Sanofi ($SNY), racing with Novo Nordisk ($NVO) to launch a combination diabetes treatment, is lining up for an August FDA approval with its dual-acting therapy after redeeming a costly coupon for a quick agency review.
The French drugmaker is pressing forward with LixiLan, a fixed-dose injection that combines the top-selling insulin Lantus with lixisenatide, an investigational Type 2 diabetes treatment that works by boosting the hormone GLP-1 to increase natural insulin production. The FDA accepted Sanofi's application and, thanks to the company's use of a so-called priority review voucher, has promised to hand down a final decision on LixiLan in 6 months instead of the usual 10.
Sanofi picked up that priority coupon in a $245 million deal with Retrophin ($RTRX) last year, redeeming it now in hopes of beating rival Novo Nordisk to what could be a blockbuster market for therapies that combine insulin and GLP-1 agonists.
Novo Nordisk leads the pack among GLP-1 drugmakers with its blockbuster Victoza, and the Danish company already markets a therapy called Xultophy that combines its top product with the long-acting insulin Tresiba.
However, due to Tresiba's surprise FDA rejection in 2013, Novo Nordisk's plans to get Xultophy on U.S. shelves hit a major delay. The company finally won stateside approval for Tresiba last year and promptly submitted Xultophy for FDA review in September. Unlike its rival, Novo Nordisk isn't working under the agency's priority review program, meaning Xultophy won't reach the market until next fall.
This isn't the first time Sanofi has used an FDA shortcut to win a blockbuster race. In 2014, it joined partner Regeneron Pharmaceuticals ($REGN) in trading $67.5 million for a priority review voucher that helped the pair leapfrog Amgen ($AMGN) in the race to commercialize new treatments for high cholesterol.
Sanofi is working to stay afloat in a changing diabetes market, preparing to face biosimilar competition for Lantus that will imperil the treatment's roughly $8 billion in annual revenue. The company has signed a handful of pipeline-building deals over the past year, working to make up ground as rivals Novo Nordisk, Eli Lilly ($LLY) and AstraZeneca ($AZN) crowd the space.
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