Cephalon, Inc. (Nasdaq: CEPH) announced today that the company has filed a marketing application with the European Agency for the Evaluation of Medicinal Products (EMEA) for a fentanyl effervescent buccal tablet in Europe. In the United States, the tablet is sold under the trade name FENTORA(R) (fentanyl buccal tablet) [C-II]. If approved, the centralized filing of this application would allow Cephalon Europe to market this product in 29 European countries.
This European submission follows the approval of FENTORA in September 2006 by the U.S. Food and Drug Administration for the management of breakthrough pain (BTP) in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. FENTORA was launched in the U.S. market in October 2006, and is the first tablet formulation of fentanyl and the first buccal tablet approved for cancer-related breakthrough pain. Cephalon is actively pursuing a clinical development program to explore additional indications for FENTORA in the United States.
Breakthrough pain is a component of chronic pain characterized by its rapid onset, moderate to severe intensity, and relatively short duration. These transient flares of pain interrupt or "breakthrough" otherwise persistent or background pain. In patients with cancer, the onset of breakthrough pain is often sudden, reaches peak intensity within 3 minutes, and lasts for a median duration of 30 to 60 minutes.
Patients experience an average of 4 episodes of breakthrough pain per day. Breakthrough pain may occur during a specific activity or incident, spontaneously with no apparent cause, or when the dose of the persistent pain medicine wears off.
According to GLOBOCAN, the prevalence of cancer in Europe is approximately 2.9 million patients. An estimated 64 percent of patients with cancer treated for persistent or background pain will experience breakthrough pain.
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 products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenic trioxide) injection, VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]; numerous products are marketed internationally.
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 Inc.'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 EMEA approval of FENTORA; 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 Inc. 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.