Amylin Pharmaceuticals and Eli Lilly confirmed European Commission approval of the GLP-1 receptor agonist Byetta® (exenatide twice-daily) as an adjunctive therapy to basal insulin, with or without metformin and/or pioglitazone (Actos®) for the treatment of adults with type 2 diabetes whose disease isn’t otherwise adequately controlled. FDA approved Byetta as an add-on therapy to insulin glargine back in October 2011.
Clearance in Europe was based primarily on data from a 30-week clinical trial in which Byetta or placebo was added to patient’s existing insulin glargine-based therapy (i.e., with or without metformin/pioglitazone or both). The results showed that after 30 weeks of therapy, patients receiving Byetta exhibited a statistically significant reduction in A1C from baseline, and in addition an average of 4 lb in weight loss. In contrast, patients continuing to receive their optimized insulin glargine-based regimen plus placebo gained about 2 lb in weight.
Lilly and Amylin ended their thirteen-year exenatide collaboration in November 2011, with a deal that effectively settled any outstanding litigation. Under terms of the deal Amylin is now responsible for all exenatide product development and commercialization worldwide, although Lilly will work with the firm on plans for non-U.S. markets during a transition period. Amylin paid Lilly $250 million up front for global rights to the drug, and will also be eligible to make revenue-sharing payments of $1.2 billion.