Zealand Pharma

Legal Proceedings Report • May 28, 2013

? The decision follows promising findings from a Phase IIa Proof-of-Concept
study
? Helsinn is planning a Phase IIb study with elsiglutide, and study activities
are expected to start in H2 2013

Copenhagen, Denmark and Lugano, Switzerland, 2013-05-28 11:16 CEST (GLOBE
NEWSWIRE) -- Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) and
its partner, the Swiss pharmaceutical group Helsinn, a leading player in the
cancer supportive care area, jointly announce that Helsinn has concluded a
Phase IIa study with elsiglutide for the prevention of chemotherapy-induced
diarrhea in cancer patients, with positive results. Elsiglutide is a potent and
selective glucagon-like-peptide-2 (GLP-2) receptor agonist invented by Zealand
and licensed to Helsinn for the development and use in cancer supportive care.

In a randomized, double-blind, placebo-controlled Proof-of-Concept Phase IIa
clinical study, Helsinn has assessed the efficacy and safety of elsiglutide for
the prevention of chemotherapy-induced diarrhea. The study was conducted under
an open Initial New Drug (IND) application with the U.S. Food and Drug Agency
in 19 European centers and enrolled 138 colorectal cancer patients. The
patients were treated with 5-fluorouracil (5-FU) based chemotherapy
(ClinicalTrials.gov Identifier: NCT01543451). Concurrently, Helsinn has
completed a Phase Ib study, showing that elsiglutide is safe and tolerated at
doses well above expectable therapeutic level.

Based on the results from the proof-of-concept study, Helsinn is now planning a
Phase IIb study to further evaluate the efficacy of elsiglutide as a novel
therapy to prevent chemotherapy induced diarrhea in cancer patients.

In a comment to the news, David Solomon, President and Chief Executive Officer
of Zealand, said: “We are highly encouraged by the important progress our
partner Helsinn is making with elsiglutide. Helsinn has a strong position in
Cancer Supportive Care, and the promising findings from the Proof-of-Concept
study leave further support for the potential of this Zealand invented peptide
drug candidate as a novel preventative therapy that may offer cancer patients
relief from chemotherapy induced diarrhea. Diarrhea is a common and in many
cases severe complication of chemotherapy, resulting in reduced quality of
life, dehydration, hospitalization and in some cases non-optimal cancer
treatment. We look forward to seeing elsiglutide be advanced to the next step
in its development.”

Riccardo Braglia, Chief Executive Officer of Helsinn Group, commented: “We are
pleased of the promising advance of elsiglutide in an underserved medical area.
The overall positive outcome of this Phase IIa clinical study is an important
milestone in the development of an effective treatment for chemotherapy-induced
diarrhea, a debilitating and potentially life threatening side effect of
chemotherapy. This is another step forward in Helsinn’s commitment to working
not only to improve the health of the Patient but to improve and maintain the
overall quality of life of the Person.”

Terms of the agreement with Helsinn and Financial outlook for 2013

Under the agreement with Helsinn, Zealand is eligible to milestone payments of
up to EUR 140 million in total, (of which EUR 14 million have been received) on
elsiglutide plus royalties on global sales of the product. Zealand retains an
option to obtain commercial rights to elsiglutide in the Nordic countries.

The promising results of Phase IIa and Helsinn’s decision to advance
elsiglutide into Phase IIb development are not associated with a milestone
payment and thus do not change Zealand’s financial outlook for 2013 as
announced in the company’s Q1 2013 Interim report on 15 May 2013.

                                  ***

For further information, please contact:

Zealand

David Solomon, President and Chief Executive Officer, Tel: +45 2220 6300

Hanne Leth Hillman, Vice President for Investor Relations & Corporate
Communications

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

Helsinn Healthcare SA

Paola Bonvicini, Head of Communication & Press Office

Tel: +41 9 1985 2121

info-hhc@helsinn.com

About Elsiglutide

Elsiglutide is a novel, potent and selective glucagon-like-peptide-2 (GLP-2)
agonist. GLP-2 is a peptide hormone produced primarily by the small intestine.
It is secreted in response to food ingestion and acts by binding to the GLP-2
receptor, which is predominantly found in the gastrointestinal tract. GLP-2
plays a key role in intestinal growth and formation by promoting regeneration
of the epithelial surface in this indication damaged by chemotherapy, the
underlying cause of chemotherapy-induced diarrhea.

About Chemotherapy Induced Diarrhea

Diarrhea is one of the most common side effects of cancer treatment, resulting
in significantly reduced patient’s quality of life and can have a profound
effect on patient’s compliance with chemotherapy regimens and schedules leading
even, in the most severe cases, to discontinuation of therapy and death.

The incidence and severity of Chemotherapy Induced Diarrhea (CID) varies
considerably with the nature and dose of the cytotoxic therapy, with regimens
containing Irinotecan and 5-fluorouracil (5-FU) being associated with rates as
high as 80%. Current pharmacologic treatments are palliative at best and help
to control and treat symptoms rather than to prevent the onset of diarrhea.

About Helsinn Group

Helsinn is a privately owned pharmaceutical group with headquarters in Lugano,
Switzerland, operating subsidiaries in Ireland, the United States and a
representative office in China. Helsinn’s business model is focused on the
licensing of pharmaceuticals, medical devices and nutritional supplement
products in therapeutic niche areas. Helsinn is an important player in cancer
supportive care. Helsinn Group in-licenses early-to-late stage new chemical
entities, completes their development through the performance of
pre-clinical/clinical studies and Chemistry, Manufacturing, and Control (CMC)
development, and files and attains their market approvals worldwide. Helsinn’s
products are out-licensed to its network of local marketing and commercial
partners, selected for their deep in-market knowledge and know-how whom Helsinn
assists and supports by providing a full range of product and scientific
management services, including commercial, regulatory, financial, legal, and
medical marketing advice. The active pharmaceutical ingredients and the
finished products are manufactured according to the highest quality, safety,
and environmental standards at Helsinn’s GMP facilities in Switzerland and
Ireland and supplied worldwide to its customers.

Further information on Helsinn Group is available at www.helsinn.com

About Zealand

Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) is a biotechnology
company based in Copenhagen, Denmark. Zealand specializes in the discovery,
optimization and development of novel peptide drugs and has a broad and mature
pipeline of drug candidates identified through its own drug discovery
activities. The company’s focus lies in the field of diabetes/metabolic
diseases, and its lead drug invention is lixisenatide, a once-daily GLP-1
agonist, which is licensed to Sanofi for the treatment of Type 2 diabetes.
Lixisenatide is approved and launched (March 2013) in Europe under the name of
Lyxumia®, and under regulatory review in a large number of other countries
globally, including in the US (NDA filed in Dec 2012) and Japan (NDA filed in
June 2012).

Zealand has a partnering strategy for the development and commercialization of
its products and in addition to the collaboration with Sanofi in Type 2
diabetes, the company has partnerships with Boehringer Ingelheim in
diabetes/obesity, Helsinn Healthcare in chemotherapy induced diarrhea and
AbbVie in acute kidney injury. For further information: www.zealandpharma.com.

Zealand can also be followed on Twitter: @ZealandPharma