Israeli company develops drug proven to slow progression of Parkinson's

Azilect not only ameliorates the symptoms of Parkinson's disease - it has been proven to slows the disease's progression, Teva Pharmaceutical Industries announced Tuesday.

The drug, an original one made by the Israeli drug company, reached all its goals in a Phase III late-stage clinical trial, the company said. It is the only drug known to not only treat the symptoms of Parkinson's, an incurable neurodegenerative condition, but to actually slow the disease.

Azilect, known as rasagiline in its generic form, is already approved to treat symptoms of Parkinson's. But the Israeli drugmaker wants U.S. and European regulators to expand the official labeling of Azilect's approved uses.

In its clinical trial, named "Adagio", patients who took a tablet of Azilect once a day experienced slower disease progression in the early part of the trial and a steadying of symptoms in the last part of the trial, Teva said yesterday. They also experienced a smaller decrease in baseline function.

Parkinson's disease patients who took Azilect tablets once a day from the time when they joined the trial demonstrated significant improvement compared to those who started the drug only nine months later.

In the trial, some patients were given an Azilect tablet once per day for 72 weeks, while others received a placebo for the first 36 weeks before being treated with Azilect. The Azilect tablets were given in strengths of 1 or 2 milligrams.

Adagio, one of the largest studies conducted on Parkinson's, encompassed 1,176 patients with very early-stage disease in 14 countries at 129 medical centers. Results were evaluated with the Total-Unified Parkinson's Disease Rating Scale, which measures the symptoms and progression of the disease, including its effects on mental state, motor skills and daily activities. The results were presented at the 12th congress of the European Federation of Neurological Societies in Madrid, Spain.

"Delaying disease progression is the most important unmet need in the management of Parkinson's disease," stated Prof. C. Warren Olanow, professor and chairman of the Department of Neurology at the Mount Sinai School of Medicine in New York, and Adagio co-principal investigator.

Azilect sales totaled $42 million in the second quarter of 2008, a 50% increase. Teva hopes Azilect sales will reach at least $1 billion a year. Total sales of drugs for treating Parkinson's are $3.7 billion annually. Teva had already reported in June that Azilect can slow the progress of Parkinson's disease.

Tal Levy adds: "We continue to recommend Teva as a defensive share, in light of the sad macro-economic situation," wrote analysts from the Excellence Nessuah investment house yesterday after Teva made its announcement of the Azilect trial results.

Despite the successful results, Excellence said: "We already knew [about] it in June, when Teva first released the summary results of the trial." The analysts say that since Azilect is profitable similar to Copaxone, with about a 35% operating profit margin, Teva has serious potential for increasing its profits. If Azilect reaches $2 billion in sales, an extreme but not impossible goal, Teva's profits would increase by 20%.

"The rigorous trial design and the fact that all three primary endpoints were met with statistical significance reinforce the quality of the data, supporting the potential for Azilect to have an effect on disease progression," said Professor Olivier Rascol of the Department of Clinical Pharmacology, University Hospital, Toulouse, France; one of two principal investigators of the trial.