Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and Sweden's Active Biotech A/B (OMX: ACTI) have reported positive results in the Phase III Allegro clinical trial of Teva's oral treatment for multiple sclerosis, Laquinimod. The results of the trial were published in the March 15 issue of The New England Journal of Medicine. The two-year study showed that oral once-daily laquinimod reduced inflammatory disease activity, measured by clinical relapses and MRI, slowed disability progression and decreased brain tissue loss. Laquinimod also had a favorable safety and tolerability profile in patients.
Teva will include the Allegro results, along with results from the Bravo second global Phase III trial, in its regulatory approval that is planned for submission to the European Medicines Agency (EMEA) in the second half of this year.
Teva SVP R&D Lesley Russell, said, “The publication of the Allegro results in a prestigious peer-reviewed journal is an important landmark as we continue to research and develop Laquinimod. We look forward to continuing to work with regulatory authorities in both the EU and the US to bring this novel therapy to the multiple sclerosis community."
“The positive findings from Allegro provided evidence that Laquinimod represents a unique approach in the treatment of multiple sclerosis - one that offers relapse management along with a significant reduction in the key outcome measures correlated to irreversible nervous tissue damage,” said principal investigator, Prof. Giancarlo Comi, Director of the Department of Neurology and Institute of Experimental Neurology at the San Raffaele Scientific Institute at the Vita-Salute San Raffaele University in Italy."
Teva's share price fell 1% by mid-afternoon on the TASE today to NIS 162.20, after falling 0.8% on Nasdaq on Friday to $43.08, giving a market cap of $40.6 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on March 18, 2012
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