Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) today announced that its global phase II GoALS trial found that glatiramer acetate (GA) was was safe and well-tolerated ineffective Amyotrophic Lateral Sclerosis (ALS) patients. However, the trial found that GA was ineffective in reducing functional deterioration in the patients. Although the found that the drug in ALS patients, the study's primary and secondary endpoints were not met. GA is the active pharmaceutical ingredient in Copaxone, Teva's ethical treatment for multiple sclerosis.
Teva VP strategic business planning Aharon Schwartz said, "Like in any clinical trial, there is usually a primary goal and several secondary goals that we try to achieve, which have significance for the clinical condition of the patient and the treatment of the disease. Our primary goal was to examine whether Copaxone could affect the progress of ALS. We deeply regret that we failed to achieve this goal. However, to put things into proportion, in the past 3-4 years no less than eight clinical trials have been conducted, and none of them succeeded."
Teva said that he primary outcome measure was change in ALS ALSFRS-R score. The secondary outcome measure was increased survival.
Schwartz stressed, however, that GA was found to be safe for use by ALS patients.
Schwartz noted, "Regarding multiple sclerosis patients, clinical trials have demonstrated that Copaxone is safe and very effective in the standard 20 mg dosage. We also conducted an interim trial with a 40 mg dosage, which we believe is more effective and there is no question about its safety."
The GoALS trial was conducted simultaneously at 13 medical centers in Israel (at Tel Aviv Sourasky Medical Center - Ichilov Hospital), Belgium, France, Germany, Italy, and the UK over a 52-week period. The trial included 336 ALS patients, some of whom received GA while the control group received a placebo.
Teva fell 1.8% at the opening on Wall Street today, and fell 1.1% on the TASE.
Published by Globes [online], Israel business news - www.globes-online.com - on March 13, 2008
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