Zealand Pharma

Earnings Release • Dec 8, 2011

Copenhagen, 2011-12-08 07:45 CET (GLOBE NEWSWIRE) -- Company Announcement

No. 27/2011

-- Top-line results from the GetGoal-M study presented by Sanofi at the 21st
World Diabetes Congress

-- Results show that, as add-on therapy to metformin, lixisenatide once-daily,
given as a morning or evening dosing, significantly improves glycemic control
after 24 weeks and is well tolerated in patients with Type 2 diabetes

Copenhagen, 8 December 2011 - Zealand Pharma A/S (NASDAQ OMX Copenhagen:
ZEAL), a Danish biopharmaceutical company dedicated to the discovery and
development of innovative peptide drugs, announces that its partner Sanofi has
presented positive top-line results from the GetGoal-M Phase III study with
lixisenatide (Lyxumia®) for the treatment of Type 2 diabetes. Lixisenatide is
an investigational once-daily GLP-1 agonist discovered by Zealand Pharma and
licensed to Sanofi.

The results were presented in an oral presentation today at 10:45am local time
(7:45am CET) at the 21st World Diabetes Congress in Dubai, United Arab
Emirates, under the following headline: “Efficacy and safety of lixisenatide QD
2) morning and evening injections versus placebo in T2DM inadequately
controlled on metformin (GetGoal-M)”.

GetGoal-M is the seventh study under the global GetGoal Phase III program, and
the eighth consecutive Phase III study including the GetGoal Duo 1 study, to
report positive results that support the efficacy and safety of lixisenatide as
a potential new treatment option for patients with Type 2 diabetes.

Commenting on today’s announcement, David Solomon, Chief Executive Officer and
President of Zealand Pharma, said: “Eight consecutively positive Phase III
studies have now been reported for lixisenatide providing a substantial body of
clinical evidence for the potential of lixisenatide as a new treatment option
for patients with Type 2 diabetes and their caregivers. Lixisenatide has been
filed for registration in Europe and regulatory submission in the United States
is expected in Q4 2012.”

GetGoal-M is a multicenter, randomized, 4-arm, double-blind, placebo-controlled
Phase III clinical study evaluating the efficacy and safety of lixisenatide
(Lyxumia®) as morning or evening injections in 680 patients with Type 2
diabetes insufficiently controlled with metformin alone.

Results from the study show that both morning and evening dosing of
lixisenatide met the primary endpoint of significant HbA1c reduction over 24
weeks versus placebo (p<0.0001). For both dosing groups fasting plasma glucose
was significantly reduced versus placebo (p<0.005). Lixisenatide also
significantly increased the proportion of patients achieving HbA1c of less than
7.0% (43% for morning dosing, 41% for evening dosing, 22% for placebo). Body
weight was reduced in all groups (-2.0 kg for lixisenatide morning and evening
dosing, -1.6kg for placebo).

1) Lyxumia® is the intended trademark for lixisenatide

2) QD = once a day

The percentage of patients requiring rescue therapy for hyperglycemia (high
blood sugar) was significantly lower in the lixisenatide morning and evening
groups than in the placebo group. Consistent with the GLP-1 class, the most
common adverse events were nausea and vomiting. There was a low incidence of
hypoglycemia (low blood sugar): 2.4% for morning lixisenatide, 5.1% for evening
lixisenatide versus 0.6% for placebo, with no severe episodes.

In November 2011, the European Medicines Agency (EMA) accepted Sanofi’s
marketing authorization application filed for lixisenatide (Lyxumia®).
Submission for regulatory approval of lixisenatide in the United States is
expected in Q4 2012.

The agreement with Sanofi and financial outlook

Under the license agreement between Sanofi and Zealand Pharma, Sanofi is
developing lixisenatide both as a stand-alone product (intended trademark
Lyxumia®) in the Phase III GetGoal program and in a combination pen device with
Sanofi’s basal insulin Lantus®. Zealand Pharma is eligible to receive remaining
milestone payments of up to USD 235 million and low double-digit royalties on
global net sales of lixisenatide and any combination product that includes
lixisenatide.

The results of GetGoal-M do not change Zealand Pharma’s financial guidance for
2011 of DKK 170 (EUR 22.8) million in revenues and other income and total
operating expenses of DKK 170 (EUR 22.8) million.

                                  # # #

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 discovered 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.

The GetGoal Phase III clinical program provides 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 has 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 and GetGoal-M 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 Phase III 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 and growing 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,
discovered by Zealand Pharma and licensed to Sanofi. In November, Sanofi filed
for marketing authorization for lixisenatide (Lyxumia®) in Europe. 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- and
radiotherapy- induced diarrhea.

Zealand Pharma specializes in the discovery, optimization and development of
novel peptide drugs, 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