Zealand Pharma

Regulatory Filings • Sep 9, 2015

-- Data demonstrate that ZP4207 was safe and well-tolerated with the ability
to provide a clinically relevant blood glucose response after repeat daily
dosing in healthy volunteers

-- The results provide further support for the use of ZP4207 as a
multiple-dose version, including potential as a component in an artificial
pancreas device, to correct low blood sugar levels in patients with Type 1
diabetes

-- Ongoing preparations for the next step clinical development of ZP4207 as a
single-dose rescue-pen for severe hypoglycemia are progressing according to
plan

9 September 2015 - Zealand announces that results from a clinical Phase Ib
trial with its novel glucagon analogue, ZP4207 show good safety and
tolerability after multiple dosing. In addition, it was shown that ZP4207 leads
to clinically relevant increases in blood glucose levels.

ZP4207, which was invented and is wholly-owned by Zealand, has shown a good
stability profile in liquid formulation, supporting its potential as a product
immediately ready for use.

The randomized, double-blind and placebo-controlled Phase Ib trial was
conducted by Zealand at a clinical diabetes center in Germany and enrolled 24
healthy volunteers. The trial objectives were primarily to evaluate safety and
tolerability and secondarily to assess pharmacokinetics and pharmacodynamics of
ZP4207 after multiple dosing. Participants in the trial received three
different doses of ZP4207, each over 5 consecutive days. The trial was funded
under a USD 1.8 million grant from the Helmsley Charitable Trust to support
preclinical and initial clinical activities related to the multiple-dose
version of ZP4207.

Commenting on the positive outcome of the Phase Ib trial, Britt Meelby Jensen,
President and CEO of Zealand, said: “We are encouraged by the results obtained
for our stable glucagon analogue, ZP4207 after repeated dosing. We are
currently advancing preparations to take a single-dose version of the product
forward in clinical development as a ready-to-use rescue pen for the treatment
of severe hypoglycemia. These latest results support also the further potential
of ZP4207 in a multiple-dose version to correct mild to moderate hypoglycemia –
e.g. as a mini-dose pen or in a dual-hormone artificial pancreas device. We
believe ZP4207 could be an important advance in the treatment of patients with
Type 1 diabetes, and the product is an important part of our growing
proprietary pipeline of novel medicines. We look forward to sharing further
news as we progress its development.”

Results from a Phase I trial with a single-dose version of ZP4207 were
announced in June this year, showing good safety and tolerability after
single-dosing in both healthy volunteers and Type 1 diabetes patients. Further,
effects were shown in raising blood glucose levels in Type 1 diabetes patients
after an insulin-induced hypoglycemic event.

Zealand is progressing preparations towards a next clinical trial with ZP4207
as a single-dose ready-to-use rescue pen to treat severe hypoglycemia events.
Based on the results from the repeat dosing Phase Ib trial, Zealand will
evaluate additional options for further development of a multiple-dose version
of ZP4207.

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For further information, please contact:

Britt Meelby Jensen, President and Chief Executive Officer

Tel: +45 51 67 61 28, email: bmj@zealandpharma.com

Hanne Leth Hillman, Senior Vice President for Investor Relations and
Communications

Tel: +45 50 60 36 89, email: hlh@zealandpharma.com

About Zealand Pharma

Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) (“Zealand”) is a biotechnology
company with leading expertise in the identification, design and development of
novel peptide medicines. Zealand has a proprietary pipeline of novel drug
candidates and a portfolio of products and projects under license
collaborations with Sanofi, Helsinn Healthcare and Boehringer Ingelheim –
primarily in the fields of cardio-metabolic diseases and acute care
indications.

The proprietary pipeline includes danegaptide for ischemic reperfusion Injuries
in Phase II development and the stable glucagon analogue, ZP4207 in two
clinical development programs; as a single-dose rescue pen for severe
hypoglycemia and as a multiple-dose version for the correction of mild to
moderate hypoglycemia, in preparation and evaluation, respectively for next
clinical phase after Phase I trials, as well as several preclinical peptide
therapeutics.

Zealand has invented lixisenatide, a once-daily prandial GLP-1 agonist, which
is marketed globally (ex-US) by Sanofi for the treatment of Type 2 diabetes.
Sanofi submitted lixisenatide for regulatory approval in the US in late July
2015, and has a combination of lixisenatide with insulin glargine (Lantus®) in
Phase III development with regulatory submissions expected in Q4 2015 in the US
and in Q1 2016 in Europe.

The company is based in Copenhagen (Glostrup), Denmark. For further information
about Zealand’s business and activities, please visit: www.zealandpharma.com