Healthcare Industry News: fentanyl buccal tablet
News Release - April 14, 2008
Cephalon Announces European Commission Approval of EFFENTORA for the Treatment of Breakthrough Cancer PainFRAZER, Pa. and MAISONS-ALFORT, France, April 14 (HSMN NewsFeed) -- 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® 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® (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.
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® (modafinil) Tablets [C-IV], FENTORA, TRISENOX® (arsenic trioxide) injection, TREANDA® (bendamustine hydrochloride), AMRIX® (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL® (naltrexone for extended-release injectable suspension), GABITRIL® (tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) Tablets [C-IV] and ACTIQ® (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 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® (liposomal doxorubicin) which is indicated in combination with cyclophospamide for first- line treatment of metastatic breast cancer; TARGRETIN® (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.
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