Across three Phase III trials, Sanofi's ($SNY) in-development replacement for Lantus was better at battling low blood sugar than the company's cash cow insulin product, providing hope for the drugmaker's diabetes business when its blockbuster goes off patent next year.
Compared to Lantus, Sanofi's Toujeo--formerly U300--reduced the rate of low blood sugar events by 31% at nighttime and 14% at any time of day, the company said. The 6-month results come from a pooled analysis of Toujeo's nearly 2,500-patient late-stage program in Type 2 diabetes, and all three of the studies met their primary endpoints, according to Sanofi.
Late last month, the European Medicines Agency accepted Sanofi's application for the next-generation insulin, the company said, and the drugmaker is awaiting official FDA acceptance of its U.S. filing.
For Sanofi, Toujeo's promise is key to the company's future in diabetes. Lantus, which brought in about $7.6 billion last year, accounts for almost 20% of the drugmaker's sales, and it's set to lose patent protection next year.
Thanks to some clever litigation and a little luck, however, Sanofi has some breathing room. First, in early 2013, the FDA unexpectedly rejected Novo Nordisk's ($NVO) Tresiba, a long-acting insulin with some superior efficacy data that threatened to unseat Lantus. Then, with rival Eli Lilly ($LLY) nigh on FDA approval for a biosimilar of the insulin treatment, Sanofi successfully blocked its path with a patent infringement suit that will likely delay any launch until 2016.
But, no matter what happens, Toujeo won't be a panacea for Sanofi's issues in diabetes. Analysts expect peak sales of about $1 billion for the treatment. Furthermore, while Lilly may be temporarily thwarted, Merck ($MRK) recently signed a deal with Samsung Bioepis, a joint venture between the South Korean giant and Biogen Idec ($BIIB), to develop and manufacture a Lantus biosimilar of its own.
And Lilly, a diabetes power in its own right, isn't sitting on its hands. The patent suit covers only a U.S. launch, so Lilly's all set to launch its biosimilar overseas next year, the company said. And peglispro, its own next-gen insulin, has already demonstrated itself superior to Lantus in late-stage studies.
- read the results