FRAZER, Pa., Dec. 31 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:
CEPH) today announced that it has submitted a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) requesting approval of
TREANDA(R) (bendamustine HCl) for Injection for the treatment of patients
with indolent B-cell non-Hodgkin's lymphoma (NHL) who have progressed
during or following treatment with rituximab or a rituximab-containing
regimen. According to the National Cancer Institute, an estimated 30,000
people in the United States will be diagnosed in 2007 with indolent NHL, a
serious and slow growing cancer of the lymphatic system that is difficult
to treat because patients are prone to relapse after treatment.
"TREANDA is the lead product in our oncology pipeline and with this
second NDA submission for the product in 2007 we have achieved a
significant milestone for our business," said Dr. Lesley Russell, Executive
Vice President, Worldwide Medical and Regulatory Operations. "The clinical
data supporting this submission highlight the potential of TREANDA to make
a meaningful difference for patients with indolent NHL who have relapsed
during or following treatment with rituximab."
The TREANDA NDA for relapsed indolent NHL is supported by three studies
in patients with NHL, including one in combination with rituximab. In these
studies, patients treated with TREANDA had a high rate of response and a
manageable and tolerable side effect profile, with adverse events similar
to those observed with other chemotherapy agents.
About TREANDA
TREANDA is a novel chemotherapeutic agent, a hybrid of a purine analog
and an alkylator. Preclinical data demonstrate that TREANDA acts in two
distinct ways to kill cancer cells. TREANDA damages the DNA in cancer
cells, which leads to cell death by a process known as apoptosis
(programmed cell death) as well as by an alternate cell death
(non-apoptotic) pathway known as mitotic catastrophe (a disruption of
normal cell division). The contribution of the purine analog to the
antitumor effect of TREANDA is under investigation but has not yet been
determined.
The protocol for the TREANDA NHL pivotal trial received special
protocol assessment (SPA) approval from the FDA in February 2006. The SPA
process allows for FDA evaluation and acceptance of a clinical trial
protocol, including trial size, clinical endpoints and/or data analysis. In
September 2007, Cephalon submitted an NDA requesting approval of TREANDA
for the treatment of patients with chronic lymphocytic leukemia (CLL), for
which the FDA has granted priority review and orphan drug status.
Cephalon holds exclusive rights to market and develop TREANDA in the
United States. TREANDA is licensed from Astellas Pharma GmbH. Bendamustine
HCl, the active ingredient in TREANDA, is marketed in Germany by Astellas'
licensee, Mundipharma International Corporation Limited, under the trade
name RIBOMUSTIN(R). In Germany, RIBOMUSTIN is indicated as a single-agent
or in combination with other anti-cancer agents for indolent NHL, multiple
myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive rights to
develop and market bendamustine HCl in Japan and selected Asia Pacific Rim
countries.
About Cephalon Oncology
Cephalon Oncology is a strategic business unit focused on the
development and commercialization of oncology products and resources for
patients and healthcare providers. The Cephalon Oncology portfolio includes
a number of promising investigational and marketed compounds. In addition
to TREANDA, the Cephalon Oncology therapeutic portfolio in the United
States includes TRISENOX(R) (arsenic trioxide) injection, a product
approved in the United States for the treatment of patients with relapsed
or refractory acute promyelocytic leukemia, and CEP-701, an oral small
molecule inhibitor of tyrosine kinases including FLT-3, TRK and JAK-2, in
phase 3 development for acute myeloid leukemia.
In Europe, Cephalon markets three additional oncology products in 19
countries.
About Cephalon, Inc.
Cephalon, Inc. is an international biopharmaceutical company, recently
inducted into the World Economic Forum Community of Global Growth
Companies. For 20 years, the company has been dedicated to the discovery,
development and commercialization of innovative products in four core
therapeutic areas: central nervous system, pain, oncology and addiction. A
member of the Fortune 1000, 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's European headquarters
are located in Maisons-Alfort, France.
The company's proprietary products in the United States include:
PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA(R) (fentanyl buccal tablet)
[C-II], TRISENOX, AMRIX(TM) (cyclobenzaprine hydrochloride extended-release
capsules), VIVITROL(R) (naltrexone for extended-release injectable
suspension), GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(TM)
(armodafinil) Tablets [C-IV] and ACTIQ(R) (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.
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 anticipated scientific
progress on its research programs; development of potential pharmaceutical
products, including the results of any clinical programs with respect to
TREANDA or the timing, acceptance or approval of any current or future
filings for regulatory approval of TREANDA or other Cephalon Oncology
compounds; interpretation of clinical results, particularly with respect to
the TREANDA clinical trials; manufacturing development and capabilities;
market prospects for its products; sales and earnings guidance; and other
statements regarding matters that are not historical facts including
statements with respect to the role TREANDA may play in the treatment of
NHL, CLL or other cancers. 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.
SOURCE Cephalon, Inc.
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Related links:
http://www.cephalon.com
http://www.prnewswire.com/comp/134563.html /
CONTACT:
Media, Jenifer Antonacci, +1-610-563-6018,
jantonac@cephalon.com, or Investors, Robert (Chip) Merritt,
+1-610-738-6376, cmerritt@cephalon.com, both of Cephalon, Inc.
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