Zealand Pharma to Present Data on Glucagon Analog, Dasiglucagon, at the 81st Annual American Diabetes Association Scientific Sessions

Wednesday, 16. June 2021 14:06

Company announcement – No. 39/2021

Zealand Pharma to Present Data on Glucagon Analog, Dasiglucagon, at the 81st Annual American Diabetes Association Scientific Sessions

  • Company to present six abstracts on ZEGALOGUE® (dasiglucagon) injection, including one oral presentation
  • Data reinforce the Company’s commitment to advancing research and development of new treatment options for people living with diabetes who experience severe hypoglycemia

Copenhagen, DK and Boston, MA, U.S. June 16, 2021 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company aspiring to change lives through the development of innovative peptide-based medicines, today announced that it will present five posters, and one oral presentation, at the upcoming 81st Scientific Sessions of the American Diabetes Association (ADA), which is being held virtually June 25-29, 2021. The Company’s research presented at ADA will feature multiple presentations related to Zegalogue® (dasiglucagon) injection, which was approved by the U.S. Food and Drug Administration (FDA) on March 22, 2021, indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.

"We are proud to share such a robust set of clinical data at this year’s ADA medical meeting,” said Adam Steensberg, Executive Vice President, Research & Development of Zealand Pharma. "Severe hypoglycemia remains a major issue and concern for people with diabetes. All the data being presented on dasiglucagon at this meeting shows Zealand’s commitment to help address this concern and to better understand how to continue to advance scientific development in this space.”
Presentation Details


Poster Title: The Next-Generation Glucagon Analog Dasiglucagon Consistently Achieves Rapid Recovery From Hypoglycemia Across Subgroups.
Author:  T Battelino, T Bailey, R Tehranchi, L Klaff, T Pieber, U Hövelmann, L Plummoershel, A Melgaard, R Aronson, L Dimeglo, T Danne
Poster Viewing Reception Date and Time:  25-29 June
Abstract Number: 2021-A-4695-Diabetes


Poster Title: Population pharmacokinetic modeling of dasiglucagon in subjects with type 1 diabetes mellitus
Author:  C Knudsen, A Valeur, ST Maarbjerg, R Tehranchi, P Diderichsen, H Witjes
Poster Viewing Reception Date and Time:  25-29 June
Abstract Number: 2021-A-5011-Diabetes


Poster Title: Integrated safety analysis of dasiglucagon for treatment of severe hypoglycemia 
Author:  S Heller, T Battelino, T. Bailey, R Tehranchi, L Klaff, T Pieber, Hövelmann, L Plum-Moerschel, A Melgaard, R Aronson, L Dimeglio, T Danne
Poster Viewing Reception Date and Time:  25-29 June
Abstract Number: 2021-A-4748-Diabetes


Poster Title: A 26-week carcinogenicity study with the novel glucagon analog dasiglucagon in CByB6F1 Tg(HRAS)2Jic mice
Author:  M Elander, A Froud
Poster Viewing Reception Date and Time:  25-29 June
Abstract Number: 2021-A-5017-Diabetes


Poster Title: Predicting true time to recovery from insulin-induced hypoglycemia with dasiglucagon
Author: T Battelino, T Bailey, R Tehranchi, L Klaff, T Pieber, U Hövelmann, L Plum-Moerchel, A Melgaard, R Aronson, L Dimeglio, T Danne, A Peters
Poster Viewing Reception Date and Time:  25-29 June 
Abstract number2021-A-4746-Diabetes


Oral Presentation Title: Dasiglucagon ready-to-use autoinjector is more reliably and quickly administered than glucagon emergency kit (GEK).
Author: N Bailey, S Fitch, J Dimsits, R Tehranchi, D Kendall, T Bailey 
Presentation Date and Time: Sunday 27th June, 8.00-10.00 AM
Abstract number2021-OR-137-Diabetes


INDICATION

ZEGALOGUE® (dasiglucagon) injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.

IMPORTANT SAFETY INFORMATION

Contraindications

ZEGALOGUE is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure and in patients with insulinoma because of the risk of hypoglycemia.

Warnings and Precautions

ZEGALOGUE is contraindicated in patients with pheochromocytoma because glucagon products may stimulate the release of catecholamines from the tumor. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

In patients with insulinoma, administration of glucagon products may produce an initial increase in blood glucose; however, ZEGALOGUE administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. ZEGALOGUE is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of ZEGALOGUE, give glucose orally or intravenously.

Allergic reactions have been reported with glucagon products; these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions.

ZEGALOGUE is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for ZEGALOGUE administration to be effective. Patients with these conditions should be treated with glucose.

Adverse Reactions

The most common adverse reactions (≥2%) associated with ZEGALOGUE in adults were nausea, vomiting, headache, diarrhea and injection site pain; in pediatrics: nausea, vomiting, headache and injection site pain.

Drug Interactions

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given ZEGALOGUE. In patients taking indomethacin, ZEGALOGUE may lose its ability to raise blood glucose or may produce hypoglycemia. ZEGALOGUE may increase the anticoagulant effect of warfarin.

Please click here to see the full Prescribing Information for Zegalogue.

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About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, development and commercialization 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 robust pipeline of investigational medicines includes three candidates in late stage development. Zealand markets V-Go®, a basal-bolus insulin delivery option for people with diabetes and has received approval for Zegalogue® (dasiglucagon), the first and only glucagon analogue for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 and above. License collaborations with Boehringer Ingelheim and Alexion Pharmaceuticals create opportunity for more patients to potentially benefit from Zealand-invented peptide therapeutics. Zealand was founded in 1998 in Copenhagen, Denmark, and has presence throughout the U.S. that includes key locations in New York, Boston, and Marlborough (MA). For more information about Zealand’s business and activities, please visit www.zealandpharma.com.

Forward-Looking Statements
This press release contains “forward-looking statements,” as that terms is defined in the Private Securities Litigation Reform Act of 1995, as amended, 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 labeling; failure to obtain regulatory approvals in other jurisdictions; product liability claims; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. 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 press release and are based on information available to Zealand Pharma as of the date of this release. 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.

For further information, please contact:

Ashley Paskalis
Syneos Health
Ashley.Paskalis@syneoshealth.com 


Zealand Pharma Investor Relations
Claudia Styslinger
Argot Partners
investors@zealandpharma.com 



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