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Active Biotech AB (BTPC) Year-End Report January - December 2013


2/13/2014 9:40:24 AM

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LUND, Sweden, Feb. 13, 2014 (GLOBE NEWSWIRE) --

Laquinimod

* Teva remains committed to the development of laquinimod (NERVENTRA®) for the treatment of multiple sclerosis (MS)
* On January 24, laquinimod received a negative opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The CHMP's opinion was based on the view that laquinimod's positive effect on reducing relapses did not outweigh the potential risks. Although the CHMP found that laquinimod has a positive effect on slowing disability in MS patients, this finding had no impact on the decision. In the risk assessment, the CHMP focused on findings in animal studies, performed in parallel with the pivotal clinical trials, relating to the potential risk of fetal damage and the potential increased risk of cancer. None of these effects have been observed in the comprehensive patient material, comprising 7,490 patient years in total, with some patients being exposed for more than seven years and tolerated treatment well.

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