Collaboration Gives Boehringer Ingelheim Rights to Zealand’s Type 2 Diabetes Candidate

BI will develop firm’s current dual glucagon/GLP-1 agonist as well as new dual agonists.

Boehringer Ingelheim (BI) and Zealand Pharma inked an exclusive global license and collaboration agreement centered on development of dual-acting glucagon and GLP-1 receptor agonists for the treatment of type 2 diabetes and obesity. The deal gives BI global development and commercialization rights to Zealand’s lead preclinical-stage glucagon/GLP-1 dual agonist, ZP2929. Zealand will carry out the first Phase I trial with the drug.

Danish firm Zealand could receive up-front, milestone, cost reimbursement, and other payments of up to €41 million (about $59 million) during the first two years of the collaboration, including €4 million (nearly $6 million) in research funding. BI will fund research, development, and commercialization of all drugs covered by the agreement, including newly discovered candidates. The partners’ collaborative research will focus on identifying, characterizing, and developing additional glucagon/GLP-1 dual agonists for new indications, along with new formulations and delivery systems.

BI’s agreement with Zealand comes just a month after FDA approved BI and Eli Lilly’s type 2 diabetes drug linagliptin. Zealand’s drug ZP2929 will not fall within the remit of BI’s diabetes drug co-development collaboration with Lilly, which the firms announced in January. Included in the BI-Lilly deal are BI’s two oral diabetes agents, linagliptin and BI10773, as well as Lilly’s two basal insulin analogues, LY2605541 and LY2963016, plus an option to co-develop and co-commercialize Lilly’s anti-TGF-beta monoclonal antibody.

Zealand’s ZP2929 will further complement BI’s pipeline in diabetes and metabolic diseases, the German firm states. “With our first diabetes treatment, linagliptin, recently approved by the FDA, we have a manifest for BI’s own research strength and its capability to bring novel medication to patients,” comments Klaus Dugi, M.D., svp for medicine. “We are therefore pleased to bundle our R&D experience with Zealand Pharma for further projects in diabetes and obesity.”

Peptide drugs firm Zealand’s lead product lixisenatide is a once-daily GLP-1 candidate for type 2 diabetes, which is undergoing Phase III development in collaboration with Sanofi. At the end of May Sanofi released new data from the GetGoal-L study being carried out as part of the nine-trial global Phase III GetGoal development program for lixisenatide. The data showed that treating type 2 diabetes patients with lixisenatide in addition to basal insulin (with or without metformin) significantly reduced HbA1c levels without significantly increasing the risk of hypoglycemia.

In Feburary Sanofi presented top-line data from the Phase III GetGoal-X study, which demonstratded the non-inferiority of once-daily lixisenatide compared with twice-daily exenatide in reducing HbA1c levels. Zealand and Sanofi are separately developing lixisenatide as combination therapy with Lantus for the treatment of type 2 diabetes.

Zealand’s clinical-stage non-diabetes pipeline includes candidates being developed in house and through partnerships for the treatment chemotherapy-induced diarrhea, inflammatory bowel/Crohn disease, atrial fibrillation, and post-surgical kidney injury.