|Lilly Diabetes President Enrique Conterno|
Eli Lilly ($LLY) is ceasing development of a long-acting insulin after testing the injection on thousands of patients in late-stage trials, nixing the program after a safety-related delay.
The treatment, dubbed peglispro, is a once-a-day insulin analog the company hoped could compete with next-generation products from rivals Novo Nordisk ($NVO) and Sanofi ($SNY). Lilly once expected to submit peglispro, which the company calls BIL, in the first quarter of 2015 but put off those plans indefinitely after some alarming liver toxicities cropped up in its 6,000-patient Phase III program.
Now Lilly is scrapping that effort entirely, saying its decision is not driven by new safety concerns but rather based on conversations with regulators and external experts on how to deal with BIL's established effects on the liver.
"While we are encouraged by the efficacy data we observed for BIL, we know that moving forward would have required a significant amount of time and investment with no assurance that we would find conclusive answers," Lilly Diabetes President Enrique Conterno said in a statement. "We are disappointed in the outcome for BIL, but we have an unprecedented opportunity to build upon the industry's broadest diabetes portfolio, which includes 6 new treatments approved since the middle of 2014."
Had Lilly's insulin gone on to win approval, it would have faced a tough commercial climate in a market now full of daily insulins that don't pose the same risks. Sanofi won approval this year for the long-acting Toujeo, and Novo Nordisk, after spending years on sideline due to a 2013 FDA rejection, finally convinced the agency to sign off on its similar Tresiba.
BIL's goal-line failure is a major blow to Lilly's diabetes pipeline, as it also excises the company from a race to commercialize promising combination treatments. Sanofi and Novo Nordisk are pushing toward the market with cocktails that combine long-acting insulin with so-called GLP-1 treatments, combinations that have demonstrated great clinical potential. Lilly was in the running with a program combining BIL with its on-the-market Trulicity, and canceling the insulin altogether means the company won't be competing in what could become a blockbuster market for combo therapies.
- read the statement