Novo Nordisk, Zealand Pharma collaborate for ZEGALOGUE for injection

Copenhagen: Novo Nordisk A/S has entered into a global license and development agreement with Zealand Pharma A/S, a biotechnology company for the commercialization of ZEGALOGUE (dasiglucagon) for injection.

ZEGALOGUE is approved by the U.S. Food and Drug Administration (USFDA) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 and above.

Under the terms of the agreement, Zealand will receive an upfront payment of DKK 25 million and is eligible to receive up to DKK 45 million in near-term development, regulatory and manufacturing-based milestones. Zealand is also eligible to receive up to DKK 220 million in sales-based milestones and tiered royalties ranging from high single-digit to low double-digit percentages on worldwide net sales of ZEGALOGUE to be marketed by Novo Nordisk. Zealand will be responsible for certain planned regulatory, development and manufacturing activities to support further development and approval outside of the U.S.

"We are extremely pleased to partner with Novo Nordisk, a global leader in diabetes, to bring Zegalogue to many more patients around the world," said Adam Steensberg, MD, Chief Executive Officer of Zealand Pharma. "This agreement is another important step in our strategy to establish commercial partnerships as we create and develop innovative next generation peptide therapeutics."

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"Although modern diabetes therapy has significantly reduced the occurrence of very low blood sugar levels, or hypoglycemia, for people with diabetes it remains feared and potentially serious," said Camilla Sylvest, Executive Vice President at Novo Nordisk. "As a world leader in diabetes care, we aim to provide convenient and simple to use solutions for people with diabetes experiencing severe hypoglycemic episodes. We are therefore excited to add Zegalogue to our portfolio of therapies."

Zealand will retain all non-licensed intellectual property rights to the company's other dasiglucagon development programs.

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Zegalogue (dasiglucagon) injection was approved by the U.S. FDA on March 22, 2021 for the treatment of severe hypoglycemia in people with diabetes. Zegalogue is available in both an auto injector and a prefilled syringe for patients with diabetes age 6 or older.

The approval was based on results from three pivotal trials in adults and children with diabetes, showing a median time to blood glucose recovery from severe hypoglycemia of 10 minutes following injection of 0.6 mg/0.6 mL of Zegalogue.

Zegalogue launched in the U.S. in late June 2021.

Founded in 1998, Zealand Pharma A/S is a biotechnology company focused on the discovery and development of peptide-based medicines. The company isMore than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of blue-chip pharma companies as well as commercial partnerships for its marketed products.

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