Indication Sought for the Management of Breakthrough Pain in Cancer
FRAZER, Pa., and MAISONS-ALFORT, France, March 26
/PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) announced today
that the company has filed a marketing application with the European Agency
for the Evaluation of Medicinal Products (EMEA) for a fentanyl effervescent
buccal tablet in Europe. In the United States, the tablet is sold under the
trade name FENTORA(R) (fentanyl buccal tablet) [C-II]. If approved, the
centralized filing of this application would allow Cephalon Europe to
market this product in 29 European countries.
This European submission follows the approval of FENTORA in September
2006 by the U.S. Food and Drug Administration for the management of
breakthrough pain (BTP) in patients with cancer who are already receiving
and who are tolerant to opioid therapy for their underlying persistent
cancer pain. FENTORA was launched in the U.S. market in October 2006, and
is the first tablet formulation of fentanyl and the first buccal tablet
approved for cancer-related breakthrough pain. Cephalon is actively
pursuing a clinical development program to explore additional indications
for FENTORA in the United States.
Breakthrough pain is a component of chronic pain characterized by its
rapid onset, moderate to severe intensity, and relatively short duration.
These transient flares of pain interrupt or "breakthrough" otherwise
persistent or background pain. In patients with cancer, the onset of
breakthrough pain is often sudden, reaches peak intensity within 3 minutes,
and lasts for a median duration of 30 to 60 minutes.
Patients experience an average of 4 episodes of breakthrough pain per
day. Breakthrough pain may occur during a specific activity or incident,
spontaneously with no apparent cause, or when the dose of the persistent
pain medicine wears off.
According to GLOBOCAN, the prevalence of cancer in Europe is
approximately 2.9 million patients. An estimated 64 percent of patients
with cancer treated for persistent or background pain will experience
breakthrough pain.
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. 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 products in the United States include: PROVIGIL(R)
(modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenic trioxide)
injection, VIVITROL(R) (naltrexone for extended-release injectable
suspension), GABITRIL(R) (tiagabine hydrochloride), and ACTIQ(R) (oral
transmucosal fentanyl citrate) [C-II]; numerous products are marketed
internationally. Full prescribing information on its U.S. products is
available at http://www.cephalon.com or by calling 1-800-896-5855.
Cephalon Europe
Cephalon has a growing presence in Europe, with more than 800 of its
3,000 employees located in various countries. Cephalon's European
headquarters and pre-clinical development center are located in
Maisons-Alfort, France, just outside of Paris. Two manufacturing plants are
located in Mitry-Mory and Nevers, France. Key business units are located in
England, Ireland, France, Germany, Italy, Spain, the Netherlands for the
Benelux countries, and Poland for Eastern and Central European countries as
well as Scandinavia. Cephalon Europe markets more than 30 products in four
therapeutic areas: central nervous system, pain, primary care, and
oncology.
In addition to historical facts or statements of current condition,
this press release may contain forward-looking statements. Forward-looking
statements provide Cephalon Inc.'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; prospects for
regulatory approval, including EMEA approval of FENTORA; manufacturing
development and capabilities; market prospects for its products; sales,
adjusted net income and basic adjusted income per common share 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 Inc. 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:
Investors, Chip Merritt, +1-610-738-6376,
cmerritt@cephalon.com, or Media, Stacey Beckhardt,
+1-610-738-6198, sbeckhar@cephalon.com, or in Europe,
Marie-Dominique de La Salle, +33 1 49 81 82 48, +33 6 75 20 72
74, mddelasalle@cephalon.com, all of Cephalon, Inc.
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