Sanofi's LixiLan hits PhIII goal, moving one step closer to a Novo showdown

Sanofi R&D head Elias Zerhouni

Sanofi's ($SNY) diabetes business--long the company's growth driver--is in for a slowdown over the next few years, and any sales expansion the French drugmaker sees will depend, in part, on new U.S. launches. Now, experimental combo med LixiLan is one step closer to joining that launch group after nailing its main goal in a late-stage trial.

In a Phase III study of 1,170 patients, LixiLan--which pairs the company's best-selling Lantus with not-yet-FDA-approved Lyxumia--reduced more blood glucose than either of its component meds did on their own over three months, Sanofi announced Wednesday. With that result in mind, it's planning to file for FDA approval in Q4 of this year and for European approval in 2016's first quarter.

According to analyst estimates, LixiLan could hit sales of €770 million by 2020--though it'll have some competition in Europe if and when it wins approval there. The drug will take on Novo Nordisk's ($NVO) Xultophy, which nabbed approval on the continent last September.

Still, Sanofi's diabetes business will welcome any sales LixiLan can rack up. Late last year, the company predicted that diabetes sales would be "flat to slightly growing" through 2018, and hitting those numbers depends rollouts of inhaled insulin Afrezza as well as LixiLan and Lyxumia--pending FDA approval.

Sanofi is also counting on its ability to convert patients from now-off-patent Lantus to follow-up med Toujeo. The drugmaker has already filed a lawsuit to keep biosimilar-maker Eli Lilly ($LLY) at bay, but that will only keep its Indianapolis-based rival tied up until June of next year at the latest. And in the meantime, other drugmakers have their own Lantus copies in the works, including partners Merck ($MRK) and Samsung Bioepis.

- read Sanofi's release
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