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2016-12-13

Zealand Pharma: Zealand initiates Phase IIa clinical trial with dasiglucagon in a dual-hormone artificial pancreas system from Beta Bionics

Press Release - No. 7 / 2016

Zealand initiates Phase IIa
clinical trial with dasiglucagon in a dual-hormone artificial pancreas system
from Beta Bionics

* An automated delivery system with both insulin and glucagon holds potential
to become a paradigm shift in the treatment of type 1 diabetes
* In December, Zealand initiated two Phase IIa trials, to test dasiglucagon's
potential in a dual-hormone artificial pancreas system
* Results from both trials are expected in H1 2017

Copenhagen, 13 December 2016
- Zealand Pharma (Zealand) today announced that it has dosed the first
patients in its Phase IIa clinical trial with dasiglucagon[1]in a
dual-hormone artificial (or bionic) pancreas system from Beta Bionics.
Dasiglucagon is a Zealand-invented glucagon analogue with a unique stability
profile in liquid formulation. The multiple-dose version of dasiglucagon is
intended for use in a dual-hormone artificial pancreas system to better
control hypoglycaemia and, potentially, hereby provide insulin treated
diabetes patients with options for easier and more effective management of
their disease.

The Phase IIa trial is the fourth Phase II trial initiated by Zealand this
year, demonstrating the significant progress in Zealand's pipeline of
proprietary product candidates.

People with type 1 diabetes depends on a complex daily insulin regimen to
control their blood glucose. They must regularly track and adjust their blood
sugar levels to reduce the acute and chronic risks associated with hypo- and
hyperglycaemia. A dual-hormone artificial (or bionic) pancreas system, which
automatically delivers insulin and glucagon, aims to mimic the function of a
healthy pancreas[2].

Steven J. Russell, MD, Massachusetts General Hospital Diabetes Center in
Boston, MA, USA, and Principal Investigator:
"Our previous studies have shown that a dual-hormonal bionic pancreas can
provide very effective management of glycemia in people with type 1 diabetes.
All of our previous studies have used glucagon that have very limited
stability, so the glucagon pump had to be refilled daily. More importantly,
the unstable glucagon formulations will not meet the regulatory requirements
to be approved for use in a bionic pancreas. This Phase IIa study will test
the effectiveness of the stable glucagon analogue dasiglucagon in the
dual-hormone bionic pancreas, comparing it with the unstable glucagon
formulation that we have used in all of our previous studies. Demonstrating
the effectiveness of a stable glucagon formulation or analogue, such as
dasiglucagon, is an essential step towards making a dual-hormone bionic
pancreas available to patients."

Adam Steensberg, Senior Vice President, Chief Medical&Development Officer,
Zealand:
"We are happy to have initiated our fourth Phase II trial this year, showing
significant progress in our clinical pipeline of medicines that we fully own
and develop ourselves. This is the first trial evaluating Zealand's glucagon
analogue, dasiglucagon, in the clinic for use in the dual-hormone artificial
pancreas, under development by Beta Bionics and Boston University. Such a
system has the ultimate potential to offer people with diabetes on insulin
therapy more efficacious, safer and easier blood sugar control."

Zealand entered into a collaboration with Beta Bionics, a Boston-based
company, earlier this year. Beta Bionics is developing a dual-hormone
artificial (bionic) pancreas system based on advanced technology that was
conceived and refined at Boston University and has been undergoing clinical
trials for nearly 10 years at the Massachusetts General Hospital and, more
recently, Stanford University, the University of North Carolina and the
University of Massachusetts. The technology is being integrated at Beta
Bionics into a pocket-sized wearable medical device called the iLetTM.

The Phase IIa trials
The aim of the Phase IIa clinical trial with Beta Bionics is to assess, for
the first time, the safety, efficacy and tolerability of dasiglucagon as part
of the Beta Bionics dual-hormone artificial (bionic) pancreas system in adult
patients with type 1 diabetes, compared to a recombinant market glucagon. In
collaboration with Beta Bionics and Boston University, the trial is conducted
at the Massachusetts General Hospital Diabetes Research Center in Boston, MA,
USA, with MD Steven J. Russell as Principal Investigator.

Earlier this month, Zealand initiated another Phase IIa trial with the aim of
assessing PK and PD responses after administration of the multiple-dose
version of dasiglucagon in adult patients with type 1 diabetes. The first
patients have been dosed.

The Phase IIa trials are designed to provide the foundation for longer
clinical trials with the multiple-dose version of dasiglucagon in the
dual-hormone artificial pancreas system. Results from both trials are
expected in H1 2017.

For further information on the Phase IIa trials, see:
ClinicalTrials.gov Identifier: NCT02916251
ClinicalTrials.gov Identifier: NCT02971228

*****

For further information, please contact

Adam Steensberg,
Senior Vice President,
Chief Medical and Development Officer

Tel.: +45 50 60 36 01
,
e-mail:ast@zealandpharma.com

Mats Blom,
Senior 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: 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 licence collaborations with Sanofi, Boehringer Ingelheim and
Helsinn, and a pipeline of proprietary product candidates that primarily
target specialty diseases with significant unmet needs.

The company's first invented medicine, lixisenatide, a once-daily prandial
GLP-1 analogue for the treatment of type 2 diabetes, is licensed to Sanofi.
Lixisenatide is marketed as Lyxumia®outside the United States and approved as
Adlyxin(TM) in the United States. Lixisenatide has been developed in a
fixed-ratio combination with basal insulin glargine (Lantus®) and is approved
as Soliqua(TM) 100/33 in the United States, and in Europe a CHMP positive
opinion recommendation was given in November (Suliqua(TM) is the brand name
in Europe).

Zealand's proprietary pipeline includes: dasiglucagon* (ZP4207) (single-dose
rescue treatment) for acute, severe hypoglycaemia (phase II); glepaglutide*
(ZP1848) for short bowel syndrome (phase II); dasiglucagon* (ZP4207)
(multiple-dose version) intended for use in a dual-hormone artificial
pancreas system for better hypoglycaemia control and diabetes management (in
phase II); and other earlier-stage clinical and preclinical peptide
therapeutics.

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 Twitter @ZealandPharma.

* Dasiglucagon and glepaglutide are proposed International Nonproprietary
Names (pINN).
---------------------------------------
1 Dasiglucagon is a proposed International Nonproprietary Name (pINN)
[2]Russel et al. "Outpatient glycemic control with a bionic pancreas in Type 1
diabetes", New England Journal of Medicine (2014)

07-16_1213 Zealand initiates Phase IIa trial with dasiglucagon
http://hugin.info/136974/R/2064427/774914.pdf

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This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Zealand Pharma via Globenewswire

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