This is a big day for Sanofi and Genzyme, its biologics arm in Boston. The FDA is slated to make a final ruling on Aubagio (teriflunomide), its new oral treatment for multiple sclerosis. For Sanofi ($SNY), which has been suffering through a long, dry spell when it comes to new approvals, the MS drug represents its best near-term hope for a blockbuster earning more than a billion dollars a year. But analysts say that even if regulators give it the green light today, which would not be surprising, the treatment faces an uphill fight once it gets to the marketplace.
Just last June the pharma giant released another batch of positive late-stage data on Aubagio, with a 36.3% drop in annual relapse rates in a placebo-controlled study. But Aubagio failed to beat out the injectable Rebif in a head-to-head study in reducing the rate of treatment failure. And Biogen Idec's ($BIIB) BG-12 has garnered much of the limelight when it comes to late-stage MS treatments.
Sanofi shifted Aubagio into Genzyme's hands after it designated the Boston subsidiary--acquired for $20 billion--its biotech leader. Genzyme is also pushing approval of Lemtrada, another MS prospect given a solid shot at an approval.
Today's outcome will also be closely watched by Sanofi's French workforce, which has been bracing for deep R&D cuts as the company shifts more of its research efforts into U.S. hands. Under CEO Chris Viehbacher Sanofi has been an outspoken champion of a top-to-bottom overhaul of R&D in an effort to spur real productivity. Sanofi's unions say that they expect up to 2,500 job cuts in France and plan to stage a strike tomorrow to voice their displeasure.
Union sources tell Reuters today that they expect the full extent of the restructuring to be spelled out in two upcoming meetings later this month and in early October. While French government officials have lent their support to the workers, Sanofi executives have shown no sign that they are willing to back down now.
- here's the story from Reuters
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