Sanofi Gains U.S. Approval for Successor to Lantus

Sanofi won U.S. approval for its diabetes treatment Toujeo, gaining a successor to the French drugmaker’s top-selling product, Lantus, which loses patent protection this year.

Toujeo, a long-acting form of insulin to help control blood sugar, was cleared by the Food and Drug Administration for use in adults with Type 1 and Type 2 diabetes, Sanofi said in a statement. The treatment is expected to be available in April, the company said.

Studies have shown that patients taking Toujeo have fewer drops in blood sugar while asleep than those taking Lantus, an advantage that Paris-based Sanofi is banking on to convince patients and doctors to switch to the new drug. Toujeo, which analysts predict will garner $1 billion in sales by 2018, is one of six treatments Sanofi is targeting for regulatory approval this year.

“Toujeo is quite critical,” Pierre Chancel, head of Sanofi’s diabetes unit, said in a telephone interview before the FDA announcement. “It’s a better tool for physicians, it’s a better tool for patients.”

Lantus generated revenue of 6.34 billion euros last year. It lost U.S. patent protection this month and will lose exclusive rights in Europe in May. Sanofi has sued Eli Lilly & Co. to block a copycat competitor from coming to market. Lilly has said it’s ready to introduce the drug in Europe as soon as May.

People with diabetes either don’t produce insulin or can’t use it properly convert food into energy.

Controlling Diabetes

About half of U.S. patients don’t have their disease under control, and Sanofi will price Toujeo at parity with Lantus in an attempt to get them to switch to the new drug, Chancel said.

Lantus costs $24.85 per milliliter and is administered in an injection pen, Jack Cox, a spokesman for Sanofi, said in an e-mail. The dose is individualized to the patient depending on type of diabetes and whether they’ve had insulin previously.

Sanofi surprised investors in October with a forecast of stalling growth at the diabetes business through 2018 after Novo Nordisk A/S cut the price of its competing Levemir treatment to win contracts with U.S. health-benefit managers. The misstep contributed to Chief Executive Officer Chris Viehbacher’s ouster that month. On Feb. 19, Sanofi said Bayer AG executive Olivier Brandicourt would become CEO in April.

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