Eli Lilly and Boehringer Ingelheim said today they will restructure their diabetes alliance as of January 1, 2015, by allowing each company to exclusively commercialize its own-developed molecules in all but the U.S. and 16 other countries.
The companies will continue co-promotion of alliance treatments in the 17 nations, which account for more than 90% of the alliance’s “anticipated market opportunity.” In addition to the U.S., the 16 other countries are Australia, Brazil, Canada, China, France, Germany, Ireland, Italy, Japan, Mexico, New Zealand, Portugal, South Korea, Spain, Taiwan, and the U.K.
Everywhere else where the alliance operates, Boehringer Ingelheim and Lilly said, they will exclusively commercialize their molecules under revised financial terms that will include an upfront payment and ongoing payments paid to Lilly in lieu of commissions.
Lilly said it plans to detail the impact to its 2014 financial guidance in its third-quarter Form 10-Q filing to be submitted to the U.S. Securities and Exchange Commission.
The restructuring comes nearly four years after the companies launched their alliance by agreeing to jointly co-develop and co-market diabetes drugs in more than 50 countries. Since January 2011, Lilly and Boehringer Ingelheim have launched three co-developed diabetes treatments—Trajenta® (linagliptin), the combination drug Jentadueto® (linagliptin/metformin HCI), and Jardiance® (empagliflozin).
A fourth treatment, Basaglar (insulin glargine injection), has won tentative approval in the U.S. and full approval in Europe. Last week, the FDA accepted for review a Lilly-Boehringer NDA for a combination treatment of Jardiance with metformin.
“The revised agreement will bring greater focus and clarity to our alliance and will benefit health care professionals, patients, and our companies,” Enrique Conterno, president, Lilly Diabetes, said in a statement.
Added Ulrich Drees, Ph.D., Boehringer Ingelheim’s corporate svp, international project management: “As our alliance continues to evolve, and with more medicines receiving approval by regulators, we have determined that enhancements are needed to reduce operational complexities in certain countries around the world.”