Regulatory setback raises fresh questions about Sanofi R&D comeback

Snubbed by regulators and experts alike, Sanofi ($SNY) is reeling back all its global marketing applications for semuloparin (Mulsevo). The drug is designed to prevent blood clots from forming in chemo patients, but insiders at the FDA as well as outside experts brought in to advise the agency concluded that the data proffered for the therapy didn't back up its case.

The regulatory brick wall that was erected in Sanofi's path comes at a bad time for the pharma giant. Sanofi has not had a new drug approval in more than two years now. And CEO Chris Viehbacher–who reorganized the R&D side of the business with great fanfare--considered semuloparin one of the company's top late-stage programs. Now the regulatory focus will shift to Aubagio and Lemtrada, two promising MS drugs at Sanofi's Genzyme unit which are up for regulatory review.

Berenberg's Alistair Campbell never considered semuloparin anything close to a blockbuster drug. But the fresh mark against the R&D division is contributing to a growing sense that Sanofi's R&D operations are in a muddle. "It's more of a sentiment setback," Campbell told Bloomberg. "It's a blow to a late-stage pipeline already seen as weaker" than that of many rivals. "Questions will remain about Sanofi's drug pipeline."

The writing on the wall for semuloparin was provided by the FDA panel on June 19. The panel voted 14 to 1 against the drug, after FDA staffers concluded that Sanofi's R&D team failed to provide "meaningful support for the approval." From the staff perspective, the data were corrupted by the fact that few patients in the pivotal study actually experienced clotting issues, with most of the patients dying from other causes, clouding the efficacy.

A spokesperson for Sanofi says that the company will reevaluate the drug and the data before executives decide on their next step with semuloparin.

- here's the story from Bloomberg

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