FRAZER, Pa. and MAISONS-ALFORT, France, April 14 /PRNewswire-FirstCall/
-- Cephalon, Inc. (Nasdaq: CEPH) announced today that the European
Commission has granted marketing authorization for EFFENTORA(TM), a buccal
tablet formulation of fentanyl. EFFENTORA is indicated for the treatment of
breakthrough cancer pain (BTCP) in adult patients who are already receiving
maintenance opioid therapy for chronic pain. The approval allows Cephalon
to market EFFENTORA in the 27 member states of the European Union (EU), as
well as Iceland and Norway.
Breakthrough cancer pain, an often debilitating condition, is
characterized by its rapid onset, moderate-to-severe intensity, and its
relatively short duration. Research studies have demonstrated that an
estimated 51-89 percent of patients with cancer who are taking around-the-
clock opioid therapy for their underlying persistent pain will experience
breakthrough pain.
"We are committed to bring new medications to the European markets that
address the needs of patients with cancer for effective supportive care
treatment, including pain management," said Alain Aragues, President
Cephalon Europe. "Cephalon continues to build its presence in Europe, the
Middle East and Africa and activities are ongoing to make EFFENTORA
available quickly in the EU member countries."
EFFENTORA utilizes the proprietary OraVescent(R) drug delivery
technology to permit absorption of the opioid fentanyl across the inner
lining of the cheek - the buccal mucosa - at a rate designed to match the
onset of a breakthrough pain episode. The safety and efficacy of EFFENTORA
have been evaluated in two double-blind, randomized, placebo-controlled
crossover studies involving a total of 248 cancer patients with
breakthrough pain who experienced between one and four episodes of
breakthrough pain per day and who were already taking maintenance opioid
therapy. An extension study has demonstrated safety and tolerability in 197
patients followed over a six-month period.
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].
About Breakthrough Cancer Pain
An estimated 3 million new cases of cancer were diagnosed in Europe in
2006. In patients with cancer, chronic pain often has two components:
persistent pain and breakthrough cancer pain. Breakthrough pain is an
intense transient flare of pain that interrupts or "breaks through" their
persistent pain. The onset of breakthrough cancer pain is often sudden,
reaches peak intensity within three minutes, and lasts for a median
duration of 30 minutes. Patients may have up to four episodes of
breakthrough pain per day. Episodes may occur during a specific activity or
incident or spontaneously with no apparent cause.
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, TRISENOX(R) (arsenic
trioxide) injection, TREANDA(R) (bendamustine hydrochloride), 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, the Middle East and Africa.
The Cephalon European headquarters and pre-clinical development center are
located in Maisons-Alfort, France, just outside of Paris. 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. Cephalon Europe markets more than 30 products in four
therapeutic areas: central nervous system, pain, primary care and oncology.
Among its oncology products, Cephalon Europe markets MYOCET(R)
(liposomal doxorubicin) which is indicated in combination with
cyclophospamide for first- line treatment of metastatic breast cancer;
TARGRETIN(R) (bexarotene) for advanced cutaneous T-cell lymphoma; and
TRISENOX for relapsed or refractory acute promyelocytic leukemia.
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; manufacturing development and capabilities; market prospects for
its products, including with respect to EFFENTORA; 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.
 back to top
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,
Stacey Beckhardt, +1-610-738-6198, sbeckhar@cephalon.com, or
Media - Europe, Marie-Dominique de La Salle, +33 1 49 81 82 48,
+33 6 75 20 72 74, mddelasalle@cephalon.com
|
