Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA; TASE:TEVA) and Swedish company Active Biotech (Nasdaq: OMX; Nordic: ACTI) have published results for their two-year Phase III Allegro clinical trial of Laquinimod, an oral treatment of relapsing forms of multiple sclerosis.
At the same time, Teva reported that Laquinimod is no longer on "fast track" US Food and Drug Administration (FDA) approval because Novartis is already marketing its multiple sclerosis oral treatment Gilenya. This is likely to add three to six months to the time it will take Teva to obtain FDA approval for Laquinimod. Teva expects the drug to be on the market by late 2012 or early 2013 at the latest.
In the Phase III Allegro clinical trial, Laquinimod showed a statistically significant 23% reduction in the annualized multiple sclerosis relapse rate, the primary endpoint, along with a significant 36% reduction in the risk of confirmed disability progression. The trial also found that treatment with Laquinimod was associated with a significant reduction in brain tissue loss, with a 33% reduction in progression of brain atrophy.
IBI analyst Natalie Gottlieb told "Globes", "We see only upside in Teva. The product is not factored into the models, and is not in Teva's forecast for 2015. The safety profile is excellent. This is a product that could take a subtantial share of the future MS market." Gottlieb estimates that Laquinimod could have peak annual sales of $600 million. She gives Teva a "Buy" recommendation, with a target price of $67.
These data will be presented as late-breaking research at the Annual Meeting of the American Academy of Neurology (AAN) in Hawaii.
Principal investigator, Professor Giancarlo Comi, Director of the Department of Neurology and Institute of Experimental Neurology at the University Vite Salute, San Raffaele, Italy said, “The Allegro study results are exciting, as they suggest that oral Laquinimod is a novel therapeutic option that safely slows multiple sclerosis disease activity and progression. Additional pre-clinical data presented at this meeting suggest that oral Laquinimod exerts a novel and protective mechanism of action within the central nervous system to significantly reduce the main neurological damage of the disease."
Teva reported that Laquinimod was safe and well-tolerated without immunosuppressive effects. The overall frequencies of adverse events, including incidence of infections, were comparable to those observed in the placebo group. The most commonly reported adverse events were headaches, naso-pharyngitis and back pain. The incidence of liver enzyme elevation was higher in Laquinimod treated patients, but these elevations were transient, asymptomatic and reversible. No deaths were reported in Laquinimod-treated patients. Teva VP global branded products Prof. Yitzhak Peterburg said, "We are very enthusiastic about the results of the Allegro study, which demonstrated that Laquinimod significantly slows the progression of disability, the primary goal of multiple sclerosis treatment. Given the efficacy, safety and tolerability data to date, Laquinimod may present a very promising treatment option to the multiple sclerosis community."
Teva expects to report results of the second Laquinimod Phase III study, Bravo, in the third quarter of 2011. Regulatory submissions are planned in the US and EU after publication of the BRAVO results.
Teva's share price fell 2.93% on Nasdaq yesterday to $48.98, giving a market cap of $43.98 billion after oral multiple sclerosis treatment competitors also published positive results. Teva's share price was down 3.2% in morning trading on the TASE.
Published by Globes, Israel business news - www.globes-online.com - on April 12, 2011
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