Sanofi withdrew its marketing authorization requests for the Mulsevo drug to prevent blood clots in chemotherapy patients, a setback for efforts by France’s biggest drugmaker to bring new medicines to patients.
Sanofi “voluntarily withdrew” its applications globally for semuloparin, also known as Mulsevo, Jean-Marc Podvin, a Sanofi spokesman in Paris, said in a telephone interview today. “We are evaluating the next steps for semuloparin, to determine the appropriate path forward for the compound.”
Semuloparin doesn’t provide enough of a benefit to outweigh its risks, a U.S. Food and Drug Administration panel decided in a 14-1 vote on June 20. The advisers supported a June 18 FDA staff report that Sanofi’s data didn’t “provide meaningful support for the approval” as a treatment for venous thromboembolism among high-risk patients receiving chemotherapy for certain cancers.
“In the grand scheme of things, in terms of potential sales lost, it’s not a massive change,” Alistair Campbell, an analyst at Berenberg Bank in London, said in a telephone interview. “It’s more of a sentiment setback. 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,” said Campbell, who had forecast annual peak sales for semuloparin of 240 million euros ($295 million) by 2017.
Sanofi Chief Executive Officer Chris Viehbacher has been seeking to bolster Sanofi’s pipeline by reorganizing research and development, dropping the least promising projects and accelerating acquisitions and partnerships. In a presentation on Sept. 14, he cited semuloparin as one of six new molecule and chemical entities that Sanofi planned to introduce in a nine-month period. Viehbacher described it as one of the assets “we thought could really make it to the marketplace,” according to a transcript of the presentation.
The European Medicines Agency said in a statement today it had received a withdrawal letter from Sanofi for Mulsevo’s marketing authorization application in the European Union.
Semuloparin risked competing with Sanofi’s own Lovenox, Eric Le Berrigaud, an analyst with Bryan Garnier & Co. in Paris, said in an interview before the FDA’s report was released last month. Lovenox, first approved in 1993, helps prevent blood clots in patients undergoing certain surgeries.
Sanofi is awaiting the FDA’s decision on whether to approve its multiple sclerosis drug Aubagio. U.S. regulators haven’t cleared a new drug from the French company since Jevtana in June 2010, for prostate cancer patients whose disease has spread.
Sanofi had asked for approval of semuloparin to treat patients with pancreatic or lung cancers or advanced or spreading solid tumors.