Press release – No. 14 / 2019

Zealand Pharma presents dasiglucagon pivotal Phase 3 trial data at the 79th Scientific Sessions of the American Diabetes Association (ADA)

• The pivotal Phase 3 trial demonstrates that a single dose of dasiglucagon rapidly increases blood glucose levels in type 1 diabetes patients with low plasma glucose
   
• The median time to plasma glucose recovery was 10 min following dasiglucagon injection, with 99% of patients having recovered within 15 minutes

Copenhagen, June 11, 2019 – Zealand Pharma A/S (“Zealand”) (NASDAQ: ZEAL) (CVR-no. 20 04 50 78), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, presented elaborated results from the pivotal Phase 3 study of dasiglucagon as treatment for severe hypoglycemia at the 79th Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, California. Abstract No. 286-OR was presented on Monday, June 10 at 4:00 PM Pacific.

Dasiglucagon has the potential to offer millions of people living with diabetes the fastest and most effective rescue treatment for severe hypoglycemia. Dasiglucagon is a potential first-in-class soluble glucagon analog invented and developed by Zealand. It is in development in the ready-to-use HypoPal® rescue pen for easy, fast and effective treatment of severe hypoglycemia.

The results were shared as an oral presentation: Phase 3 Results for dasiglucagon as a fast and effective treatment for severe hypoglycemia, by Professor, Dr. Thomas R. Pieber, Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Diabetology. The study confirmed the efficacy and safety of dasiglucagon in the treatment of hypoglycemia in type 1 diabetes subjects. The data demonstrate superiority of dasiglucagon compared to placebo following a single subcutaneous dose administered to subjects with type 1 diabetes mellitus with insulin-induced hypoglycemia. Additionally, the study compared the glycemic response and tolerability observed after administration of dasiglucagon with that of GlucaGen®.

“The Phase 3 data in this multi-center study confirmed dasiglucagon as a potential emergency glucagon treatment with a fast recovery profile. Recovery was observed within 10 minutes for almost two-thirds of the subjects,” commented Professor, Dr. Thomas R. Pieber, Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Diabetology.

“The pivotal Phase 3 data established the fast onset of action by dasiglucagon, which we believe is of major importance when treating severe hypoglycemia,” said Adam Steensberg, Executive Vice President and Chief Medical and Development Officer at Zealand Pharma. “We believe that people living with insulin-dependent diabetes should be offered new alternatives to treating severe hypoglycemia, and we are excited about the opportunity for the dasiglucagon HypoPal® rescue pen.”

For further information, please contact:

Emmanuel Dulac, President and Chief Executive Officer
Tel.: +45 50 60 36 36, e-mail: edu@zealandpharma.com

Lani Pollworth Morvan, Investor Relations and Communication
Tel.: +45 50 60 37 78, e-mail: lpm@zealandpharma.com

Dasiglucagon (glucagon analog stable in liquid formulation) for use in other indications
Dasiglucagon is a Zealand-invented glucagon analog with a unique stability profile in a ready-to-use aqueous solution. It is also in development for two additional indications: treatment of type 1 diabetes with a next-generation artificial pancreas, and treatment for children born with a genetic mutation that causes congenital hyperinsulinism (CHI).

About type 1 diabetes and hypoglycemia
People with type 1 diabetes suffer from insulin deficiency and inappropriate glucagon secretion. Both hormones are essential to ensure stable and healthy blood glucose levels. Consequently, patients must monitor and adjust their blood glucose levels to remain in proper glycemic control, as both high and low blood glucose may affect their health, both in the short and long term.

Severe hypoglycemia is an acute, life-threatening condition resulting from a critical drop in blood glucose levels associated primarily with insulin therapy. Severe hypoglycemia occurs most frequently in people with type 1 diabetes due to injecting insulin multiple times daily. It is the biggest concern for insulin-dependent patients and the most feared complication of diabetes treatment. The condition is characterized by confusion, seizures, and often loss of consciousness that can result in death if left untreated.

When a patient has a hypoglycemic event, a second person must assist in treatment. Currently marketed formulations of glucagon for the treatment of severe hypoglycemia require mixing first by the person assisting to treat and then immediate administration due to poor drug stability. Dasiglucagon is being developed to offer a stable ready-to-use rescue treatment for severe hypoglycemia.

About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Zealand’s portfolio also includes two clinical license collaborations with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals.

Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.  

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