FRAZER, Pa. and MAISONS-ALFORT, France, Jan. 24 Cephalon, Inc., (Nasdaq: CEPH) announced today that the European Committee forMedicinal Products for Human Use (CHMP) of the European Medicines Agency hasissued a positive opinion regarding EFFENTORA(TM), the company's fentanylbuccal tablet pain medication. In March 2007, Cephalon submitted theEFFENTORA European new drug application for the treatment of breakthrough painin adult cancer patients who are already receiving maintenance opioid therapyfor chronic cancer pain. The CHMP recommendation for EFFENTORA will now beforwarded to the European Commission for final marketing approval, whichtypically occurs within 60 to 90 days.
"We believe this product, once approved, will be an exciting addition toour European product portfolio and will provide a tremendous benefit topatients suffering from breakthrough cancer pain," said Alain Aragues,President Cephalon Europe. "Cephalon is committed to bringing innovativemedications to the European market and we are delighted to receive thispositive opinion for EFFENTORA from the CHMP."
The prevalence of cancer in Europe is estimated at approximately 2.9million patients according to the most recent report from GLOBOCAN, aworldwide database of cancer statistics. A large majority of these patientswill experience breakthrough cancer pain, a transitory exacerbation of painthat occurs on a background of otherwise controlled persistent chronic pain.Patients experience intense transient flares of pain that interrupt, or "breakthrough," their background persistent pain. Breakthrough pain ischaracterized by its rapid onset, moderate-to-severe intensity and arelatively short duration. In cancer, the onset of a breakthrough painepisode is often sudden, reaching peak intensity within three minutes with amedian duration of 30 minutes and an average of four episodes per day.Episodes may occur during a specific activity or incident or spontaneouslywith no apparent cause.
In September 2006, the fentanyl buccal tablet formulation was approved inthe United States under the trade name FENTORA(R) (fentanyl buccal tablet)[C-II].
Founded in 1987, Cephalon, Inc. is an international biopharmaceuticalcompany dedicated to the discovery, development, and marketing of innovativeproducts in four core therapeutic areas: central nervous system, pain,oncology and addiction. Cephalon currently employs approximately 3,000people. U.S. sites include the company's headquarters in Frazer,Pennsylvania, and offices, laboratories or manufacturing facilities in WestChester, 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) (arsenictrioxide) injection, AMRIX(R) (cyclobenzaprine hydrochloride extended-releasecapsules), VIVITROL(R) (naltrexone for extended-release injectablesuspension), GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(TM) (armodafinil)Tablets [C-IV] and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. Thecompany also markets numerous products internationally. Full prescribinginformation on its U.S. products is available at http://www.cephalon.com or bycalling 1-800-896-5855.
Cephalon has a growing presence in Europe, with more than 800 of its 3,000employees located in various countries. Cephalon's European headquarters andpre-clinical development center are located in Maisons-Alfort, France, justoutside of Paris. Two manufacturing plants are located in Mitry-Mory andNevers, France. Key business units are located in England, Ireland, France,Germany, Italy, Spain, the Netherlands for the Benelux countries, and Polandfor Eastern and Central European countries as well as Scandinavia. CephalonEurope markets more than 30 products in four therapeutic areas: cent