Cephalon Raises Sales Targets

Baldino said he expected a "modest launch" for the sleep-disorders drug Nuvigil in 2007. A cousin of Provigil, the drug is still under review by the FDA. Even when the agency approves Nuvigil, Baldino said Cephalon will devote most of its marketing muscle to Provigil. By 2010, he added, Cephalon will begin a campaign to switch patients from the older drug to the newer treatment.

Not long ago, Cephalon feared that Provigil would lose patent protection due to a series of challenges by generic-drug companies. If that had happened, Cephalon would have wanted to get Nuvigil on the market as quickly as possible. But in rapid-fire order, Cephalon negotiated deals with four companies, protecting Provigil from copycats until October 2011.

Now, the regulatory delays for Nuvigil don't seem as troublesome. The FDA granted conditional approval in May, and the agency is supposed to act by late December.

Cephalon is talking to the FDA about a proposed warning on the labels of both drugs for a rare, dangerous skin disease called Stevens-Johnson syndrome. The discussion emerged after the FDA in August rejected a Cephalon application for Sparlon to treat attention deficit hyperactivity disorder in children.

The FDA found one suspected case of the dangerous syndrome in Sparlon clinical trials. Cephalon presented data disputing the diagnosis, but the FDA held firm. Sparlon, Provigil and Nuvigil all contain the ingredient modafinil. The Sparlon dose was higher than the doses for the sleep-disorder drugs. Provigil and Nuvigil aren't for children.

Baldino told analysts that listing Stevens-Johnson syndrome on the Provigil and Nuvigil labels probably wouldn't affect sales of either drug because the medications will be prescribed only for adults.

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