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Teva Says Parkinson's Drug Is First to Slow Disease (Update3)

By Alex Kuli

Aug. 26 (Bloomberg) -- Teva Pharmaceutical Industries Ltd. said its Azilect pill is the first to slow the progression of Parkinson's disease in new findings that may increase sales of the medicine to more than $1 billion.

Patients who took the 1-milligram dose of Azilect at the outset of an 18-month trial showed ``significant improvement'' over patients who started nine months later, Petah Tikvah, Israel-based Teva said in a statement today. The test results were presented at a medical conference in Madrid today.

Azilect, Teva's second original product, was introduced in 2005 to treat the symptoms of Parkinson's, an incurable disease that destroys patients' nerve functions. Teva needs to replace revenue from its first original drug, Copaxone for multiple sclerosis, before it loses patent protection in 2014. Peak sales of the pill may now surpass $1 billion, instead of an estimated $250 million a year, said Ronny Gal, who follows Teva at Sanford C. Bernstein in New York, in a June 16 interview.

``The importance of this news is that there is scientific confirmation that has been presented before an audience of doctors,'' said Yoav Burgan, an analyst at Leader Capital Markets Ltd. in Tel Aviv.

Today's data may increase Azilect's share of the $3.68 billion global market for Parkinson's disease medicines, said Moshe Manor, who heads up Teva's innovative drug development.

``Now it's proven that if you treat earlier, you can protect the patient from further deterioration,'' Manor said in a telephone interview today. ``This slowing down effect will probably continue to be sustained over time.''

Burning Dopamine

Teva rose 29 cents to $46.87 at 4 p.m. in New York. In Tel Aviv, the stock closed up 2.8 shekels, or 1.7 percent, at 166.80 shekels.

Parkinson's disease strikes when patients lose brain neurons that produce dopamine, a hormone that helps transmit signals from the brain to the body. The disruption to the nervous system causes tremors, difficulty in speaking and walking, and depression.

Azilect inhibits production of an enzyme that burns up dopamine, thereby increasing levels of the hormone. Doctors can prescribe it on its own, thought they often recommend it in combination with levodopa, a drug that the body converts into dopamine.

Early Intervention

Today's findings on Azilect could support a strategy of ``early intervention,'' said Anthony Schapira, a neurologist at the Royal Free and University College Medical School in London, before the data was released. Currently, most Parkinson's specialists wait until the symptoms become disabling before putting patients on a drug regimen, he said.

Neurologists will want to examine the trial results before changing their prescribing habits for Azilect, said Kieran Breen, director of research at the U.K. society, in an Aug. 11 telephone interview.

``That's one of the big problems with Parkinson's -- it's such a heterogeneous condition you have to look at a large number of people over a long period of time,'' Breen said.

The expanded use of Azilect could propel Teva's share price above $50 in New York for the first time, said Gilad Alper, an analyst at Excellence Nessuah in Tel Aviv, before the data was released.

Azilect prescription numbers began to climb on June 16, when Teva first said that the study had achieved all its main goals without disclosing what the goals were, Manor said. He declined to say how much sales have increased.

Azilect's Label

Teva will use today's data to try to persuade the U.S. Food and Drug Administration to label Azilect as a means of stopping symptoms from deteriorating. The Israeli company plans to make a formal application by year's end, and may get a decision a year later. It's also possible the FDA may ask for more tests, Manor said.

Teva developed the medicine with Danish drugmaker H. Lundbeck A/S. The pill had sales of $120 million last year, compared with $950.6 million for Boehringer Ingelheim GmbH's Mirapex and $693 million for GlaxoSmithKline Plc's Requip, according the companies' annual reports.

Boehringer is also conducting a test to see whether Mirapex slows the progression of Parkinson's, according to a statement on the German company's Web site. Boehringer's drug works by stimulating dopamine receptors, ``tricking'' the brain into thinking that the hormone is being produced.

Teva plans to publish today's study in a peer reviewed journal, Manor said, declining to give details.

``I think the data speaks for itself,'' he said.

To contact the reporter on this story: Alex Kuli in Budapest at akuli@bloomberg.net.

Last Updated: August 26, 2008 16:23 EDT

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