FRAZER, Pa. and MAISONS-ALFORT, France, Jan. 24 /PRNewswire-FirstCall/
-- Cephalon, Inc., (Nasdaq: CEPH) announced today that the European
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency has issued a positive opinion regarding EFFENTORA(TM), the
company's fentanyl buccal tablet pain medication. In March 2007, Cephalon
submitted the EFFENTORA European new drug application for the treatment of
breakthrough pain in adult cancer patients who are already receiving
maintenance opioid therapy for chronic cancer pain. The CHMP recommendation
for EFFENTORA will now be forwarded to the European Commission for final
marketing approval, which typically occurs within 60 to 90 days.
"We believe this product, once approved, will be an exciting addition
to our European product portfolio and will provide a tremendous benefit to
patients suffering from breakthrough cancer pain," said Alain Aragues,
President Cephalon Europe. "Cephalon is committed to bringing innovative
medications to the European market and we are delighted to receive this
positive opinion for EFFENTORA from the CHMP."
The prevalence of cancer in Europe is estimated at approximately 2.9
million patients according to the most recent report from GLOBOCAN, a
worldwide database of cancer statistics. A large majority of these patients
will experience breakthrough cancer pain, a transitory exacerbation of pain
that occurs on a background of otherwise controlled persistent chronic
pain. Patients experience intense transient flares of pain that interrupt,
or "break through," their background persistent pain. Breakthrough pain is
characterized by its rapid onset, moderate-to-severe intensity and a
relatively short duration. In cancer, the onset of a breakthrough pain
episode is often sudden, reaching peak intensity within three minutes with
a median duration of 30 minutes and an average of four episodes per day.
Episodes may occur during a specific activity or incident or spontaneously
with no apparent cause.
In September 2006, the fentanyl buccal tablet formulation was approved
in the United States under the trade name FENTORA(R) (fentanyl buccal
tablet) [C-II].
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 proprietary products in the United States include:
PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenic
trioxide) injection, 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.
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'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 with respect to final marketing approval of EFFENTORA
by the European Commission; 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
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, Robert (Chip) Merritt,
+1-610-738-6376, cmerritt@cephalon.com, or Media - United States,
Candace Steele, +1-610-727-6231, csteele@cephalon.com, or
Cephalon Europe, Marie-Dominique de La Salle, +33-1-49-81-82-48,
or +33-6-75-20-72-74, mddelasalle@cephalon.com, all of Cephalon,
Inc.
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