Sanofi’s U300 Controls Glucose With Fewer Night Dips in Study

Sanofi’s experimental U300 insulin controlled glucose as well as the company’s best-selling Lantus in a late-stage study, with fewer dangerous dips in blood sugar at night.

In a trial among 811 patients with type 2 diabetes who were already being treated with long-acting insulin, 23 percent fewer of those who added the new drug experienced a drop in night-time blood sugar levels over six months than those who added Lantus, Paris-based Sanofi said in a statement today. The results were presented at a diabetes meeting in Melbourne.

The prospects of U300 are critical for Sanofi to maintain its lead in the $35-billion-a-year diabetes market. Lantus was Sanofi’s biggest-selling product with sales of 4.96 billion euros ($6.72 billion) last year, and will lose patent protection in 2015. Today’s results confirm similar findings presented in June, and show U300 is approvable, said Richard Parkes, an analyst at Deutsche Bank AG in London.

“The ideal situation for them is they’ve got something that’s Lantus, but slightly better,” Parkes said by phone today. “That allows you to protect a significant portion of your franchise from biosimilar risk.”

U300 may reach $1 billion in sales by 2018, according to analysts at Berenberg Bank and Sanford C. Bernstein & Co.

Sanofi fell 1.9 percent to 75.78 euros as of 11:20 a.m. in Paris, the lowest price in more than a month. In a separate trial among patients who were not already taking insulin, U300 did not achieve a statistically significant reduction in nocturnal hypoglycemia compared with Lantus, Sanofi said today.

That group of patients may not be the main market for the drug, Parkes said. U300 is a high-concentration form of insulin designed for patients who have to take two doses of Lantus, and who have a high risk of hypoglycemia because they’ve been on insulin for several years, he said.

“The bottom line is this makes no difference to this product getting approved,” Parkes said.