This excerpt taken from the TEVA 6-K filed Aug 26, 2008.
Results Presented at 12th Congress of European Federation of Neurological Societies
Jerusalem, Israel, August 26, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announces that results of the phase III ADAGIO trial were presented today during the 12th Congress of European Federation of Neurological Societies (EFNS) in Madrid, Spain as part of a "Late Breaking News" session. The ADAGIO study showed that Parkinson's disease (PD) patients who took AZILECT® (rasagiline) 1mg tablets once-daily upon entry into the trial, demonstrated a significant improvement compared to those who initiated the drug 9 months later. The 1mg dose met all three primary endpoints, as well as the secondary endpoint, with statistical significance.
The primary analysis included three hierarchical endpoints based on Total-UPDRS (Unified Parkinson's Disease Rating Scale) scores: A) superiority of slopes in weeks 12-36 (-0.05; p=0.013, 95%CI -0.08,-0.01), B) change from baseline to week 72 (-1.7 units; p=0.025, 95%CI -3.15,-0.21), and C) non-inferiority of slopes (0.15 margin) in weeks 48-72 (0.0; 90%CI -0.04,0.04). The safety profile of AZILECT® seen in the ADAGIO study was similar to previous experience with AZILECT®.
Main results were presented at the congress by Professor Olivier Rascol, M.D., Ph.D., Department of Clinical Pharmacology, University Hospital, Toulouse, France, one of two principal investigators of the trial.
"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 Prof. Rascol. "The successful outcome of the study provides further rationale for the early use of AZILECT® among Parkinson`s disease patients," he added.
"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, New York, NY, and ADAGIO co-principal investigator. "The ADAGIO study, the first of its kind, was prospectively designed to demonstrate if AZILECT® can slow down the progression of Parkinson's disease. Results of the study show that early treatment with once-daily rasagiline 1mg tablets provided significant clinical benefits that were not obtained by those patients where initiation of AZILECT® therapy was delayed by nine months."
The ADAGIO study, one of the largest conducted in PD, included 1,176 patients with very early Parkinson's disease in 14 countries and 129 medical centers who were randomized to receive rasagiline 1 or 2 mg/day for 72 weeks (early start) or placebo for 36 weeks followed by rasagiline 1 or 2 mg/day for 36 weeks (delayed start).
Description of trial results can be found online (http://www.abstracts2view.com/ana ) in the abstract submitted by Prof. Olanow and Prof. Rascol to the 133rd Annual Meeting of the American Neurological Association, Salt Lake City, UT, September 21-24, 2008 .
Prof. Olanow will be presenting these results during the Works in Progress poster session on Tuesday, September 23, 2008. The abstract was also chosen to be presented orally by Prof. Olanow on Tuesday from 11:45am-noon.
Teva intends to submit these results to the regulatory authorities in the U.S. and Europe. Based on these results, Teva will work with the regulatory authorities to incorporate the results into the label for AZILECT®.
For more information on AZILECT®, please visit www.azilect.com.