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United Kingdom Expands Approval For Provigil (Modafinil) To Include Sleep Apnea/ Hypopnea Syndrome, Narcolepsy

WEST CHESTER, Pa., Dec. 3 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that it has received marketing approval from the Medicines Control Agency (MCA) in the United Kingdom to expand the label of Provigil® (modafinil) to treat excessive daytime sleepiness in patients with obstructive sleep apnea/hypopnea syndrome. The 200 mg tablet of Provigil was also approved, in addition to the 100 mg dosage currently available in this territory. Cephalon UK Limited will officially launch the new indication at a symposium during the British Thoracic Society meeting being held December 4-6 in London.

"We are pleased that the data used to support this label expansion was accepted by the UK regulatory authority," said Paul Blake, MB, FRCP, Senior Vice President of Clinical Research and Regulatory Affairs at Cephalon. "Achievement of this milestone will enable us to grow the market for modafinil in the United Kingdom and sets the stage for regulatory submissions in other European countries over the next year."

The UK approval is the first of two regulatory milestones that Cephalon expects to achieve this year for Provigil. Cephalon intends to file an application with the U.S. Food and Drug Administration at year-end seeking to expand the label of Provigil to include treatment of excessive sleepiness associated with sleep disorders beyond narcolepsy.

Provigil
Modafinil is the first in a new class of wake-promoting agents and is currently approved in more than 20 countries for the treatment of excessive daytime sleepiness associated with narcolepsy. Provigil was initially launched in the UK in 1998 for the treatment of narcolepsy.

In controlled clinical trials, Provigil has been found to be generally well tolerated with a low incidence of adverse events relative to placebo. The most commonly observed adverse events associated with the use of Provigil were headache, infection, nausea, nervousness, anxiety and insomnia.

Obstructive Sleep Apnea Hypopnea Syndrome
Obstructive sleep apnea/hypopnea syndrome is a serious and potentially life-threatening sleep disorder affecting four percent of middle-aged men and two percent of middle-aged women. Individuals with obstructive sleep apnea hypopnea syndrome experience frequent awakenings throughout the night as a result of blockage of the airway during sleep. This disruption of sleep leads to excessive daytime sleepiness causing many people to doze off repeatedly throughout the day -- at their jobs and at home.

The most commonly used standard treatment is continuous positive airway pressure (CPAP). A nasal CPAP device can prevent airway closure while in use, but despite this treatment many patients continue to experience residual excessive sleepiness.

Cephalon, Inc.
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 employs 1,200 people in the United States and Europe. The company markets three proprietary products in the United States and 22 products internationally. Full prescribing information on Cephalon's US products is available by calling 1-800-896-5855.

Cephalon's biotechnology pipeline is focused on the identification of novel molecules that affect cell survival and death. Additional information about Cephalon and its subsidiaries can be obtained by visiting the company's Website at http://www.cephalon.com .

Cephalon UK Limited has headquarters in Guildford and markets drugs to treat a number of central nervous system disorders. In collaboration with Novartis, Cephalon UK markets Tegretol® (carbamazepine), Ritalin® (methylphenidate), Anafranil® (clomipramine) and Lioresal® (baclofen). Also included in this collaboration is Provigil (modafinil) for the UK. In addition, Cephalon UK also markets Gabitril® (tiagabine monohydrate) and Actiq ® (fentanyl -- as citrate) in the UK and Ireland.

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 projections, 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 such as those set forth below and 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.


SOURCE: Cephalon, Inc.

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