Sanofi is using its $245 million coupon for a quick FDA review to speed up the approval process for a combination of its top-selling insulin and a new diabetes drug, angling to beat rival Novo Nordisk to the market.
Eli Lilly's decision to pull the plug on development of long-acting insulin candidate peglispro was not a big surprise after the company put the program on the back burner earlier this year over safety risks. Peglispro was facing a market that is getting increasingly challenging, in part because of Lilly's own biosimilar effort aimed at insulin kingpin Lantus, one with huge upside potential.
Sanofi has put off one biosimilar threat to Lantus till the end of 2016. In a patent settlement announced on Monday, the French drugmaker and U.S.-based Eli Lilly & Co. agreed to a royalty deal covering Lantus SoloStar, the injectable pen version of Sanofi's basal insulin.
Sanofi's second pivotal trial for a new diabetes drug combo came through with positive head-to-head results against Lantus, according to its biotech partner. And that clears the last hurdle standing in the way of marketing applications on both sides of the Atlantic as it tries to shore up an eroding blockbuster franchise against heated competition.
Drugmakers are ready to pounce on Japan's rapidly growing pharmaceutical market, and Sanofi and Gilead are hopping on the bandwagon with a fresh crop of approvals. Sanofi got a regulatory OK for diabetes newcomer Toujeo, while Gilead got a greenlight for hep C combo med Harvoni in the country.
Which diabetes med is likely to be on top in 2020? According to FirstWord Pharma, that would be--surprise!--Lantus, albeit as a $5 billion shadow of its former self. Januvia should keep its hold on second prize with almost $4 billion, while Novo Nordisk's NovoRapid and Lilly's Humalog remain in the top 5 with $3.6 billion and $3.04 billion in sales.
Sanofi has news for all of the payers, providers and patients who thought the French drugmaker would discount its newly approved insulin Toujeo to get it established in the market. Think again.
Novo Nordisk says the FDA has accepted its reapplication of its long-acting insulin Tresiba, setting it up for an October decision and a launch yet this year if approved this time around. Execs at Sanofi will certainly be watching the calendar just as closely given that a Tresiba launch will complicate the French drugmaker's efforts to its new long-acting insulin Toujeo established as the clear successor to aging Lantus.
Sanofi has its second diabetes approval in as many months: Toujeo, its long-acting follow-up to the megablockbuster Lantus. It's a big moment for the French drugmaker and its diabetes franchise, which needs the new drugs to perform, and quickly, to cushion the blow from forthcoming Lantus biosimilars.
Eli Lilly's long-acting basal insulin peglispro is on the back burner now. Some analysts figure it's well on its way to being canned. But the news isn't quite as bad for Lilly as one might expect--nor quite as good for the drug peglispro was hoping to challenge, Sanofi's Lantus.