Results Of ADAGIO Study With AZILECT(R) In Parkinson's Disease Published In New England Journal Of Medicine

Main Category: Parkinson's Disease
Article Date: 24 Sep 2009 - 6:00 PDT

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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).1 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."

Teva to Host Conference Call with Professor C. Warren Olanow, MD

Teva will host a conference call with Professor C. Warren Olanow, MD, co-principal investigator of the ADAGIO trial and William Marth, President and Chief Executive Officer, Teva North America to discuss the ADAGIO study results on Thursday, September 24, 2009, from 8:30 a.m. - 9:30 a.m. ET. The number to call from within the United States is (866) 700-7101 or (617) 213-8837 internationally and using the participant code 30733492. The call will also be webcast and may be accessed through the Company's website at http://www.tevapharm.com. Following the conclusion of the call, a replay of the webcast will be available within 24 hours at the Company's Web site. To access the replay, go to Investor Relations and click on Conference Calls.

About ADAGIO

ADAGIO (Attenuation of Disease progression with AZILECT® GIven Once-daily) was a randomized, multi-center, double-blind, placebo-controlled, parallel-group study prospectively examining rasagiline's potential disease-modifying effects in 1,176 patients with early, untreated Parkinson's disease. Patients from 129 centers in 14 countries participated and were randomized to initiate treatment for 72 weeks with rasagiline 1mg/day or 2mg/day, or to initiate treatment for 36 weeks with a placebo followed by 36 weeks with rasagiline 1mg/day or 2mg/day.

The primary analysis included three hierarchical endpoints based on total scores in the Unified Parkinson's Disease Rating Scale (UPDRS). AZILECT® 1 mg/day early-start met all endpoints of the primary analysis: less deterioration in UPDRS score than placebo between weeks 12 and 36; less worsening than delayed-start in UPDRS score in comparing change between baseline and week 72 despite being on the same medication for the last 9 months; and non-inferiority to delayed-start in rate of deterioration between weeks 48 and 72. The ADAGIO study also confirmed the positive symptomatic effect and safety profile of AZILECT®, in line with prior studies.2

About AZILECT®

AZILECT® (rasagiline) 1mg tablets are indicated for the treatment of the signs and symptoms of Parkinson's disease both as initial therapy alone and to be added to levodopa later in the disease. AZILECT® 1mg tablets are now available in 38 countries, including the U.S., Canada, Israel, Mexico and all of the European Union countries, where it is marketed by Teva in collaboration with Lundbeck A/S as part of a long-term strategic alliance.

About Parkinson's Disease

Parkinson's disease is an age-related degenerative disorder of the brain. Symptoms can include tremor, stiffness, slowness of movement and impaired balance. An estimated four million people worldwide suffer from the disease, which usually affects people over the age of 60.

Source
Teva