Zealand Pharma

Regulatory Filings • Jul 28, 2011

Copenhagen, 2011-07-28 07:44 CEST (GLOBE NEWSWIRE) -- Company Announcement

No. 12/2011

Zealand Pharma announces that Sanofi confirms development plans for lixisenatide
as monotherapy and in combination with Lantus® to treat Type-2 diabetes

-- Lyxumia® (lixisenatide monotherapy) on track towards regulatory filing in
Europe later this year and expectedly in the US in H2 2012

-- Phase III studies of lixisenatide in combination with Lantus® expected to
start in early 2013 with the device intended for commercial use

Copenhagen, 28 July 2011 - Zealand Pharma A/S (NASDAQ OMX: ZEAL), a
biopharmaceutical company based in Denmark, announces that its partner Sanofi
today in its Q2 release has confirmed plans for the development of lixisenatide
for the treatment of Type-2 diabetes. Lixisenatide is a once-daily GLP-1
agonist discovered by Zealand and licensed to Sanofi, which is developing the
drug as both monotherapy, under the brand name Lyxumia®, and in combination
with Lantus®, its world leading basal insulin product.

The global GetGoal Phase III program for the evaluation of Lyxumia® in more
than 4,300 patients with Type-2 diabetes is nearing completion. Consistently
positive results have been reported from five of the nine GetGoal studies to
date showing an attractive efficacy and safety profile for the drug. Following
the recent publication of additional supportive data from the GetGoal studies
at the American Diabetes Association (ADA)'s 71st Scientific Sessions, and with
the remaining four GetGoal studies expected to complete and report in 2011,
Lyxumia® remains on track for a regulatory filing in Europe later this year and
expectedly in the US in the second half of 2012.

Sanofi today announced that it expects to be in a position to start Phase III
studies of lixisenatide in combination with Lantus® in early 2013 with the
device intended for commercial use. As part of the GetGoal programme, two
studies, GetGoal-L and GetGoal-L-Asia, have already assessed the efficacy and
safety of lixisenatide as an add-on to basal insulin, including Lantus®, and
the results have demonstrated that the combination significantly reduces HbA1c
(a measure of long term blood glucose levels) while confirming a strong safety
profile.

Commenting on today's announcement, David Solomon, President and Chief
Executive Officer of Zealand Pharma, said: “We are excited by the continued
progress of Lyxumia® and delighted that Sanofi remains fully committed also to
the development of the drug in combination with Lantus® - a therapeutic
approach with the potential to offer incremental benefits to patients with
Type-2 diabetes.”

Under the licence agreement with Sanofi, Zealand Pharma is eligible to receive
total remaining milestone payments of up to EUR 235 million and low
double-digit royalties on worldwide sales of both Lyxumia® (lixisenatide as
monotherapy) and combination products including lixisenatide.

Zealand Pharma will announce its H1 2011 interim report on 18 August 2011.
Details of the related conference call and webcast will be issued in due
course.

For further information, please contact:

Zealand Pharma A/S

David Solomon, President and Chief Executive Officer

Tel: +45 4328 1200

Hanne Leth Hillman, Vice President for IR & Corporate Communications

Mobile: +45 5060 3689

About Lyxumia® (lixisenatide)

Lyxumia® (lixisenatide), a once-daily GLP-1 receptor agonist, is completing
Phase III development for the treatment of patients with Type 2 diabetes.
Lixisenatide was invented by Zealand Pharma and global rights are licensed to
Sanofi (EURONEXT: SAN and NYSE: SNY).Lyxumia® is the intended trademark for
lixisenatide in monotherapy. Lixisenatide is not currently approved or licensed
anywhere in the world.

About GLP-1 receptor agonists

GLP-1 (Glucagon-like peptide-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 to stimulate insulin secretion by
pancreatic beta cells. GLP-1 receptor agonists comprise an established class of
diabetes drugs approved by regulatory authorities and marketed globally as an
add-on treatment for patients with Type 2 diabetes. Their use is endorsed by
the European Association for the Study of Diabetes, the American Diabetes
Association, the American Association of Clinical Endocrinologists and the
American College of Endocrinology. Several novel GLP-1 receptor agonists are in
development.

About the GetGoal Phase III clinical program

The GetGoal Phase III clinical program will provide data for the efficacy and
safety of lixisenatide in adults with Type 2 diabetes treated with various oral
anti-diabetic agents or insulin. With nine trials in the program, GetGoal
started in May 2008 and has enrolled more than 4300 patients. To date
GetGoal-X, GetGoal-Mono, GetGoal-L Asia, GetGoal-S and GetGoal-L have reported
and all with positive top-line results, offering clinical support for the
efficacy and safety profile of lixisenatide. Further results from the GetGoal
Phase III program are expected during 2011.

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 Lyxumia®
(lixisenatide), a once-daily GLP-1 agonist licensed to Sanofi, who has Lyxumia®
in late-stage Phase III development for the treatment of Type 2 diabetes.
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 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 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 more information please visit www.zealandpharma.com