Cephalon Receives Approval to Market Modafinil for Shift Work Sleep Disorder in Germany
FRAZER, Pa., Aug. 30 /PRNewswire-FirstCall/ — Cephalon, Inc. announced today that the company has received authorization from the Federal Institute for Drugs and Devices (BfArM) to market modafinil tablets in Germany for the treatment of moderate to severe chronic shift work sleep disorder with excessive sleepiness in patients working night shifts, if measures of sleep hygiene have not led to a satisfactory improvement. Marketed under the trade name VIGIL(R), modafinil has been available in Germany since 1998.
“Germany is the third European country to approve modafinil for the treatment of shift work sleep disorder and to recognize the need to treat it. This new indication capitalizes on the strong clinical data surrounding this medication and allows us to improve the quality of life of the people suffering from this debilitating disorder,” said Alain Aragues, President, Cephalon Europe.
Modafinil
Modafinil is the first and only medication in a new class of wake- promoting agents believed to work selectively through the sleep/wake centers to activate the cortex of the brain. The medication is currently approved in more than 20 countries and available under several brand names (PROVIGIL(R), ALERTEC(R), MODIODAL(R), MODASOMIL(R), MODAVIGIL(R) VIGIL). In 2004, the United States Food and Drug Administration approved PROVIGIL(R) (modafinil) [C-IV] Tablets for improving wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder (SWSD). PROVIGIL was originally approved in 1998 for improving wakefulness in patients with excessive sleepiness associated with narcolepsy.
About Cephalon
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products to treat sleep and neurological disorders, cancer and pain. Cephalon currently employs approximately 2,300 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 Salt Lake City, Utah, and suburban Minneapolis, Minnesota.
The company currently markets four proprietary products in the United States: PROVIGIL(R), GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II] and TRISENOX(R) (arsenic trioxide) injection and more than 20 products internationally. Full prescribing information for all U.S. products is available at http://www.cephalon.com/ or by calling 1-800-896-5855 (PROVIGIL, GABITRIL, and ACTIQ) or 1-800-715-0944 (TRISENOX).
Cephalon Europe
Cephalon Europe has headquarters in Maisons-Alfort France and offices in the United Kingdom, Germany and Switzerland employing more than 600 people. European operations market more than 20 pharmaceutical products such as ACTIQ(R) for cancer pain; GABITRIL(R) for seizures associated with epilepsy; modafinil under the brand names PROVIGIL(R), MODIODAL(R) and VIGIL(R) for excessive sleepiness associated with multiple disorders; and SPASFON(R), an antispasmodic.
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, sales and earnings 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.
Cephalon, Inc.
CONTACT: Media: Sheryl Williams, +1-610-738-6493, swilliam@cephalon.com,or Investors: Robert (Chip) Merritt, +1-610-738-6376, cmerritt@cephalon.com,both of Cephalon
Web site: http://www.cephalon.com/
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