
By Amy Swinderman
DETROIT—In
comparative genomic research project using data that
is already available in the public domain, researchers from Wayne
State University (WSU) and the Genome Institute of Singapore
have identified primate-specific sequences in the human genome.
According to the researchers, who summarized their findings in
the July 6 online edition of the Proceedings of the National Academy of
Sciences, the study has many implications for the field of genomics
research.
According to the researchers, the study, “Global discovery of primate-specific genes in the human genome,” offers an explanation for
lineage-specific uniqueness that is based on something completely
new in evolution, not on changes to old sequences or structures.
Perhaps more importantly, the researchers believe the study itself provides an interesting critique of current genomic research methods.
The researchers began their quest to find primate-specific genes
by noting that despite the increasing availability of genome and
transcriptome sequence data, the genomic basis of primate phenotypic uniqueness remains obscure. According to Dr. Leonard
Lipovich, assistant professor of the Center for Molecular Medicine
and Genetics and Department of Neurology at WSU’s School of
Medicine and principal investigator of the study, this challenge is
due to multiple factors.
First, searching for non-conserved genes isn’t emphasized by any
of the major players in genomics research, Lipovich says. Although
factors such as segmental duplications and positive selection have
received much attention as potential drivers of primate phenotypes,
single-copy primate-specific genes are poorly characterized, he says.
de novo continued on page 26
This is such an underrepresented area
of research, and one take-home message
we have is that people should be looking
at publicly available data more.”
— Dr. Leonard Lipovich, assistant professor of the Center for
Molecular Medicine and Genetics and Department of Neurology
at WSU’s School of Medicine
Sticking its feet into the pool HIGH
Alnylam joins GSK in donating
intellectual property to patent pool
for neglected tropical diseases
FIVE
Alnylam extends
RNAi therapeutics
collaboration with
Novartis into a
fifth year
By Jeffrey Bouley
CAMBRIDGE, Mass.—Since
it established a patent pool
to aid in the discovery and development of new medicines for the treatment of 16 neglected tropical diseases in March, U.K.-based GlaxoSmithKline PLC
(GSK) has been a bit lonely, with no one else joining it
there. But that all changed in early July, when Alnylam
Pharmaceuticals Inc. became the first company to contribute intellectual property to the pool.
All told, Alnylam will contribute more than 1,500
issued or pending patents on its RNA interference
(RNAi) technology patent estate to the patent pool—
tripling the number of patents in the pool, which GSK
jump-started with 800 patent filings of its own. Both
companies hope that the combined intellectual property (IP) will lead to many new targets and treatments
pool continued on page 27
Alnylam is the first company to join GSK’s patent pool
for neglected tropical diseases, but it probably won’t
be the last.
CAMBRIDGE, Mass. —RNAi
t h e r a p e u t i c s c o m p a ny
Alnylam Pharmaceuticals
Inc. in mid-July elected
to extend the company’s
RNAi therapeutics collaboration with Novartis for a
fifth and final planned year,
five continued on page 28
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de novo
“There is a seldom-challenged assumption in the genomics field that functional
genes must be broadly evolutionarily conserved and protein-coding,” Lipovich says.
“You hear a lot about using genome and transcriptome data to look at conserved genes,
but investigators tend to ignore genomic
intervals outside of those known genes. The
efforts that are out there are unimaginative
and focus primarily on finding homologs of
known protein-coding genes in additional
species, not on non-conserved genes and
their possible role in the genomic basis of
interspecies distinctions.”
A second challenge, Lipovich notes, is
that too much genomic and transcriptiome
sequencing is being done without sufficient downstream efforts to analyze the
sequence data.
“The fact that we have genome and transcriptome databases is not, by itself, helpful,” he notes. “What might be helpful is
developing new algorithmic approaches. In
addition, these datasets frequently are not
put together in a way that can help test specific hypotheses.”
The Genome Institute of Singapore’s SenKwan Tay, who worked on the study as an
extension of a dissertation for his M.Sc.
degree in bioinformatics, adds that data on
the genomes of humans and our nearest
relative, the chimpanzee, show a 99 percent
similarity in their sequences. Explanations
for the substantial phenotypic differences
between the two species not only include
sequence differences, but also regulatory
and genome structure differences and species-specific indels, Tay says.
“While the genome and transcriptome
sequence data provide a lot of what we know
about interspecies sequence and genomic
structure differences, we still don’t understand exactly how, mechanistically, these
differences lead to phenotypic differences
such as the uniquely higher cognitive capacity in humans, etc.,” Tay says.
To address both of these concerns, the
researchers screened a catalog of 38,037
human transcriptional units (TUs), compiled from EST and cDNA sequences in
conjunction with the FANTOM3 transcriptome project and interrogated the intersection of transcriptome data and multispecies genome alignments to search for
primate-specific genes. The comparative
study, using transcriptome sequencing and
transcript-to-genome alignments, mapped
the human transcripts from FANTOM
against the genomes of a number of organisms, including the chimpanzee, to discover
de novo gene genesis.
“We searched for new classes
of interspecies differences,
specifically entirely new genes
in primates, because such
genes might provide another
explanation for lineage-specific
uniqueness that is based on
something completely new in
evolution, not on changes to old
sequences or structures.”
— Sen-Kwan Tay, Genome Institute of Singapore
“We searched for new classes of interspecies differences, specifically entirely new
genes in primates, because such genes might
provide another explanation for lineagespecific uniqueness that is based on something completely new in evolution, not on
changes to old sequences or structures,” Tay
explains.
The researchers identified 131 TUs from
transcribed sequences residing within primate-specific insertions in nine-species
sequence alignments and outside of segmental duplications.
Exons of 120 (92 percent) of the TUs contained interspersed repeats, indicating that
repeat insertions may have contributed to
primate-specific gene genesis. Fifty-nine (46
percent) primate-specific TUs may encode
proteins, the researchers also found.
Although primate-specific TU transcript lengths were comparable to known
human gene mRNA lengths overall, 92 (70
percent) primate-specific TUs were singleexon. Thirty-two (24 percent) primate-specific TUs were localized to subtelomeric and
pericentromeric regions.
Forty (31 percent) of the TUs were nested
in introns of known genes, indicating that
primate-specific TUs may arise within older,
protein-coding regions.
Primate-specific TUs were preferentially
expressed in reproductive organs and tissues consistent with the expectation that
emergence of new, lineage-specific genes
may accompany speciation or reproduction.
Of the 33 primate-specific TUs with human
Affymetrix microarray probe support, 21
were differentially expressed in human teratozoospermia.
“This paper suggests that the emergence
of primate-specific and functional transcripts that due to de novo insertions, not
arising from duplication and subsequent
accelerated sequence evolution,” Tay says.
“By excluding segmental duplications often
synonymous with gene genesis, we have also
shown that there exists single-copy transcripts which are also unique to primates
and presented initial evidence for function
for these transcripts. For example, 21 of our
131 primate-specific transcripts were found
to be differentially expressed in a separate
study on severe teratozoospermia in men.
A comparison of our primate-specific transcripts with primate orphan genes identified
in a recent paper (Toll-Riera, et al.) shows no
overlap—an indication that the global primate-specific transcript catalog is far from
saturated and many primate-specific genes
are still to be discovered.”
The broader implication of the study is
that not all genes are necessarily conserved
and protein-coding, Tay says.
“There are genes that are ‘neither,’ but
they are interesting because of their recent
origin and possibly functional roles in reproduction and behavior,” he says. “Such genes
need to be included in drug target screens,
RNA structure analyses, etc. We need to
understand the mechanisms underlying the
birth of these insertions, especially their
non-repetitive portions.”
To accomplish that, researchers will now
need to update the set of primate-specific
transcripts as new data becomes available,
Tay says. This will enable the researchers to
confirm that such evolutionary novelties are
expressed, he adds.
“Additionally, there is a set of human transcripts which are deleted in chimpanzees
but conserved in the rhesus macaque, and
possibly other primate genomes,” Tay says.
“Such gene loss in the chimpanzees may
also contribute to the phenotypic differences
between them and us.”
The study may also serve as a paradigm of
how research can be conducted differently,
Lipovich says.
“This is such an underrepresented area
of research, and one take-home message
we have is that people should be looking
at publicly available data more,” Lipovich
says. “We established an generally applicable paradigm for exploiting the union of two
publicly available resources: genome-wide
sequence alignments and transcriptome
data. Our approach was unbiased in that
it considered all publicly available human
transcriptome data, not just transcriptome
data supporting already-known genes.
Mapping this transcriptome data onto multispecies genomic alignments enabled us to
discover primate-specific genes outside of
annotated, known genes.” DDN
DDN Editconnect:
Your key to additional
story content
AT THE END of every bylined story in DDN, you’ll find
an Editconnect code, like the one in the GlaxoSmithKlineAlnylam story running on pages 24, 27 and 28: E080918.
Each code is your portal to additional content for our
stories and is found on our Web site atwww.drugdiscoverynews.com. Simply click the Editconnect button on our
home page, enter the code and access our story archives.
GlaxoSmithKline’s headquarters in Middlesex in the United Kingdom
Two Xs mark diagnostic spot Protein
Exosome and DxS to collaborate on
development of blood-based tests
for key cancer mutations
By Lloyd Dunlap
NEW YORK—Exosome
Diagnostics Inc. has tapped London-based
DxS Ltd. to partner with on the development of blood-based companion diagnostics for key cancer gene mutations, such as KRAS,
BRAF and EGFR. If successful with the initial mutations, the program will be extended to others. The collaboration will use DxS’
industry-leading Scorpions real-time PCR mutation test kits in
conjunction with Exosome’s xOS technology, which harvests highquality nucleic acids from blood exosomes.
The collaboration will initially focus on developing blood-based
measurement for predicting patient response to targeted therapies.
Blood-based mutation measurement is particularly valuable in circumstances where tissue bioavailability is limited such as in lung,
pancreatic and ovarian cancers.
“There are over 180 companies investigating over 370 different
molecular targeted cancer therapies, many of which will require
high-quality, molecular companion diagnostics,” says James
McCullough, CEO of Exosome. “DxS is the gold standard in detecting these mutations.”
Exosomes are small microvesicles shed by all solid tumors into
blood and other body fluids. They contain virtually the entire cancer tumor transcriptome. Exosome has identified most mRNA and
miRNA in circulating tumor derived exosomes, all protected in the
exosome lipid bi-layer from any blood-based RNase. The company’s
initial research findings were published in the December 2008 issue
of Nature Cell Biology.
“We isolate the exosome and extract the nucleic acid,” McCullough
says, noting that exosomes provide a pure nucleic acid fraction that is
present in a relatively high concentration. “We can extract 200 to 500
ng/ml of serum and higher when there is a good tumor burden.”
DxS’ Scorpion probes target key mutations directly from blood.
pool
for neglected tropical diseases (NTDs), with
or without contributions from anyone else.
“We are delighted that Alnylam will join
GSK in this important program by adding
their unique RNAi technology to the patent pool,” says Andrew Witty, CEO of GSK.
“The key objective of the pool is to make
it easier for researchers across the world
to access intellectual property that may be
useful in the search for new medicines to
treat neglected tropical diseases. The more
companies, academic institutions and foundations that join the pool, the more effective it will be. Alnylam’s announcement …
Andrew Witty, CEO of GlaxoSmithKline
“Our relationship with Exosome is R&D-based,” notes Dr.
Stephen Little, CEO of DxS, differentiating it from his company’s
recently announced collaboration with Boehringer Ingelheim, which
involves drug therapy. “We’re striving to improve the usability of our
products by moving from biopsied tissue to blood, which is a much
easier test to do. The challenge is primarily one of sensitivity in the
diagnostic sense. If you don’t get 100 percent, you have to balance
convenience against sensitivity.”
Little notes that availability of tissue samples is one key; in colorectal cancer, for example, something like 90 percent sensitivity
We’re striving to improve the usability of our
products by moving from biopsied tissue to
blood, which is a much easier test to do.”
— Stephen Little, CEO of DxS
might be required, whereas in lung cancer, where you can’t get a
sample easily, maybe 75 percent would suffice.
Exosome will be responsible for the methodology to extract
the tumor cells, which will then be transferred to DxS for testing.
Exosome’s McCullough adds that the two companies are also investigating tumor profiling by looking at a number of genes expressed
in exosomes that create a fingerprint for cancer type—melanoma,
brain cancer, pancreatic cancer, and so forth—that would be important for early detection and monitoring disease progression.
The IP position of the joint effort may not be clear for a year or
two, Little states, noting: “To me, this is a technology that is ‘yes’ or
‘no’. “From our perspective, it makes the testing process simpler and
easier and will make adoption for clinical use that much faster. If
the technology works, it can be extended to any mutation as an ideal
solution in personalized medicine. The nub of the project is, does it
work well enough?”
To that question, McCullough and Little are of like mind—in a
year, they should have their answer. DDN
is therefore a welcome and significant step
forward.”
As of late July, no other companies had
come forward to join, but GSK Director
of Product Communications Lisa Behrens
says, “Our announcement about the patent pool and the subsequent posting of the
patents and patent applications on gsk.
com attracted a lot of interest from a number of quarters. We’ve been in discussion
with a number of groups about the patent pool but are not in a position to share
more specific information at the moment.
Over time, we hope there will be more
announcements along the lines of the one
we made with Alnylam.”
“I strongly suspect that other companies
and organizations will join and participate in
this patent pool,” says Dr. John Maraganore,
CEO of Alnylam. “I think that we will not
be the last one by any stretch of the imagination. I do think that because we are likeminded with GSK about our commitment
to these types of diseases and patient-physician needs, we’ve been quicker to respond
than others, but this is just the beginning.”
The diseases targeted by the pool are the
16 diseases identified by the U.S. Food and
Drug Administration (FDA) for its own
NTD initiative: tuberculosis, malaria, blinding trachoma, buruli ulcer, cholera, dengue/
dengue haemorrhagic fever, racunculiasis,
fascioliasis, human African trypanosomiasis, leishmaniasis, leprosy, lymphatic
filariasis, onchocerciasis, schistosomiasis,
soil transmitted helminthiasis and yaws.
The geographic focus of the pool will be the
world’s least developed countries as identified by the United Nations and includes
much of western and central Africa as well
Power
Celera issues licenses for
five oncology targets to
Bayer Schering Pharma
By Jeffrey Bouley
ALAMEDA, Calif. —Celera Corp. has
announced an exclusive license agreement providing Berlin-based Bayer
Schering Pharma AG with access to
five cancer-related targets for therapeutic development and in vivo diagnostic
imaging. These therapeutic targets are
over-expressed on the surface of several different tumor cell types and were
identified using Celera’s proteomics
discovery platform.
Janine Tychsen, a spokesperson for
Bayer Schering Pharma, says that the
therapeutic and diagnostic applications
are of equal importance to her company. She was unable to disclose any
information about the five targets aside
from the fact they involve oncology and
they are early-stage projects.
“This agreement allows us to expand
our existing research portfolio in the
area of cancer-related targets,” says
Dr. Khusru Asadullah, head of Target
Discovery at Bayer Schering Pharma.
“We look forward to exploring the full
potential of these promising target canprotein continued on page 29
The patent pool for neglected tropical diseases isn’t GSK’s first foray into collaborations and partnerships
related to underserved areas and neglected diseases, one of those other efforts being the African Malarial
Partnership Programme.
as several countries in Southeast Asia.
By adopting a more flexible approach
to intellectual property, the patent pool is
intended to facilitate access to compounds
and technologies for organizations that want
to conduct research on treatments for these
neglected diseases. What Alnylam brings to
the table is an RNAi platform that provides
an innovative approach to drug discovery
and development through gene silencing, which targets the cause of diseases by
potently silencing specific messenger RNAs,
thereby preventing disease-causing proteins
from being made.
Although he admits that parting with any
kind of IP is a move that will make a company take pause, Maraganore says that being
too conservative in protecting Alnylam’s
own interests would be hard to justify when
his company touts itself as being committed to the innovation of medicines, including important new medicines for neglected
diseases that afflict millions of people each
year.
“We have built a strong IP base over the
years and broadly enabling technology platform for RNAi, and it would be impossible
patents continued on page 28
HIGH-VALUE VACCINE INVESTMENT
Juvaris to use Antigen
Discovery’s protein
microarray screening
system to discover diseasespecific antigens and fuel
its vaccine pipeline
By David Hutton
BURLINGAME, Calif.—Juvaris BioTherapeutics
Inc., a biotechnology company developing
adjuvanted vaccines for infectious diseases,
recently announced a collaborative agreement with Antigen Discovery Inc. (ADi).
Juvaris officials say the company will use
ADi’s high-throughput protein microarray
screening system to help it discover diseasespecific antigens to fuel Juvaris’ vaccine
pipeline.
Juvaris will sponsor research for multiple disease targets and pay Irvine-based
ADi upfront payments, development milestones and royalties on licensed products
in exchange for full product development
rights to all fields except diagnostics, which
will belong to ADi.
Financial details of the collaboration were
not disclosed.
Grant Pickering, president and CEO of
Juvaris, said obtaining access to the ADi
platform is a “transformational event for
Juvaris,” and will enable to company to develop proprietary, high-value vaccines. ADi’s
antigen discovery platform involves assaying the entire proteome of a disease target to
identify every possible protein antigen. The
selected antigens are derived from reactive
antibodies generated by infected individuals
and therefore mimic the presence, accessibility and antigenicity of relevant proteins from
the particular pathogens in humans.
The system will be used to identify protective antigens using sera from patients
infected with particular target diseases,
Pickering says.
“Juvaris’ adjuvant, JVRS-100, has been
five
through October 2010.
Initiated in October 2005, the
“landmark alliance,” as Alnylam
calls it, is focused on the discovery,
development, and commercialization of RNAi therapeutics toward
a defined number of Novartisselected disease gene targets.
“This is the second extension
that Novartis has elected to make,
which we believe reflects the success of our collaborative efforts
as well as the scientific progress
we have made in advancing our
innovative technology to patients,”
says Dr. John Maraganore, CEO of
Alnylam. “Novartis has been an
industry pioneer in recognizing
the potential of RNAi therapeutics
as a new class of medicines, and
we look forward to continuing our
work with them.”
In the Novartis-Alnylam collaboration, both companies are jointly
responsible for RNAi discovery
activities and Novartis is generally
shown in the clinic to enhance both antibody
and T-cell mediated immune responses,
which will be necessary to produce immunity to many of the infectious disease targets
that have not been addressed via vaccination,” he explains. “The ADi antigen discovery platform is efficient, productive and has
been validated across a number of infectious
diseases. The ADi methodology results in
the discovery of immunodominant antigens
that contain either conformational or linear
epitopes. Having the ability to screen the
entire proteome of highly-complex pathogens using full proteins versus DNA fragments allows for the discovery of conformational epitopes, which are the highest quality
antigenic targets for vaccine development, as
well as rare antigens that are overshadowed
by immunodominant antigens but could
provide breakthrough protective immunity
when used as vaccines.”
“Juvaris will evaluate the resulting antigens for immunogenicity and efficacy in preclinical models of the appropriate infectious
disease,” Pickering adds. “Antigens which
confer protection following vaccination
will be evaluated for suitability for product
development.”
Keith B. Hoffman, head of business development at ADi, says the company is quite
happy to partner with Juvaris due to its
personnel, financial backers and impressive development history with vaccines and
related therapeutics.
“Juvaris has the entire vaccine development engine, ADi has the antigen content—a
perfect fit,” he says. “After screening thousands of patient samples, we have proven
the utility of our platform across multiple
infectious diseases. ADi’s antigen discovery
platforms leverage genomics and proteomics
advances to provide Juvaris with the most
comprehensive and powerful leads for their
vaccine formulations. We very much look
forward to working with Juvaris to discover
important antigens to facilitate not only vaccine development to prevent or treat disease,
responsible for development and
commercialization of RNAi therapeutic products.
With the extension of the alliance term, Novartis will continue
to fund collaboration research and
development efforts conducted by
Alnylam.
Novartis retains its rights and
conditions as per the original 2005
agreement. This includes a right to
Juvaris’ JVRS-100 candidate is one of many products in the pipeline that could benefit from Antigen’s system.
but also diagnostics to manage disease.”
According to Hoffman, the process distinguishes antigens that best stimulate the
immune system and are thus ideal targets
for vaccine and diagnostic development.
ADi has successfully identified and refined
more than 1,500 immunodominant and
serodiagnostic antigens via the screening of
thousands of human subjects across dozens
of pathogens.
“On ADi’s proteome chips, each specific
spot represents a known protein expressed
from a corresponding ORF expression plasmid,” he says. “Once a positive spot is identified, we know instantly which gene it is,
and what specific plasmid clone to use to
proceed to next validation step.”
Hoffman adds that they do not pre-select
or purify, and the entire proteome is mined.
“What this all means is that ADI’s discovery platform is the most effective and comprehensive way to screen immune responses against pathogen proteomes for vaccine
antigen discovery,” he says. “The technology
will also likely be useful in facilitating other
aspects of vaccine development, for exam-
exercise a non-exclusive platform
from Alnylam, in exchange for
certain payments due upon platform license exercise, as well as an
undisclosed payment and future
milestones and royalties.
Further, Novartis retains certain
rights to purchase Alnylam equity
up to its current ownership level,
which is approximately 13.4 percent. DDN
Alnylam CEO John Maraganore calls the continuing collaboration a “landmark alliance.”
ple; evaluating vaccine formulations and/
or adjuvants, designing vaccination protocols, pre-selecting and monitoring clinical
trial subjects, etc. As our relationship with
Juvaris yields vaccine leads, we hope that
the collaboration may expand into some, or
all, of the additional areas.”
Infectious diseases result in a quarter of
worldwide deaths each year. The majority
of diseases where vaccines have not been
developed to date are highly complex organisms that require novel technologies, such as
ADi’s, to facilitate discrimination of protective antigens from a large number of nonprotective antigens.
Juvaris currently boasts a robust pipeline
with two clinical development programs
employing its adjuvant, JVRS-100, that
Pickering says the company believes will
produce more effective seasonal and pandemic influenza vaccines.
“The seasonal flu vaccines available today
are largely ineffective in the elderly, as they
produce only modest antibody responses,”
he notes. “As a result, 90 percent of the mor-
patents
to build the kind of company we
aspire to be and ignore the health
needs of so many people in some
of the world’s poorest nations,”
Maraganore notes. “There are
leaders and turtles. Leaders stick
their necks out and turtles pull
them back into their shells. We
want to be a leader, and that means
finding your moral compass and
being willing to perhaps take a
little trade-off and face the potential goblins that come from putting
your IP out there for free.”
Alnylam will be providing
RNAi intellectual property, technology and know-how on a royalty-free, non-profit basis in “leastdeveloped countries” via licensing
agreements with qualified third
parties engaged in research efforts
focused on discovery of new medicines for NTDs and their distribution to least developed countries.
In the near term, Alnylam’s
RNAi technology is expected to
VACCINE continued on page 29
help validate novel drug targets for
the discovery and development of
treatments for the targeted NTDs.
For example, the technology has
already helped to identify new
targets for malaria treatments. In
the future, RNAi therapeutics may
themselves be developed and used
directly in the treatment of more
neglected tropical diseases. DDN
Alnylam researchers are pitching in to
help fight neglected diseases.
protein
VACCINE
didates with regard to therapeutic
interference for anti-tumor therapy as well as in in vivo diagnostic
imaging.”
Under the terms of the agreement, Bayer Schering Pharma will
pay Celera a one-time fee for the
exclusive access to the five targets.
Additional payments are due upon
achievement of certain development and commercial milestones,
and if a product is commercialized
Celera will be entitled to royalties
based on net sales of that product.
However, while it licensed the
in vivo diagnostic rights, Celera
retains in vitro diagnostic rights,
should the company decide to
develop and commercialize related
companion in vitro diagnostics
that are specific to therapeutic
candidates arising from Bayer
Schering Pharma’s program.
“We are not looking at pursuing
any kind of therapeutic targets,”
notes Dr. David Speechly, vice
president of corporate affairs at
Celera. “We are firmly focused on
molecular and in vitro diagnostics
for genomic, proteomic and other
applications. The potential power
of proteins as a diagnostic tool in
bidity and mortality that occurs
each year from flu translates into
tens of thousands of deaths due to
influenza. T-cell responses from
natural infection correlate with
protection from influenza in the
elderly. Our adjuvant has shown
the ability, in the clinic, to produce
T-cell mediated immunity, which
may result in the production of a
seasonal flu vaccine that would
protect the elderly.”
Moreover, Pickering points out
that the pandemic influenza vaccine that is stockpiled for a potential
avian flu outbreak requires multiple doses of large amounts of antigen and is not effective against the
strains of avian flu that have been
circulating for the past few years.
“ The CDC showed that our
adjuvant, when combined with
the stockpiled vaccine in preclinical studies, was able to confer single-dose protection against
the matched and drifted strains
(currently circulating) of avian flu
using less than 10 percent of the
current antigen,” he says.
Juvaris’ proprietary vaccine
pipeline consists to two highlypromising vaccines, including a
prophylactic HSV-2 Vaccine combining its adjuvant, JVRS-100,
with all of the critical antigens to
prevent viral entry at every critical
phase—initial attachment, receptor binding and fusion.
Juvaris also has a universal flu
vaccine combining its adjuvant,
JVRS-100, with conserved Flu A
and Flu B sequences to prevent
serious infection with whatever
circulating strains may exist from
year-to-year.
“Currently, seasonal flu vaccines
require annual modification in
anticipation of the upcoming circulating strains,” Pickering says.
“This predictive aspect results in
mismatched vaccine strains every
few years, which produces substantially higher morbidity and
mortality, which could be averted
with the incorporation of a universal flu vaccine.” DDN
Explaining Cheese.
A client asked OffWhite Salter to help improve their sales by explaining very technical cheese.
So we explained cheese. Now everyone understands and buys cheese. Can we explain anything for you?
We are firmly focused
on molecular and in
vitro diagnostics for
genomic, proteomic
and other applications.
The potential power of
proteins as a diagnostic
tool in diseases like
cancer is something
that we are quite
excited about.”
— David Speechly, V.P. of
corporate affairs, Celera
diseases like cancer is something
that we are quite excited about—
not just the ability to identify therapeutic targets but to do things like
more broadly determine disease
progress and monitor that.”
“This agreement combines the
strength of our novel proteomics
target discovery platform with
Bayer Schering Pharma’s expertise in research and development,” notes Dr. Steve Ruben, vice
president of proteomic research
at Celera. “We believe this new
relationship with Bayer Schering
Pharma allows us the flexibility to
advance part of our broad pipeline
of validated targets for additional
future value.”
The original discussions for the
licensing deal began with Bayer
Schering Pharma approaching
Celera based on the fact that the
latter company “owns know-how
and patent applications on several
innovative antibody target candidates for oncology and diagnostic
imaging,” Tychsen says. DDN
Specializing in Life Science Laboratory Equipment and Instrumentation Marketing Since 1985.
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research &
development
b r i e f s
Biogen Idec and Acorda sign
$500 million+ MS drug deal
CAMBRIDGE, Mass.—Biogen
Idec and Acorda
Therapeutics announced July 1 that they will
collaborate on Fampridine-SR, a novel, oral
sustained-release compound being developed
to improve walking ability in people with multiple sclerosis, in markets outside the United
States. Biogen Idec will assume clinical and
regulatory responsibilities for and commercialize Fampridine-SR and any aminopyridine products developed under the agreement in ex-U.S.
markets worldwide. Biogen Idec will pay Acorda
an upfront payment of $110 million, up to
$400 million in regulatory and sales milestone
payments and tiered, double-digit royalty payments. The door is also open for the companies
to carry out future joint development activities
under a cost-sharing arrangement.
THE Y’RE BONDED BY BLOOD
Catalyst Biosciences, Wyeth Pharmaceuticals
team up to treat hemophilia in collaboration
worth up to $500 million
By Lori Lesko
SOUTH SAN FRANCISCO, Calif.—Biotech innovator Catalyst Biosciences
Inc. has granted Wyeth Pharmaceuticals exclusive worldwide rights
to develop and commercialize CB 813, a recombinant human coagulation Factor VIIa, to treat and prevent acute bleeding in hemophilia
patients. The companies also teamed up for a two-year research
agreement to discover and develop additional Factor VIIa compounds.
The collaboration, announced June 30, includes an upfront pay-
LabCorp acquires Monogram
Bioscicences in all-cash deal
BURLINGTON, N.C. —Laboratory Corp. of
America Holdings, also known as LabCorp,
last month entered into a merger agreement
with Monogram Biosciences Inc. under which
LabCorp will acquire all of the outstanding
shares of Monogram in a cash tender offer for
$4.55 per share, for an implied total equity
value of approximately $106.7 million, or a total
enterprise value of approximately $155 million.
David P. King, Labcorp chairman and CEO, said
in a statement that Monogram Biosciences’s
excellent clinical reputation, market-leading
infectious disease test and companion diagnostic and exciting technology platform for
oncology offers LabCorp a substantial growth
opportunity.
blood continued on page 34
Catalyst Biosciences
inks $195 million
research pact with
AZ’s MedImmune
SAN FRANCISCO, Calif.—One week after heralding a new partnership with Wyeth Pharmaceuticals, Catalyst Biosciences has
unveiled a research and licensing agreement with MedImmune
worth up to $195 million in upfront fees, employee support
and milestones. MedImmune, the global biologics unit of
AstraZeneca PLC, has agreed to develop drug candidates
against two targets, one of which will address inflammatory
and autoimmune diseases.
Under the terms of the partnership, announced July 7,
MedImmune will support the discovery research and preclinical development of Alterase therapeutics against an
undisclosed target, with an option to expand the agreement
to include a second target. MedImmune, headquartered in
BioSante and Cell Genesys
sign merger agreement
LINCOLNSHIRE, Ill.—BioSante Pharmaceuticals
Inc. and Cell Genesys announced in July that
they have entered into a definitive merger
agreement by which the companies will merge
in an all-stock transaction, with BioSante as
the surviving company. Cell Genesys stockholders will receive 0.1615 of a share of BioSante
common stock for each share of Cell Genesys
common stock they own. Based on the companies’ closing stock prices on June 29, this
represents $0.347 per share of consideration
to be received by the Cell Genesys stockholders, or a total consideration of approximately
$38 million, and a premium of 12 percent to
the closing sale price of Cell Genesys’ common stock on that date. Upon completion of
the transaction, BioSante stockholders prior
to the merger are expected to own approximately 60.4 percent of the outstanding shares
of the combined company and the former Cell
Genesys stockholders are expected to own
39.6 percent.
ment of $21 million, with the potential to bring South San Francisco’s
Catalyst up to $40 million over the next two years. The ultimate
value of the deal, not counting any eventual royalties, could amount
to $500 million in research funding and milestone payments.
Based in Collegeville, Pa., Wyeth, one of the world’s largest research-driven pharmaceutical companies, has the option to
extend the two-year research portion of the collaboration for up to
three additional years. During the research term of the agreement,
Catalyst will receive support for up to 12 full-time employees.
The deal stipulates that Wyeth will be responsible for the development, manufacturing and worldwide commercialization of products
resulting from the collaboration. In addition, during the research
term, Wyeth would have the right of first negotiation to two other
Catalyst programs—one on Factor IX—which is in discovery, and
another on an undisclosed clotting factor discovered by Catalyst to
treat hemophilia and other bleeding conditions. Catalyst’s role in the
collaboration is to discover the compounds and conduct preclinical
development.
The lucrative venture is not expected to be compromised or
altered by Pfizer’s $68 billion merger with Wyeth in January. Catalyst
Biosciences CEO Nassim Usman remains confident that the terms of
the Wyeth partnership will stand.
“We feel pretty strongly that there will be good continuity going
forward following the Pfizer acquisition of Wyeth,” Usman says.
Bob Repella, executive VP and general manager, Wyeth’s biopharma business unit
pact continued on page 32
Antibody partnership has eggs-cellent potential
Morphotek partners with
Synageva BioPharma
to develop therapeutic
monoclonal antibodies
By Lloyd Dunlap
EXTON, Pa.—Using
its Synageva Expression
Platform (SEP) technology and related
expertise, Synageva BioPharma Corp. will
produce and develop a Morphotek therapeutic monoclonal antibody, states Dr.
Philip M. Sass, executive vice president and
chief operating officer of Morphotek Inc.
SEP is an integrated platform of proprietary
systems for protein production, processing and purification. Monoclonal antibodies
that result from the collaboration may have
potential for treatment of various forms of
cancer and infectious disease.
Morphotek, a subsidiary of Eisai Corp.
of North America, uses its proprietary
Morphodoma technology to generate fully
human antibodies, including antibodies
optimized for affinity and/or titer, targeted
against disease-associated antigens. The
company leverages its other technology,
morphogenics, to improve and enhance
the activity of the antibodies that are genantibody continued on page 34
Protein partners from opposite sides of the Pacific
California-based
Maxygen and Japanbased Astellas form
joint venture around
protein therapies
By Jeffrey Bouley
REDWOOD CITY, Calif. —Roughly
10 months after Maxygen Inc.
entered into an agreement with
Tokyo-based Astellas Pharma
Inc. for worldwide rights to commercialize the California-based
company’s MAXY-4 lead candidates for all autoimmune diseases
and transplant rejection, the two
entities have decided to establish
a joint venture focused on the discovery, research and development
of multiple protein pharmaceutical programs, including Maxygen’s
MAXY-4 program and other earlystage programs.
Maxygen will contribute substantially all of its programs and
technology assets in protein pharmaceuticals, including its existing
MAXY-4 collaboration agreement
with Astellas, together with $10
million in cash. In this joint venture, Maxygen would have an 83
percent ownership interest.
Astellas also will invest $10
million in the joint venture in
exchange for the remaining ownership interest in the joint venture of
approximately 17 percent. The deal
does allow for Astellas to acquire
all of Maxygen’s ownership interest in the joint venture if desired,
at specified exercise prices that
will increase each quarter from
$53 million to $123 million over the
three-year term of the option.
“This arrangement will allow
Maxygen to meet three very important goals,” says Russell Howard,
Maxygen’s CEO. “First, the development of our MAXY-4 program will
continue exactly as planned with
Astellas. Our partner Astellas is
well-suited for exploitation of nextgeneration CTLA4-Ig products in
both transplantation and various
autoimmune diseases. Second,
this agreement provides for up to
$30 million of new funding from
Astellas for several early-stage discovery programs using our core
MolecularBreeding platform technology. Third, this agreement creates a clear path for significant value
creation over the next few years.”
If Astellas does not exercise its
buy-out option before the threeyear option term expires, all rights
to the protein therapeutics developed through the joint venture
(with the exception of any product
for which Astellas has exercised
its license option) will be retained
by the joint venture, and Astellas
will be required to provide up to
18 months of transition funding
to the joint venture in the form of
revolving loans of up to $20 million
Howard notes. “Also, this transaction represents a key component of the corporate strategy we
announced last October.”
Under that strategy, Maxygen
reduce its spending on its MAXY-G34
product for the treatment of chemotherapy-induced neutropenia—
which reported positive results in
mid-July Phase IIa study in breast
cancer patients—while continuing
to seek a partner for that program,
on pre-agreed terms if the MAXY4 collaboration agreement between
the joint venture and Astellas
remains in force.
“This deal will allow us to shift
most of our protein pharmaceutical operating assets into a joint
venture that is substantially funded by Astellas. We believe this
venture provides us with the best
opportunity to capture value from
these assets for our shareholders,”
as well as terminate approximately 30 percent of its workforce in a
staggered fashion over the first four
months of this year.
Maxygen will retain the
MAXY-G34 program in its entirety and will not transfer it to the
joint venture, Howard notes. This
also means that the previously
announced licensing arrangement
with Cangene Corp. for acute radiation syndrome remains in place.
As a result of this joint venture
transaction, substantially all of
Maxygen’s research and development operations and personnel
would be transferred to the new
joint venture.
“We intend to restructure and
downsize Maxygen’s corporate and
administrative staff and expenses to best align the company’s
operations with its future busipacific continued on page 33
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A merger of equals in specialty diagnostics
Viracor merges molecular
diagnostic testing services
with IBT Laboratories’
focus on immunology
testing to create specialty
diagnostics company
By David Hutton
LEE’S SUMMIT, Mo. —ViraCor Laboratories
and IBT Laboratories announced recently
they will merge to form a specialty diagnostics company that will work with biopharmaceutical clients on research and development and clinical-trial testing.
Uniting the strengths of ViraCor and IBT,
the new company will have an enhanced
R&D infrastructure and broad scientific
proficiency that will allow it to create an
expanded menu of diagnostic tests to serve
the unmet needs of physicians, hospitals
and researchers in the immunology and
infectious disease arenas nationwide. The
company also will offer an extensive range
of services to biopharmaceutical clients
seeking support for discovery and clinicaltrial testing.
According to John Martin, president of
ViraCor, the companies share many values
and areas of expertise.
“Separately, our companies have become
market leaders in niche areas and enjoyed
significant growth over the last few years,”
says Martin, who will become president of
the combined company. “Both companies
have grown significantly the last few years
and this merger will allow ViraCor and
IBT to leverage each company’s individual
strengths in order to expand our presence
and broaden our services. ViraCor and IBT
have complementary areas of expertise and
complementary strengths. By joining forc-
es, the company can grow more quickly and
diversify the services we offer faster than we
could as separate companies.”
While financial terms of the deal were not
released, the merger of ViraCor and IBT creates a combined company with more than
200 employees that serves more than 4,000
physicians, hospitals, commercial laboratories and biopharmaceutical companies.
The new company’s broad test menu
includes cellular, immunology and allergy testing services as well as molecular
assays that detect and monitor microbial
pathogens.
ViraCor founder and CEO Phillip “Flip”
Short will step down from his role as CEO
and serve on the new company’s board. IBT
founder Dr. John Halsey will continue to
work with the new company as a consultant.
Dr. Laurence R. McCarthy, a venture partner at Ampersand Ventures who served as
executive chairman of IBT’s board of directors, will serve as executive chairman of the
combined company’s board of directors.
The combined company will operate out
of its two current laboratory facilities located 22 miles apart in Lee’s Summit, Mo., and
Lenexa, Kan.
“This deal was actually a merger of equals,
not an acquisition,” notes Maureen Loftus,
president of IBT, who will serve as chief
business officer of the combined company.
“ViraCor and IBT will not be eliminating
jobs. In fact, the goal is to continue to grow
the combined organization and consequently adding jobs to support that growth.”
Loftus also points out that ViraCor and
IBT share a dedication to unsurpassed client service as well to pioneering science that
addresses the unmet diagnostic needs of
countless patients.
“By combining our expertise and resources, we have created a company with an
unmatched commitment to patient care, a
PACT
Gaithersburg, Md., will be responsible for all development, manufacturing and commercialization efforts for
any products it discovers.
Alterases are next-generation proteases engineered by
Catalyst to cleave to and inactivate disease-causing proteins. While existing proteases—Botox, Xigris and blood
products Factor VII and Factor IX—act against a single
target, the disease target for Alterases can be changed
to potentially act against a range of diseases, explained
Catalyst Biosciences CEO Nassim Usman. Catalyst can
take those proteases and make them work more effectively so the targets can be changed and new diseases could
be targeted with Alterases.
“We are very pleased to add MedImmune, a leading
developer of biologic therapies, as a partner,” Usman
said in a company press release. “Our Alterase drug
discovery engine is creating novel next-generation protein therapeutics against a broad variety of important
disease targets. Collaborations such as this demonstrate the high value of our discovery and proteinengineering capabilities.”
Furthermore, the collaboration with Wyeth for the
treatment of hemophilia, announced June 30, and the
MedImmune partnership, announced one week later, along
with a $40 million round of venture financing last year,
gives Catalyst enough cash through 2013, Usman said. Both
deals provided new upfront capital to Catalyst, with Wyeth
paying $21 million in cash upfront, and MedImmune to pay
an undisclosed upfront cash payment.
“This deal was actually a merger of equals,
not an acquisition. ViraCor and IBT will
not be eliminating jobs. In fact, the goal
is to continue to grow the combined
organization and consequently adding
jobs to support that growth.”
— Maureen Loftus, president of IBT Laboratories
rich diagnostic test menu, and deep R&D
capabilities that will continue to set new
standards for quality service and science in
the clinical laboratory industry,” she says.
The deal didn’t happen overnight, though.
Loftus notes that conversations between the
companies have been occurring informally
for several years, though talks specific to
this merger began in earnest late in 2008.
“We have discussed merger and acquisition opportunities with other companies in
the past, but none related or linked to this
merger,” she adds.
Both Loftus and Martin agree that the most
important goal of the combined company is
to continue providing exceptional customer
service and ensuring its customers’ needs are
being met by developing high-quality assays
and unique tests that improve patient care
and better the overall healthcare landscape.
“We also will be working to thoroughly
integrate our companies while continuing
to grow our immunology and allergy and
infectious disease test menus in the months
to come,” adds Martin. “In fact, ViraCor and
IBT have several new assays in development
right now. Additionally, we are looking forward to introducing our clients them to our
expanded menu of tests and scientific expertise.”
Martin also points out that by joining
forces and marrying the companies’ respective scientific expertise, ViraCor and IBT can
grow more quickly and diversify their services and test menu faster than they could as
separate companies.
“In addition, the combined company can
have a greater impact on patient care and
science, and offer even greater value to our
clients nationwide,” he adds.
Established in 2000, ViraCor specializes in infectious disease testing and working with patients who have compromised
immune systems. IBT was established in
1983 and has developed tests for allergies
to roughly 900 substances, including eggs,
peanuts and milk.
Combined, Loftus says success of the
merged companies will be measured in continued growth over the next several years.
“We plan to achieve this goal by continuing to meet and exceed client expectations
by developing new assays that will help
our physicians and hospital partners better
serve their patients,” she says. DDN
We have no plans to take additional
venture funding. At the moment,
we’re going to focus on the existing
collaborations and our internal programs,
too, of course. While the deals are
enormous for us, they are in the early
stages of development and we can’t say at
this point, the impact these collaborations
will have on Big Pharma.”
— Nassim Usman, CEO, Catalyst Biosciences
Catalyst’s latest collaborations are part of a larger partnering strategy that includes a partnership with Wyeth’s
pharmaceutical division, formed in 2007, for its Alterase
therapeutics platform. In addition, Catalyst partnered
with Centocor Research & Development Inc. in 2008 for
the development of two Alterase drug candidates.
These lucrative deals, all flush with cash, means
Catalyst, a private company with 50 employees, may not
have to raise venture capital funding again in the future.
“We have no plans to take additional venture funding,” Usman said. “At the moment, we’re going to focus
on the existing collaborations and our internal programs, too, of course. While the deals are enormous for
us, they are in the early stages of development and we
can’t say at this point, the impact these collaborations
will have on Big Pharma.” DDN
The partnership with MedImmune, along with a recently announced deal with
Wyeth and a recent financing round, gives Catalyst funding through 2013, notes
Catalyst CEO Nassim Usman.
elan
(ACC-001) is also under development.
The transaction is expected to close in
the second half of 2009, pending regulatory
approvals. Both companies’ boards of directors have approved the deal.
For J&J, the deal is inherently risky, but
also potentially very lucrative, with no available treatments to stop or reverse brain
damage caused by Alzheimer’s disease currently on the market—one estimated to have
roughly 5.3 million patients in the United
States and more than 100 million worldwide
expected eventually as the population ages.
“This transaction will be a key component
in achieving our vision to develop treatments
that target underlying disease biology, there-
progression of Alzheimer’s disease.”
According to Bob Purcell, director of corporate relations for Elan, the deal was part
of a strategic review the company launched
in January to seek partners and minority
investors to help it reduce debt, cut costs and
increase profits.
The J&J deal will help Elan reduce its net
debt by 70 percent to $400 million, help cut
costs by $100 million annually, and enable it
to make a pre-tax profit by the end of next
year, Purcell says.
“We talked to about 30 companies, most
of which were major players in pharma,” he
says. “Many companies were interested in us
because of our pipeline. Specifically, we were
looking for a partner with financial resources, scientific or development expertise, and a
commercial reach in the global marketplace.
We talked to about 30 companies, most of
which were major players in pharma. Many companies
were interested in us because of our pipeline.
Specifically, we were looking for a partner with financial
resources, scientific or development expertise, and a
commercial reach in the global marketplace. J&J ticked
off all those boxes. The agreement with J&J provides Elan
with significant financial flexibility and the resources to
further invest in and accelerate the development of our
pipeline. We are confident this will enable Elan to move
into an exciting new phase focused on defining the future
of degenerative neurological therapies.”
— Bob Purcell, director of corporate relations for Elan
by helping to prevent some of society’s most
devastating illnesses,” said Dr. Husseini
Manji, global therapeutic head of neuroscience at J&J’s R&D division, in a statement.
“We expect to focus our resources on bringing the AIP Program to fruition as quickly as
possible because of its potential to slow the
pacific
ness needs,” says Isaac Stein, the executive chairman of the board of directors of
Maxygen. “As a part of this process and
following an appropriate transition period after the closing of the joint venture
transaction, we also expect Maxygen’s
current senior management team—Russell Howard, Larry Briscoe and Elliot
Goldstein—will be leaving the company.”
However, Grant Yonehiro, Maxygen’s
chief business officer, is expected to serve
as CEO of the joint venture.
In addition to securing a majority ownership of the joint venture and retaining the MAXY-G34 program, Maxygen
will continue to retain a number of other
assets, including approximately $200
million in cash, 22 percent ownership
interest in Codexis Inc. and a revenue
stream from Maxygen’s biofuels license to
Codexis. The company is also still eligible
for a potential $30 million milestone payment from Bayer HealthCare LLC as well
as the MolecularBreeding platform and
intellectual property portfolio, including
certain additional fields of application of
J&J ticked off all those boxes. The agreement with J&J provides Elan with significant financial flexibility and the resources to
further invest in and accelerate the development of our pipeline. We are confident this
will enable Elan to move into an exciting
new phase focused on defining the future of
“This deal will allow us to
shift most of our protein
pharmaceutical operating
assets into a joint venture
that is substantially
funded by Astellas.
We believe this venture
provides us with the best
opportunity to capture
value from these assets
for our shareholders.”
— Russell Howard CEO, Mayxgen
the technology platform that have not yet
been licensed, and a fully funded vaccine
discovery program.
Assuming that all the customary closing conditions take place, the two companies expect the joint venture transaction
to close late in the third quarter of this
year or early in the fourth quarter. DDN
degenerative neurological therapies.”
The AIP program was attractive to J&J
because of its advanced development stage,
Purcell adds. In particular, bapineuzumab—
one of five Alzheimer’s disease candidates
Elan is pursuing—was an attractive program to J&J because of its unique approach
to treating Alzheimer’s disease, he says.
“The thing that is interesting about this
drug is that it has the potential to be a disease-modifying product,” Purcell says.
“While other approaches treat Alzheimer’s
disease symptomatically, this is the first
product that will actually modify the course
of the disease. It is an orally administered,
passive therapy infusion that puts antibodies into a patient’s system. It interferes
with beta-amyloid forming plaques that
are believed to underlie Alzheimer’s disease neuropathology, and prevents it from
creating a tangle. This is a really exciting
opportunity for Elan, and J&J is a strong
partner who will has the resources to help
move bapineuzumab forward.”
Although the two companies’ stocks
responded differently to the announcement—Elan’s have spiked, while J&J’s have
slumped—analysts called the deal a win-win
for both companies.
“It’s good news for Alzheimer’s patients
and their families,” said Erik Gordon, an
analyst and professor at the University of
Michigan’s Ross School of Business. “For J&J,
it looks like a high-risk but reasonable bet.”
Citing generic competition, sluggish pipelines, pending healthcare reform proposals
and the economic recession, analyst Steve
Brozak of WBB Securities agreed: “J&J
needed to do this,” he said.
Some investors may still be nervous given
Elan’s partnership with Biogen to market Tysabri, a multiple sclerosis drug that
was pulled from the market in 2005 and
relaunched a year later. Just last week, the
drug was linked to a tenth case of the rare
brain infection progressive multifocal leukoencephalopathy, or PML.
However, the bad news about Tysabri
appears to be baked into the stock, as it is
a well-known risk, said Barron’s writer
Teresa Rivas.
“For Elan, it goes without saying that
partnering with the most respected company in the world is a boon, especially one with
the financial heft to endure a deep recession,” Rivas wrote. “And with a near-even
split of the profits, it stands to reap many of
the same benefits as J&J if its Alzheimer’s
drugs can deliver. Ultimately, J&J and Elan
have struck a deal that’s beneficial to both,
and may launch the companies to the forefront of a market that is growing around
the world. For uncertain times, these shares
may well be a remedy.” DDN
DDN
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story in DDN, you’ll find an
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antibody
“[Morphodoma]
starts with human
antibodies,
and it does not
manipulate the
antibodies in vitro
or convert mouse
antibodies to
human antibodies
We are always
exploring new
ways that may
enhance the
manufacturing
process for our
antibody products
as a means to
fulfill Eisai’s
human healthcare
mission.”
erated by the Morphodoma technology,
Sass explains.
“Unlike other technology, Morphodoma
starts with human antibodies, and it does
not manipulate the antibodies in vitro or
convert mouse antibodies to human antibodies,” Sass says. “We have a rich pipeline
of antibody products such as MORAb-003,
or farletuzumab, for ovarian cancer in Phase
III, MORAb-009 for pancreatic cancer in
Phase II and MORAb-004 that is pan-cancer
specific in Phase I. We are always exploring
new ways that may enhance the manufacturing process for our antibody products as
— Dr. Philip M. Sass,
executive vice
president and
chief operating
officer of
Morphotek
Working toward
a better future
So are we.
quality
health
selection
delivery
Diabetes. Heart disease. Cancer.
Every dollar spent on JAX® Mice & Services is an investment
in our shared future. It supports our common research goals
and helps to sustain the many valuable mouse models and
resources available only from The Jackson Laboratory.
Ask for the
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1-800-422-6423
support
More Info @adv-connect.com
JacksonLaboratory_thirdpg_DDN.indd 1
es such that our vectors presently express
protein at ~5 g/L and are set to reach ~10
g/L later this year.
“Since egg white is an extremely stable,
protein-friendly environment, it enables
development of potential therapeutic proteins that are difficult to effectively express
with other technologies,” Joshi continues.
“In addition, certain proteins expressed
through SEP have advantageous glycosylation patterns with respect to their potential
activity. For example, Synageva and its partners will be able to develop and commercialize next-generation monoclonal antibodies (mAbs) with glycosylation patterns that
increase ADCC activity up to 100-fold—thus
increasing potency and potentially efficacy
for oncology targets; novel therapeutic proteins for orphan diseases without available
therapies; and next generation and follow-on
cytokines, with certain compounds possessing significantly superior activity profiles.”
Morphotek’s Sass notes that the company
has extensive collaborations with investigators at leading corporate and academic
institutions and a deep portfolio of antibodies for possible development and licensing in several therapeutic categories. The
company develops protein and antibody
products through the use of novel and proprietary technologies. These technologies
have been successfully applied to a variety
of molecules that are suitable for pharmaceutical product development in the areas of
antibody therapeutics, protein therapeutics,
product manufacturing, drug target discovery and improved output traits for commercial applications.
The company is currently focusing its
platform on the development and manufacturing of therapeutic antibodies for the
treatment of cancer, inflammation and infectious disease. DDN
— A.J. Joshi, senior V.P. of
Synageva Medical Operations &
Commercial Development
etary SEP is its ability to express almost any
biopharmaceutical protein, Joshi says.
“Our team begins by sequencing the
human protein of interest and designing
constructs whereby this sequence is inserted alongside a customized, tissue specific
promoter,” he says. “The unique combination of the vector and promoter drives
expression of the protein of interest in egg
white. Synageva’s research team continues
to make unprecedented scientific advanc-
BLOOD
Pfizer’s commitment to furthering its
biotech aspects were made clear in April,
when it named Wyeth’s R&D chief, Mikael
Dolsten, as head of the proposed merger’s
biotherapeutic’s research group, Usman
says. Dolsten has referred to the collaboration with Catalyst as an “excellent fit,” which
provides the opportunity to expand Wyeth’s
hemophilia franchise.
Usman stated in a company press release
that Catalyst is “thrilled to join forces with
Wyeth, a biopharmaceutical company at the
forefront of both hemophilia treatment and
the development and commercialization of
biologic therapies. This collaboration highlights the value Catalyst has created in our
Factor VIIa portfolio of products. Revenues
generated from research collaborations such
as this one allow us to continually expand
and support existing discovery efforts
around bleeding disorder product candidates and the engineering of new Alterase
therapeutic products.”
In April, Wyeth reported that its three
hemophilia products on the market, Xyntha,
ReFacto and BeneFIX, produced $206 million in worldwide sales revenue during the
first quarter of 2009, down 14 percent from
one year prior.
Wyeth’s expertise made for the ideal partner in this venture, as well as Wyeth’s longstanding commitment to developing biologics, Usman says. Wyeth’s financial terms
may have made the deal too good to refuse.
This is actually the second collaboration
between the two companies. Catalyst and
Wyeth first partnered up in January 2007 to
discover and investigate potential therapies
for oncology and metabolic disease.
Bob Repella, executive vice president
and general manager of Wyeth’s biopharma
business unit, says Wyeth was attracted to
the collaboration “because of its advanced
technology in protein engineering, and their
work on CB 813, one of Catalyst’s Factor VIIa
variants. Wyeth brings an established franchise for hemophilia A and hemophilia B,
and has extensive expertise and resources in
biological manufacturing, hemophilia clinical programs, regulatory expertise and commercialization of hemophilia products and
biologics in general.”
In addition to CB 813, “Catalyst brings
technology and know-how for identifying,
modifying and characterizing proteases,
including catalytic activity, altered specificity, resistance to inhibitors, enhanced or
reduced co-factor dependence and increased
pharmacokinetic or pharmacodynamic
activity,” Repella says.
“About one in 5,000 males is born with
hemophilia A, and about one in 30,000
males is born with hemophilia B,” Repella
notes. “According to the World Federation of
Hemophilia (WFH), an estimated 400,000
people worldwide are living with hemophilia. Only 25 percent receive adequate treatment. The WFH is striving to close this gap.
In the United States, the CDC estimates that
18,000 individuals—primarily males—live
with hemophilia.”
The Catalyst/Wyeth collaboration has
the potential to develop therapies to not
only effectively treat hemophilia patients,
but other bleeding conditions, as well,
Repella says. This includes people who suffer profuse bleeding as a result of surgery
or trauma. DDN
Morphotek is one of
the leaders in the
antibody space with
their high affinity
antibodies against a
variety of targets.”
a means to fulfill Eisai’s human healthcare
mission.”
Synageva and Morphotek initiated discussions earlier this year, notes Dr. A.J. Joshi,
senior vice president of Synageva Medical
Operations & Commercial Development.
“Morphotek is one of the leaders in the
antibody space with their high affinity antibodies against a variety of targets,” he states.
“SEP is an ideal platform for antibodies,
both neutralizing antibodies and in particular antibodies that work by killing their
targets (high ADCC or cytotoxicity) such
as antibodies for various cancers. We are
looking forward to a fruitful and long-term
relationship with Morphotek.”
The fundamental strength of the propri-
4/9/09 8:01:19 AM
The Strongest Faculty and Most Leading Edge Science
of Any Protein Engineering Conference
IBC Celebrates the 20th Annual International Conference
Antibody Engineering
Antibody Engineering and Immunotherapeutics
for the 21st Century
December 6-10, 2009 • Sheraton San Diego Hotel and Marina • San Diego, CA
Sessions for 2009:
Co-Located with
IBC’s 7th Annual International Conference
Antibody Therapeutics
December 8-10, 2009
Sessions for 2009:
• Antibody Repertoires and Responses
• Antibodies in a Complex Environment
Delegates may
• Antibodies – Not Just for Injection
attend the sessions of
• Antibody Polyspecificity and Single
both conferences and
Molecule Imaging
select from more than
• Bispecific Antibodies and
100 speaker
Antibody Combinations
presentations.
• Expanding our Grasp and Use of Binding Sites
in the Human Immune System
• Exploring the Limits of Tumor Targeting with
Molecular Formats
• Engineering Antibodies to Improve Cancer Therapy
• Pre-Conference Workshop: Working with IMGT
and other Ab Sequence Databases
• Business, Regulatory and
Intellectual Property
• Preclinical Development of
Antibody Therapeutics
• Clinical Development: Cancer
• Clinical Development: Alzheimer’s
and Others
• Clinical Development:
Autoimmune Diseases
• Clinical Development:
Inflammation and Infection
• Join the More than 700 International Delegates at the Original Annual Protein Engineering Meeting
• Learn from a Leading International Faculty of more than 100 Speakers
Keynote Presentation
Human Antibodies in Immunity and Tolerance
Michel Nussenzweig, M.D., Ph.D.,
Investigator, Howard Hughes Medical Institute, Sherman Fairchild Professor
and Senior Physician, The Rockefeller University
Call for Posters and Student Poster Competition
Share scientific progress from your lab with other attendees at this meeting – and support the education and professional development of students
with the Student Poster Competition. Get more details on how to submit your poster abstract at www.IBCLifeSciences.com/antibodyeng
• Learn from a leading international faculty of more than 100 speakers
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Register Today: www.IBCLifeSciences.com/antibodyeng
Use priority code: D9172DDN
D9172 DDN TabAugust.indd 1
7/24/09 4:17:33 PM
Sensitive and precise tool for
measuring endogenous
kinase activity
PerkinElmer Inc.
The AlphaScreen SureFire technology
is a precise assay that is sensitive
enough to measure basal activation
in primary cells expressing endogenous levels of kinase or receptor
target. The cell-based assay platform
provides a reliable tool for direct
measurement of endogenous receptor activation, and can also be used
to assess responses to intracellular
kinase inhibitors. The homogeneous
nature of this technology allows highthroughput analysis of kinase signaling pathways and can be used to
identify drugs that modulate kinase
activity.
PerkinElmer Inc.
781-663-6900
www.perkinelmer.com
Microarray system advances
process for HLA in stem
cell and solid organ
transplant research
Invitrogen, part of Life
Technologies Corp.
Invitrogen, part of Life Technologies
Corp., has announced the commercial availability of a state-of-the-art,
automated, research-use microarray
system designed to simplify immunogenetic testing, including human
leukocyte antigen (HLA) research. The
new Prodigy system is an advanced
DNA and protein analysis tool that
simplifies and accelerates histocompatibility research, vaccine and drug
development, and disease association studies. The Prodigy system is
a high-throughput, next-generation,
sequence-specific oligonucleotide
probe system that streamlines sample workflow for hybridizing, detecting
and analyzing HLA markers in largevolume variation analysis and genotyping research studies. The Prodigy system has five times the density capacity of current bead-based assays and
is enabled by push-button, walk-away
automation, enabling researchers to
spend valuable time reviewing data
or preparing more samples. Prodigy
is inherently scalable to include multiplexing capability for more than 500
analytes, while providing high resolution, efficiency and reliability. It is also
capable of industry-leading throughput
that equates to approximately 290
genotypes in nine hours, and includes
integrated software that simplifies
data analysis and interpretation.
Invitrogen, part of Life Technologies Corp.
800-955-6288, Option 3, Ext. 46029
www.invitrogen.com
Perform a wide range of in
vitro ADME assays with
24-hour, unattended operation
BioTrove
The newest addition to the RapidFire
instrumentation por tfolio, the
RapidFire 300 system, enables
researchers to perform a wide range
of in vitro ADME assays with 24-hour,
unattended operation. The RapidFire-
MS system streamlines drug discovery workflow, significantly decreasing
the processing time compared to
conventional MS-based technologies
and helps to eliminate bottlenecks in
drug discovery while providing accurate results for data-driven decision
making. RapidFire 300 can fully integrate with any manufacturer’s triple
quadrupole mass spectrometer and
provide data compatible with customers’ existing laboratory information
management systems. The RapidFire
300 system can be used for a variety
of in vitro ADME applications, including CYP inhibition, metabolic stability, p-glycoprotein inhibition, plasma
protein binding, permeability assays
(Caco, PAMPA) and CYP Induction.
BioTrove
781-721-3600
www.biotrove.com
Automated vial
weighing station
Matrical Bioscience
Matrical recently launched the Vial
Weighing Station, a module that offers
a single-vial capture mechanism to
weigh up to 210 grams of liquid, solids or powders. This station boasts
interchangeable adapters to allow for
different size vials (2mL, 8mL, 20mL,
etc.). It may be integrated into the
reformatting module of Matrical’s
Ministore automated sample storage, management and retrieval system or AutoMAP Automated Assay
Platform. This module enables vials
to be weighed as they are processed
in either system and the data is correlated with initial tare weight to speed
the inventory control process for
samples. This design reduces manual weighing steps and ensures accurate accounting for these precious
samples. When used within these
systems, this Sartorius weigh cell is
automatically calibrated. Turnaround
time is quick at 4 seconds per vial.
Matrical Bioscience
509-343-6225
www.matrical.com
Sensors for real-time
multiplex protein biomarker
detection
Axela Inc.
Axela Inc. has introduced panelPlus
Multiplex Sensors and an introductory
assay menu for oncology, cardiology
and infectious disease research. This
assay format provides the industry’s
first real-time, user-configurable multiplex assays. The kits provide the
freedom to combine ready-to-use panelPlus Analytes with the researchers’
own targets without increasing sample consumption. Biomarker discover-
new products
ies can now be analyzed with existing
markers to facilitate both validation
and routine analysis of new panels.
Axela Inc.
866-942-9352
www.axela.com
Assay kits for measuring
beta-galactosidase activity
AnaSpec
AnaSpec has released three new
assay kits for measuring beta-galactosidase activity: the SensoLyte MUG
beta-Galactosidase Assay Kit (Ex/
Em= 360/460 nm); the SensoLyte
FDG beta-Galactosidase Assay Kit
(Ex/Em= 490/520 nm); and the
SensoLyte ONPG beta-Galactosidase
Assay Kit (Abs=420 nm).
AnaSpec
408-452-5055
www.anaspec.com
Freeze dryer for busy
laboratories constrained by
available space
SP Industries Inc.
For busy laboratories constrained
by available space, the VirTis Ultra
Freeze Dryer from SP Industries Inc.
offers up to 2.13 square meters (22
square feet) of useable shelf area in a
compact footprint of just 1.13 square
meters (12 square feet). Designed for
R&D and light manufacturing applications such as tissue banking, ceramics processing, lyophilisation of microtitre plates and diagnostic reagents,
the Ultra delivers high efficiency at a
low operating cost. Available with 25,
dling, Twister II for microplate handling, LabChip GXII for microfluidic
protein characterization, and various
accessories for complete workflow
automation. The LabChip GXII is
Caliper’s high-throughput system for
analyzing protein size, concentration
and purity and serves as a replacement for traditional polyacrylamide
gel electrophoresis (PAGE).
Caliper Life Sciences Inc.
508-435-9500
www.caliperls.com
Fast, easy, reliable microplate
sealing
Agilent Automation Solutions
The PlateLoc Thermal Microplate
Sealer from Agilent Automation
Solutions offers speed, a small footprint, ease of use and dependability,
automatically accommodating deep
well, assay, PCR and compound storage microplates. The PlateLoc Sealer
is ideal for robotic integration, featuring an extended-travel plate stage,
RS-232 serial port and ActiveX control. In order to minimize system
downtime when replenishing consumables, the instrument features
an easy-to-access, top-loading seal
roll support. Three different types of
interchangeable sealing material are
available from Agilent Automation:
peelable, pierceable or clear, enabling
an optimized solution to be provided
for a wide variety of applications.
Agilent Automated Solutions
408-553-2424
www.velocity11.com
High-performance, spherical
media columns offer
resolution with speed
Teledyne Isco
Teledyne Isco announces the introduction of RediSep Rf Gold highperformance silica columns, giving
organic chemists the flexibility to run
purifications optimized for resolu-
35 and 50 litre condensers, the Ultra
can be configured with a wide variety
of options that are customizable for
each application. The Ultra is sized
specifically for the solvent load, reducing the need for specialized utilities
and HVAC capacity.
Caliper Life Sciences Inc. has
launched the Staccato Protein
Workstation to address bottlenecks
in the characterization of biological
therapeutics and biogenerics caused
by increased sample requirements of
quality by design (QbD) parameters.
The system incorporates the Sciclone
ALH 3000 for automated liquid han-
Teledyne Isco
800-228-4373
www.isco.com
Primers for PCR and DNA
sequencing
Eurofins MWG Operon
Eurofins MWG Operon is now offering
PCReady primers to life science companies and academic research institutions in the Americas. PCReady primers offer Eurofins MWG Operon customers a way to streamline the ordering and procurement process of PCR
and sequencing primers from 15-29
bases in length. PCReady primers can
be designed with the Primer Design
Tool and ordered online. Eurofins
MWG Operon delivers 20 nmol of
desalted primer that is dried and
ready for buffer addition. Available at
a flat rate price of $4.90 per PCReady
primer, regardless of length.
Eurofins MWG Operon
800-688-2248
www.operon.com
Multiplex assay for analysis
of heat shock proteins
Assay Designs Inc.
Assay Designs Inc. has announced
the release of the first commercially
available multiplex assay dedicated
to the analysis of heat shock proteins and molecular chaperones, the
MultiBead HSP/Chaperone 8-Plex
Kit. The bead-based multiplex immunoassay enables measurement of
HSP client proteins (Akt and Akt
phosphor-Ser473) and HSPs (Hsp27
phospho Ser15, Hsp27 phosphoSer82, Hsp40, Hsp60, Hsp70 and
Hsp90 alpha) in cell lysates. The
assay utilizes monoclonal antibodies
or antigen affinity purified polyclonal
antibodies covalently coupled to latex
beads. The detection antibodies are
conjugated to biotin followed by a
streptavidin-PE conjugate and analyzed on a dual-laser flow cytometer.
The HSP/Chaperone panel provides a
sensitive, rapid and specific method
for accurately determining analyte levels in cell lysates.
Assay Designs Inc.
800-833-8651
www.assaydesigns.com
SP Industries Inc.
800-431-8232
www.virtis.com
Workstation for automated
protein sample preparation
and analysis
Caliper Life Sciences Inc.
uses the same method settings as a
standard column on most flash chromatography systems—simply replace
your column with a higher performance Rf Gold silica column.
tion or optimized for speed. Utilizing
patent-pending small, spherical silica
media, RediSep Rf Gold columns
allow you to run your separations in
two different modes, Gold Resolution
or Gold Speed. Gold Resolution mode
is used for closely eluting compounds
that don’t typically separate on standard flash-grade silica gel columns.
The media can handle difficult purifications such as trace compounds
and isomers. Gold Resolution mode
LC technology that
dramatically increases
laboratory productivity
Thermo Fisher Scientific Inc.
Thermo Fisher Scientific Inc. has
announced the expansion of its
quaternary solvent delivery systems
with the release of the Accela 600
For
For more
more information,
information, visit
visit www.DrugDiscoveryNews.com
www.DrugDiscoveryNews.com
HPLC and Accela 1000 U-HPLC. The
new systems are designed to enable
rapid method development while significantly reducing solvent consumption. Both Accela systems feature
innovative Force Feedback Control
(FFC), which enables the delivery
of accurate and precise gradients
under all operating conditions. This
provides the flexibility of quaternary
solvent delivery with unparalleled performance for HPLC and U-HPLC applications. These systems complement
the full range of Thermo Scientific
mass spectrometers.
Thermo Fisher Scientific
800-532-4752
www.thermo.com
Compact, affordable flow
cytometer allows scientists
to conduct complex cell
analysis at their benchtops
Millipore Corp.
Millipore Corp. has announced the
launch of the new guava easyCyte
8HT flow cytometry system. This
compact, affordable, six-color detec-
tion system with 96-well automation allows scientists to move their
research out of the core lab into their
own lab. The guava easyCyte 8HT
six-color detection enables researchers to carry out highly multiplexed
experiments in which six targets and
eight parameters can be simultaneously analyzed in a single sample of
cells. The six-color detection range
also gives researchers greater freedom to choose fluorescent dyes with
well-separated emission spectra,
which reduces the chance of overlap
in the resulting signals and improves
data quality.
Millipore Corp.
978-715-4321
www.millipore.com
Complete top-down biomarker
discovery workflow
Bio-Rad Laboratories Inc.
Bio-Rad Laboratories Inc. has
launched the Lucid ID Access Pack,
the first product designed for the
Lucid Proteomics System, a proteomics solution in development by Bio‑Rad
and Bruker Corp. that will combine Bio-Rad’s ProteinChip surfaceenhanced laser desorption/ionization
(SELDI)-based array technology with
Bruker’s ultrafleXtreme MALDI-TOF/
TOF mass spectrometer, enabling
researchers to use both top-down and
bottom-up proteomics approaches for
biomarker discovery on the same
system. A distinct advantage of the
Lucid ID Access Pack is the ability
to identify peptides under 4 kilodaltons directly on a ProteinChip array
after a simple, one-step enrichment.
Identification of proteins and peptides
over 4 kilodaltons that require trypsin
digestion is demystified by following
Bio‑Rad’s Biomarker Purification and
Identification Guide and by using
ProteinChip arrays in conjunction with
Bruker’s ultrafleXtreme MALDI-TOF/
TOF, which has been optimized for the
ability to read ProteinChip arrays. This
new high-performance system delivers the resolution required for rapid,
high-confidence protein identification.
For convenience, the Lucid ID Access
Pack is also backwards-compatible
with other Bruker autofleX and ultrafleX MALDI TOF/TOF systems.
Bio-Rad Laboratories Inc.
510-724-7000
www.bio-rad.com
Microfluidic perfusion
for live cell imaging
CellASIC
CellASIC has introduced the ONIX
Microfluidic Perfusion System, delivering a better method to culture cells
on the microscope stage and control real-time media perfusion during
live cell time-lapse experiments. The
instrument’s easy-to-use format and
performance allows any user to run
live cell imaging experiments with
confidence. Cutting-edge microfluidics
enable precise changeover between
media solutions, parallel experiments
for cost-efficient data collection and
high-quality CO2/temperature control. Cell migration and chemotaxis
studies are also made possible by a
proprietary chemogradient. The ONIX
adds on to your existing microscope.
CellASIC
510-895-1985
www.cellasic.com
Fast and efficient PARP
inhibitor screening
BMG LABTECH GmbH
BMG LABTECH’s FLUOstar Omega
has been proven to be an important
tool in the screening of PARP inhibitors. This multidetection microplate
reader is able to perform the complex
assays needed for the evaluation of
PARP inhibitors. The capability of the
FLUOstar Omega to read numerous
detection modes including fluorescence, luminescence and absorbance,
facilitates simple and rapid measurement of all aspects of PARP inhibitor
evaluation using a single machine.
BMG LABTECH GmbH
919-806-1735
www.bmglabtech.com
Easy, controlled cell freezing
BioCision LLC
BioCision LLC has launched CoolCell,
a cooling device that achieves controlled cell freezing of biomedical
samples at -1 degree Celsius per
minute without the use of alcohol.
CoolCell’s Solid State Core and insu-
new products
AUGUST 2005
2009 • Drug Discovery News 37
NOVEMBER
lated design precisely control heat
removal during freezing to ensure
repeatable, constant rate cooling
down to cryogenic storage temperature. Unlike current cell freezing
methods, CoolCell works without
alcohol and retains a constant cooling rate, resulting in a reliable and
consistent -1 degree Celsius per minute freeze rate every time. CoolCell
can be used again minutes after a
freeze cycle, eliminating hours of
waiting time between cycles. CoolCell
requires no maintenance and holds
up to 12 cryotube samples.
BioCision LLC
888-478-2221
www.biocision.com
Faster, safer and
cleaner reactions
Syrris
Africa is a range of fully automated,
flexible and easy-to-use microreactor flow systems. The Africa system
allows R&D chemists working in discovery and process development to
accelerate compound synthesis and
reaction optimization. Fully automated hardware is controlled by the Africa
software to enable unattended runs.
Reagents are injected and products
are collected automatically. Increase
reaction rates more than one hundred-fold by superheating reactions
significantly above reflux e.g. dichloromethane to 100 degrees Celsius,
acetonitrile to 150 degrees Celsius
and water to 170 degrees Celsius.
Reduce impurities via reproducible
reaction control and optional use of
solid phase reagents, catalysts or
scavengers. The Flow Liquid Liquid
Extraction Module (FLLEX) enables
two immiscible phases to be mixed
and separated in flow, immediately
following the reaction. A sample of
reaction mixture can be taken,
diluted and analyzed by HPLC in an
entirely automated fashion. Excellent
correlation with shake flask method.
Only small amounts of material react
at any time, minimizing exotherms
and the quantity of any hazardous
intermediates.
Syrris
617-848-2997
www.syrris.com
Entry-level acid-resistant
evaporator
Genevac Ltd.
The EZ-2 HCl Evaporator from Genevac
provides laboratories with an efficient
and safe means of routinely removing
strongly acidic chemicals from their
samples. Incorporating Genevac proven market-leading centrifugal evaporation technology in a compact and
easy-to-use benchtop model, the EZ-2
HCl can routinely handle 6N HCl solutions. The innovative design of the
EZ-2 HCl presents real advantages
for all chemists faced with removing
both regular solvents and strongly
acidic chemicals. Intuitive controls
and large LCD display provide ease
of use comparable to a typical rotary
evaporator yet the EZ-2 HCl can process many more samples per unit
time. Smart evaporator software provides true walk-away automation so
and carboxyl surfaces utilize a proprietary thin-film coating technology to
produce a uniform, functionalized surface for cell culture.
BD Biosciences
201-847-6800
www.bd.com
Simple, rapid assay offers low
enzyme consumption
Cisbio Bioassays
The new HTRF SIRT1 assay, developed
by Cisbio Bioassays using its patented
HTRF technology, is a homogeneous
method for directly measuring SIRT1’s
deacetylation activity. This simple and
rapid assay offers the advantage of
very low enzyme consumption compared to other conventional assays.
The HTRF SIRT1 assay now enables
the identification of both inhibitors
and activators of SIRT1 activity, and
also discriminates polyphenolic compounds.
Cisbio Bioassays
888-963-4567
www.htrf.com
Automated, vacuum-based
solid-phase extraction
Hamilton Robotics
simple and sample safe that anyone
can use it with confidence. The proprietary pump technology, combined
with a visible glass condenser trap
and easy access solvent drain valve,
makes the EZ-2 HCl one of the most
compact and reliable sample evaporators available. The EZ-2 HCl uses
inert and corrosion-proof materials
to enable high concentrations of
hydrochloric acid and acid chlorides
to be removed without any loss of
performance or long-term deterioration in the system. These include a
PTFE-coated evaporation chamber, a
glass condenser with FEP tubing and
all metallic parts coming into contact
with removed solvent manufactured
from highly durable and acid-resistant
Hasteloy C steel.
Genevac Ltd.
845-267-2211
www.genevac.org
Chemically defined, animalfree surfaces enhance cell
performance and improve cellbased assay reproducibility
BD Biosciences
BD Biosciences, a segment of Becton,
Dickinson and Co., has launched its
new line of BD PureCoat cell culture
surfaces designed to improve cell
performance and assay reproducibility. BD PureCoat surfaces improve cell
attachment, increase proliferation and
enhance recovery from freeze-thaw for
a variety of primary, transfected and
transformed cells in serum-reduced
or serum-free culture conditions,
allowing researchers to produce more
cells in better-defined conditions.
BD PureCoat surfaces maintain the
integrity of the cell monolayer, offering superior consistency in cell-based
assays versus standard tissue-culture
surfaces. The new BD PureCoat amine
Hamilton Robotics introduces the
Microlab Nimbus Vacuum System
(NVS), an integrated platform for
automated vacuum-based separations. Nimbus NVS integrates liquid
handling workstation capabilities with
a vacuum manifold, pump and collection device for solid-phase extraction (SPE) of analytes from complex
biological mixtures in 96-well plate
format. Upon completion of a series
of wash steps, an extraction reagent
is added to remove the analyte from
the matrix. A final vacuum step is
then performed to transfer the now
purified analyte into a 96-well collection plate. An optional labware
gripper arm with extended off-deck
reach enables seamless integration
with a number of third-party devices,
and a new graphical user interface
provides easy instrument control
and method programming for users
of any experience level. Automated
SPE on the Nimbus platform delivers
highly reproducible isolations, walkaway operation and higher throughput. Vacuum-based SPE offers many
advantages over syringe-based filter
techniques, including higher recovery
and reproducibility.
Hamilton Robotics
800-648-5950
www.hamiltonrobotics.com
STATS
Study finds large pharmas getting more drugs into
development, terminating unpromising candidates
BOSTON— Large pharmas, under
pressure to bring new medicines
to market faster, have been getting
more drug candidates into development in recent years and have
become more aggressive in terminating unpromising candidates,
according to a study recently completed by the Tufts Center for the
Study of Drug Development.
One in six self-originated compounds that entered clinical testing
at large pharmaceutical companies
from 1993 to 2004 was expected
to eventually attain marketing
approval, the study found.
“Increasing the pace of new
d r u gs e nt e r i n g deve l o p m e nt
and terminating candidates that
are unlikely to succeed is the
right combination of trends that
will help the industry counter
the expected decline in revenues
due to scheduled patent expirations,” says Tufts CSDD Director
of Economic Analysis and study
author Joseph A. DiMasi.
According to the study, the
share of new self-originated drugs
that were terminated during
Phase I and Phase II clinical testing increased from 1993-1998 to
1999-2004.
The study also found that the
inlicensing of products into the
clinical pipelines of the top 50
firms, a practice that gained
much industry attention in recent
years, reached a high point at
the end of the 1990s. After peaking at 28 percent for drugs that
first entered clinical testing in the
1999-2001 period, licensed products as a share of the total development portfolios of big pharma
dropped to just under 16 percent
for 2005-2007.
“The decline in the share of
drugs that were licensed-in at large
pharmaceutical firms likely reflects
both a reinvigoration of discovery
efforts and a recent shift in licensing strategies that focuses more on
the smaller number of available
late-stage compounds to help offset weak short-term growth prospects,” DiMasi says.
The study, reported in the
July/August Tufts CSDD Impact
Report, also found that for the top
50 global firms, the annual rate at
which drugs enter clinical testing
increased 31 percent from 19992001 to 2002-2007; nearly threequarters of the drugs in the portfolios of the top pharmaceutical firms
that reached clinical testing from
1993-2007 originated in and were
developed by the firms; and while
clinical success rates for drugs
varied widely by therapeutic class,
of six specific broad therapeutic
categories analyzed, oncologic/
immunologic and central nervous
system had the greatest number of
drug candidates entering clinical
testing over the 1993-2007 period.
The Tufts Center for the Study
of Drug Development is a nonprofit research group affiliated
with Tufts University. DDN
Drug Discovery News (USPS 024-504) is published monthly by Old River Publications, LLC, 19035 Old Detroit Road, Suite 203,
Rocky River, OH 44116; 440-331-6600. Periodical postage paid at Cleveland, Ohio and additional mailing offices. Publisher assumes no
responsibility for unsolicited material or prices quoted in the magazine. Contributors are responsible for proprietary classified information.
©2009 by Old River Publications. All rights reserved. Reproduction, in whole or in part, without written permission of the publisher
is expressly prohibited. Back issues, when available, cost $7 each within the past 12 months; $12 each prior to the past 12 months.
Back orders must be paid in advance by check.
Drug Discovery News is distributed without charge in North America to qualified drug discovery research professionals. Paid subscriptions
to those not qualified cost $65 annually to the U.S. and Canada and $150 to all other countries. All payments must be made in U.S. funds
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POSTMASTER: Send address changes to Drug Discovery News, PO Box 3100, Langhorne, PA 19047-8800.
advertiser’s index
Applied Scientific Instruments.................38 www.ASIimaging.com
Assay Designs, Inc....................................17 www.assaydesigns.com
Asuragen, Inc............................................25 www.asuragen.com
BD Biosciences – Discovery Labware.......39 www.bdbiosciences.com
Beckman Coulter Genomics, Inc.................5 www.beckman.com
Bio-Rad Laboratories............................7, 21 www.bio-rad.com
Cambridge Healthtech Institute...............18 www.healthtech.com
Cisbio US, Inc...........................................33 www.htrf.com
Hamilton Company...................................11 www.hamiltoncompany.com
IBC Life Sciences.....................................35 www.ibclifesciences.com
Invitrogen – Part of
Life Technologies, Inc...........................40 www.invitrogen.com
Millipore Bioscience Division......................9 www.millipore.com
Mirus Bio Corporation................................3 www.mirusbio.com
OffWhite Salter, LLC.................................29 www.offwhitesalter.com
PlanetConnect, Inc...................................15 www.lifesciencesymposium.com
R&D Systems, Inc.....................................31 www.RnDSystems.com
Roche Applied Science...............................2 www.roche-applied-science.com
Society for Biomolecular Sciences ..........23 www.sbsonline.org
The Jackson Laboratory............................34 www.jax.org
MARKETPLACE
For advertising info, please contact Larry Doyle at (610) 619-3568
Marketplace Ad Rates
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researching and developing
tomorrow’s drugs is your science.
finding you the best scientific workforce is ours.
kellyscientific.com
Pharmaceutical research and development is your focus; why spend valuable time
away from it trying to source, screen, and recruit your ideal workforce? Let that be our
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NEW BD PureCoat Cultureware
Where life thrives on the surface
Improved Cell
Attachment
and Increased
Proliferation
BD PureCoat amine, a positively
charged surface, and BD PureCoat
carboxyl, a negatively charged surface,
are chemically-defined, animal-free
enhanced cell culture surfaces.
TM
Both provide improved cell attachment,
increased proliferation, and enhanced
recovery from freeze-thaw for a
broad range of primary, transfected,
transformed, and fastidious cell types
in serum-reduced or serum-free culture
conditions. BD PureCoat surfaces allow
you to grow more cells and run assays
in defined conditions.
To learn more, please visit
bdbiosciences.com/purecoat
BD, BD logo, and all other trademarks are the property of Becton, Dickinson and Company. ©2009 BD.
BD Biosciences
Two Oak Park
Bedford, MA 01730
bdbiosciences.com
Get the outsourced support you need at every
step of the screening and profiling process.
The SelectScreen® suite of services makes it
easier to expect more...and get it.
More means unparalleled customer support and service–and an
experience that includes:
• Short cycle times and high-quality results, on time, every time
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• Choice in biochemical and cellular assay technologies across multiple
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Get the support you deserve and can rely on. To learn how other scientists are
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visit www.invitrogen.com/experienceusDDN.
Invitrogen SelectScreen: Library Screening | Kinase Profiling | GPCR Profiling
Nuclear Receptor Profiling | Pathway Profiling | P450 Profiling | hERG Screening
© 2009 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners.

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