Zealand Pharma

Legal Proceedings Report • Feb 7, 2013

Copenhagen, 2013-02-07 08:06 CET (GLOBE NEWSWIRE) -- Zealand Pharma (NASDAQ OMX
Copenhagen: ZEAL) announces that its licensing partner Sanofi (EURONEXT: SAN
and NYSE: SNY) has today provided an update on the status of the Lyxumia®
(lixisenatide) /Lantus® (insulin glargine) combination programs. In its 2012
full year earnings report, Sanofi stated that, owing to a recent technical
issue encountered during the development of the Fix-Flex combination device,
Phase III development for the combination of Lantus®/Lyxumia® will not be
initiated in 2013, as previously planned.

Lyxumia® is a new, once-daily GLP-1 agonist invented by Zealand Pharma and
licensed to Sanofi globally. Sanofi is responsible for the development and
commercialization of the product, and is developing it for the treatment of
Type 2 diabetes both as a stand-alone product and in combination with Lantus®,
Sanofi’s world-leading basal insulin product.

Sanofi has filed for regulatory approval of lixisenatide in a large number of
countries globally, including in the US, where an NDA was filed with the FDA in
December 2012.

On Monday, 4 February 2013, Zealand Pharma along with Sanofi announced that
Lyxumia® had been granted Marketing Authorization in Europe for the treatment
of adults with Type 2 diabetes. The Marketing Authorization, which covers the
27 EU countries as well as Norway, Iceland and Lichtenstein, was granted on the
basis of results from Sanofi’s international GetGoal Phase III program,
involving more than 5,000 patients with Type 2 diabetes in 11 clinical studies.
Regulatory approval for lixisenatide has also been granted in Mexico.

For the Lantus®/Lyxumia® combination product, Sanofi is developing the Fix-Flex
device to allow for flexible dosing of Lantus® together with a fixed dose of
Lyxumia®. In H2 2012, Sanofi entered industrialization, validation, usability
and manufacturing phases with the Fix-Flex device in preparation for Phase III
clinical studies of the combination product. In parallel, Sanofi is evaluating
a Fixed-Ratio combination device; patient enrollment in a Phase IIb study of
the Fixed-Ratio combination has been completed and study results are expected
to be presented at a medical congress in 2013.

As part of the GetGoal program, a large number of patients were studied for an
evaluation of the effects of Lyxumia® in combination with basal insulin,
including Lantus® (706 patients treated with a free combination of Lyxumia® and
Lantus® in three trials: GetGoal-L, GetGoal-L Asia and GetGoal Duo 1). Results
from the GetGoal program demonstrate the clinical rationale for Lyxumia® as an
add-on treatment to Lantus®. Zealand Pharma believes that having demonstrated a
pronounced effect on post-prandial glucose, the combination of Lyxumia® with
Lantus® can offer significant benefits in the treatment of diabetes.

Sanofi is currently reassessing timelines for the Lyxumia®/Lantus® combination
development programs and an update is expected in due course.

Commenting on the update from Sanofi, David Solomon, President and CEO of
Zealand Pharma, said: "While a delay by our global partner Sanofi to the
timelines for start of Phase III studies of the Lantus®/Lyxumia® combination
product is disappointing, the development is continuing and we look forward to
further progress and the resolution of any technical issues. We also look
forward to European launch of Lyxumia®, which we believe will provide further
evidence of the key therapeutic benefits and unique positioning of this GLP-1
product for use in combination with Lantus®."

Financial guidance for 2013 and the terms of the Sanofi agreement

Zealand Pharma will provide financial guidance for 2013 in connection with the
release of its 2012 full-year announcement on 14 March 2013.

Under the license agreement with Sanofi, which covers lixisenatide and
combination products, including lixisenatide, Zealand Pharma is entitled to
tiered low double-digit percentage royalties on global net sales of Lyxumia®
and fixed low double-digit percentage royalties on full net sales of
combination products including lixisenatide1.

Further, the company is eligible to receive remaining development, regulatory
and sales milestone payments of up to USD 215 million, which include USD 40
million for a depot formulation of Lyxumia® not currently in active
development1.

References

1. Zealand Pharma pays 13% to Alkermes (former Elan) and 0.5% to SIP®
   technology inventor on all income from lixisenatide

.

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For further information, please contact:

David H. Solomon, President and Chief Executive Officer

Tel: +45 2220 6300

Hanne Leth Hillman, Vice President and Head of IR & Corporate Communication

Tel: +45 5060 3689, email: hlh@zealandpharma.com

About lixisenatide (Lyxumia®)

Lixisenatide (Lyxumia®) is a glucagon-like peptide-1 receptor agonist (GLP-1
RA) for the treatment of patients with Type 2 diabetes mellitus. GLP-1 is a
naturally-occurring peptide hormone that is released within minutes after
eating a meal. It is known to stimulate glucose-dependent insulin secretion by
pancreatic beta cells and suppress glucagon secretion from pancreatic alpha
cells.

Lixisenatide is invented by Zealand Pharma and global rights to the product are
licensed to Sanofi. Lyxumia® is the proprietary name approved by the European
Medicines Agency (EMA) for the GLP-1 RA lixisenatide.

About Zealand Pharma

Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) is a biotechnology company
based in Copenhagen, Denmark. Zealand Pharma specializes in the discovery,
optimization and development of novel peptide drugs and has a broad and mature
pipeline of drug candidates identified through its own drug discovery
activities. The company’s focus lies in the field of diabetes/metabolic
diseases, and its lead drug invention is lixisenatide (Lyxumia®), a once-daily
GLP-1 agonist, which is licensed to Sanofi for the treatment of Type 2
diabetes. Lyxumia® is approved in Europe (February 2013), and under regulatory
review in a large number of other countries globally. In the US, a decision on
NDA filing acceptance is expected from the FDA in Q1 2013.

Zealand Pharma has a partnering strategy for the development and
commercialization of its products and in addition to the collaboration with
Sanofi in Type 2 diabetes, the company has partnerships with Boehringer
Ingelheim in diabetes/obesity, Helsinn Healthcare in chemotherapy induced
diarrhea and AbbVie in acute kidney injury. Zealand Pharma focuses its
activities in disease areas where existing treatments fail to adequately serve
patient needs and where the market potential for improved treatments through
the use of peptide drugs is high. For further information:
www.zealandpharma.com

About Sanofi Diabetes

Sanofi strives to help people manage the complex challenge of diabetes by
delivering innovative, integrated and personalized solutions. Driven by
valuable insights that come from listening to and engaging with people living
with diabetes, the Company is forming partnerships to offer diagnostics,
therapies, services and devices, including innovative blood glucose monitoring
systems. Sanofi markets both injectable and oral medications for people with
Type 1 or Type 2 diabetes.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients’ needs. Sanofi has core
strengths in the field of healthcare with seven growth platforms: diabetes
solutions, human vaccines, innovative drugs, consumer healthcare, emerging
markets, animal health and the new Genzyme. Sanofi is listed in Paris
(EURONEXT: SAN) and in New York (NYSE: SNY).