Teva: Azilect slows Parkinson's

Teva Pharmaceutical Industries last week revealed positive results for the drug it developed in-house to treat Parkinson's disease.

Teva, the world's biggest maker of generic drugs, stated that a daily 1-milligram dose of Azilect slowed the progression of Parkinson's disease in a Phase III clinical trial. Parkinson's has until now been characterized by inevitable progression of nervous system degeneration.

The Israeli company is promoting the drug together with the Danish company Lundbeck in 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. 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 by patients.

The study also confirmed the safety and tolerability of Azilect and based on these results, Azilect (rasagiline) could become the first treatment for Parkinson's disease to be recognized as actually slowing the progress of the disease, the companies said. No other treatment has been effective beyond alleviating symptoms.

"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. Copaxone, a non-interferon treatment for relapsing-remitting multiple sclerosis, is another in-house drug for Teva, which otherwise focuses mainly on copycat (generic) versions of drugs developed by other companies. Copaxone became the No. 1 global treatment for multiple sclerosis in the first quarter.

Global sales of Azilect rose 50% in the first quarter of 2009 against the parallel quarter to $37.5 million. Sales were $120 million in 2007.

"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 Clal Finance. "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," he added. "However, it will take time until Azilect's impact becomes substantial."

The analyst noted that while Azilect's patent runs until 2012, the outcome of this clinical trial could enable an extension until 2017.

Bank Hapoalim analyst Gilad Sarig estimated Azilect's potential sales at $1 billion a year.

"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 Teva until the timetable with the U.S. Food and Drug Administration becomes clear.

The study protocol was based on the recommendations and guidance of the FDA. The 18-month cinical trial, the first of its kind, is one of the largest conducted on Parkinson's disease, involving 1,176 patients with early Parkinson's disease in 14 countries and 129 medical centers.