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Teva Gets Parkinson's Drug OK

Robert Steyer

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.

Azilect was approved in Europe and Israel in 2005, and is available in 13 European Union countries, where Teva collaborates in marketing with the Danish drug company Lundbeck.

Azilect was developed by Teva based on research from the Technion Israel Institute of Technology. The drug was known as Agilect while it was being developed in the U.S., where Teva will handle the marketing. Teva said it is waiting to hear whether Japan's Eisai will co-promote the drug in the U.S. Since 2003, Teva and Eisai have been testing Azilect as a treatment for Alzheimer's disease.

Azilect took a number of regulatory detours before reaching the U.S market. Teva submitted its original application in September 2003, and the FDA granted conditional approval in July 2004. Teva filed answers to FDA's questions, but the agency told Teva in August that it was delaying a final decision because certain issues needed to be resolved.

The company warns patients to avoid eating foods, drinking beverages and taking dietary supplements that contain tyramine. Because it is a monoamine oxidase inhibitor, Azilect affects the body's ability to process tyramine, an amino acid that regulates blood pressure. Certain foods -- such as red wine, smoked or cured meats, many cheeses and saukerkraut -- raise tyramine levels, creating a dangerous spike in blood pressure.

The company also is warning patients about taking the medication with other prescription drugs. "It seems prudent, in general, to avoid the combination of Azilect with antidepressants," Teva says. It adds that patients should avoid additional types of medications, ranging from other monoamine oxidase inhibitors to methadone, as well as St. John's Wort and certain over-the-counter cold remedies.