Israeli court tells Teva to return Copaxone, pay Proneuron; more ammo for Mylan?

Teva CEO Erez Vigodman

An Israeli court ordered Teva Pharmaceutical ($TEVA) to not only return the Copaxone (glatiramer acetate) multiple sclerosis drug it licensed from Proneuron Biotechnologies but also return 14 indications it received for other nervous system drugs. Oh, and pay Proneuron the equivalent of $128,666 as well.

Israel-based Proneuron sued Teva in 2007 on grounds the drug giant exceeded its licensing agreement by conducting a clinical trial on patients with amyotrophic lateral sclerosis despite Proneuron's own findings there was no scientific basis for such a trial and could be harmful to those tested. Three years ago, Teva settled 6 suits brought by patients involved in those trials.

The low financial award to Proneuron belied the reality that Copaxone was a valuable product for Teva, which had obtained marketing approval for it in the United States. Not until the middle of this month did a generic get U.S. market approval when Sandoz received FDA clearance for its version.

As for the court ruling on the Proneuron suit, Teva said it was considering an appeal of the decision to a higher court. It defended its handling of the ALS trials as a good-faith effort to see if the drug could treat the disease. It added that no patients were in danger.

In the settlement with the 6 trial patients, who were backed by the Ministry of Health and the hospital where the trial was conducted, Teva admitted no wrongdoing, but paid an undisclosed amount of money to the patients who claimed damages from the trial, including shortening their life expectancies.

The Teva trial, by the way, confirmed what Proneuron had insisted was the case: that the drug was ineffective in treating the disease known in the U.S. as Lou Gehrig's disease.

Mylan Chairman Robert Coury

In rejecting Teva's latest bid for Mylan ($MYL), about $40 billion, Mylan Chairman Robert Coury could have been referring in part to the Copaxone case when he lashed out at Teva as a company with which he did not want to be associated: "We do not wish to make Teva's problems Mylan's problems."

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- and a release from the FDA