FDAnews
www.fdanews.com/articles/73856-teva-and-active-biotech-submit-ind-for-laquinimod

TEVA AND ACTIVE BIOTECH SUBMIT IND FOR LAQUINIMOD

June 29, 2005

Teva Pharmaceutical and Active Biotech have submitted an investigational new drug application to the FDA to initiate a clinical trial in the U.S. with laquinimod to assess drug-drug interaction.

Based on the results of this study and of the ongoing Phase IIb study in Europe, the Phase III clinical program to confirm the efficacy and safety of laquinimod in relapsing forms of MS, is planned to start in 2006. Laquinimod is a novel orally administered immunomodulatory substance, developed by Active Biotech and recently licensed to Teva.

A double-blind, placebo-controlled multicenter phase IIb clinical study is currently on-going in several European countries, in which the effects of laquinimod, administered orally, once-daily, at dose levels of 0.3 and 0.6 mg/day, are compared to those of placebo over 9 months of treatment.