Zealand Pharma

Regulatory Filings • Jun 28, 2013

Copenhagen, 2013-06-28 08:41 CEST (GLOBE NEWSWIRE) -- ? Zealand’s world-leading
peptide innovation provides for the approval of Lyxumia® as the first GLP-1
agonist in Japan to be used in combination with basal insulin

? Lyxumia® is also approved in the European Union, Australia and Mexico, in
which markets Sanofi is in the process of making the product available for
patients and their caregivers

? Under the license agreement with Sanofi, Zealand is entitled to tiered low
double-digit percentage royalties on world-wide sales of Lyxumia®

Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) informs that today
Lyxumia® was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW)
for the treatment of Type 2 diabetes. Lyxumia® (lixisentatide) is a once-daily
prandial GLP-1 receptor agonist invented by Zealand and with world-wide rights
to develop and market the product licensed to Sanofi (EURONEXT: SAN and NYSE:
SNY) for the treatment of Type 2 diabetes.

Lyxumia® is the first of Zealand’s peptide drug innovations to have reached the
market for the benefit of patients.

Commenting on the Japanese approval of Lyxumia® and the importance of this
milestone to Zealand, President and CEO, David Solomon said:

“We are delighted that our drug invention, lixisenatide (developed and marketed
as Lyxumia® by Sanofi) has now reached the market also in Japan to the benefit
of the large number of patients with Type 2 diabetes, whose blood glucose is
not adequately controlled with existing medication, including patients on basal
insulin.

“Zealand is world leading in peptide drug innovation and design, and the
regulatory approvals of Lyxumia® now in Europe, Japan, Australia and Mexico and
the encouraging launch by Sanofi, a top-leading diabetes company, of the
product in the first European markets, is a strong validation of our
capabilities. Importantly also, the revenue to Zealand from Sanofi’s sales of
Lyxumia® is expected to help leverage our pipeline activities and further
increase our corporate value.”

In Japan, Lyxumia® is the first GLP-1 agonist based therapy to be approved for
use in combination with basal insulin., indicated for patients with Type 2
diabetes mellitus when the following do not provide adequate glycemic control:
diet and exercise and sulfonylureas (with and without biguanides) or diet and
exercise and soluble prolonged-acting or intermediate-acting insulin (with and
without sulfonylureas).

In a Sanofi press release today, Pierre Chancel, Senior Vice-President, Global
Diabetes at Sanofi, commented:

“Lyxumia, as the first GLP-1 receptor agonist approved in Japan for use in
combination with basal insulin, will be a valuable new treatment option for
many of the country’s 6 million plus people living with type 2 diabetes,” and
he continued

“The MHLW decision immediately enables the use of Lyxumia, which works in a way
that complements basal insulin.”

Effective control of overall glucose excursions associated with diabetes
requires good control of both fasting plasma glucose (FPG) and post-prandial
glucose (PPG) levels. Treatment with basal insulin provides effective control
of HbA1c by primarily targeting FPG 1,2. As diabetes progresses over time,
however, patients treated with basal insulin may no longer stay at their HbA1c
goals, despite good control of FPG. When this happens, adding a medicine such
as Lyxumia®, which targets post-prandial glucose (PPG), may be an effective
therapeutic strategy for these patients to improve overall glucose levels and
reach HbA1c goals.

Lyxumia® is now approved in the European Union, Japan, Australia and Mexico. In
the United States, the New Drug Application (NDA) submitted for the product to
the Food and Drug Administration (FDA) by Sanofi is currently being reviewed.

Financial outlook for 2013 and terms of the agreement with Sanofi

The approval of Lyxumia® in Japan does not change the 2013 Financial Outlook
for Zealand as announced by the company in its Interim Report for Q1 2013 on 15
May 2013 (Company Announcement no. 14/2013).

Under the license agreement with Sanofi, Zealand is entitled to up to a total
of USD 275 million in milestone payments, of which up to potentially USD 175
million are outstanding. Further, Zealand will receive tiered low double-digit
percentage royalties on Sanofi’s global sales of Lyxumia® and fixed low
double-digit percentage royalties on global full net sales of the
Lantus®/Lyxumia® combination product.

                                  ***

For further information, please contact:

David Solomon, President and Chief Executive Officer – Tel: +45 22 20 63 00

Hanne Leth Hillman, Vice President, Head of Investor Relations & Corporate
Communications – Tel: +45 50 60 36 89, email: hlh@zealandpharma.com

References

1. Aronoff et al. Glucose metabolism and regulation: Beyond insulin and
   glucagon. Diabetes Spectrum 2004; 17(3): 183–190.

2. Riddle et al. Contributions of basal and postprandial hyperglycemia over
   a wide range of A1c levels before and after treatment intensification in type 2
   diabetes. Diabetes Care 2011; 34(12): 2508–2514.

About Lyxumia® (lixisenatide)

Lyxumia® (lixisenatide) 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 suppress glucagon secretion from pancreatic alpha
cells and stimulate glucose-dependent insulin secretion by pancreatic beta
cells.

Lixisenatide is invented by Zealand and world-wide rights to develop and market
the product are licensed to Sanofi (EURONEXT: SAN and NYSE: SNY). Lixisenatide
is approved and marketed by Sanofi in Europe under the brand name Lyxumia®, for
the treatment of adults with type 2 diabetes mellitus to achieve glycemic
control in combination with oral glucose-lowering medicinal products and/or
basal insulin when these, together with diet and exercise, do not provide
adequate glycemic control. Lyxumia® is also approved in Mexico and Australia
for the treatment of adults with Type 2 diabetes. The proprietary name for
lixisenatide in the United States is under consideration.

About Zealand

Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) is a biotechnology
company based in Copenhagen, Denmark. Zealand 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 cardio-metabolic diseases,
diabetes and obesity in particular, and its lead drug invention is
lixisenatide, a once-daily GLP-1 agonist, which is licensed to Sanofi for the
treatment of Type 2 diabetes. Lixisenatide is approved in Europe, Japan,
Australia and Mexico and marketed by Sanofi under the name of
Lyxumia®.Lixisenatide is under regulatory review in a large number of other
countries globally, including in the US (NDA submission accepted in Feb 2013).

Zealand 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.

For further information: www.zealandpharma.com.

@ZealandPharma