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"Entrepreneurship is the last refuge of the trouble making individual."
Natalie Clifford Barne
American Writer |
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October 26, 2009
Deal will Provide Cephalon New Path Forward for Development of its Tumor
Necrosis Factor Inhibitor
FRAZER, Pa. and WELLESLEY, Mass., Oct. 26 /PRNewswire-FirstCall/ -- Cephalon,
Inc. (Nasdaq: CEPH) and BioAssets Development Corporation (BDC), a privately
held biopharmaceutical company, today announced that the companies have signed
an agreement that will provide Cephalon with an option to acquire BDC. Under
the terms of the option agreement, Cephalon will pay BDC an upfront payment of
$30 million and, assuming exercise of the option, an additional payment on the
closing of the acquisition. BDC stockholders could also receive additional
future payments related to regulatory and sales milestones. The option
agreement is subject to customary closing conditions including the receipt of
necessary BDC stockholder approvals.
BDC is currently conducting a Phase two placebo-controlled proof of concept
study with the tumor necrosis factor (TNF) inhibitor, etanercept, epidurally
administered to a minimum of 40 patients with sciatica. Sciatica is a
neuropathic inflammatory pain condition that occurs when the sciatic nerve is
compressed, injured or irritated. BDC has secured an intellectual property
estate around use of TNF inhibitors for sciatic pain in patients with
intervertebral disk herniation, as well as other spinal disorders.
"BioAssets offers an estate of intellectual property and scientific expertise
that will allow us to evaluate our own domain antibody tumor necrosis factor
inhibitor, CEP-37247 (formerly known as ART-621), for the treatment of
sciatica," said Frank Baldino, Jr., Ph.D. chairman and CEO of Cephalon.
"Combining these two innovations helps fulfill our strategy to address unmet
patient needs, while focusing on specialty physicians."
"Development of an improved non-surgical therapy for sciatica presents a
pressing unmet medical need and a potentially significant commercial
opportunity," commented James Gorman, M.D., Ph.D., CEO of BioAssets.
"Cephalon combines an innovative TNF inhibitor pipeline with a well
established pain therapeutic franchise. I believe these capabilities uniquely
position Cephalon to develop and commercialize a novel biologic therapy for
these patients."
Cephalon may exercise its option at any time from the closing date of the
option agreement until the date that is 60 days after receipt of one-month
patient response data from the Phase two proof of concept study. Data are
anticipated to be available in the second half of 2010.
The Cephalon pipeline of pain products includes intravenous celecoxib and two
tamper-deterrent opioid medications. Earlier this year, Cephalon completed
the acquisition of Arana Therapeutics and added to its pipeline several domain
antibody biologics targeted to inflammatory diseases and cancer. One of those
compounds CEP-37247 (formerly known as ART-621) is a tumor necrosis factor
inhibitor. The complete Cephalon pipeline can be viewed at
http://www.cephalon.com/our-science/pipeline/.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company
dedicated to the discovery, development and commercialization of many unique
products in four core therapeutic areas: central nervous system, inflammatory
diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500
Index, Cephalon currently employs approximately 3,000 people in the United
States and Europe. U.S. sites include the company's headquarters in Frazer,
Pennsylvania, and offices, laboratories or manufacturing facilities in West
Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis,
Minnesota.
Cephalon has a growing presence in Europe, the Middle East and Africa. The
Cephalon European headquarters and pre-clinical development center are located
in Maisons-Alfort, France, just outside of Paris. Key affiliates are located
in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the
Benelux countries, and Poland for Eastern and Central European countries. Cephalon Europe markets more than 30 products in four areas: central nervous
system, pain, primary care and oncology.
The company's proprietary products in the United States include: NUVIGIL¨
(armodafinil) Tablets [C-IV], TREANDA¨ (bendamustine hydrochloride) for
Injection, AMRIX¨ (cyclobenzaprine hydrochloride extended-release capsules),
FENTORA¨ (fentanyl buccal tablet) [C-II], TRISENOX¨ (arsenic trioxide)
injection, GABITRIL¨ (tiagabine hydrochloride), PROVIGIL¨ (modafinil) Tablets
[C-IV], and ACTIQ¨ (oral transmucosal fentanyl citrate) (C-II). The company
also markets numerous products internationally. Full prescribing information
on its U.S. products is available at http://www.cephalon.com or by calling
1-800-896-5855.
About BioAssets Development Corporation
BioAssets Development Corporation is a private company pioneering novel spine
indications for emerging and marketed biologic drugs. The Company's lead
initiative focuses on the development of a TNF inhibitor therapy to treat the
underlying cause of pain in sciatica. For more information, visit
www.biodevco.com.
In addition to historical facts or statements of current condition, this press
release may contain forward-looking statements. Forward-looking statements
provide Cephalon's current expectations or forecasts of future events. These
may include statements regarding whether Cephalon ultimately will acquire BDC,
anticipated scientific progress on its research programs, development of
potential pharmaceutical products such as an anti-TNF reactor agent, the
relative value to Cephalon's business and the effect on Cephalon's long-term
growth of biologic products and the possible acquisition of BDC,
interpretation of clinical results, prospects for regulatory approval,
manufacturing development and capabilities, market prospects for its products,
sales and earnings guidance, and other statements regarding matters that are
not historical facts. You may identify some of these forward-looking
statements by the use of words in the statements such as "anticipate,"
"estimate," "expect," "project," "intend," "plan," "believe" or other words
and terms of similar meaning. Cephalon's performance and financial results
could differ materially from those reflected in these forward-looking
statements due to general financial, economic, regulatory and political
conditions affecting the biotechnology and pharmaceutical industries as well
as more specific risks and uncertainties facing Cephalon such as those set
forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities
and Exchange Commission. Given these risks and uncertainties, any or all of
these forward-looking statements may prove to be incorrect. Therefore, you
should not rely on any such factors or forward-looking statements.
Furthermore, Cephalon does not intend to update publicly any forward-looking
statement, except as required by law. The Private Securities Litigation
Reform Act of 1995 permits this discussion.
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