Boehringer Ingelheim, Zealand Pharma deal with diabetes

COPENHAGEN, Denmark and INGELHEIM, Germany—Pharmaceuticalleader Boehringer Ingelheim and Copenhagen-based Zealand Pharma have announcedan exclusive global license and collaboration agreement for dual-actingglucagon and GLP-1 receptor agonists for treating patients with Type-2 diabetesas well as patients with obesity. Under the terms of the agreement, BoehringerIngelheim will obtain global development and commercialization rights toZP2929, Zealand Pharma's lead glucagon/GLP-1 dual agonist drug candidate, andwill fund the research, development and commercialization of products under theagreement. Zealand Pharma is responsible for conducting the first Phase I studyof ZP2929, and the two companies will focus on identifying and developingadditional glucagons/GLP-1 dual agonists for new indications, formulations anddelivery systems.

For the first two years, Zealand Pharma stands to receivesignature, milestone and others payments of up to 41 million euros(approximately $58 million), including cost reimbursements as well as researchfunding of up to 4 million euros (approximately $5.7 million). If certainpre-defined development, regulatory and commercial milestones are met, ZealandPharma stands to receive payments for ZP2929 as well as additional milestonepayments if other products included in the collaboration are advanced throughdevelopment. Zealand Pharma is also entitled to tiered royalties in the rangeof high single- to low double-digits on global sales of products covered by theagreement, and retains co-promotion rights in Scandinavia.

"We are extremely pleased to have signed this license andcollaboration agreement with Boehringer Ingelheim, which has recentlystrengthened its commitment to the important field of diabetes," David H.Solomon, President and Chief Executive Officer of Zealand Pharma, said in astatement about the collaboration. "ZP2929 is one of Zealand Pharma's mostinnovative peptide drug candidates, having shown significant pre-clinicalpromise for patients with Type-2 diabetes and obesity."

GLP-1 (or Glucagon-like peptide-1) is naturally releasedfrom cells in the gut after eating, and helps initiate the secretion andrelease of insulin from the pancreas in the presence of high blood glucose. Insulinthen works to control the movement of blood glucose into cells, which reducesthe risk of hyperglycemia. This is the normal mechanism of action for insulinin the body. GLP-1-based peptide drugs are artificially produced forms ofGLP-1, and these GLP-1 analogs or GLP-1 receptor agonists mimic the body'sprocess of stimulating insulin production more naturally than administeringinsulin directly. Using these analogs or receptor agonists also has positiveeffects in the gut by increasing satiation after eating, which can result inweight loss, a positive outcome for diabetes patients. Evidence frompreclinical studies also supports the claim that GLP-1 helps preserve thefunctioning of the beta cells that produce insulin, thereby possibly helping toslow the progression of Type-2 diabetes.

"Our focus to develop innovative diabetes treatments isreinforced by the in-licensing of a very interesting compound from ZealandPharma, which complements Boehringer Ingelheim's pipeline in diabetes andmetabolic diseases very well," Prof. Klaus Dugi, Ph.D., Boehringer Ingelheim'sCorporate Senior Vice President of Medicine, said in a press release regardingthe deal. "With our first diabetes treatment linagliptin recently approved bythe FDA, we have a manifest for Boehringer Ingelheim's own research strengthand its capability to bring novel medication to the patients. We are thereforepleased to bundle our R&D experience with Zealand Pharma for furtherprojects in diabetes and obesity."

The agreement is expected to positively affect ZealandPharma's revenues and other income by DKK 150 million (approximately $28million) for the year of 2011, but is not expected to affect the company'sguidance on total operating expenses of DKK 170 million (approximately $32.5million).

"Togetherwith Boehringer Ingelheim, we look forward to advancing the development ofZP2929 into Phase I as part of our joint efforts to bring novel and bettertreatments to the market to help improve the lives of diabetes patients,"Solomon said in a press release.