Mylan Gets Tentative Generic Approval

NEW YORK – Mylan Laboratories Inc. said Thursday that it received a tentative regulatory approval for a generic version of Cephalon Inc.’s Provigil, a drug used to treat excessive tiredness related to sleep disorders.

The Food and Drug Administration issues tentative approvals when a branded drug has unexpired patents or exclusivity rights. According the FDA’s Orange Book of approved drugs, Provigil is covered by patents that expire in 2007 and 2014. Woodcliff Lake, N.J.-based Barr Pharmaceuticals Inc. received a tentative approval for modafinil – the generic name for Provigil – last January.

Both Mylan’s and Barr’s tentative approvals cover 100 milligram and 200 milligram tablets, the same doses sold by Cephalon. In afternoon trading on the New York Stock Exchange, shares of Canonsburg, Pa.-based Mylan fell 20 cents to $15.71 and Barr shares fell 92 cents, or 2 percent, to $45.95.

Separately Thursday, Cephalon said that a late-stage study showed its Nuvigil drug, which uses the same active ingredient as Provigil, successfully improved wakefulness in patients suffering from narcolepsy, shift work sleep disorder or obstructive sleep apnea/hypopnea syndrome. Cephalon plans to file an application for Nuvigil by the end of this quarter.

If approved, Nuvigil could provide Cephalon with a patent-protected therapy for excessive sleepiness just as generics begin to enter the market. The West Chester, Pa. company is testing the drug at doses of 150 milligrams and 250 milligrams – higher than those available for Provigil.

Cephalon said in November that it expects Provigil – its highest selling drug – to post sales of $450 million to $415 million for 2004 then grow to $550 million to $600 million in 2005.

Cephalon shares rose 91 cents to $49.42 in afternoon trading on the Nasdaq.