Zealand Pharma

Regulatory Filings • Feb 5, 2015

Copenhagen, 2015-02-05 12:00 CET (GLOBE NEWSWIRE) --
-- Elsiglutide is a GLP-2 receptor agonist with potential as a first-ever
therapy to help cancer patients avoid a serious and life-threatening
condition
-- The first patients have been treated in this Phase IIB dose-finding trial
and study results are expected in H1 2016

Copenhagen, Denmark and Lugano,Switzerland – 5 February 2015 – Zealand Pharma
A/S (“Zealand”) (Nasdaq Copenhagen: ZEAL) and Helsinn Healthcare S.A.
(“Helsinn”) jointly announce that Helsinn has started a Phase IIB clinical
dose-finding trial of elsiglutide for the prevention of chemotherapy-induced
diarrhea (CID). The first patients out of a planned total of 600 patients with
colorectal cancer treated with chemotherapy have been dosed in the trial.

Elsiglutide is a novel GLP-2 peptide receptor agonist invented by Zealand.
Global development and commercial rights to elsiglutide for its use in cancer
supportive care outside the Nordic countries are licensed to Helsinn.

Many cancer patients who receive chemotherapy, in particular 5-fluorouracil
(5-FU)-based regimens such as FOLFOX and FOLFIRI, suffer from severe diarrhea
induced by damage to their intestines caused by the chemotherapy. The condition
can lead to dehydration, hospitalization, sub-optimal cancer treatment and
markedly reduced quality-of-life for the patients. 5-FU based chemotherapy
regimens are used in particular to treat colorectal, head and neck as well as
breast cancers.

In Phase I and Phase IIA clinical trials, elsiglutide demonstrated favorable
results in the prevention of diarrhea in colorectal cancer patients receiving
chemotherapy and a good safety profile. In pre-clinical studies, elsiglutide
has been shown to consistently stimulate growth of the small intestinal mucosa
and decrease the incidence and severity of CID, in addition to improving bowel
function, which supports its potential use in the treatment of
gastro-intestinal disorders. Currently, no effective treatment exists for CID.

Britt Meelby Jensen, President and Chief Executive Officer of Zealand,
commented: "The advance of elsiglutide into Phase IIB development is an
important milestone for Zealand, as it adds further to the progress and
potential in our portfolio of proprietary and partnered novel therapeutics.
Helsinn has a world leading position in cancer supportive care and, if the
beneficial effects seen with elsiglutide can be confirmed, it opens important
new treatment options for cancer patients of not only relieving a serious
side-effect but also providing a possible basis for a more effective cancer
treatment.”

Riccardo Braglia, Chief Executive Officer of Helsinn, said:
“Chemotherapy-induced diarrhea is a debilitating side-effect of chemotherapy
which significantly impacts on the ability of patients to benefit from cancer
treatment regimens. It is a significant area of unmet need in the treatment of
cancer. Helsinn is committed to supporting patients with the highest-quality
cancer supportive care treatments, and elsiglutide has shown strong promise in
preclinical and early clinical studies. We are excited to be advancing this
product into the next phase of its development.”

Elsiglutide Phase IIB design and other development activities

The Phase IIB trial with elsiglutide is a randomized, double-blind, parallel
group, placebo-controlled, dose finding study, which is planned to enroll up to
600 colorectal cancer patients receiving 5-FU-based chemotherapy regimens
(FOLFOX or FOLFIRI). The trial includes a subgroup of 120 patients who will be
treated also with an approved monoclonal antibody. The study objective is to
assess the efficacy of three different doses of subcutaneous elsiglutide versus
placebo in the prevention of CID. The primary endpoint is the proportion of
patients experiencing diarrhea of grade 2 or more during the first cycle of
5-FU based chemotherapy. The results of the Phase IIB trial are expected to be
available in the first half of 2016.

Helsinn is also conducting a large international, multi-center, prospective,
cohort observational study involving more than a hundred sites in six European
countries and in the United States to better understand the incidence and
clinical impact of chemotherapy-induced diarrhea in colorectal and breast
cancer patients.

Results from the Phase IIB trial together with the outcomes of the
observational study will help shape the design of a potential Phase III pivotal
development program for elsiglutide.

Terms of the Helsinn agreement and financial outlook

Under the agreement between Zealand and Helsinn, Helsinn is responsible for the
conduct and the financing of all clinical development and commercialization of
elsiglutide. Zealand is eligible to receive milestone payments of up to EUR 140
million (of which EUR 16 million have been received to date) and high
single-digit royalties on global sales of elsiglutide. Zealand also retains an
option to obtain commercial rights to elsiglutide in the Nordic countries.

There is no milestone payment associated with the advance of elsiglutide into
Phase IIB development, and this event therefore has no financial impact for
Zealand. Zealand will present its financial guidance for 2015 on 13 March 2015
in connection with the release of its Full Year Announcement and Annual Report
for 2014.

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For further information, please contact:

Zealand Pharma

Britt Meelby Jensen, President and Chief Executive Officer
Tel: +45 51 67 61 28, email: bmj@zealandpharma.com

Hanne Leth Hillman, Vice President, Head of Investor Relations & Corporate
Communications
Tel: +45 50 60 36 89, email: hlh@zealandpharma.com

Helsinn Group

Paola Bonvicini, Head of Communication & Press Office
Tel: +41 91-985-21-21, email: info-hhc@helsinn.com

About the Helsinn Group

Helsinn is a family run, privately owned pharmaceutical group focused on
building quality cancer care with a large portfolio of products. Founded in
1976 with headquarters in Lugano, Switzerland, Helsinn also has 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 the therapeutic area of
cancer care.

Helsinn Group in?licenses early?to?late stage new chemical entities, completing
their development by performing preclinical and clinical studies and associated
manufacturing activities. Helsinn then prepares necessary regulatory filings in
order to achieve marketing approvals worldwide. Helsinn's products are
out?licensed to its global network of marketing and commercial partners that
have been selected for their local market knowledge. Helsinn supports these
partners by providing a full range of product and scientific management
services, including commercial, regulatory, and medical marketing advice. In
March 2013, Helsinn established a new commercial organization within its
subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales
and marketing activities within the U.S. market. Helsinn’s products are
manufactured according to the highest quality, safety, and environmental
standards at Helsinn's GMP facilities in Switzerland and Ireland from where
they are then supplied worldwide to customers.

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

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 filing for Lyxumia® is planned for Q3 2015 and US/EU filings 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