• 12.12.2011, Teva conducted an unethical experiment in humans in order to protect Copaxone, The-Marker

Proneuron represented by Adv. Gabriel Moyal Maor, Adv. Yaron Sobol and Adv. Eleanor Stark from Hamburger Evron law firm submitted its main evidence affidavits in the lawsuit against Teva. The affidavits claim that the pharmaceutical company has negligently performed a futile clinical trial on ALS (Amyotrophic Lateral Sclerosis) patients in order to protect the sales of Copaxone - Teva's flagship drug for MS (Multiple Sclerosis). Furthermore, claims Proneuron, the performance of such trial violates Teva's material contractual obligations to Proneuron.

Teva claims that the clinical trial was well based and received all required approvals. However, Proneuron argues that Teva has deceived the regulatory authorities, consulting scientists and the participating patients. In addition Proneuron has indicated that the investigative committee which was formed by the Israeli Ministry of Health, examined the allegations made by one of the patients who participated in the clinical trial, and published a criticizing report on the decision to perform the clinical trial the way it was conducted and severely criticized the trial. Following said report, several patients who participated in the trial filed a tort lawsuit against Teva and those who approved and managed the conduct of the clinical trial.

The Plaintiff Proneuron, requests the court to order the return of the license it granted to Teva for further drug development for treatments for neurodegenerative diseases of the central nervous system.

The Tel Aviv District Court determined in its preliminary rulings that Teva shall disclose to Proneuron, documents which Teva had claimed to be confidential. This ruling was in line with the Israeli Supreme Court's ruling which defined the subject matter of Proneuron's lawsuit - the conduct of clinical trials in humans - as a matter of public interest. The Supreme Court also determined in a precedent ruling that the disputes between Proneuron and Teva shall be publicly resolved in an Israeli court despite the agreement between the parties that provided for a confidential arbitration in London, UK.

Proneuron claims that, not withstanding the negative results of pre-clinical studies performed on animals, Teva knowingly performed trial on humans, although the prospects for success were low. For example, a preclinical trial performed on mice which Teva did not disclose to Proneoron, indicated that the life expectancy of female mice treated with Copaxone was shortened.

Proneuron also argues that the documents it received from Teva as a result of the discovery process, provide that Teva's decision to perform the trial resulted solely from commercial considerations.