Zealand Pharma

Regulatory Filings • May 23, 2016

-- The briefing documents posted on FDA’s website include results from the two
Phase III trials with the lixisenatide/Lantus® combination, not previously
published
-- US regulatory decisions on lixisenatide and the lixisenatide/Lantus®
combination are expected in July and August 2016, respectively

Copenhagen, 23 May 2016 – Zealand announces that the US Food and Drug
Administration (FDA) today has made briefing documents on lixisenatide and the
lixisenatide/Lantus® combination available on its website. The documents relate
to the upcoming meeting of the Endocrinologic and Metabolic Drugs Advisory
Committee, scheduled by the FDA for 8:00 am to 5:00 pm ET on 25 May 2016 to
discuss the New Drug Applications (NDAs) for the two drug products intended for
the treatment of adults with Type 2 diabetes. The NDAs were submitted by
Sanofi.

The briefing documents contain the key points for discussion at the Advisory
Committee meeting and background information on lixisenatide and the
lixisenatide/Lantus® combination. This include the results from Sanofi’s two
clinical Phase III trials with the lixisenatide/Lantus® combination, LixiLan-L
and LixiLan-O, which have not previously been published. The briefing documents
can be accessed under the following link:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Endocrino
logicandMetabolicDrugsAdvisoryCommittee/ucm491062.htm

Lixisenatide is a once-daily GLP-1 receptor agonist, invented by Zealand and
with global development and commercial rights licensed to Sanofi. The
lixisenatide/Lantus® combination is a fixed-ratio combination of lixisenatide
and basal insulin glargine (100 U/mL), developed by Sanofi under the license
agreement with Zealand.

Sanofi submitted the US NDA on lixisenatide in July 2015 and it was accepted by
the FDA for regulatory review in September 2015. A regulatory decision on
lixisenatide is expected in July 2016. In December 2015, Sanofi submitted the
US NDA on the lixisenatide/Lantus® combination product, redeeming a Priority
Review Voucher with the submission. In February the FDA accepted the NDA for
priority review with a regulatory decision expected in August 2016.