Thursday, 15 March 2012

Teva plans to file an application for laquinimod approval in Europe

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (OMX: ACTI) announced publication of the result from III ALLEGRO study in the March 15 issue of The New England Journal of Medicine. The companies had previously reported positive top-line data from the study.

According to the companies the data showed oral once-daily laquinimod reduces inflammatory diseases activity measures by clinical relapses and MRI, slows disability progression and decreases brain tissue loss. The safety and tolerability profile relapsing-remitting multiple sclerosis patients is ”favourable”.

The companies are planning to file for regulatory approval in Europe in the second half of this year. In the United States a further study is needed since the second of the efficacy-focused Phase 3 studies called Bravo did not meet the primary endpoint and the FDA asked for a further study. Active Biotech has advanced almost 20% in today’s session.

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