Teva says laquinimod NDA submission 'premature'

Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) said it would be "premature" to submit an NDA at this time for laquinimod and will be working with FDA to design an additional trial for the relapsing-remitting multiple sclerosis (RRMS) product. Teva, which made the comments during its 3Q11 results call, had planned to submit an NDA for the product early next year. The company did not disclose a potential timeline for an additional trial. Teva has exclusive, worldwide rights to laquinimod from Active Biotech AB (SSE:ACTI), which fell SEK7.60 (27%) to SEK20.30 on Wednesday.

Laquinimod has completed the Phase III BRAVO and ALLEGRO trials. The product met ALLEGRO's primary endpoint of significantly reducing annualized relapse rate (ARR) from baseline to two years vs. placebo, but missed the same endpoint in BRAVO. Laquinimod is a quinoline-3-carboxamide immunomodulator (see BioCentury, Aug. 8). ...