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FDA expands uses for sleep medication

Tue, Jan. 27, 2004
Linda Loyd
The Philadelphia Inquirer

Cephalon Inc. said yesterday that it received approval from the U.S. Food and Drug Administration to sell its narcolepsy drug, Provigil, to treat a broader range of sleep disorders, including sleepiness suffered by night-shift workers.

Provigil is now approved only for those who suffer from narcolepsy, a disorder in which people suddenly fall asleep during waking hours.

In September, an FDA advisory panel recommended to the FDA that use of Provigil be expanded to treat fatigued shift workers whose shifts make it hard to stay awake on the job, and to treat obstructive sleep apnea, a condition in which nighttime sleep is interrupted by irregular breathing.

The FDA usually follows its advisory panels' recommendations.

"This new label allows us to bring Provigil to millions of new patients and thousands of new prescribers," said chairman and chief executive officer Frank Baldino. "We believe this will have a positive impact on the company's performance."

The FDA first approved Provigil, also known as modafinil, in December 1998 for narcolepsy, which affects up to 200,000 Americans.

Now, Cephalon will market Provigil to a broad group of physicians, including general and family practitioners, and not just sleep specialists, psychiatrists and neurologists.

"With these [additional] labels, we can bring Provigil to 20 million patients. We have had a lot of off-label use," Baldino said. Cephalon has increased its sales force from about 350 people to 500, Baldino said.

"Three to five years out, Provigil could be a billion- dollar drug. I'm pretty confident in that number," Baldino said.

Last year, 375,000 Provigil prescriptions were written in the third quarter. Fourth-quarter and full-year earnings will be announced on Feb. 12. Cephalon has projected Provigil sales will be $287 million to $292 million for 2003.

Analysts estimate that 80 percent of Provigil prescriptions now are for "off-label" treatment of sleepiness and fatigue from illnesses such as depression, Parkinson's disease, chronic fatigue syndrome and multiple sclerosis.

"We introduced Provigil back in 1999. It was the first drug in history to treat wakefulness in narcolepsy patients," Baldino said. "Now, for a second and third time, Provigil is the first drug approved for obstructive sleep apnea and shift-work sleep disorder."

He said Cephalon eventually might promote Provigil on direct-to-consumer television advertising to try to reach shift workers and those suffering from sleep apnea.

"Our strategy the next couple of years will be to bring it to general practitioners through our sales representatives, and ads in medical journals and marketing journals that physicians read," Baldino said.

"It's a mistake to do direct-to-consumer advertising too soon. In the long run, I'm not ruling it out. In the short term, I am."

About 12 million Americans suffer from obstructive sleep apnea, according to the National Institutes of Health. Six million people in the United States work permanent or rotating night shifts, and are at risk for shift-work sleep disorder, the company said.

Cephalon, founded in 1987, develops and sells drugs to treat sleep and neurological disorders, cancer and pain. The company employs more than 1,600 people in West Chester; Salt Lake City, Utah; Guildford, England; Martinsried, Germany; and Maisons-Alfort, France.

Cephalon bought the rights for Provigil from French drugmaker Laboratoire L. Lafon.

Shares of Cephalon closed up 68 cents, or 1.21 percent, at $56.68 on the Nasdaq stock market.

© Copyright 2004, The Philadelphia Inquirer