Sanofi’s experimental diabetes drug U300 helped control glucose with fewer patients experiencing incidents of dangerously low blood-sugar levels at night than the company’s Lantus in two clinical trials.
The findings suggest U300 is potentially a “next-generation insulin” that improves on the drugmaker’s top-selling Lantus, Pierre Chancel, head of Sanofi’s diabetes division, said. Paris-based Sanofi announced results in a statement today from two late-stage studies, one of which is being presented at the American Diabetes Association’s meeting in Chicago.
The prospects of U300 are critical for Sanofi to maintain its lead in the $35-billion-a-year diabetes market. Lantus, also known as insulin glargine, which last year garnered 4.96 billion euros ($6.51 billion) in sales, will lose patent protection in 2015. Sanofi needs a successor to the medicine and is also testing Lantus in combination with Lyxumia, another diabetes treatment belonging to a class of drugs known as GLP-1 analogues.
If such results are confirmed, U300 will be “a better tool” than Lantus, Chancel said in a telephone interview. It’s “a tool that would retain the value of glargine,” including its safety profile, while offering “other interesting features,” such as a lower risk of night-time hypoglycemia. “It’s a great opportunity,” he said.
Full results from the trial dubbed EDITION 1 were presented at the medical meeting. In its statement today, Sanofi also announced an analysis of results from a second late-stage trial on U300 dubbed EDITION 2. Results from both studies were consistent, Riccardo Perfetti, vice president of global medical affairs for diabetes at Sanofi, said during an interview.
U300 “should allow Sanofi to defend its position in the diabetes space,” Vincent Meunier, an analyst at Exane BNP Paribas in Paris, said in a June 20 telephone interview. “It’s good news for them.”
The new formulation has a different pharmacokinetic and pharmacodynamic profile compared to Lantus, meaning that it works differently once inside the body, Perfetti said.
U-300 has a “super-flat profile,” with the insulin released more evenly and no accumulation problems, he said. This is probably the reason why fewer people experienced hypoglycemia events, a common side effect among diabetics, said Perfetti.
The new product is a “significant milestone” for Sanofi and “if positive trends emerge in both efficacy and safety terms, then Sanofi would be in a position to switch old formulation to the new,” Eric Le Berrigaud, an analyst at Bryan Garnier & Co. in Paris who has a “buy” recommendation on Sanofi, said in a note to clients on June 17. U-300 “has to be seen as the first line of defense for Lantus,” he said. Lyxumia “is Sanofi’s second-line of defense for Lantus.”
A surge in obesity and sedentary lifestyles around the globe have kindled a surge in diabetes cases. The market is likely to grow to more than $58 billion in 2018 from $35 billion in 2012, Standard & Poor’s wrote in an October report.
Sanofi is still seeking ways to bolster its diabetes pipeline beyond insulins and Lyxumia, Chancel said during the interview.
“We are still interested in the pre-injection space,” Chancel said. “We are looking at potential opportunities.”
Sanofi will be holding a conference call with investors on June 24 at 2 p.m. Paris time to discuss U300 and its diabetes strategy.