Setback, and Success, for BI-Lilly Diabetes Alliance
Boehringer Ingelheim and Eli Lilly reported mixed results today in a pair of joint diabetes drug development efforts, pulling back from development of a basal insulin analog comprising one of four drugs in their research alliance, but promising to continue developing the other three—one of which has delivered promising topline results for four completed Phase III clinical trials.
BI opted to terminate their joint development effort for Lilly’s LY2605541 “given independent strategic portfolio considerations,” the companies said in a statement, with Lilly taking back sole worldwide development and commercialization rights.
Lilly made clear it would waste no time resuming solo development of LY2605541, saying that in addition to the five ongoing IMAGINE clinical trials, it would proceed with Phase III clinical trials previously planned for the basal insulin analog. If those trials for LY2605541 are successful, Lilly said, it could submit the drug candidate to regulators for approval as early as 2014, as previously announced.
In addition to supporting regulatory submissions, the Phase III studies will be used for evaluating safety, efficacy, and differentiation of LY2605541.
"We're encouraged by the preclinical, Phase I and II data we’ve seen for our novel basal insulin," Gwen Krivi, Ph.D, vp, diabetes product development with Lilly Diabetes, said in a statement.
Ulrich Drees, BI’s corporate senior vp, international project management, said in the same statement that his company and Lilly remained committed to the three other drug candidates in their diabetes research alliance—the insulin glargine product LY2963016; Trajenta® (linagliptin); and empagliflozin.
For empagliflozin—a sodium glucose co-transporter-2 (SGLT2) inhibitor being studied for treatment of patients with type 2 diabetes—BI and Lilly trumpeted topline Phase III results showing that once-daily 10 and 25 mg dosages of the drug candidate met its primary efficacy endpoint, namely significant change in HbA1c from baseline compared to placebo.
“Boehringer Ingelheim and Lilly are very encouraged by the efficacy and safety results for empagliflozin," said Klaus Dugi, M.D., BI’s corporate senior vp, medicine. Similarly, Enrique Conterno, president of Lilly Diabetes, said in a statement: "We are pleased with these results.”
The trials were pivotal studies for empagliflozin completed in 2012. BI and Lilly said they anticipate filing for regulatory review in the U.S., Europe, and Japan this year. Also in 2013 and in 2014, BI and Lilly said, they plan to present detailed data disclosures for many of these studies at scientific medical meetings and publications.
In addition, empagliflozin will also be studied in a Phase III program consisting of eight multinational clinical trials—including a large cardiovascular outcome trial—set to enroll more than 14,500 patients.
BI and Lilly launched their diabetes drug alliance in January 2011.