Zealand Pharma

Regulatory Filings • Aug 20, 2016

-- The FDA had requested updated information on the pen delivery device for
iGlarLixi as part of its New Drug Application, which has been submitted by
Sanofi
-- Consequently, the FDA has extended their review time by three months
-- A regulatory decision on iGlarLixi in the U.S. is now expected at the end
of November 2016
-- Zealand’s financial guidance for 2016 remains unchanged

Copenhagen, 20 August 2016 – Zealand Pharma (Zealand) announced today that
Sanofi has submitted updated information on the pen delivery device for
iGlarLixi to the U.S. Food and Drug Administration (FDA) as part of the New
Drug Application (NDA) for the product. IGlarLixi is a once-daily, fixed-ratio
combination of lixisenatide (Adlyxin(TM)) and insulin glargine 100 Units/mL
(Lantus®) for the treatment of adults with type 2 diabetes. The submission of
the additional information, requested by the FDA, constitutes a Major Amendment
to the NDA, resulting in an extension of the Prescription Drug User Fee Act
(PDUFA) goal date by three months. A U.S. regulatory decision on iGlarLixi is
now expected before the end of November 2016.

Zealand invented lixisenatide, a once-daily prandial GLP-1 receptor agonist,
for the treatment of type 2 diabetes and granted global development and
commercial rights to the product, including for use in combinations, to Sanofi.
On 27 July 2016, lixisenatide was approved by the U.S. FDA under the brand name
Adlyxin(TM) for the treatment of adults with type 2 diabetes. Lixisenatide is
approved and marketed globally by Sanofi outside the U.S. under the brand name
Lyxumia®.

Sanofi submitted the NDA for iGlarLixi to the FDA in December 2015, and on 25
May 2016, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of
the FDA recommended, by a vote of 12 to 2, its approval.

Britt Meelby Jensen, President and Chief Executive Officer of Zealand
commented: “The extension of FDA’s review time for iGlarLixi by three months to
November 2016 is related to a request for additional information on the pen
device. IGlarLixi is a combination of two already FDA approved diabetes
medicines and has in clinical trials demonstrated significant benefits for
adults with type 2 diabetes. The combination received a convincing positive
recommendation for approval by an FDA advisory committee in May, and Sanofi
believes that the additional information submitted will result in an offering
that will serve the patient needs.”

Sanofi submitted the fixed-ratio combination of lixisenatide
(Adlyxin(TM)/Lyxumia®) and basal insulin glargine 100 Units/mL (Lantus®) for
regulatory review by the European Medicines Agency (EMA) in March 2016. A
regulatory decision is expected in Q1 2017.

Financial guidance for 2016 remains unchanged

The extension of the FDA review time for Sanofi’s NDA for iGlarLixi in the U.S.
by three months does not change Zealand’s financial guidance for 2016.

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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