FYI
Cephalon Sees FDA Approval of Provigil for Narcolepsy 'Any Day'
New York, Dec. 15 (Bloomberg) -- The U.S. Food and Drug Administration is likely to clear Cephalon Inc.'s Provigil drug for narcolepsy within the next two weeks, company officials said.
The company expects FDA approval ''any day,'' said Frank Baldino, president and chief executive officer at money-losing Cephalon, which has yet to win FDA approval for any new drug.
The company last December received a so-called approvable letter from the FDA, which generally means the agency is working to resolve minor details and is ready to approve the drug.
The FDA has a target to act on the drug by the end of the year, said J. Kevin Buchi, vice president for finance and chief financial officer at Cephalon. ''I think it's on schedule for that,'' he said following a presentation to investors and analyst at the ING Baring Furman Selz healthcare conference being held in New York through tomorrow.
An FDA approval would be a welcome step forward for the West Chester, Pennsylvania-based biotechnology company. Cephalon shares have fallen from 40 over the past three years as the company's Myotrophin drug for Lou Gehrig's disease encountered repeated setbacks.
Shares in Cephalon rose 17/32 to close at 8 1/16 today.
Cephalon's future value is tied to drugs led by Provigil, analysts have said, because few people will still bet on approvals for Myotrophin.
Narcolepsy -- a neurological disorder where a patient suffers uncontrollable or near uncontrollable fits of dream sleep
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