Mixed Phase III results for Teva's MS drug laquinimod

2 August 2011

There were mixed but largely disappointing Phase III trial results for Israel-based Teva Pharmaceutical Industries (Nasdaq: TEVA) regarding its experimental multiple sclerosis drug laquinimod, which failed to reduce MS relapses any better than placebo.

The company said primary endpoints of reducing relapses were not statistically significant, but following a standard adjustment, in accordance with a pre-defined sensitivity analysis, laquinimod significantly reduced the annualized relapse rate (p=0.026). Laquinimod also demonstrated significant reductions in both brain volume loss and the risk of disability progression, while maintaining a favorable safety and tolerability profile. Nevertheless, Teva said it aims to submit the drug for regulatory approval by early next year.

“Laquinimod is dead, if not regulatorily, then commercially,” Ori Hershkovitz, a partner at Tel Aviv-based Sphera Funds Management, told news service Bloomberg. Sphera does not have a position in Teva shares; the firm’s ADRs dropped 6.1% to $43.79 in pre-marker New York trading yesterday.

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