ADAGIO Trial Results Show Teva's AZILECT(R) 1 mg Tablets Slow Progression of Parkinson's Disease

Tuesday August 26, 6:20 am ET

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Results Presented at 12th Congress of European Federation of Neurological Societies
JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA - News) 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.

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