Zealand Pharma

Legal Proceedings Report • May 4, 2016

-- In the trial, elsiglutide reduced the incidence of chemotherapy-induced
diarrhea in colorectal cancer patients receiving 5-FU based chemotherapy
regimens, but not sufficiently to meet the primary endpoint for statistical
significance
-- Elsiglutide was observed to be safe and well tolerated in this patient
population
-- Helsinn is working on potential development options for elsiglutide to be
decided following a full evaluation of the Phase IIb data set
-- The top-line results from the elsiglutide Phase IIb trial have no effect on
Zealand’s financial guidance for 2016

Copenhagen, 4 May 2016 – Zealand announces that Helsinn has reported top-line
results from its clinical Phase IIb dose-finding trial to assess the efficacy
of elsiglutide in the prevention of diarrhea induced by chemotherapy in
patients with colorectal cancer. The results showed a positive numerical but
not statistically significant effect of elsiglutide on the primary endpoint,
defined as the proportion of patients experiencing a maximum grade ? 2 diarrhea
during the first cycle of chemotherapy. In the trial, elsiglutide demonstrated
a favorable safety and tolerability profile.

Elsiglutide is a novel GLP-2 analogue invented by Zealand. Global development
and commercialization rights to the compound are licensed to Helsinn for its
therapeutic use in the field of cancer supportive care. Results from a previous
clinical Phase IIa trial conducted by Helsinn have shown that elsiglutide
reduces the severity of chemotherapy-induced diarrhea (CID) in colorectal
cancer patients with a good safety profile. Diarrhea is one of the most
debilitating side effects associated with cancer treatment and in particular
chemotherapeutic agents containing 5-Fluorouracil (5-FU). No effective approved
treatment for chemotherapy-induced diarrhea exists today.

Britt Meelby Jensen, President and Chief Executive Officer of Zealand,
commented on the results: “Diarrhea is a significant burden for many cancer
patients receiving 5-FU based chemotherapy, and there is no effective approved
treatment available. We are impressed by Helsinn’s commitment to the clinical
development program with elsiglutide to help improve life for these patients,
and we will now wait to get full understanding of Helsinn’s intended path
forward for the program.”