After a scathing staff review, Sanofi walked away from an FDA panel with mixed messages on its long-delayed multiple sclerosis drug, as agency advisers said the injection wasn't too risky to approve but took issue with the drugmaker's trial design.
Sanofi's multiple sclerosis drug Lemtrada may be too dangerous to warrant FDA approval, agency staff said, potentially damning news for an injection that has slogged through 25 years of back-and-forth development.
Genzyme's Framingham, MA, plant came to the rescue last year, supplying its rare-disease drug Fabrazyme that had been in short supply after viral contamination forced the closure of another facility in 2009. Now, the drugmaker intends to invest $80 million in downstream processing at the facility.
Sales of Sanofi's rare-disease drug Fabrazyme have been on an upward trajectory since it got on top of supply issues last year with FDA approval of a new U.S. manufacturing plant. Sales are so good that the French drugmaker will plow another $80 million into expanding production at the Framingham, MA, facility.
No buyer's remorse for Sanofi CEO Chris Viehbacher. Acquiring Genzyme for $20.1 billion in 2011 has paid off handsomely, Viehbacher told the Boston Globe in an interview--and not only in terms of drug sales and new regulatory approvals.
The U.K.'s cost-effectiveness analysts aren't sure Sanofi's new multiple sclerosis pill is worth the price--even at a discount. In a new review, the National Institute for Health and Care Excellence found information on Aubagio wanting, and so it asked the French drugmaker's Genzyme unit for more.
Sanofi's Genzyme got a double dip of good news Friday for its expansion in the multiple sclerosis market. First Europe's drug regulator gave a nod to Lemtrada for treating the disease. Then, as a bonus, it gave a designation to Genzyme's potential blockbuster Aubagio that will keep its patent protected longer.
Two years after leaving the biotech giant Genzyme, Henri Termeer has found increased demand for his expertise and personal resources from a growing crowd of startups in the Boston area and The Netherlands, he told FierceBiotech in an interview. Read more >>
Sanofi CEO Chris Viehbacher has been openly critical of his research operation in Toulouse, France. He said the researchers are costing too much money and haven't developed an important drug in 20 years.
The market for multiple sclerosis drugs is expected to reach nearly $20 billion by 2020, and Sanofi and Biogen Idec each want a big piece of that for their oral MS drugs.