Cephalon submits new drug application for NUVIGIL(TM)

FRAZER, Pa., March 31 /PRNewswire-FirstCall/ — Cephalon, Inc.(Nasdaq: CEPH – News) announced today that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration in seeks approval to market NUVIGIL(TM) (armodafinil) [C-IV] tablets to improve wakefulness in patients suffering from excessive sleepiness associated with narcolepsy, shift work sleep disorder (SWSD), and obstructive apnea/hypopnea syndrome of sleep (OSA/HS). NUVIGIL is a single isomer formulation of modafinil, the active pharmaceutical ingredient contained in PROVIGIL® (modafinil) [C-IV] tablets.

The NDA is based on positive results from four double-blind, randomized, placebo-controlled studies of NUVIGIL in patients with excessive sleepiness associated with narcolepsy, SWSD, or OSA/HS. The data in this presentation show that the primary endpoints of all studies were met and suggest that NUVIGIL differs from PROVIGIL.

"This is the third of five FDA approvals we will pursue over a 15-month period," said Dr. Paul Blake, executive vice president of Global Clinical Research and Regulatory Affairs at Cephalon. "Cephalon is a pioneer in the development of compounds to improve wakefulness, and this timely introduction allows us to strengthen our leadership position in the treatment of sleep-wake disorders," added Dr. Blake.

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About clinical studies

In four 12-week studies, daily doses of 150 and 250 milligrams of NUVIGIL or placebo were administered to approximately 1,000 patients with excessive sleepiness associated with narcolepsy, OSA/HS, or SWSD. The primary endpoints in all studies were measures of latency objective sleep (wake maintenance test or multiple sleep latency test) and medical grading of clinical global impression change. In each study, patients treated with NUVIGIL showed statistically significant improvement in both primary endpoints compared to placebo (all p values ​​<0.05). Additionally, recordings and patient diaries showed that, compared to placebo, NUVIGIL did not disrupt patients' normal sleep schedule.

In these Phase 3 studies, NUVIGIL was generally well tolerated, with a safety profile consistent with that observed in the PROVIGIL studies. The most common adverse effects observed included headache, nausea, dizziness, insomnia, and anxiety.

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About excessive sleepiness

Excessive sleepiness is the primary symptom (and often the most debilitating feature) experienced by patients with OSA/HS, SWSD, and narcolepsy.Associated with reduced activity in the cerebral cortex of the brain, the defining characteristic of excessive sleepiness is a consistent inability to remain awake and alert enough to safely and successfully perform the tasks of daily living. While millions of Americans suffer from excessive sleepiness associated with narcolepsy, OSA/HS, and SWSD, they are often misdiagnosed, with the underdiagnosis rate estimated to be between 50 and 90 percent. People who experience excessive sleepiness and seek medical attention often complain of fatigue, tiredness, lack of attention, lack of energy, lack of motivation, difficulty concentrating, sleep disturbances, snoring, or difficulties at work.

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Cefalon, Inc.

Cephalon currently employs approximately 2,300 people in the United States and Europe. US sites include the company's corporate headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's European offices are located in Guildford, England, Martinsried, Germany and Maisons-Alfort, France.

The company currently markets three proprietary products in the United States: PROVIGIL, GABITRIL® (tiagabine hydrochloride) tablets, and ACTIQ® (oral transmucosal fentanyl citrate) [C-II], and more than 20 products internationally. More information about Cephalon and complete prescribing information about its products in the US is available at http://www.cephalon.com or by calling 1-800-896-5855.

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 the anticipated scientific progress in its research programs, the development of potential pharmaceutical products, the interpretation of clinical results, particularly with respect to the NUVIGIL Phase 3 trials, the prospects for regulatory approval of NUVIGIL, the date expected product launch and potential benefits of NUVIGIL. , manufacturing development and capabilities, market prospects for its products, sales and earnings guidance, and other statements regarding matters that are not historical facts. You can 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. , as set forth in its reports on Forms 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 such forward-looking factors or statements. Additionally, Cephalon does not intend to publicly update any forward-looking statements, except as required by law. The Private Securities Litigation Reform Act of 1995 allows for this discussion.