Sanofi earns a "modest" win with positive oral MS PhIII data

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Yesterday morning we gained word that Biogen Idec's BG-12 held up nicely in the detailed look at a late-stage study for multiple sclerosis, leaving it waiting for final Phase III results by the end of the year. And in the evening Sanofi took its turn at bat in the race to get a new oral MS drug on the market, offering up positive pivotal data on teriflunomide--recently billed as one of its top 6 Phase III drug candidates.

The two-year TEMSO study data revealed a 31% drop in the risk of annual relapses for both the 7 mg and 14 mg doses, with slightly more than half of the patients free of relapses over the course of the study--compared to 45.6% of the placebo arm. The risk of 12-week confirmed disability progression, a secondary endpoint, dropped by 30%.

"The magnitude of the benefits observed in patients receiving teriflunomide was modest but similar to those reported for the existing injectable disease-modifying therapies approved for use in patients with multiple sclerosis," the study's authors concluded.

Tim Coetzee, chief research officer for the U.S. National Multiple Sclerosis Society, told The Canadian Press that he wasn't exactly floored by the new teriflunomide data. The drug, which will be marketed as Aubagio, did however offer providers a potential new treatment that could be added to the growing mix used to treat patients.

"One of the challenges of MS is that it's widely variable," Coetzee said. "And consequently some individuals respond differently than others. And so having another treatment option available that would show effectiveness for relapsing forms of the disease would be an important step forward."

Novartis ($NVS) has been able to get to the market with the first oral MS drug, Gilenya. And it did so as Merck KGaA's oral cladribine stumbled and then crashed, leaving the German company regrouping behind a new set of assets which will take a considerable amount of study to get to the regulatory stage. Biogen has offered the most compelling data for a late-stage MS drug, with a 53% drop in the risk of annual relapses compared to a placebo.

- read the Sanofi release
- here's a link to the NEJM study
- check out the story from The Canadian Press

Related Articles:
Detailed BG-12 data supports Biogen's blockbuster MS ambitions
Sanofi lines up a growing slate of late-stage drug prospects
Study: MS drugs' benefits carry a steep price
Sanofi touts two-year results of MS drug teriflunomide