ADAGIO clinical trial results demonstrating AZILECT's efficacy published

Results from the ADAGIO trial, published online today in The New England Journal of Medicine, demonstrated that Parkinson’s disease patients receiving AZILECT^® (rasagiline) 1mg/day 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). This finding is consistent with a possible disease-modifying effect for AZILECT^® (rasagiline) 1mg/day.

Professor C. Warren Olanow, MD, Department of Neurology, Mount Sinai School of Medicine, New York and co-principal investigator of the ADAGIO study, commented, “A therapy that slows or stops disease progression is the greatest unmet need in the treatment of patients with Parkinson’s disease. Current therapies do not prevent the development of disability in such patients. The results of the ADAGIO study provide support for the possibility that early treatment with AZILECT^® (rasagiline) 1mg/day may slow the development of disability.”

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.

Professor Olivier Rascol, Department of Clinical Pharmacology, University Hospital, Toulouse, France and ADAGIO co-principal investigator, stated, “The results of the ADAGIO study provide novel data to support the use of AZILECT^® 1mg daily as initial treatment of patients with Parkinson's disease. The ADAGIO study, which utilized a novel trial design with three primary endpoints, suggests that the drug has a positive impact on slowing the progression of patients' disability, beyond its already known symptomatic benefit.”

In the study, rasagiline 2mg/day, which is not a marketed dose for AZILECT^®, did not meet the second primary endpoint. As discussed in The New England Journal of Medicine article, it is possible that a greater symptomatic effect of the 2mg/day dose may have masked a benefit associated with early-start treatment in the population of patients with very mild disease included in the ADAGIO study. A post-hoc analysis conducted on a sub-group of patients with highest baseline UPDRS (the upper quartile) showed positive results with the 2mg/day dose, supporting this hypothesis.

“Patients with Parkinson’s disease are in need of treatments that can slow or even halt the progression of their disease. After years of clinical experience and innovative scientific study with AZILECT^®, we are proud to have contributed to the expanding body of knowledge in Parkinson’s disease,” said William S. Marth, President and Chief Executive Officer of Teva North America. “Teva has been working to respond to questions raised by the FDA regarding ADAGIO and anticipates further discussions with the FDA to review and interpret the findings from this landmark study. Following those discussions, we expect to file a supplemental NDA in 2010, with the scope of any modification to the AZILECT^® 1mg/day label remaining subject to the conclusion of those discussions.”