Lilly's LY2963016 insulin glargine non-inferior to Lantus

Eli Lilly and Co. (NYSE:LLY) and Boehringer Ingelheim GmbH (Ingelheim, Germany) said once-daily subcutaneous LY2963016 met the primary endpoint of non-inferiority to once-daily Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY) in reducing HbA1c from baseline to week 24 in diabetics in two open-label Phase III trials. ELEMENT-1 enrolled 535 Type I diabetics who received mealtime Humalog insulin lispro, while ELEMENT-2 enrolled 756 Type II diabetics inadequately controlled on at least two oral diabetes medicines. In both trials, the hypoglycemia rate was similar in patients receiving LY2963016 -- a basal insulin analog -- vs. Lantus. Data were presented at the American Diabetes Association meeting in San Francisco.

LY2963016 is under review in the U.S., EU and Japan to treat Type I and II diabetes. Lilly said LY2963016 has the same amino acid sequence as Lantus and therefore was submitted in the U.S. under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. The PDUFA date is not disclosed. In January, Sanofi filed suit in the U.S. District Court for the District of Delaware against Lilly alleging Lilly's NDA for LY2963016 infringes patents covering Lantus. The case is ongoing. ...