- The Company Anticipates Third Quarter 2007 Filing for the Treatment of
Chronic Lymphocytic Leukemia -
FRAZER, Pa., June 28 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:
CEPH) today announced that, based on data from a European study, it now
plans to file in the third quarter of 2007 a new drug application (NDA)
with the U.S. Food and Drug Administration (FDA) for TREANDA(R)
(bendamustine HCl) for the treatment of chronic lymphocytic leukemia (CLL).
"We are pleased to have the opportunity to submit an earlier than
expected NDA filing for TREANDA," said Dr. Lesley Russell, Executive Vice
President, Worldwide Medical and Regulatory Operations. "TREANDA offers a
new and alternative treatment approach to cancers such as non-Hodgkin's
lymphoma and chronic lymphocytic leukemia and underscores our enthusiasm
for the spectrum of products and compounds in the Cephalon Oncology
portfolio."
A large, multi-center phase 3 clinical trial conducted in Europe
evaluated the safety and efficacy of bendamustine, the active ingredient in
TREANDA, compared to chlorambucil in patients with treatment-naive B-CLL.
The data from this trial met its primary endpoint of overall response rate
and will be the basis for the company's NDA filing for the CLL indication.
The company anticipates that results from this study will be released at
the upcoming American Society of Hematology annual meeting in December
2007.
Cephalon's phase 3 clinical trial evaluating the safety and efficacy of
TREANDA in patients with indolent non-Hodgkin's lymphoma (NHL) who are
refractory to the monoclonal antibody rituximab remains on schedule. The
company anticipates filing an NDA for this indication in the fourth quarter
of 2007.
Cephalon's senior management will review the company's product pipeline
and discuss research and development initiatives at its Research and
Development Day today beginning at approximately 12:00 p.m. EDT and ending
at 3:00 p.m. EDT. The presentation will be webcast live on the investor
relations section of its website at http://www.cephalon.com. The webcast
will be archived for one week following the broadcast. To access the
webcast, log on to the company's website at http://www.cephalon.com and
click on "Investor Information," then "Webcast." Please click on the link
and follow the prompts for registration and access.
About TREANDA
TREANDA is the first rationally engineered purine alkylator hybrid
designed to combine an alkylator and an antimetabolite. Preclinical data
suggest the novel multi-action, anti-tumor effects of TREANDA may be
attributed to its unique chemical design. These data show that TREANDA
induces rapid, sustained single- and double-strand DNA damage, which
results in apoptosis, or programmed cell death in the tumor. The DNA
disruption caused by TREANDA appears to be more extensive and durable than
that caused by traditional alkylators. TREANDA also induces mitotic
checkpoint inhibition, which results in non-apoptotic cell death.
Cephalon holds exclusive rights to market and sell TREANDA in the
United States. TREANDA is licensed from Astellas Deutschland GmbH.
Bendamustine, the active ingredient in TREANDA, is marketed in Germany by
Astellas' licensee, MundiPharma International 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 in Asia.
About Cephalon Oncology
Cephalon created Cephalon Oncology, 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 (APL), and CEP-701
(lestaurtinib), an oral small molecule inhibitor of tyrosine kinases
including FLT-3, TRK and JAK-2, in phase 3 development for acute myeloid
leukemia (AML).
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical
company dedicated to the discovery, development and marketing of innovative
products in four core therapeutic areas: central nervous system, pain,
oncology and addiction. Cephalon has delivered a seven-year compound annual
growth rate (CAGR) greater than 75% and 2006 revenue of $1.760 billion. 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, VIVITROL(R) (naltrexone for extended-release injectable
suspension), GABITRIL(R) (tiagabine hydrochloride), 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 any clinical programs with respect to TREANDA or the
timing of any NDA filings for TREANDA; interpretation of clinical results,
particularly with respect to the TREANDA clinical trials or the timing of
the release of clinical trial results; manufacturing development and
capabilities; market prospects for its products, including the timing of
the commercial launch of TREANDA or the clinical utility of TREANDA; 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
http://www.prnewswire.com/comp/134563.html/
CONTACT:
Media - Jenifer Antonacci, +1-610-738-6674,
jantonacci@cephalon.com; Investors - Robert (Chip) Merritt,
+1-610-738-6376, cmerritt@cephalon.com, both of Cephalon, Inc.
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