Zealand Pharma

Earnings Release • Feb 8, 2012

Top-line results from GetGoal-P show that lixisenatide significantly reduces
blood glucose levels (HbA1c)

Copenhagen, 2012-02-08 07:36 CET (GLOBE NEWSWIRE) -- Company announcement

No. 2/2012

Copenhagen, 8 February 2012 - Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL),
a Danish biopharmaceutical company dedicated to the discovery and development
of innovative peptide drugs, announces that Sanofi today in its Full Year 2011
results announcement reported positive top line results from the GetGoal-P
Phase III study. GetGoal-P is one of the studies in the global GetGoal Phase
III program for lixisenatide, a once-daily investigational GLP-1 agonist for
the treatment of Type 2 diabetes, invented by Zealand Pharma and licensed to
Sanofi.

The GetGoal-P study evaluated the effects of lixisenatide as an add-on therapy
to pioglitazone with or without metformin and compared to placebo in patients
with Type 2 diabetes. A total of 484 patients received either lixisenatide or
placebo.

In the study, lixisenatide achieved its primary efficacy endpoint of
significantly reducing blood glucose levels (HbA1c) compared to placebo
(p<0.0001) with HbA1c decreasing from a mean baseline value of 8.08% to a mean
value of 7.06% after 24 week in the patient group receiving lixisenatide and
from 8.05% to 7.59% in the placebo group. Safety and tolerability results were
consistent with other studies within the GetGoal program. Results from
GetGoal-P also showed that symptomatic hypoglycemia rates were low in both
groups. Patients randomized to the lixisenatide group had an incidence of
symptomatic hypoglycemia at 24 weeks of 3.4% compared to 1.2% in the placebo
group. As expected for a GLP-1 agonist, the most frequent adverse event was
nausea, with 1.9% of patients discontinuing due to nausea in the lixisenatide
arm vs. none in the placebo group. The full study results from the GetGoal-P
study are planned for presentation at a future medical congress.

Lixisenatide (Lyxumia®) has delivered positive results throughout the GetGoal
Phase III program, which comprises ten completed studies, of which eight have
now reported, and has involved more than 4,500 patients with Type 2 diabetes.
The results support the efficacy and safety of lixisenatide as a monotherapy,
in combination with oral anti-diabetes drugs and in combination with basal
insulin.

Commenting on today’s announcement, David Solomon, President and Chief
Executive Officer of Zealand Pharma, said: “The positive results from GetGoal-P
is another important milestone in the Phase III clinical development program
for lixisenatide, the Zealand Pharma invented diabetes drug. We are pleased to
see the consistently supportive results being reported from the GetGoal Phase
III program, having led to a regulatory filing for lixisenatide in Europe in
November 2011 – and expected to support a planned filing in the US in Q4 2012.”

Sanofi is developing lixisenatide both in a single pen (Lyxumia®), which is now
in the registration phase of development, and in a combination pen device with
Sanofi’s world leading basal insulin Lantus® (insulin glargine). The
commencement of Phase III studies for a combination product using an injection
device allowing a variable Lantus® dose with a fixed lixisenatide dose is on
track for early 2013.

The agreement with Sanofi

Under the license agreement between Sanofi and Zealand Pharma, Zealand Pharma
is eligible to receive additional development and sales milestone payments of
up to USD 235 million and low double-digit percentage royalties on global net
sales of lixisenatide and any combination product that includes lixisenatide.

                                  # # #

For further information, please contact:

David H. Solomon, President & CEO, Tel: +45 2220 6300

Hanne Leth Hillman, Vice President for IR & Corporate Communication,

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

About lixisenatide (Lyxumia®)

Lixisenatide, a glucagon-like peptide-1 (GLP-1) agonist for once-daily dosing,
is in development for the treatment of patients with Type 2 diabetes mellitus.
Lixisenatide was invented by Zealand Pharma and has been licensed to Sanofi.
Lyxumia® is the intended trademark of lixisenatide. Lixisenatide is not
currently approved or licensed anywhere in the world.

GLP-1 is a naturally-occurring peptide that is released within minutes of
eating a meal. It is known to suppress glucagon secretion from pancreatic alpha
cells and stimulate insulin secretion by pancreatic beta cells. GLP-1 receptor
agonists are in development as an add-on treatment for Type 2 diabetes and
their use is endorsed by the European Association for the Study of Diabetes
(EASD), the American Diabetes Association (ADA), the American Association of
Clinical Endocrinologists and the American College of Endocrinology.

About the GetGoal Phase III clinical program

The GetGoal Phase III clinical program provided data for lixisenatide in adults
with Type 2 diabetes treated in monotherapy, with various oral anti-diabetic
agents or in combination with basal insulin. The GetGoal program started in May
2008 and enrolled more than 4,500 patients. To date, top-line results have been
reported from the GetGoal-X, GetGoal-L, GetGoal-L Asia, GetGoal-Mono,
GetGoal-S, GetGoal-F1, GetGoal-M and Get-Goal-P studies, all supporting
potential efficacy and safety for lixisenatide. Further, positive top-line
results have been reported from the Phase III GetGoal Duo 1 study (also known
as EFC10781*) supporting in particular the efficacy and safety of lixisenatide
for use in combination with Lantus® (insulin glargine). Further results are
expected in 2012.

• NCT00975286 on www.clinicaltrials.gov

About Zealand Pharma

Zealand Pharma A/S is a public (NASDAQ OMX: ZEAL) biopharmaceutical company
based in Copenhagen, Denmark with a mature clinical pipeline of innovative
peptide based drugs. The company's lead product is lixisenatide (Lyxumia® 1)),
a once-daily GLP-1 agonist for the treatment of Type 2 diabetes, invented by
Zealand Pharma and licensed to Sanofi. In November, Sanofi submitted a
marketing authorization application (MAA) for lixisenatide (Lyxumia®) in Europe
and submission for regulatory approval of lixisenatide in the United States is
expected in Q4 2012. Zealand Pharma also has a collaboration with Boehringer
Ingelheim covering glucagon/GLP-1 dual agonists, including ZP2929 for the
treatment of diabetes and obesity, and a license agreement with Helsinn
Healthcare on elsiglutide, a clinical stage GLP-2 drug for the treatment of
chemotherapy-induced diarrhea.

Zealand Pharma specializes in the discovery, optimization and development of
novel peptide drugs with favorable therapeutic attributes, and all drug
candidates in its pipeline have been identified through the company's own drug
discovery activities. Zealand Pharma's products target 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.

Note 1) Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is
not currently approved or licensed anywhere in the world.