By Michael Fitzhugh
A new diabetes pact with Boehringer Ingelheim could help Eli Lilly (LLY) rebuild its diabetes pipeline with new mid- and late-stage diabetes treatments after two of its most promising medicines for the disease were derailed in 2010.
The agreement covers five medicines, at least four of which the companies plan to develop and commercialize jointly. It also gives both companies a chance to earn payouts with or without achieving final approvals for the drugs.
“For Lilly, this alliance expands our range of offerings for people with diabetes, strengthens our diabetes care capabilities, and offers the prospect of near-term revenue opportunities as we address the upcoming loss of patent exclusivity for several of our products,” says John Lechleiter, Lilly’s CEO and chairman.
In October 2010, Lilly suffered duel blows to its diabetes pipeline, erasing hopes for near-term revenue from new therapies. First, the U.S. Food and Drug Administration refused to approve Bydureon, a weekly-dosed version of its blockbuster diabetes treatment Byetta developed with Amylin Pharmaceuticals (AMLN) and Alkermes (ALKS). Then Lilly and MacroGenics decided to suspend a trial of teplizumab, an experimental monoclonal antibody that failed to adequately help people with type 1 diabetes.
Lilly is losing patent protection on some of its best-selling drugs. To address the expected loss of revenue to generic drug competitors, Lilly’s CEO Lechleiter has sought out new collaborations to compensate for these impending losses.
Under terms of the new deal, Lilly will make a one-time payment of $389 million (€300 million) to Boehringer. Boehringer will also be eligible to receive up to a total of $810.6 million (€625 million) in regulatory milestones for two oral diabetes agents, linagliptin and BI10773.
Lilly will be eligible to receive up to $650 million for meeting regulatory milestones on the two basal analogue insulins it is contributing to the partnership, LY2605541 and LY2963016.
The agreement also includes an option for Boehringer to co-develop and co-commercialize a mid-stage Lilly drug that could help patients with diabetes and chronic kidney disease, an action that could yield up to $525 million for Lilly.
Each company will be entitled to potential performance payments on sales of the molecules they contribute to the collaboration should any of the medicines gain marketing approval from regulators.