Zealand Pharma

Regulatory Filings • Sep 30, 2014

Copenhagen, 2014-09-30 13:00 CEST (GLOBE NEWSWIRE) --
-- Time-based milestone payment of EUR 2 (DKK 15) million to be received in
accordance with Zealand’s financial guidance for 2014
-- Patient dosing in Phase IIb study of elsiglutide for the prevention of
chemotherapy-induced diarrhea to start at the end of 2014
-- Ongoing clinical observational study expected to provide useful information
on the incidence of chemotherapy-induced diarrhea

Copenhagen, 30 September 2014 – Zealand Pharma A/S (Zealand) (NASDAQ OMX
Copenhagen: ZEAL) reports a time-based milestone payment of EUR 2 (DKK 15)
million from its partner Helsinn. The payment relates to the license agreement
between Zealand and Helsinn on elsiglutide as a potential first-in-class
therapy to prevent chemotherapy-induced diarrhea in cancer patients.

Elsiglutide is a novel GLP-2 peptide receptor agonist, invented by Zealand and
licensed globally to Helsinn for its therapeutic use in Cancer Supportive Care.
Helsinn has evaluated elsiglutide in a Phase IIa trial with supportive results
for its effect and safety in the prevention of diarrhea in colorectal cancer
patients receiving chemotherapy. Based on these results, Helsinn is now in
final preparations for a larger Phase IIb dose-finding trial with planned start
of patient dosing at the end of 2014.

As part of the elsiglutide development program, Helsinn has also undertaken a
large international, multi-center, prospective, cohort observational study in
the US and in Europe, to assess the incidence of chemotherapy-induced diarrhea
in colorectal and breast cancer patients.

In a comment to the outlook for elsiglutide and the receipt of the milestone
payment from Helsinn, David H. Solomon, President and CEO of Zealand, said:
“Elsiglutide is a very exciting product in our partnered portfolio, and we are
very pleased about Helsinn’s strong commitment to the program and the planned
start of patient dosing in Phase IIb within the coming months. We believe
elsiglutide has the potential to greatly improve the quality of life for cancer
patients receiving chemotherapy – and with additional upside potential if this
peptide treatment can reduce diarrhea as a serious side effect of chemotherapy
to an extent where it may have a beneficial secondary effect in the form of a
more optimal cancer treatment.”

Financial Guidance for 2014

For the full year 2014, Zealand expects revenue from milestone payments and
from Lyxumia® sales royalties.

With the DKK 15 (EUR 2) million payment from Helsinn, the expected total
milestone revenue amounts to DKK 133 (EUR 18) for the year in accordance with
previous financial guidance. The Helsinn payment has been booked as revenue in
the 3rd quarter for receipt of the cash in the 4th quarter 2014.

Royalty revenue on Lyxumia® amounted to DKK 8.1 (EUR 1.1) million in the 1st
half of 2014. No guidance on 2014 royalty revenue can be provided, as Sanofi
has given no guidance on sales.

Net operating expenses for 2014 are expected at DKK 195-205 (EUR 25-28) million.

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For further information, please contact:

David Solomon, President and Chief Executive Officer
Tel: +45 22 20 63 00

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

About Zealand

Zealand Pharma A/S (“Zealand”) (NASDAQ OMX 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 a mature
portfolio of therapeutic products, both proprietary and partnered. The
company’s focus lies in the field of cardio-metabolic diseases, diabetes and
obesity in particular, and it has its first product, lixisenatide, a once-daily
prandial GLP-1 agonist for the treatment of Type 2 diabetes, marketed as
Lyxumia® under a license agreement with Sanofi. Lyxumia® is approved in several
countries globally, including Europe and Japan. In the US, submission of an NDA
is expected in 2015, after completion of a cardiovascular outcome study, ELIXA.
A once-daily single injection combination of Lyxumia® and Lantus® (LixiLan) is
in Phase III development by Sanofi with planned first regulatory filing as
early as at the end of 2015.

Zealand has a partnering strategy to leverage its activities and competences,
while ensuring funding and sharing risk. In addition to the license agreement
with Sanofi in Type 2 diabetes, the company has two collaborations with
Boehringer Ingelheim in diabetes/obesity and cardio-metabolic diseases, one
with Lilly in diabetes and obesity, and one with Helsinn Healthcare in
chemotherapy induced diarrhea.

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