Genzyme/Sanofi's oral MS drug Aubagio beats placebo in PhIII

Genzyme continues to build the large late-stage data package for teriflunomide, an oral multiple sclerosis drug that the company and its owner, Sanofi ($SNY), are developing to compete in the blockbuster market for MS therapies that are swallowed rather than injected. And the latest study results show that patients on the drug had a statistically significant drop in relapse rates. 

In the Phase III "TOWER" study, patients on a daily 14 mg dose of teriflunomide had a 36.3% drop in annualized relapse rate--which was the main goal of the study--compared with those taking a placebo. There was also a 31.5% drop in the risk of disability among patients on that dose of Genzyme's drug compared with placebo patients, the company said on Friday. No new side effects cropped up in this trial that hadn't been seen in previous studies.

Teriflunomide, which Sanofi hopes to market as Aubagio, has yet to impress experts and analysts as much as Biogen's promising oral MS drug BG-12, and it's unlikely that these data from TOWER will change that. The drug previously failed to beat the injected MS treatment Rebif in reducing the risk of treatment failure, for instance. And safety of oral MS drugs will need to be clean to win over doctors who are already comfortable with prescribing tried-and-true injectable therapies.

"These encouraging results are consistent with the results on relapse rate and disability that were observed in the TEMSO study and highlight the promise of teriflunomide as a potential new treatment for many patients with relapsing MS," Genzyme's CEO, David Meeker, said in a statement.

Genzyme, which is the hub of Sanofi's rare disease drug business, took the lead on building the entire MS franchise for Sanofi through the integration of the Cambridge, MA-based biotech and the French drug giant that began after Sanofi's $20.1 billion buyout of Genzyme last year, Meeker said at a conference on Cape Cod last month. Genzyme has submitted teriflunomide data for review in Europe and the U.S., Reuters reported, and the company also aims to seek regulatory nods for perhaps the most promising candidate in its MS pipeline, Lemtrada.

- here's the release
- see Reuters' article
- and RTTNews' report

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