FDA Decision Expected in October 2008
FRAZER, Pa., Feb. 19 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:
CEPH) today announced that the U.S. Food and Drug Administration (FDA) has
accepted the company's new drug application (NDA) for 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 were expected to 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. Cephalon
submitted the TREANDA application for relapsed indolent NHL in December
2007 and a decision from the FDA is expected by October 31, 2008.
"We are pleased that the application for TREANDA to treat relapsed
indolent NHL is on track. With two NDAs for TREANDA pending review
decisions, 2008 is a significant year for this product and bodes well for
the future of Cephalon in oncology," said Dr. Lesley Russell, Executive
Vice President, Worldwide Medical and Regulatory Operations.
The TREANDA NDA for relapsed indolent NHL is supported by three studies
in patients with NHL, including two single-agent studies and 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 such as myelosuppression (decrease in blood counts),
nausea, and vomiting.
About TREANDA
TREANDA is a hybrid of a purine analog and an alkylator making it a
novel chemotherapeutic agent. 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 precise mechanism of action of TREANDA in humans
has not been fully characterized.
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
2007, Cephalon filed a request for orphan drug status for TREANDA as a
treatment for patients with relapsed indolent NHL and the company is in
discussion with FDA about this application.
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; a decision by the FDA is expected by March 20, 2008.
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
tradename 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.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical
company 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. The company'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(R) (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 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. 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
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CONTACT:
Media: Jenifer Antonacci, +1-610-738-6674,
jantonac@cephalon.com, or Investors: Robert (Chip) Merritt,
+1-610-738-6376, cmerritt@cephalon.com, both of Cephalon, Inc.
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