According to an Oppenheimer analyst, Teva Pharmaceutical Industries Ltd. is fraught with rising challenges and ambiguity due to its multiple sclerosis (MS) treatment that failed to meet its endpoint.
Earlier on Monday, Israel based Teva said that a late-stage clinical trial for its experimental drug, laquinimod (an oral MS treatment) failed to decrease annual relapse rates in MS patients. The study comprising a total of 1,331 patients were assigned to one of the 3 treatment arms: laquinimod, a placebo, or Avonex (an older MS drug manufactured by Biogen Idec Inc.)
Teva said that patients assigned to the Laquinimod and Avonex treatment groups had more severe multiple sclerosis than those on placebo because the MRI scans of these patients revealed more brain lesions. The company added that laquinimod would achieve its primary endpoint of decreasing relapse rates if the study results are altered to eliminate to imbalance between the 3 groups.
US-FDA and European regulatory approval is still being sought by Teva and its partner Active Biotech. In a first late-stage trial conducted in December, the drug is said to have achieved its main goal.
THE OUTLOOK: In a research note on Tuesday, analyst Christopher Holterhoff said that it is uncertain whether the US-FDA will recognize altered data of a latest study as consequential or ask Teva to conduct another study.
The analyst wrote: “We are unaware of a precedent case where an MS drug was approved without two statistically significant trials.”
The shares of the drug maker were demoted to “perform” from “outperform” by the analyst followed by the removal of the price target.
THE STOCK: In afternoon trading, US traded shares of Teva dropped 2.3 percent, or 99 cents, to $42.77.