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2016-11-22

Zealand Pharma: The U.S. FDA approves Soliqua(TM) 100/33 for the treatment of adults with type 2 diabetes

Company announcement - No. 46 / 2016
The U.S. FDA approves Soliqua(TM) 100/33 for the treatment of adults with type
2 diabetes

* FDA approval triggers a $25 million milestone payment and double-digit
percentage royalties of net sales of Soliqua(TM) to Zealand
* Sanofi plans to make Soliqua(TM) available in U.S. retail pharmacies in
January 2017
* Zealand management will host a teleconference on Tuesday 22 November at 4pm
CET

Copenhagen, 22 November 2016 -
Zealand Pharma (Zealand) announced today that Sanofi has received U.S. Food
and Drug Administration (FDA) approval for Soliqua(TM) 100/33 (insulin
glargline and lixisenatide injection) 100 Units/mL and 33 mcg/mL for the
treatment of adults with type 2 diabetes inadequately controlled on basal
insulin (less than 60 Units daily) or lixisenatide (AdlyxinTM).

SoliquaTM100/33 will be delivered in a single pre-filled pen for once-daily
dosing covering 15 to 60 Units of insulin glargine 100 Units/mL and 5 to 20
mcg of lixisenatide using SoloSTAR®technology, the most frequently used
disposable insulin injection pen platform in the world.[1]SoliquaTM100/33
will be available in U.S. retail pharmacies in January 2017.

Britt Meelby Jensen, President and Chief Executive Officer of Zealand
commented:
"I am
very excited about FDA's approval of Soliqua(TM). The fixed-ratio combination
of Lantus®and lixisenatide is a new drug, that has proven to outperform its
individual components.

The U.S. approval of Soliqua(TM) comes only 10 days after CHMP recommended
approval of Suliqua(TM) in the EU, making November 2016 one of the most
important months in the history of Zealand. Together
with
lixisenatide, which was approved in the U.S. in July this year under the brand
name Adlyxin(TM), we expect
substantial
revenue growth in the years to come. This gives us the financial strength to
deliver on our strategy to develop our own product candidates, glepaglutide
and dasiglucagon all the way to registration".

Elias Zerhouni, M.D., President, Global R&D, Sanofi commented:

"Sanofi continues to be a pioneer in developing diabetes therapies and in
bringing forward new treatment options for the approximately 50 percent of
patients whose blood sugar levels remain uncontrolled on daily basal insulin.
Soliqua 100/33 is an alternate new approach that can help adults living with
type 2 diabetes uncontrolled on basal insulin or lixisenatide to reach their
treatment goal.
"

SoliquaTM100/33 is the combination of Lantus®(insulin glargine 100 Units/mL)
and lixisenatide, a GLP-1 receptor agonist, in a once-daily injection,
studied in a Phase 3 program of more than 1,900 patients. In an insulin
intensification study, SoliquaTM100/33 showed better HbA1c (average blood
sugar over time) lowering versus Lantus®with a majority of the 736 patients
(55% vs. 30%) achieving the American Diabetes Association target of less than
7% at 30 weeks. Patients treated with SoliquaTM100/33 experienced similar
rates of documented (<70 mg/dL) hypoglycemia compared to Lantus®-treated
patients.

CHMP positive opinion recommending Suliqua
TM

in the EU

Earlier in November, Sanofi received a positive opinion from the Committee for
Medicinal Product for Human Use (CHMP) of the European Medicines Agency (EMA)
recommending approval of Suliqua(TM) (brand name in Europe). A formal
decision by the European Commission is expected in the coming months. Once
approved, Sanofi will make Suliqua(TM) available in the EU in two pre-filled
SoloSTAR®pens (10-40 SoloSTAR®pen and 30-60 SoloSTAR®pen).

Conference call on Tuesday, 22 November 2016 at 4 pm CET / 10 am EDT
Zealand's senior management will host a conference call Tuesday, 22 November
at 4 pm CET to give an update on the implications for Zealand. Participating
in the call will be Britt Meelby Jensen, President and Chief Executive
Officer, Mats Blom, SVP and Chief Financial Officer and Adam Steensberg, SVP
and Chief Medical and Development Officer. The presentation will be followed
by a Q&A session.

The conference call will be conducted in English and the dial-in numbers are:

DK standard access +45 32 71 16 60
UK and international +44 (0) 20 3427 1919
U.S. (free dial-in) +1 646 254 3362

Kindly inform the operator of the following passcode: "Zealand Pharma" or
4119215.

A live audio webcast of the call including an accompanying slide presentation
will be available via the following
link,http://edge.media-server.com/m/p/ykcwu3fnaccessible also from the
company's website (www.zealandpharma.com). Participants are advised to
register for the webcast approximately 10 minutes before the start.

A replay of the event will be made available from the Investor section of
Zealand's website following the call.

Terms of the license agreement with Sanofi

Under the terms of the license agreement between Sanofi and Zealand, which
covers lixisenatide and any combination product that includes lixisenatide,
Sanofi is responsible for all development and commercialization including the
financing.

The approval of Soliqua(TM) by the U.S. FDA triggers a milestone payment of
$25 million to Zealand from Sanofi. Zealand is eligible to receive remaining
milestone payments of up to $110 million as well as royalties on global
sales. Royalties correspond to tiered, low double-digit percentages of
Sanofi's global sales of AdlyxinTM/Lyxumia®plus a fixed low double-digit
percentage of global net sales of SoliquaTM/SuliquaTM.

*****

For further information, please contact:

Britt Meelby Jensen,
President and Chief Executive Officer
Tel.: +45 51 67 61 28, e-mail:
bmj@zealandpharma.com
Mats Blom,
Senior Vice President, Chief Financial Officer

Tel.: +45
31 53 79 73
, e-mail:
mabl@zealandpharma.com

About Soliqua
(TM)

Soliqua(TM) is a once-daily, titratable fixed-ratio combination of
lixisenatide GLP-1 receptor agonist (Adlyxin(TM)/Lyxumia®) and basal insulin
glargine 100 units/ml (Lantus®) for the treatment of adults with type 2
diabetes.

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotechnology
company focused on the discovery, design and development of innovative
peptide-based medicines. Zealand has a portfolio of medicines and product
candidates under licence collaborations with Sanofi, Boehringer Ingelheim and
Helsinn, and a pipeline of proprietary product candidates which primarily
target specialty diseases with significant unmet needs.

The company's first invented medicine, lixisenatide, a once-daily prandial
GLP-1 analogue for the treatment of type 2 diabetes, is licensed to Sanofi.
Lixisenatide is marketed as Lyxumia®outside the United States and approved as
Adlyxin(TM) in the United States. Lixisenatide has been developed in a
fixed-ratio combination with basal insulin glargine (Lantus®) and is approved
as Soliqua(TM) in the United States, and in Europe a CHMP positive opinion
recommendation was given on 11 November. Suliqua(TM) is the brand name in
Europe.

Zealand's proprietary pipeline includes: Dasiglucagon*(ZP4207) (single-dose
rescue treatment) for acute, severe hypoglycaemia (Phase II); Glepaglutide*
(ZP1848) for short bowel syndrome (Phase II); Dasiglucagon* (ZP4207)
(multiple-dose version) intended for use in a dual-hormone artificial
pancreas system for better hypoglycaemia control and diabetes management (in
preparation for Phase II); and other earlier stage clinical and preclinical
peptide therapeutics.

Zealand is based in Copenhagen (Glostrup), Denmark. For further information
about the company's business and activities, please visit
www.zealandpharma.com or follow Zealand on Twitter @ZealandPharma.
* Dasiglucagon and Glepaglutide are proposed International Nonproprietary
Names (pINN).
---------------------------------------
[1]Data on file: IMS Q_Global Q4/2015, V.Kircher

46-16_1122 US approval of SoliquaTM
http://hugin.info/136974/R/2058430/771449.pdf

---------------------------------------
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Zealand Pharma via Globenewswire

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