ARTICLE: Panel OKs Expanded Uses For Cephalon Drug

[Murray Charters <mcharters@xxxxxxxxxxxxxx>]

Panel OKs expanded uses for Cephalon drug
John George

4:29 PM EDT Thursday

A Food and Drug Administration advisory committee on Tuesday recommended 
expanding the approved uses for Cephalon
Inc.'s narcolepsy drug Provigil.

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee 
stopped short of approving Cephalon's request
to market the drug generally for any disorders linked to sleeping disorders.

Instead, the panel recommended expanding the drug's label to include its use in 
treating daytime sleepiness associated
with shift work and sleep apnea.

The FDA, which almost always follows the recommendations of its advisory 
committees, will review the panel's finding
and is expected to determine the precise language of the modified label for 
Provigil before the end of the year.

Frank Baldino, Cephalon's chairman and CEO, said the company plans to expand 
its sales force in order to call on a
broader range of doctors, including generalists, once the expanded label is in 
place. The company now primarily markets
Provigil to sleep specialists and neurologists.

Nasdaq temporarily suspended trading of Cephalon's stock pending the outcome of 
the committee meeting. After trading
resumed, Cephalon's stock climbed $1.23 per share and closed at $46.90.

Provigil is already widely prescribed by doctors for off-label uses such a 
treating fatigue in patients with sleep
apnea, Parkinson's disease, multiple sclerosis, chronic-fatigue syndrome and 
depression.

Sales of Provigil are expected to top $300 million this year.

SOURCE: American City Business Journals / Philadelphia Business Journal, PA


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