Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and Active Biotech AB (Stockholm: ACTI.ST) announced today the submission of an investigational new drug application (IND) to the US Food and Drug Administration (FDA) to initiate a clinical trial in the US with laquinimod to assess drug-drug interaction.
Laquinimod is a novel orally administered immunomodulatory substance, developed by Active Biotech and recently licensed to Teva. The companies believe that Laquinimod has the potential to be the first orally-administered disease modifying treatment for multiple sclerosis, both as a single agent therapy and in combination with Teva's Copaxone.
A double-blind, placebo-controlled multi center phase IIb clinical study is currently ongoing 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 nine months of treatment.
Based on the results of the US and European studies, the phase III clinical program to confirm the efficacy and safety of laquinimod in relapsing forms of multiple sclerosis (MS) is planned to start in 2006.
Teva president and CEO Israel Makov said, "This IND filing is an important step towards the initiation of pivotal studies with laquinimod which, along with Teva's development of an oral form of Copaxone, enhance the likelihood that Teva will be the first to market an oral treatment. This further demonstrates our commitment to developing new and improved therapies for multiple sclerosis patients in order to help treat their disease and improve their quality of life".
Active Biotech president and CEO Sven Andreasson said, "We are very pleased to see how Teva's development program is diligently progressing towards starting phase III studies in the US and Europe."
Published by Globes [online], Israel business news - www.globes.co.il - on Tuesday, June 28, 2005