Cephalon, Inc. (Nasdaq:
CEPH) commented on the announcement today by the National Cancer Institute
(NCI) and one of its Cooperative Clinical Trials Groups, the Cancer and
Leukemia Group B (CALGB), regarding event-free and overall survival results
from a clinical trial using TRISENOX(R) (arsenic trioxide) injection in
newly diagnosed patients with acute promyelocytic leukemia (APL). After
reviewing the results from more than 500 patients in the study, a data
safety monitoring board notified the investigators and the NCI of the
positive results and the findings are being released based on their impact
on the treatment of APL. A complete scientific presentation of these study
results is planned for the annual meeting of the American Society of
Clinical Oncology (ASCO) in June 2007.
Dr. Lesley Russell, Executive Vice President, Worldwide Medical and
Regulatory Operations, Cephalon, said, "The results of this study showing a
survival benefit associated with the use of TRISENOX in patients with APL
are an important development for physicians and patients, as demonstrated
by the urgency to disseminate the results to clinicians in an expedited
manner. We are encouraged by the oncology community's continued interest in
the potential of TRISENOX, and these study results reinforce Cephalon's
commitment to build a fully integrated oncology business."
TRISENOX is indicated for the induction of remission and consolidation
in patients with APL who are refractory to, or have relapsed from, retinoid
and anthracycline chemotherapy, and whose APL is characterized by the
presence of the t(15;17) translocation of PML/RAR-alpha gene expression.
Full prescribing information, including boxed warning, is available at
TRISENOX. While Cephalon is evaluating these study results
as well as other areas of interest to consider future development of
TRISENOX, the product is not presently indicated or approved by the U.S.
Food and Drug Administration (FDA) for use in any other disease or related
cancer beyond its labeled indications.
In addition to TRISENOX, the Cephalon Oncology therapeutic portfolio in
the United States includes two other compounds in late-stage clinical
development: TREANDA(R) (bendamustine HCl), a bi-functional cytotoxic in
phase 3 development for chronic lymphocytic leukemia (CLL) and non-Hodgkins
lymphoma (NHL), 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). Neither compound is presently
indicated or approved by the FDA for these or any other diseases.
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 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 currently markets six proprietary products in the United
States: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA(TM) (fentanyl
buccal tablet) [C-II], TRISENOX, VIVITROL(R) (naltrexone for
extended-release injectable suspension), GABITRIL(R) (tiagabine
hydrochloride), ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II], and
numerous products internationally.
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; interpretation of clinical results, including the results of the
NCI/CALGB study of TRISENOX; prospects for regulatory approval, including
with respect to any potential future indications for TRISENOX;
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.
Cephalon, Inc.
cephalon
View drug information on Naltrexone Hydrochloride Tablets; Trisenox.