Zealand Pharma

Earnings Release • Mar 19, 2015

The results support re-submission by Sanofi for regulatory approval of
lixisenatide in the US in Q3 2015

Copenhagen, 2015-03-19 07:09 CET (GLOBE NEWSWIRE) -- 19 March 2015 – Zealand
Pharma (Nasdaq Copenhagen: ZEAL) (“Zealand”) informs that Sanofi today has
announced top-line results of the ELIXA study. ELIXA is the Phase IIIb
cardio-vascular safety outcomes trial, which compared lixisenatide (Lyxumia®)
to placebo in a high-risk population of adults with Type 2 diabetes for the
evaluation of cardiovascular safety.

The results from the study, which enrolled more than 6,000 patients, showed
that lixisenatide was non-inferior, although not superior, to placebo for
cardiovascular safety.

Lixisenatide is a once-daily prandial GLP-1 receptor agonist, invented by
Zealand and developed and marketed worldwide ex-US by Sanofi. Lixisenatide is
not approved in the US.

The full results of ELIXA will be presented Monday, June 8, 2015, at the
American Diabetes Association (ADA) 75th Scientific Sessions in Boston by the
ELIXA steering committee, chaired by Dr. Marc Pfeffer. The results will also be
included in the U.S. New Drug Application (NDA) of lixisenatide, which Sanofi
announced to be on track for re-submission to the U.S. Food and Drug
Administration in Q3 2015.

In a comment to this announcement, Britt Meelby Jensen, President and CEO of
Zealand, said:

“We are extremely pleased about the top-line results from the ELIXA study,
demonstrating there is no additional cardiovascular risk related to treatment
with lixisenatide in a high-risk patient population. We see the results
providing further support for the therapeutic benefits of Lyxumia® as a novel
prandial GLP-1 agonist and very importantly, the route is now clear for
regulatory re-submission of the product in the US by Sanofi in Q3 this year.”

                                  ?????

For further information, please contact:

Britt Meelby Jensen, President and Chief Executive Officer

Tel: +45 5167 6128, email: bmj@zealandpharma.com

Hanne Leth Hillman, Vice President and Head of IR & Corporate Communications

Tel: +45 5060 3689, email: hlh@zealandpharma.com

About ELIXA

ELIXA (Evaluation of cardiovascular outcomes in patients with Type 2 diabetes
after acute coronary syndrome during treatment with lixisenatide) is the first
event-driven cardiovascular outcomes study to provide data for a glucagon-like
peptide-1 receptor agonist (GLP-1 RA). ELIXA was a randomized, double-blind,
parallel group trial designed to evaluate cardiovascular risk, comparing
lixisenatide to placebo in a high-risk population of adults with type 2
diabetes. More than 6,000 adults with type 2 diabetes and high CV risk (i.e.,
patients who have recently experienced a spontaneous acute coronary syndrome
event) participated in the trial. The composite primary endpoint, which was
evaluated for non-inferiority and superiority, comprised cardiovascular (CV)
death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization
for unstable angina. The global ELIXA study started in June 2010 and was
completed in 2015.

About Zealand Pharma

Zealand Pharma A/S (“Zealand”) (Nasdaq Copenhagen: ZEAL) is a biotechnology
company based in Copenhagen, Denmark. Zealand has leading expertise in the
discovery, design and development of novel peptide medicines and possesses
in-house competences in clinical trial design and management with a therapeutic
focus on metabolic diseases and acute care indications. The company is
advancing a proprietary pipeline of novel medicines alongside a partnered
product and development portfolio.

Zealand’s first invented medicine, lixisenatide, a once-daily prandial GLP-1
agonist for the treatment of Type 2 diabetes, is marketed globally (ex-US) as
Lyxumia® and in Phase III development as a single-injection combination with
Lantus® (LixiLan), both under a global license agreement with Sanofi. US
regulatory submission of Lyxumia® is planned for Q3 2015 and US/EU regulatory
submissions for LixiLan in Q4 2015.

Zealand proprietary pipeline includes danegaptide (prevention of Ischemic
Reperfusion Injury) and the stable glucagon product, ZP4207 (treatment of
severe hypoglycemia) as well as several preclinical peptide therapeutics.
Partnering represents an important component of strategy to leverage in-house
expertise, share development risk in large clinical trials, provide funding and
commercialize the company’s products. Zealand currently has global license
agreements and partnerships with Sanofi, Helsinn Healthcare, Boehringer
Ingelheim and Eli Lilly.

For further information: www.zealandpharma.com Follow us on Twitter
@ZealandPharma