Zealand Pharma

Regulatory Filings • Dec 23, 2015

-- The regulatory submission is an important step towards potentially making
LixiLan available as a new treatment option for adult Type 2 diabetes
patients in the US
-- Sanofi has redeemed a Priority Review Voucher for LixiLan, which will
shorten the regulatory review time from 10 months to 6 months, if the FDA
accepts the submission
-- Including the USD 20 million payment from Sanofi, milestone revenue to
Zealand in 2015 amounts to EUR 21 million, in accordance with the financial
guidance
-- All pipeline development milestones outlined by Zealand for achievement in
2015, have now been successfully met

Copenhagen, 23 December 2015 – Zealand announced that today, Sanofi confirmed
that it has submitted a New Drug Application (NDA) for LixiLan to the US Food
and Drug Administration (FDA).

LixiLan is an investigational single-injection, fixed-ratio combination of
lixisenatide and insulin glargine for the treatment of Type 2 diabetes. Insulin
glargine, marketed globally by Sanofi as Lantus®, is the world-wide most
prescribed basal insulin product for the treatment of diabetes. Lixisenatide is
a once-daily prandial GLP-1 receptor agonist, invented by Zealand and with
global development and commercial rights out-licensed to Sanofi. Lixisenatide
is marketed outside the US by Sanofi as Lyxumia® for the treatment of Type 2
diabetes. In the US, the FDA accepted Sanofi’s NDA for lixisenatide in
September 2015 with a regulatory decision expected in Q3 2016 in accordance
with the standard FDA review time.

As part of the US submission of LixiLan, Sanofi has redeemed a Priority Review
Voucher. This means that if the FDA accepts the NDA, the regulatory review time
for the product will be shortened to 6 months from the standard 10 months. A
regulatory submission of LixiLan in Europe is expected by Sanofi in Q1 2016.

Commenting on the submission of LixiLan in the US, Britt Meelby Jensen,
President and CEO of Zealand, said: “This milestone represents an important
step towards potentially introducing LixiLan as a promising new combination
medicine for Type 2 diabetes patients in the US. Sanofi’s decision to redeem a
Priority Review Voucher on LixiLan is a sign to us on how valuable they
consider the product to be. For Zealand, today’s news brings us closer to a
potential significant revenue growth based on US royalties.

“I am pleased to confirm that all the pipeline and business milestones we set
out to achieve in 2015, have now been successfully met, and the USD 20 million
milestone payment from Sanofi strengthens our financial position as we move
into 2016. We will continue to focus on advancing our pipeline of novel
proprietary medicines to accelerate value creation for patients and our
shareholders, and we foresee another year with a strong activity level and
substantial news flow.”

The US NDA submitted for the LixiLan combination includes results from two
pivotal Phase III trials; LixiLan-L and LixiLan-O, which included 1,906
patients with Type 2 diabetes. Positive top-line results from the two trials
demonstrate that LixiLan significantly lowers three-month average blood sugar
levels (HbA1c) compared to both insulin glargine and lixisenatide. The
proprietary name for the fixed-ratio combination is under consideration. Its
safety and efficacy have not been evaluated by any regulatory authority.

Financial guidance for 2015 and terms of the license agreement with Sanofi

The submission of a US NDA for LixiLan is associated with a USD 20 million (EUR
18 million) milestone payment from Sanofi to Zealand. With this payment,
Zealand has realized milestone revenue from license partners of DKK 159 million
(EUR 21 million) in 2015, in line with its revenue guidance. On top of
milestone payments, Zealand receives royalty revenue on Sanofi’s sales of
Lyxumia® outside the US which amounted to DKK 20.6 million (EUR 2.7 million)
for the first nine months of 2015.

2015 full year net operating expenses are expected to be in the high end of a
range of DKK 225-235 million (EUR 30-32 million).

The global license agreement with Sanofi covers lixisenatide (Lyxumia®) and any
combination products, which include lixisenatide. Under the terms of the
agreement, Sanofi is responsible for all development and commercialization
including the financing, and Zealand is eligible to receive progress-driven
milestone payments and royalties on global sales. Remaining milestone payments
amount to USD 140 million, while royalties correspond to tiered, low
double-digit percentages of Sanofi's global sales of lixisenatide plus a fixed
low double-digit percentage of the global full net sales of LixiLan.

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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, Investor Relations and Communications
Tel: +45 50 60 36 89, email: hlh@zealandpharma.com

About Zealand Pharma

Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) (“Zealand”) is a biotech company
with leading-edge scientific expertise in turning peptides into medicines.
Zealand has a growing proprietary pipeline of novel specialty drug candidates
and a mature portfolio of products and projects under license collaborations
with Sanofi, Helsinn Healthcare and Boehringer Ingelheim.

Zealand’s first invented medicine, lixisenatide, a once-daily prandial GLP-1
analogue for the treatment of Type 2 diabetes, is marketed globally (ex-US) as
Lyxumia® by Sanofi and under regulatory review in the US. The license agreement
with Sanofi covers also LixiLan, which is a single-product combination of
lixisenatide and insulin glargine (Lantus®). LixiLan has been submitted for
regulatory review in the US and regulatory submission is expected in the EU in
Q1 2016.

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, in Phase II preparation
both as a single-dose rescue pen for severe hypoglycemia and for multiple-dose
use to treat and control mild to moderate hypoglycemia; ZP2929 for
diabetes/obesity in Phase I; as well as several preclinical peptide
therapeutics.

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