Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency

Press release – No. 6 / 2024

Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency

Copenhagen, Denmark, May 31, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for dasiglucagon solution for injection in the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus.

"We are very pleased that the European regulatory authorities have recommended approval of dasiglucagon as a rescue treatment for very low blood sugar in people with diabetes," said Adam Steensberg, Chief Executive Officer of Zealand Pharma. "This is an important step in achieving our ambition of bringing this product to many more patients around the world through our partnership with Novo Nordisk, a global leader in diabetes."

The positive opinion from the CHMP will be referred to the European Commission (EC) for a final decision whether to grant marketing authorization in the European Union (EU). Zealand expects this decision within approximately three months. Dasiglucagon injection was approved by the U.S. FDA in March 2021 under the brand name Zegalogue®.

About Dasiglucagon Injection

Dasiglucagon injection was approved under the brand name Zegalogue® by the U.S. FDA on March 22, 2021, for the treatment of severe hypoglycemia in pediatric and adult people with diabetes aged 6 years and above. Zegalogue® is available in the U.S. in both an autoinjector and a prefilled syringe. The U.S. 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 dasiglucagon. In these Phase 3 trials, the most common adverse events reported (≥2%) were nausea, vomiting, headache, diarrhea, and injection site pain in adults; and nausea, vomiting, headache and injection site pain in pediatric patients.

Zegalogue® is a registered trademark of Novo Nordisk A/S.

About the Collaboration with Novo Nordisk

In September 2022, Zealand entered into a global license and development agreement with Novo Nordisk A/S to commercialize Zegalogue®. Under the terms of the agreement, Zealand is eligible to receive up to DKK 265 million in development, regulatory, manufacturing and sales-based milestones, as well as 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 is responsible for certain planned regulatory, development and manufacturing activities, including the Marketing Authorization Application (MAA) to the EMA, to support further development and approval outside of the U.S. Zealand retains all non-licensed intellectual property rights to the company’s other dasiglucagon development programs.

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of peptide-based medicines. More 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 pharma companies as well as commercial partnerships for its marketed products.

Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand’s business and activities, please visit www.zealandpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements that provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, the occurrence of adverse safety events; risks of unexpected costs or delays; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates or expansion of product labelling; failure to obtain regulatory approvals in other jurisdictions; and product liability claims. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

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