Crunch Time at Teva

 

Teva Pharmaceutical (TEVA) may hear today from the Food and Drug Administration on a new treatment for the symptoms of Parkinson's disease.

For the generic-drug giant, FDA approval would give it a second brand-name neuroscience drug -- joining Copaxone for multiple sclerosis -- as it tries to diversify its product line.

For patients, the drug, Agilect, offers another medication to ease the symptoms of this progressive neurological disorder. There are many drugs on the market, including generic brands, but none can reverse the damage of a disease that affects 1 million people in the U.S. and 3 million in the rest of the world.

At best, drugs like Agilect can address symptoms, such as tremors and a lack of balance, to help patients live as normally and as long as possible.

"At this time no treatment has been shown to slow or stop the progression of this disease," says the National Parkinson Foundation. "There is no standard or 'best' treatment." As their disease gets worse, patients often take more than one drug. In some severe cases, doctors recommend brain surgery.

Because there's no dominant treatment, Parkinson's disease remains a popular research subject with several compounds now in mid- to late-stage clinical trials, says Sagient Research Systems of San Diego. A recent report by Sagient's BioMedTracker, which analyzes trends in biotechnology, says, "in early disease, there are no new drugs with both impressive efficacy and side effect profiles, but we believe Agilect will have modest [market] penetration."

No Cures

Named for the British physician who discovered it in 1817, Parkinson's disease is caused by the death of or damage to certain nerve cells in the brain. The cells produce dopamine, which help regulate movement and balance. When the dopamine-secreting cells die, the other movement-control centers in the brain become unregulated.

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