FDA moves pump life back into Sanofi

Finally, some good news for Sanofi-Aventis. The FDA has given its blessing to the French drugmaker's new heart medicine Multaq as a treatment for atrial fibrillation. The drug is a cornerstone of Sanofi's plans to shore up sales as it loses patent protection on drugs that account for some 20 percent of its revenues. And the agency gave a shot in the arm to Sanofi's Lantus drug as well, pointing to "inconsistencies" in new studies that raised the spectre of a link between cancer and the diabetes treatment.

And the good news couldn't come at a better time; the company has been burdened by bad press over the past week, with the Lantus safety concerns drawing fire. Stock analysts have pummeled the company as the new studies uncovered a potential link between Lantus and cancer risk. (Sanofi CEO Chris Viehbacher called the database analyses "junk science" and promised a clinical trial to disprove the risk.) Those worries sent shares tumbling by 13 percent or so.

Plus, this week Sanofi announced another round of job reductions, this time via "voluntary departures," which are being offered to 1,300 workers, mostly in Europe. It's part of a new strategy for R&D, which Viehbacher hopes will bear innovative fruit, but the plant closures and selloffs--not to mention the job reductions--are sure to cause internal turmoil in the short term.

Now, though, pharma analysts are perking up, even as the FDA launches a safety review of Lantus, saying it plans to look at multiple data sources as well as the newly published research. Investors are listening; Sanofi stock has started to recover, picking up 3.1 percent yesterday after the FDA's Lantus statement. "The worries over Lantus also are abating," Philippe Lanone of Natixis Securities told Bloomberg. "We can look at Sanofi's future more serenely now." Presumably Viehbacher and company have cheered up, too.

- get the FDA's Lantus statement
[1]- see the release from Sanofi [2]
- read the Bloomberg piece [3]
- check out the Lantus news [4] from Reuters

Related Articles:
FDA panel backs Sanofi's megablockbuster Multaq [5]
Potential Sanofi blockbuster gets FDA staff endorsement [6]
Sanofi-Aventis scores positive data in Multaq trial [7]
Sanofi-Aventis wins priority review for Multaq [8]