Eli Lilly and Co. and Boehringer Ingelheim have agreed to jointly develop and commercialize a portfolio of diabetes compounds now in mid- and late-stage development.

Eli Lilly, Boehringer Ingelheim, diabetes, diabetes compounds, oral diabetes agents, linagliptin, BI10773, basal insulin analogues, LY2605541, LY2963016, anti-TGF-beta monoclonal antibody, type 2 diabetes, alliance, John Lechleiter, Andreas Barner

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Lilly, Boehringer Ingelheim team on diabetes treatments

January 12th, 2011

INDIANAPOLIS and INGELHEIM, Germany – Eli Lilly and Co. and Boehringer Ingelheim have agreed to jointly develop and commercialize a portfolio of diabetes compounds now in mid- and late-stage development.

The companies said Tuesday that the compounds in the agreement include Boehringer Ingelheim's two oral diabetes agents, linagliptin and BI10773, and Lilly's two basal insulin analogues, LY2605541 and LY2963016, along with the option to co-develop and co-commercialize Lilly's anti-TGF-beta monoclonal antibody.

Lilly and Boehringer Ingelheim noted that the alliance will leverage the collective scientific expertise and business capabilities of two leading, research-driven pharmaceutical companies to address patient needs arising from the growing global diabetes epidemic.

"We are very excited about this new and extensive alliance with Boehringer Ingelheim, with whom we have partnered successfully in the past," stated John Lechleiter, Lilly chairman and chief executive officer. "Working together, we will comprise one of the most robust diabetes pipelines in the pharmaceutical industry. 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."

The companies reported that diabetes affects an estimated 285 million adults worldwide and more than 24 million people in the United States, with about 90% to 95% of those affected having type 2 diabetes. Diabetes costs approximately $174 billion per year in direct and indirect medical expenses in the U.S.

What's more, according to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, about 60% of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.

"Boehringer Ingelheim and Lilly have agreed to form a strategic alliance in diabetes at a time point when we at Boehringer Ingelheim are entering another new therapeutic area with innovative compounds out of our own research and development operations," commented Andreas Barner, chairman of the board of managing directors at Boehringer Ingelheim. "This cooperation will give Boehringer Ingelheim and Lilly the combined benefits of Lilly's expertise in the diabetes market and two basal insulin analogues as well as Boehringer Ingelheim's rich and innovative late-stage pipeline."

Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor discovered by Boehringer Ingelheim and being developed as an oral once-daily tablet for the treatment of Type 2 diabetes. It is currently under regulatory review in the U.S., Europe and Japan Boehringer Ingelheim's BI10773, a sodium-dependent glucose co-transporter-2 (SGLT-2) inhibitor, began enrollment in Phase III clinical trials last year. It belongs to a new, emerging class of diabetes compounds that block tubular reabsorption of glucose in the kidney. Currently there are no SGLT-2 inhibitors approved for use, according to the company.

Lilly's two basal insulin analogue candidates are expected to enter Phase III clinical testing in 2011. The two candidates are LY2605541, a structurally novel basal insulin analogue, and LY2963016, a new insulin glargine product.

The agreement also includes an option for Boehringer Ingelheim to co-develop and co-commercialize another Lilly diabetes molecule, an anti-TGF-beta monoclonal antibody, which is currently in Phase II of clinical testing in patients with diabetes with chronic kidney disease.