FDA Advisory Committee Recommends Expanded Label for PROVIGIL; FDA Action on Cephalon, Inc. Application is Expected by Year-end
Thursday September 25, 2:32 pm ET
Investor Conference Call Number and Time Changed
WEST CHESTER, Pa., Sept. 25 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH - News) announced today that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) has recommended that the label for PROVIGIL® (modafinil) [C-IV] be expanded.
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This is based on positive results presented by Cephalon from multiple clinical studies demonstrating the safety and effectiveness of PROVIGIL versus placebo in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work sleep disorder
The FDA will consider the recommendation of the advisory committee and by year-end is expected to determine the precise language of the modified label for PROVIGIL. PROVIGIL currently is approved for marketing in the United States as a treatment for excessive daytime sleepiness associated with narcolepsy. Cephalon is requesting that the drug's label indicate that it is a treatment for a broader group of patients who suffer excessive sleepiness associated with other serious sleep-related disorders.
"An expanded PROVIGIL label would create a tremendous opportunity to meet the needs of a large number of patients who suffer from these disorders," said Frank Baldino, Jr., Ph.D., Chairman and CEO of Cephalon. "We are increasing our existing sales force in anticipation of the need to educate a broader group of physicians about the proper use of PROVIGIL. Physician education is the key to ensuring that patients who are candidates for treatment with PROVIGIL have access to the therapy."
As expected, the advisory committee was asked to respond to general questions posed by the FDA about Cephalon's Supplemental New Drug Application (sNDA). The agency asked the committee to review specific clinical data presented by the company and to discuss whether the diseases studied by the company represent the universe of sleep and wakefulness disorders and whether valid measures of sleepiness were used in research.
David F. Dinges, Ph.D., Chief, Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania School of Medicine, said: "The committee's positive recommendation to expand the drug's label represents a vote of confidence in the clinical and safety profile of PROVIGIL. The medical benefits of PROVIGIL in this patient population have been well documented. An expanded label would allow Cephalon to present new data to physicians so they can reach a broader group of patients in need."
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 in the clinical trials reviewed by the committee were similar to those found in the label and included headache, infection, nausea, nervousness, anxiety and insomnia. For full prescribing information about PROVIGIL please visit provigil.com or call 1-800-896-5855.
Cephalon's management will discuss the FDA advisory committee proceedings with investors during a conference call beginning at 3 p.m. U.S. EDT on Thursday, September 25, 2003. To participate in the conference call, dial (913) 981-5533 and refer to Conference Code Number 621617. Individual investors are encouraged to log onto the investor relations section of www.cephalon.com and click on the webcast to access the live call.
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 1,300 people in the United States and Europe. Cephalon's major European offices are located in Guildford, England, Martinsried, Germany, and in Maisons-Alfort, France. For more information on Cephalon, please visit cephalon.com.
The company currently markets three proprietary products in the United States: PROVIGIL, GABITRIL® (tiagabine hydrochloride) and ACTIQ® (oral transmucosal fentanyl citrate) [C-II] and more than 20 products internationally.
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 timing of FDA action on Cephalon's sNDA, the opportunity created by an expanded PROVIGIL label, the impact of physician education on patient access to PROVIGIL, 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 including 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. |
