FRAZER, Pa., Oct. 31 /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 indolent B-cell non-Hodgkin's lymphoma (NHL)
that has progressed during or within six months of treatment with rituximab or
a rituximab-containing regimen. The data supporting the FDA approval show
that TREANDA is effective, has a tolerable side effect profile in patients
with indolent NHL and that treatment results in a high durable response rate.
In March of this year, TREANDA received approval for the treatment of patients
with chronic lymphocytic leukemia, the most common form of leukemia in the
United States.
Indolent NHL, a subset of non-Hodgkin's lymphoma, is a slow growing but
serious cancer of the lymphatic system that is not curable with currently
available treatments. Patients with indolent NHL are prone to multiple
relapses after initial therapy. According to the National Cancer Institute,
an estimated 30,000 people in the United States will be diagnosed this year
with indolent NHL.
"Because most patients with indolent non-Hodgkin's lymphoma eventually
become resistant to existing treatments, new treatment options like TREANDA
are needed to improve patient outcome," stated Dr. Bruce Cheson, Professor of
Medicine at Georgetown University Hospital, Washington, D.C. and TREANDA
clinical investigator. "The TREANDA pivotal trial shows that it is an
effective and well-tolerated chemotherapy that offers a delay in disease
progression for more than nine months."
According to Dr. Lesley Russell, Executive Vice President and Chief
Medical Officer, Cephalon, "We are excited about this second FDA approval for
TREANDA in 2008. This approval of TREANDA for indolent non-Hodgkin's lymphoma
is a significant milestone in our development of a diverse oncology portfolio
of products that improve patient outcomes."
The FDA approval is supported by a pivotal trial of 100 patients with
indolent B-cell NHL who had progressed during or within six months of
treatment with a regimen that included rituximab. The pivotal study
demonstrated that patients had a high response rate to treatment with TREANDA,
and these responses to the treatment were durable. The results from the
pivotal study showed that treatment with TREANDA as a single agent resulted in
an overall response rate of 74 percent, which means that after treatment, the
cancer diminished or disappeared in approximately three out of four patients.
Additionally, patient response to treatment in the pivotal study lasted a
median of 9.2 months and patients remained alive and their disease did not
progress for a median of 9.3 months.
The safety of TREANDA is also supported by a secondary monotherapy study.
In the pivotal and secondary studies for TREANDA in indolent NHL, the most
common non-hematologic adverse reactions (frequency > 15%) are nausea,
fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache,
weight decrease, dyspnea, rash and stomatitis. The most common hematologic
abnormalities (frequency >15%) are lymphopenia, leukopenia, anemia,
thrombocytopenia and neutropenia.
In addition to its proven efficacy and tolerable side effect profile,
TREANDA has a convenient dosing schedule as a treatment for indolent NHL. An
intravenous infusion takes 60 minutes and can be administered in an outpatient
setting, reducing the time it takes for patients to be treated. The
recommended dose for indolent NHL is 120 mg/m2 administered on days one and
two of a 21-day cycle, for up to eight cycles.
About TREANDA
TREANDA is a novel treatment with a unique chemical structure that is
synthesized to combine an alkylating group and a purine-like benzimidazole
component. Though the exact mechanism of action of TREANDA remains unknown,
TREANDA may act in two distinct ways to kill cancer cells. Preclinical
studies suggest that TREANDA may lead to cell death by a process known as
apoptosis (programmed cell death) as well as by an alternate cell death
pathway which disrupts normal cell division known as mitotic catastrophe (a
non-apoptotic pathway).
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. In
Germany, bendamustine 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 select Asia Pacific Rim countries.
About Cephalon Oncology
Cephalon, a leading biopharmaceutical company, is building a diversified
portfolio of oncology products that represents a comprehensive approach to
extend and enhance the lives of patients with cancer. 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 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 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.
