- First New Agent for CLL Patients Approved by the FDA since 2001 -
FRAZER, Pa., March 20 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:
CEPH) today announced that the U.S. Food and Drug Administration (FDA) has
approved TREANDA(R) (bendamustine hydrochloride) for Injection for the
treatment of patients with chronic lymphocytic leukemia (CLL), a slowly
progressing blood and bone marrow disease. The American Cancer Society
estimates that more than 15,000 new cases of this rare disease will be
diagnosed in the United States this year. The TREANDA application as a CLL
treatment received priority review from the FDA and was approved within six
months of the September 2007 submission. Cephalon anticipates that TREANDA
will be available to physicians and patients as a CLL treatment in the
United States in April 2008.
To view the Multimedia News Release, go to:
http://www.prnewswire.com/mnr/treanda/32349/.
"TREANDA is an important new treatment for patients with chronic
lymphocytic leukemia, and this first-cycle approval by FDA represents a
significant milestone in the growth of our oncology business," said Dr.
Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory
Operations. "With a strong pipeline of near- and longer-term opportunities,
Cephalon Oncology is poised to deliver therapies that target both
hematologic cancers and solid tumors for patients in need of new options."
Dr. Bruce Cheson, Clinical Professor of Hematology/Oncology, Georgetown
University School of Medicine, Washington D.C., stated, "Patients with
chronic lymphocytic leukemia can often live normal lives for many years
because of treatments that control the disease over the long-term. TREANDA
is an effective new option that offers a delay in disease progression, an
important goal for patients with chronic lymphocytic leukemia."
In a randomized, international, multicenter, open-label pivotal study
of 301 treatment-naive patients with CLL, those who received TREANDA had
better clinical outcomes compared to patients treated with chlorambucil, an
FDA-approved chemotherapy for patients with CLL. Specifically, TREANDA
patients had a significantly higher overall response (59 percent of
patients responded to TREANDA and 26 percent of patients responded to
chlorambucil; p < 0.0001). Patients who received TREANDA also had a higher
complete response rate than those treated with chlorambucil (8 percent vs.
<1 percent), which means that after treatment with TREANDA, some patients
had no signs of disease in their blood.
Importantly, TREANDA patients also had a significantly longer
progression- free survival (18 months vs. 6 months; Hazard Ratio = 0.27; p
< 0.0001), meaning the disease did not get worse for a significant period
of time. The response to TREANDA lasted longer (duration of response) than
in patients who received chlorambucil (19 months vs. 7 months). The most
common adverse events in the trial were myelosuppression, fever, nausea,
and vomiting.
TREANDA has been granted orphan drug status by the FDA for the
treatment of CLL. The orphan drug designation will provide marketing
exclusivity in this indication until March 2015.
About TREANDA
TREANDA has a unique chemical structure with two primary components, an
alkylating group and a benzimidazole component. Preclinical data suggest
that TREANDA can lead to cell death via several pathways. 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 exact mechanism of action of TREANDA remains
unknown.
In December 2007, Cephalon submitted an NDA requesting approval of
TREANDA for the treatment of patients with indolent (slow-growing)
non-Hodgkin's lymphoma who have progressed during or following treatment
with rituximab or a rituximab-containing regimen and anticipates a review
decision by October 31, 2008. 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.
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(R) (arsenic trioxide) injection, TREANDA, 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, including the anticipated availability of
TREANDA in the United States or the benefits TREANDA may provide; 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, Jenifer Antonacci, +1-610-738-6674,
jantonac@cephalon.com; or Candace Steele, +1-610-727-6231,
csteele@cephalon.com; Investors, Robert 'Chip' Merritt,
+1-610-738-6376, cmerritt@cephalon.com
|
