Press release - No. 9/2018
Zealand and Roche Diabetes Care enter Phase 3 study collaboration for treatment of congenital hyperinsulinism with
dasiglucagon
- Zealand has entered a collaboration agreement with Roche Diabetes Care to use its Accu-Chek® Combo pump system
in the Phase 3 trials with dasiglucagon for treatment of congenital hyperinsulinism (CHI).
- The Phase 3 trials are set to start in second half of 2018.
Copenhagen, Denmark, April 11, 2018 - Zealand Pharma ("Zealand") reports that it has engaged in a collaboration with Roche
Diabetes Care, a global leader in integrated diabetes management solutions, for the Phase 3 trials with dasiglucagon for treatment
of congenital hyperinsulinism (CHI). Zealand is responsible for conducting the Phase 3 trials, while Roche Diabetes Care provides
its Accu-Chek® Combo pump system for this study under the terms of the agreement. Together, the two companies aim
to evaluate the potential for a new non-surgical treatment for children with CHI.
Britt Meelby Jensen, President and CEO of Zealand, comments: "We are pleased to work with Roche Diabetes Care
products for the Phase 3 study of dasiglucagon for treatment of congenital hyperinsulinism. In the trials, neonates and children
with CHI will be given low doses of dasiglucagon infused via the Accu-Chek® Combo pump system. We are excited about
pursuing the development of a treatment for this severe and rare disease affecting neonates and children."
Ulf Meiertoberens, Lifecycle Leader Insulin Delivery Systems at Roche Diabetes Care, comments: "We are impressed with
the progress made by Zealand with dasiglucagon, now Phase 3 ready, for the treatment of congenital hyperinsulinism and are happy to
be able to contribute with our expertise and the Accu-Chek® Combo pump system, and together with Zealand evaluate this
potential new therapy option for children affected by CHI."
CHI is a rare medical condition in neonates and children. Due to a genetic defect in the insulin producing cells, these children
are born with too high blood insulin levels, resulting in persistent low blood glucose throughout childhood. Current treatment
options are insufficient and the most severely affected children need to have their pancreas surgically removed within the first
months of life in order control the blood glucose levels.
In the Phase 3 program, Zealand will evaluate the potential of continuous dasiglucagon infusions delivered via the
Accu-Chek® Combo pump system to prevent hypoglycemia in up to 50 children with CHI and thereby reduce morbidities
associated with persistent hypoglycemia as well as neurodevelopmental defects and need for having their pancreas surgically
removed.
Dasiglucagon is a potential first-in-class glucagon analog invented and developed by Zealand. It is stable in aqueous
formulation and suitable for pump use and thereby for potential treatment of CHI. In January 2018, the U.S. Food and Drug
Administration (FDA) approved Zealand's Investigational New Drug (IND) application for initiation of two Phase 3 clinical trials of
dasiglucagon in CHI. This approval enables Zealand to proceed into Phase 3 development of dasiglucagon for the treatment of CHI in
2018.
For further information, please contact:
Britt Meelby Jensen, President and CEO
Tel.: +45 51 67 61 28, e-mail: bmj@zealandpharma.com
Mats Blom, Executive Vice President, Chief Financial Officer
Tel.: +45 31 53 79 73, e-mail: mabl@zealandpharma.com
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, design
and development of innovative peptide-based medicines. Zealand has a portfolio of medicines and product candidates under license
collaborations with Sanofi and Boehringer Ingelheim, and a pipeline of internal product candidates focusing on specialty
gastrointestinal and metabolic diseases.
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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