Teva Pharmaceutical Industries Ltd. and Active Biotech AB have submitted an investigational new drug application (IND) to the US FDA to initiate a clinical trial in the US 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 programme to confirm the efficacy and safety of laquinimod in relapsing forms of MS, is planned to start in 2006, according to a Teva release.

Laquinimod is a novel orally administered immunomodulatory substance, developed by Active Biotech and recently licensed to Teva.

Israel Makov, president and CEO of Teva stated, "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."

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 Copaxone, Teva's well-established and leading product on the market today, release says.

A double-blind, placebo-controlled multi centre 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.