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Will FDA require Teva to run another study?

Analyst drops Teva shares to 'perform'

Israeli drug maker faces growing challenges and uncertainty surrounding its multiple sclerosis treatments, Oppenheimer analyst says

Teva Pharmaceutical Industries Ltd. faces growing challenges and uncertainty surrounding its multiple sclerosis treatments, according to an Oppenheimer analyst.

 

The Israeli drug maker said Monday that its experimental drug, laquinimod, an oral MS treatment, did not reduce patients' annual relapse rates in a late-stage clinical trial. The study involved 1,331 patients who were treated with one of three options: Laquinimod, a placebo, or Avonex, an older MS drug made by Biogen Idec Inc.

 

Teva said MRI scans showed the patients in the laquinimod and Avonex groups had more brain lesions, which indicates they had more severe multiple sclerosis, and if study results are adjusted to remove that imbalance, laquinimod met its main goal of lowering the relapse rate.

 

Teva and its partner Active Biotech still plan to seek approval of laquinimod in the US and the European Union. In December, the companies said the drug met its main goal in its first late-stage trial.

 

Analyst Christopher Holterhoff said in a research note Tuesday it is unclear whether the US Food and Drug Administration will accept adjusted data from the latest study as meaningful or require Teva to run another study.

 

"We are unaware of a precedent case where an MS drug was approved without two statistically significant trials," the analyst wrote.

 

He downgraded shares of the drug maker to "perform" from "outperform" and removed a price target.

 

 


פרסום ראשון: 08.05.11, 07:53
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