Zealand Pharma

Regulatory Filings • Sep 17, 2015

-- Short Bowel Syndrome (SBS) is a gastro-intestinal specialist care
indication and a medical area of high unmet medical needs
-- GLP-2 based therapy has demonstrated clinical benefits in patients with
SBS, and ZP1848 has a unique stability profile in liquid formulation with
potential for convenient administration
-- Enrolment of the first patients into a Proof-of-Concept trial is planned
for Q1 2016
-- The start of Phase II development of ZP1848 for SBS is an important step in
line with Zealand’s strategic focus on increasing the value of the
proprietary pipeline
-- The ZP1848 program in SBS will be presented at Capital Markets Days in New
York and Copenhagen in November 2015

Copenhagen, 17 September 2015 - Zealand announces the initiation of a clinical
Phase II development program for its proprietary peptide therapeutic, ZP1848,
for the treatment of Short Bowel Syndrome (SBS). ZP1848 is a long-acting,
stable and soluble GLP-2 receptor agonist invented and wholly owned by Zealand.

Professor, MD, Ph.D and lead study investigator, Palle Bekker Jeppesen, the
Department of Medical Gastroenterology, University Hospital of Copenhagen,
commented:

“Short Bowel Syndrome is a very serious condition affecting a growing number of
patients who have had larger parts of their intestines removed. Patients with
Short Bowel Syndrome have reduced ability to absorb nutrients and to maintain
adequate fluid and electrolyte balance, which makes many of them dependent on
regular access to parenteral (intravenous) nutritional support through a
central catheter. This is associated with shortened life span, potentially
life-threatening complications including sepsis, blood clots, liver or renal
damage, and severely reduced quality-of-life. GLP-2 based therapy has
demonstrated the ability to improve intestinal absorption with the potential to
reduce the need for parenteral support and offer patients relief and
flexibility. ”

In preclinical studies, ZP1848 has shown efficacy on small intestine growth and
demonstrated the physico-chemical properties of a long-acting, stable and
soluble peptide therapeutic with the potential for convenient administration in
liquid formulation. Zealand has also investigated ZP1848 in a combined single
(SAD) and multiple (MAD) ascending dose Phase I trial. Results from this trial
demonstrated that ZP1848 is safe and well tolerated with a supportive effect on
bowel function. The attractive potential identified for ZP1848 in Short Bowel
Syndrome and the opportunity for Zealand to initiate a clinical Phase II
development program in this specialist care indication is an important step in
line with the company's strategic focus on increasing the value of its
proprietary pipeline.

Commenting on the advance of ZP1848 into Phase II development, Britt Meelby
Jensen, President and Chief Executive Officer of Zealand said:

“We have for some time been aware of the attractive opportunity for ZP1848 in
SBS, and we are very pleased to be in a position to advance the product into
Phase II development. It is our belief that this Zealand invented peptide
therapeutic has high potential to help patients with SBS better manage their
disease with fewer side effects. That we now advance ZP1848 into clinical Phase
II Proof-of-Concept is an important step in the expansion of our pipeline of
proprietary peptide medicines in alignment with our value growth strategy.”

The Phase II Proof-of-Concept trial is planned as a randomized, double-blind,
dose-finding trial to investigate the clinical efficacy and safety of ZP1848 in
patients with SBS. The primary objective of the trial will be to assess
intestinal absorption. The first patients are planned to be enrolled and dosed
in Q1 2016.

                                  ?????

Capital Market Days in New York and Copenhagen in November 2015

Zealand will host Capital Market Days in November in New York (Tuesday 3
November) and at the company’s address in Glostrup, Copenhagen later in
November (date TBC). At these events, in addition to other pipeline updates,
the new clinical program for ZP1848 in SBS will be presented. Final invitations
with full agendas and speaker names are expected to be issued before the end of
September.

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 &
Communications

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

About Short Bowel Syndrome

Short Bowel Syndrome (SBS) is a complex chronic disease characterized by severe
or complete loss of bowel function. SBS can result from either physical removal
of portions of the small intestine and colon or from loss of function as a
result of bowel damage. The primary underlying causes of SBS are Crohn’s
disease, ischemia, radiation and colon cancer.

Patients with SBS have reduced intestinal absorption and ability to maintain
protein-energy, fluid, electrolyte, or micronutrient balances when on a
conventionally accepted, normal diet. Many are therefore dependent on constant
parenteral (intravenous) supplements in the form of fluids, salts and nutrition
to maintain body homeostasis. Before the 1970s, this group of patients often
died because of dehydration and malnutrition. Today, the implementation of
parenteral support, including the possibility of home administration, via a
catheter placed in a central vein close to the heart, has increased survival
and life expectancy for patients with SBS, resulting in high prevalence growth.
There are estimated 10-20,000 SBS patients in the US and a similar number in
the EU

Patients dependent on regular parenteral support experience a number of
serious and life-threatening complications associated with their disease and
treatment including shortened life span, high risk of sepsis, blood clots or
liver damage, and reduced quality-of-life due to the time required for and
consequences of frequent access to an intravenous pump.

Teduglutide (Gattex®/ Revestive®), a GLP-2 receptor agonist, was approved in
2012 and launched in 2014 in both the US and Europe as the first medicine
indicated for the treatment of SBS. .

About Zealand Pharma

Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) (“Zealand”) is a medicinal biotech
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, ZP1848 for Short Bowel Syndrome in Phase II
development and the stable glucagon analogue, ZP4207 as a single-dose rescue
pen for severe hypoglycemia in preparation for Phase II, and ZP4207 as
multiple-dose use for the correction of mild to moderate hypoglycemia in
evaluation for the next clinical development step after Phase I, 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®)
which is on track for regulatory submission in the US in Q4 2015 and in Europe
in Q1 2016.

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