Teva Gets Parkinson's Drug OK

Teva Pharmaceutical Industries(TEVA) received Food and Drug Administration clearance to sell Azilect, a once-daily pill for treating symptoms of Parkinson's disease.

Azilect will be available in 8 to 10 weeks. The drug is approved by the FDA as a single therapy for early-stage Parkinson's disease and as an adjunct therapy for moderate to advanced Parkinson's disease. For this latter group of patients, Azilect will be used with the stronger drug levodopa.

Parkinson's disease causes a progressive loss of nerve-cell function in the brain, producing such symptoms as unsteady gait, shaking and muscle stiffness. Teva says the disease affects some 4 million people worldwide, including 1 million in the U.S.

The announcement, however, didn't do much for Teva's stock, which slipped 9 cents to $38.18 by late afternoon.

Azilect is the second brand-name drug for Teva, the world's largest generic drug company. It also sells Copaxone, an injectable treatment for multiple sclerosis. For the quarter ended March 31, Copaxone produced sales of $329 million, up 29% from the year-ago period, and accounted for nearly 20% of Teva's first-quarter revenue.

Azilect has the opportunity to be the "ideal little brother" to Copaxone because both reach the neuroscience market, says Richard Watson, of William Blair & Co., in a Wednesday research report. He predicts Azilect could reach peak annual sales of $250 million by 2010.

Azilect is entering a crowded U.S. market, filled with brand-name and generic drugs that treat symptoms of Parkinson's disease, but which don't cure the condition. Azilect belongs to a class of drugs called monoamine oxidase inhibitors, and Watson says it offers greater dosing convenience, better efficacy and fewer side effects than older drugs in this class.

He estimates the combined U.S. and European market at $1.5 billion for Parkinson's disease treatments, but adds that the strong presence of generics may cause the revenue opportunities, especially in the U.S., to be "artificially depressed." Watson, who has an outperform rating on Teva, doesn't own shares. His firm is a market maker.