Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) today announced that its multiple sclerosis pill, laquinimod, appears to slow the disease and is well-tolerated by people with the relapsing form of the incurable condition. The Phase II clinical trial of 306 people in nine countries included volunteers with the most common, relapsing-remitting form of the disease in which patients have varying levels of recovery and periods of remission between flare-ups.
Laquinimod is Teva's second drug for multiple sclerosis after Copaxone, which has $1.7 billion in annual sales.
Teva is jointly developing Laquinimod with Active Biotech AB (OMX: ACTI) of Sweden. The Italian team found laquinimod showed a 40% reduction in the mean number of inflammatory lesions of the brain that are a hallmark of the disease, compared with a placebo. When the researchers expanded their trial by a further 12 weeks, people showed a 60% median reduction in the number of brain lesions, a Teva spokesman said. A lower dose showed no statistically significant effects versus the placebo but people taking the drug tolerated both amounts.
In an accompanying commentary in "Lancet", researchers from the Mayo Clinic in the US wrote that the drug now needs to be tested head-to-head against other treatments to demonstrate it is better or at least as good an option. Mark Keegan and Brian Weinshenker wrote, "However, continued vigilance is needed because serious side effects are commonly not evident until phase III studies are started or until after approval."
Teva is conducting Phase III clinical trials of laquinimod in the US, Europe, and Israel.
Last week, Teva reported positive results of its Phase III clinical trial for Azilect, which showed that the drug delayed the onset of Parkinson's disease. Teva fell 1.8% on Nasdaq yesterday to $44.18, and was down 0.1% in morning trading on the TASE.
Published by Globes [online], Israel business news - www.globes-online.com - on June 23, 2008
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