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Teva, Lundbeck say Azilect slows Parkinson's

Reuters - 41 minutes ago
TEL AVIV/STOCKHOLM, June 16 - Teva Pharmaceutical Industries Ltd revealed 
positive results on Monday for its Azilect Parkinson's treatment, boosting 
its shares and those of Danish partner Lundbeck .
Tel Aviv-traded shares in Teva jumped 3.2 percent while Lundbeck was up 3.7 
percent at 1336 GMT.
Teva, the world's biggest maker of generic drugs, said it intends to submit 
these results to the regulatory authorities in the United States and Europe.
It said the 1 mg tablets of its Azilect drug slowed the progression of 
Parkinson's disease in a Phase III trial. It promotes the drug with Lundbeck 
in the three major European markets: Britain, Germany and France.
Teva and Lundbeck said 1 mg tablets of Azilect met all three primary end 
points in the trial, as well as the secondary and additional end points, all 
with statistical significance.
The study also confirmed the safety and tolerability of Azilect and based on 
these results, Azilect could become the first Parkinson's disease treatment 
to receive an indication for slowing the progress of the disease, the 
companies said.
"These positive results could dramatically increase the market potential for 
Azilect, allowing Azilect to join Copaxone as another major Teva drug for 
neurological disorders," Shlomo Yanai, president and chief executive of 
Teva, said in a statement.
Teva's Copaxone became the No. 1 global treatment for multiple sclerosis in 
the first quarter.
"Azilect, an innovative drug that was not very significant, becomes a drug 
with the potential to be a blockbuster," said Gal Reiter, an analyst at 
Israeli brokerage Clal Finance.
SALES TO JUMP
Global sales of Azilect rose 50 percent in the first quarter from a year 
earlier to $37.5 million. It sales were $120 million in 2007.
"If in the past we estimated the potential sales of the drug at $300 
million, now we estimate that the potential has at least doubled," Reiter 
said.
"However, it will take time until Azilect's impact becomes substantial."
The analyst noted that while Azilect's patent runs until 2012, this clinical 
trial could enable an extension until 2017.
Bank Hapoalim analyst Gilad Sarig estimated Azilect's potential sales at $1 
billion.
"It is expected to become the leading drug in the Parkinson's market within 
a few years," he said in a research note, adding he is not changing his 
forecasts for the company until the timetable with the FDA becomes clear.
The study protocol was based on the recommendations and guidance of the U.S. 
Food and Drug Administration. The 18-month study, the first of its kind, is 
one of the largest conducted in Parkinson's disease, involving 1,176 
patients with early Parkinson's disease in 14 countries and 129 medical 
centres.
Teva also said the 2 mg dose in the study met two of the three primary end 
points as well as the secondary end point. It was also found to be safe and 
well tolerated.
Rayilyn Brown
Director AZNPF
Arizona Chapter National Parkinson Foundation
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