Cephalon

Drug Store News, Feb 16, 2004

The FDA late last month extended the indications for Cephalon's Provigil (modafinil), a medicine prescribed previously only to narcoleptics, to include a broader range of sleep disorders, including excessive sleepiness in people who have been diagnosed with obstructive sleep apnea and shift work sleep disorder.

With the new indications, the potential market for Provigil may grow beyond 20 million patients. Beforehand, the drug was approved for use in a patient population of 200,000 Americans diagnosed with narcolepsy.

"Three to five years out, Provigil could be a billion-dollar drug. I'm pretty confident in that number, commented Frank Baldino, chairman and chief executive officer of Cephalon's Cephalon, following news of the FDA's decision.

Before news of the new indications had been released, Cephalon had projected Provigil would reach fiscal 2004 sales of $375 million to $425 million. A sales lift may not be realized immediately, however, as analysts have estimated that as many as 80 percent of Provigil prescriptions were written "off-label" to treat the new indications.

Cephalon has recently increased its sales force from about 350 people to 500.