The Future of Sanofi SA (ADR) (SNY)’s Insulin Empire

Sanofi SA (ADR) (NYSE:SNY) appeared at the American Diabetes Association meeting last month, touting data for the new insulin U300 and a combo therapy involving its approved drugs Lyxumia and Lantus. Could these new drugs keep Sanofi SA (ADR) (NYSE:SNY) near the top of the diabetes market heap?

Lantus is Sanofi SA (ADR) (NYSE:SNY)’s top-selling product, earning 5 billion euros (or about $6.5 billion at current exchange rates) in sales last year. But the drug’s patent will expire in 2015 and there’s competition in the pipes. The delay of Novo Nordisk A/S (ADR) (NYSE:NVO)’s competitor opened a window for Sanofi SA (ADR) (NYSE:SNY), but Eli Lilly & Co. (NYSE:LLY)’s candidate might cause some trouble.

Here’s a look at the contenders that could sustain Sanofi SA (ADR) (NYSE:SNY)’s insulin empire.

U300: Lantus successor

Sanofi SA (ADR) (NYSE:SNY) has provided a data sneak peek for U300, a long-acting insulin product meant to act as Lantus’ improved successor. This data comes from the first half of a quartet of late-stage trials reporting this year.

U300 showed non-inferiority to Lantus when it came to managing blood sugar. But the drug more importantly showed an improvement at reducing nocturnal hypoglycemia — or nighttime low blood sugar — which is harder to manage.

Sanofi plans to file for regulatory approval in the first half of 2014. But if U300 should somehow crash before launch, Sanofi has a backup plan.

Lyxumia + Lantus = LixiLan

The GLP-1 agonist Lyxumia won approval in several regions including the European Union and Japan but is still awaiting FDA review. GLP-1s are typically prescribed in a combo therapy including insulin for type 2 diabetes. Sanofi has paired Lyxumia with Lantus in an injection-pen device called LixiLan, which the company hopes will win patients over with its dosage convenience.

Sanofi plans to start late-stage LixiLan trials in the first half of 2014. The company stepped up production due to delays that struck a potential competitor from Novo Nordisk A/S (ADR) (NYSE:NVO).

The competition

Novo Nordisk A/S (ADR) (NYSE:NVO)’s long-acting Tresiba, also called degludec,received a complete response letter from the FDA in February that requests additional cardiovascular safety data. Novo said it wouldn’t have the data this year and analysts estimate that it’ll take two to three years to get the kind of evidence the FDA’s requesting. The delay opens up a nice market window for Sanofi.

But Eli Lilly & Co. (NYSE:LLY)’s LY2605541 is still moving through the pipes.