Amylin Pharmaceuticals is taking Eli Lilly to court over the latter’s recently announced type 2 diabetes drug development deal with Boehringer Ingelheim (BI), claiming the agreement will lead to anticompetitive activity on Lilly’s part and a breach of strategic alliance agreements. Amylin and Lilly have an almost 10-year partnership centered on commercializing the now FDA-approved injectable diabetes drug Byetta® (exenatide) and the long-acting exenatide formulation Bydureon™, which has yet to be approved in the U.S. but just last month was recommended for approval in Europe by the EMA’s CHMP advisory committee.
One of the drugs covered under Lilly and BI’s type 2 diabetes drug partnership, signed in January, is the oral dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, which Amylin says will directly compete with exenatide products. Linagliptin is currently under regulatory review in Europe and Japan, and received FDA approvalon May 3. Amylin is seeking a preliminary and permanent injunction to stop Lilly using the same sales force to sell both exenatide and linagliptin.
“We are disappointed that we could not resolve this matter amicably and that we were forced to bring legal action to protect our rights, our products, and our shareholders,” Amylin states. “Notwithstanding this litigation, we intend to continue to collaborate with Lilly in the development and commercialization of exenatide products.”