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|June 07, 2007 1:49 p.m.|
|Teva And Active Biotech To Initiate Pivotal Phase III Trial Program Of Oral Laquinimod For Relapsing Multiple Sclerosis|
Jerusalem, Israel and Lund, Sweden, June 7, 2007 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech AB (OMX NORDIC: ACTI) today announced that the companies are initiating a clinical Phase III program for laquinimod, a novel once-daily, orally administered immunomodulatory compound for the treatment of relapsing multiple sclerosis (RMS). The studies will now begin following the successful conclusion of a second phase II study and the outcome of discussions with the U.S. Food And Drug Administration (FDA) and the European Medicines Agency (EMEA). The companies are to commence two global Phase III trials of laquinimod during this year. The Phase III trials will take place in centers in the United States, Europe, and other locations worldwide, to further Confirm the results of the Phase II trials. "We are extremely excited about initiating the Phase III clinical program for oral laquinimod, as we believe laquinimod is a potential new and convenient treatment option for MS patients," said Shlomo Yanai, President and CEO of Teva Pharmaceutical Industries Ltd. "The accelerated development of oral laquinimod is part of our commitment to MS patients to develop additional improved therapies that combine superior efficacy and excellent safety." "Laquinimod has the potential to be a novel, orally-administered disease modifying treatment for people suffering from multiple sclerosis," said Sven Andrasson, President and CEO of Active Biotech. "Laquinimod would represent a milestone for patients as it would provide them with an efficacious and safe treatment, as well as a new drug delivery option that is suitable for long-term treatment."