Teva settles Copaxone ALS clinical trial case

Teva has settled a lawsuit brought by six ALS patients treated with Copaxone in an unsuccessful clinical trial.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has settled its lawsuit with six people with Amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease) who were treated with Copaxone at Sourasky Medical Center (Ichilov Hospital) in Tel Aviv. Earlier this week, the parties notified the Central District Court that they had reached a financial settlement, which includes confidentiality and the dismissal of the claim. Judge Yehzkel Keinar congratulated the parties on the settlement and dismissed the case without ordering court costs.

Copaxone is Teva's brand drug for the treatment of multiple sclerosis, which, like ALS, is a neuro-muscular degenerative disease.

In January 2010, Gabriel Sbah, Hanan Perez, and the heirs of the late Yosef Sidis sued Teva for damages related to a clinical trial the company conducted in the second half of 2006 on ALS patients. When the study ended in 2008, Teva announced that it had failed.

Besides Teva, other parties affiliated with the clinical trial were also sued, including the Ministry of Health, Ichilov Hospital, the chairman of the hospital's ethics committee, and the study's chief researcher at the hospital. The claimants contended that the clinical trial was negligent and harmful, and shortened their life expectancy. They claimed that the researchers treated them like guinea pigs on the ground that the patients had nothing to lose.

Teva and the other defendants rejected the claims, arguing that this was a worthy and justified clinical trial that met all accepted standards and criteria. "It is very hard to describe a clearer case in which the risk-reward balance was so obvious in favor of the study," they said in their statement of defense. Teva said that while analysis of the trial's results did not find that Copaxone was effective in treating ALS, it did no harm.

Teva said today, "Teva wishes to emphasize that there was no flaw in the study, and that it was conducted under the necessary permits and with the most meticulous standards applicable to studies of this kin. Teva completely voluntarily decided to end the legal proceedings with a settlement for humanitarian reasons, in the belief that the patients should now focus solely on the difficult struggle with their disease."

Proneuron case continues

Teva faces another lawsuit over the use of Copaxone to treat ALS, which was filed by Proneuron Biotechnologies Inc., Teva's partner in the development of the drug. Proneuron, founded by Prof. Michael Schwartz of the Weizmann Institute of Science and which is no longer in business, claims that Teva conducted the ALS study even though it knew that Copaxone would not help patients. The trial is ongoing, and the parties are not in contact for a settlement.

Published by Globes [online], Israel business news - - on November 15, 2012

© Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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