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Bravo or bravado? Teva, Active move baseline to make PhIII oral MS miss a hit

This article was originally published in Scrip

Executive Summary

Teva Pharmaceutical Industries and Active Biotech both saw their share price drop sharply after they said that oral laquinimod missed the primary endpoint of a major study, BRAVO – the second pivotal Phase III trial testing the investigational immunomodulator in relapsing-remitting multiple sclerosis. The drug did not significantly reduce annualised relapse rate from baseline to two years over placebo, and yet Teva said an adjusted analysis shows the drug was successful in reducing relapse and that it still plans to submit regulatory applications in the US and EU in early 2012.

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