Healthcare Industry News: fentanyl buccal tablet
News Release - January 24, 2008
Cephalon's EFFENTORA Receives Positive Opinion from European Regulatory Authorities for the Management of Breakthrough Cancer PainFRAZER, Pa. and MAISONS-ALFORT, France, Jan. 24 (HSMN NewsFeed) -- 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® (fentanyl buccal tablet) [C-II].
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® (modafinil) Tablets [C-IV], FENTORA, TRISENOX® (arsenic trioxide) injection, 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, 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.
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