Zealand and Beta Bionics to collaborate on the development of a first-in-class dual-hormonal bionic pancreas system for treatment of people with type 1 diabetes

• Synergistic match of Beta Bionics's dual-hormonal, artificial, or bionic, pancreas device platform, the iLet, and Zealand's novel liquid stable glucagon analog, ZP4207
• An automated insulin + glucagon delivery system with integrated continuous blood glucose monitoring and mathematical dosing algorithms offers the potential for a paradigm shift in the treatment of diabetes
• Expected next step under the collaboration is the initiation of clinical trials in H2 2016
• Zealand's financial guidance for 2016 remains unchanged

COPENHAGEN, Denmark, June 10, 2016 -- Zealand Pharma, or Zealand, a peptide drug discovery, design and development company, and Beta Bionics, a medical technology company, jointly announced today that they have engaged in a collaboration. The objective of the collaboration is to combine essential proprietary product rights from each party to advance a new dual-hormonal artificial, or bionic, pancreas system to the next step in its clinical development. Such a system has the ultimate potential to offer people with diabetes on insulin therapy more efficacious, safer, and easier blood sugar control for better long-term disease management and outcomes.

The new system under the collaboration is based on an advanced bionic pancreas platform technology, developed at Boston University and Beta Bionics, which has been integrated into a pocket-sized wearable medical device, calledthe iLet. Boston University has granted an exclusive worldwide license of the iLet technology to Beta Bionics. The bionic pancreas technology in the iLet is designed for automated delivery of both insulin and glucagon analogs and has been tested and refined in nearly 10 years of clinical trials. All of these trials used recombinant human glucagon, which necessitated daily reconstitution at the point of care.

In future trials, Zealand will evaluate a multiple-dose version of its proprietary novel glucagon analog, ZP4207, with the iLet. ZP4207 is invented and developed by Zealand and has been shown to have a unique stability profile for use in liquid formulation.

Britt Meelby Jensen, President and Chief Executive Officer of Zealand: "We are truly excited about our collaboration with Beta Bionics. It allows us to evaluate our novel liquid glucagon, ZP4207, in the clinic for use in the state-of-the-art iLet device developed by Beta Bionics and Boston University. I believe we stand in front of a unique opportunity to develop a system for automated delivery of both insulin and glucagon and with the potential to offer a paradigm shift in the treatment of diabetes. Together with Beta Bionics, we have a vision of making the iLet device and our novel liquid formulation glucagon available for people with diabetes as soon as development timelines allow, and we look forward to starting our first joint clinical trials in people with type 1 diabetes later this year."   

Professor Ed Damiano, co-developer of the iLet technology, Professor of Biomedical Engineering at Boston University, and President and Chief Executive Officer of Beta Bionics, added: "We have long awaited and eagerly anticipated the development of a stable pumpable glucagon analog suitable for chronic use in our dual-hormone bionic pancreas. This has proven to be a challenging task. We are therefore very pleased that Beta Bionics now has access to Zealand's novel investigational glucagon analog, and that Zealand now has our bionic pancreas platform to administer it. We at Beta Bionics and Zealand share a deep appreciation for the synergy that comes from combining our two complementary technologies. Our collaboration is fueled by a common commitment to bring about a paradigm shift in diabetes management, and to fulfill the promise and potential that our partnership holds for the health and well-being of people with type 1 diabetes and their families."

People with type 1 diabetes have impaired pancreatic function. They suffer from insulin deficiency and inappropriate and inadequate glucagon secretion - both endogenous hormones are essential to ensure stable and healthy blood glucose metabolism. People with type 1 diabetes depend on a complicated daily insulin regimen to control hyperglycemia (high blood glucose levels) and carbohydrates to manage hypoglycemia (low blood glucose levels). They must constantly track and adjust their blood sugar levels to remain healthy and reduce the chronic and acute risks associated with hypo- and hyperglycemia. Today, many people with type 1 diabetes are on insulin pump therapy to control their blood sugar levels. A dual-hormone bionic pancreas, which automatically determines both insulin and glucagon doses and then delivers insulin and glucagon analogs, can much more faithfully mimic the function of a healthy pancreas and significantly improve diabetes management, relative to insulin pump therapy. A fully automated system would at the same time offer a significant relief to people with type 1 diabetes. A scalable commercial dual-hormone system has so far remained elusive, due to the lack of a stable, pumpable, liquid formulation of either glucagon or a glucagon analog product.

In out-patient and home-use randomized cross-over trials, the bionic pancreas technology that has been integrated into the iLet, has shown significant reductions in blood glucose levels, reductions in hypoglycemia, and reductions in intersubject as well as intrasubject glycemic variability in adults, adolescents, and pre-adolescents with type 1 diabetes (New England Journal of Medicine. 2014, 371:313-25; Lancet Diabetes and Endocrinology. 2016, 4:233-43).  These trials have been conducted in collaboration with endocrinologists at the Massachusetts General Hospital, Stanford University, the University of Massachusetts Medical Center, and the University of North Carolina.

Zealand has evaluated ZP4207 in Phase Ia and Phase Ib single and multiple ascending dose trials. In these trials, ZP4207 was observed to be safe and well tolerated with the ability to provide a clinically relevant blood glucose response.

Zealand and Beta Bionics expect as a next step in their collaboration to initiate a Phase IIa clinical trial to test safety and efficacy of ZP4207 when used in the iLet. The trial is expected to enroll the first patients with type 1 diabetes in H2 2016.   

Zealand retains its financial guidance for 2016

The collaboration with Beta Bionics and the clinical activities expected to be initiated in H2 2016 for ZP4207 when used in the iLet will not change Zealand's financial guidance for 2016.