Company on Target to File Second New Drug Application for TREANDA by End of
2007
FRAZER, Pa., Oct. 23 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:
CEPH) today announced positive results from a Phase 3 clinical trial of
TREANDA(R) (bendamustine HCl) in patients with indolent non-Hodgkin's
lymphoma (NHL) whose cancer is no longer responsive to treatment with
rituximab. The study met its primary endpoints of overall response rate and
median duration of response, while demonstrating a manageable tolerability
profile. 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.
The Phase 3, multicenter, single-arm study evaluated the efficacy and
safety of single-agent TREANDA in 100 patients with relapsed,
rituximab-refractory NHL. The overall response rate, as assessed by an
independent radiological committee, was 75% (p<0.0001) and the median
duration of response was 40 weeks (or 9.2 months). The overall response
rate includes the percent of patients in the trial who had a complete,
unconfirmed complete or partial response to treatment. The most common side
effects included nausea, fatigue, neutropenia, diarrhea and vomiting. The
company anticipates that the results of this study will be released at the
upcoming American Society of Hematology (ASH) annual meeting in December
2007.
"We are encouraged that these results replicate those seen in our Phase
2 study, confirming the substantial efficacy in this difficult to treat
population," said Dr. Lesley Russell, Executive Vice President, Worldwide
Medical and Regulatory Operations. "Based on these positive results, we are
on track to file a New Drug Application in the fourth quarter for TREANDA
in patients with indolent NHL who have failed treatment with rituximab."
The protocol for the NHL pivotal trial received special protocol
assessment (SPA) approval from the U.S. Food and Drug Administration (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, which will be used as the basis of an efficacy claim
to support a New Drug Application (NDA).
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 orphan drug status.
About TREANDA
TREANDA is a rationally designed purine analog/alkylator hybrid.
Preclinical data demonstrate that TREANDA acts in two ways to kill cancer
cells. TREANDA damages the DNA in cancer cells, which leads to the normal
path of cell death (apoptosis). It also stops cancer cells from dividing to
create new cancer cells. This dual-action of TREANDA may be attributable to
its unique chemical design.
Cephalon holds exclusive rights to market and develop TREANDA in the
United States. TREANDA is licensed from Astellas Deutschland 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 market and sell bendamustine HCl in Japan and selected Asian
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 or acceptance 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.
 back to top
Related links:
http://www.cephalon.com
http://www.prnewswire.com/comp/134563.html/
CONTACT:
Media, Sheryl Williams of Cephalon, Inc.,
+1-610-738-6493, swilliam@cephalon.com, or Investors, Robert
(Chip) Merritt of Cephalon, Inc., +1-610-738-6376,
cmerritt@cephalon.com
|
