The results of Teva Pharmaceutical Industries Ltd.'s (Nasdaq: TEVA; TASE: TEVA) Adagio study of its Azilect drug for Parkinson's disease were today published in the online edition of "The New England Journal of Medicine". The results demonstrated that Parkinson’s disease patients receiving 1 mg daily dosages of Azilect at the start of the study (early-start group) experienced superior benefit over 18 months compared with those who started the exact same treatment nine months later (delayed-start group).
The findings point to the possibility that Azilect can slow or stop the progression in Parkinson's disease at this dosage. Teva said that Azilect is the first Parkinson’s disease treatment to succeed in a prospective delayed-start study, a trial design specifically developed to test for the possibility of a disease-modifying effect.
Azilect is an original drug developed by Teva. It currently has annual sales of $220 million.
Teva CFO Eyal Deshe believes that the publication of the study will boost Azilect sales. "Sales have risen strongly since the publication of the Adagio trial results. The present article is a breakthrough for us. It reaches tens of thousands of doctors, and is an immense sales promotion. We believe that Azilect will become a very big product, distinguished from all other treatments."
Teva chief R&D officer Ben Zion Weiner said, "The US Food and Drug Administration (FDA) basically compelled us to conduct this study. Three measures determine whether the drug passed, and we met all three measures." He noted that the trial included 1,176 patients at 129 clinical centers in 14 countries, which he called an "incredibly strong study".
Patients were treated underwent a 72-week trial with Azilect 1mg/day or 2mg/day, or underwent treatment for 36 weeks with a placebo followed by 36 weeks with Azilect 1mg/day or 2mg/day. The 2 mg/day dosage did not meet one of the trial measurements, and did not show a statistically significant improvement in the patients' condition. Weiner was not disappointed. "I'd have been disappointed if the lower dosage did not meet the criteria, because that's the dosage now on sale in the market," he said.
Teva announced the results of the trial, which showed that Azilect can delay the onset of Parkinson's disease, in June. Teva has asked the FDA to change the indication of Azilect, and included the results of the trial in its negotiations with the FDA on the application.
Weiner believes that the talks will take several months at least, and noted that Teva was meanwhile continuing its review of the long-term effects of Azilect beyond 18 months.
"Globes": Since Azilect is already on the market, and the studies had positive findings, should doctors give it to patients to delay the onset of Parkinson's even before the change in indication?
Weiner: "I believe that doctors who read the article know that Azilect met the three criteria, and noted that fact. I hope that doctors will prescribe the drug immediately when a patient shows signs of Parkinson's disease."
Teva rose 0.8% at the opening on Nasdaq today to $51. The share rose 0.1% on the TASE to NIS 190.70
Published by Globes [online], Israel business news - www.globes-online.com - on September 24, 2009
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