UPDATED: Sanofi snags FDA OK for oral MS drug Aubagio, prices at $45K

Sanofi ($SNY) won a badly needed FDA approval Wednesday for its oral multiple sclerosis drug Aubagio (teriflunomide). And soon after the news hit a representative for Sanofi subsidiary Genzyme said that the MS treatment will be priced at $45,000 a year, angling in to grab market share.

"The price of Copaxone is 7% more," the rep added. "The price of Avonex is 8% more and the price of Gilenya is 28% more than the price of Aubagio." The new treatment was filed for approval by Sanofi's biologics arm, Genzyme, which will now handle the marketing.

"In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo," commended Dr. Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients."

"We'll stack up quite well with what's out there," David Meeker, the CEO at Genzyme, tells FierceBiotech. All of the drugs available carry warnings about significant side effects. And the injectables on the market present an added burden for the population that oral drugs can eliminate. 

"I do predict movement," he added about the patients and physicians considering treatment regimens. "There's going to be a significantly increased willingness to try new things." And after Lemtrada makes it through the approval process on MS, where it's given a good shot at an approval, the Genzyme MS franchise will grow. "These new drugs will be highly complementary, providing meaningful choices."

For Sanofi, the agency's approval marks a key win after a lengthy drought of new approvals. In the next step, Sanofi will work to steal a march on Biogen Idec ($BIIB), which has won the spotlight on MS with its experimental MS drug BG-12. The Aubagio program, which was transferred over to its biologics arm Genzyme as it seeks an OK on Lemtrada as well, failed to beat out the injectable Rebif. The key challenge here, though, will be Aubagio's ability to gain market share among new oral therapies. But some analysts aren't hopeful that the newly approved treatment can come close to blockbuster status.

 "We doubt the drug will seriously affect Gilenya or Tysabri, where prescriptions are largely driven by efficacy," Berenberg Bank's Alastair Campbell told Bloomberg. Datamonitor assessed peak sales at just a little above $350 million for the top global commercial markets, according to a report from Reuters.

The approval will bolster CEO Chris Viehbacher as he continues to push a big shakeup on the R&D side of the business. But it may not be welcomed by the company's French employees, who are staging a strike today to protest deep cuts anticipated for the European side of the operation.  

R&D hasn't always been easy at Sanofi. Weeks after Genzyme filed its application for Lemtrada as a new treatment for multiple sclerosis, regulators handed the NDA back, telling the biologics arm of Sanofi that it needs to complete a rewrite before they can properly assess it. But the Aubagio sign-off follows an important approval for its cancer division. Just days ago Sanofi got its first green light for Zaltrap, a cancer drug developed with Regeneron ($REGN). It's a second-line approval, in a market already dominated by Roche's ($RHHBY) Avastin and Bristol-Myers Squibb's ($BMY) Erbitux. But it's a step forward after a couple of oncology setbacks--and a first step toward hundreds of millions in sales.

- here's the FDA press release
- and the Genzyme release
- read the Reuters story
- here's the Bloomberg report

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