Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) announced today that they have completed patient enrollment in a Phase III clinical trial of Teva's Multiple Sclerosis treatment Laquinimod.
The Allegro study in relapsing-remitting multiple sclerosis (RRMS) is designed to evaluate the efficacy, safety, and tolerability of the oral investigational compound, Laquinimod in the treatment of RRMS.
Recruitment of over 1,000 patients at 152 sites throughout North America, Europe and Asia was finalized in November. Enrollment began about a year ago.
Teva will pay a $5 million milestone payment to Active Biotech now that recruitment has been completed.
A second Phase III clinical trial evaluating Laquinimod, called Bravo, is currently enrolling patients globally. The Bravo trial aims to provide risk-benefit data for Laquinimod versus Avonex, an available injectable treatment.
Previous data from the phase IIb core study and its 36-week extension period (presented at the World Congress on Treatment and Research in MS in September) demonstrated the rapid onset and sustained efficacy of Laquinimod in reducing disease activity, as well as the favorable safety profile of the compound.
Teva already makes Copaxone for the treatment of MS, but has had little success with an oral version of the drug, which has failed in two trials, including an improved version. The company therefore obtained a license for oral Laquinimod from Active Biotech.
Teva is also developing another MS drug, ATL/TV 1102, a novel, anti-sense drug, which has so far significantly reduced disease activity in patients with RRMS. Teva said that, on the basis of these results, it would conduct additional pre-clinical and clinical research before continuing to a Phase III study.
Shares in Teva rose 0.5% on Nasdaq yesterday to $42.88, giving a market cap of $33.36 billion. Teva shares rose 1.08% in early trading on the TASE this morning.
Published by Globes [online], Israel business news - www.globes-online.com - on November 18, 2008
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