Zealand Pharma

Regulatory Filings • Nov 3, 2011

First Zealand Pharma discovered peptide drug now in registration phase, a key
corporate milestone achieved

Copenhagen, 2011-11-03 07:42 CET (GLOBE NEWSWIRE) -- Copenhagen, 3 November
2011 - Zealand Pharma (NASDAQ OMX: ZEAL.CO), a Danish biopharmaceutical company
dedicated to the discovery and development of innovative peptide drugs,
announces that its partner Sanofi has submitted a marketing authorization
application (MAA) for Lyxumia® (lixisenatide) in Europe. Sanofi announced the
news in the company's Q3 report this morning. Lixisenatide is a once-daily
GLP-1 receptor agonist discovered by Zealand Pharma and licensed to Sanofi,
which is completing Phase III development of the drug as a new treatment for
Type-2 diabetes.

The MAA includes documentation from the extensive international GetGoal Phase
III program, comprising data from nine studies and more than 4,300 patients.
The GetGoal program provides data to support lixisenatide's intended use for
the treatment of adults with Type-2 diabetes mellitus to achieve glycemic
control in patients not adequately controlled on oral anti-diabetics and/or
basal insulin; as add-on treatment to metformin; a sulfonylurea or a
combination of metformin and a sulfonylurea; or in combination with basal
insulin.

Zealand Pharma's President and Chief Executive Officer, David Solomon,
commented: “The European submission is a major achievement, bringing
lixisenatide into the final phase before market launch, and represents a
transformational milestone for Zealand Pharma. The GetGoal program has
established clinical support for broad use of lixisenatide as a monotherapy and
as an add-on to existing treatments, including in combination with basal
insulin. We are confident that the drug will quickly find an important role in
the management of Type-2 diabetes.”

Results from the GetGoal program support lixisenatide's efficacy profile with a
consistent HbA1c reduction as the primary endpoint, driven by an effective
reduction of fasting blood glucose level and by a pronounced post-prandial
glucose lowering. As expected from a GLP-1 receptor agonist, a beneficial
effect in body weight was observed Lixisenatide once-daily, with a one-step
dose increase regimen and a single maintenance dose, was well tolerated and led
to significantly improved glycemic control with low risk of hypoglycemia in the
overall GetGoal program. Nausea and vomiting, albeit mild and transient, were
the most commonly reported adverse events in most studies.

Positive top-line results reported from GetGoal-X, GetGoal-L, GetGoal-L Asia,
GetGoal-Mono, GetGoal-S and GetGoal-F1 are available at Zealand Pharma's
website ir.zealandpharma.com and on www.sanofi.com. Further results from the
GetGoal Phase III program are expected to be presented at international
conferences during late 2011 and 2012.

Submission for regulatory approval of lixisenatide in the United States is
expected in Q4 2012.

Financial outlook

Under the agreement with Sanofi, Zealand Pharma is eligible to receive
remaining milestone payments of up to USD 235 million covering lixisenatide
once-daily formulation, depot formulation and any combination product including
lixisenatide. There will be no milestone payment associated with the European
submission but there will be a milestone payment relating to the completion of
the full GetGoal Phase III program, which is expected in the first quarter of
2012.

Zealand Pharma is also eligible to low double-digit royalties on worldwide
sales of lixisenatide and of any combination product including lixisenatide.

The submission of Lyxumia® in Europe does not change Zealand Pharma's financial
guidance for 2011 of total operational expenses of approximately DKK 170
million (EUR 22.8 million) and of revenues and other operational income of DKK
150 million (EUR 20 million) stemming from the agreement with Boehringer
Ingelheim, signed in June 2011. Zealand Pharma provides no further guidance on
revenues.

                                  # # #

For further information, please contact:

David Horn Solomon, President and Chief Executive Officer

Tel: +45 2220 6300

Hanne Leth Hillman, Vice President for IR & Corporate Communication

Tel: +45 5060 3689

About Lyxumia® (lixisenatide)

Lixisenatide, a glucagon-like peptide-1 agonist (GLP-1), is in development for
the treatment of patients with type 2 diabetes mellitus. Lixisenatide was
discovered by Zealand Pharma A/S and the global rights are 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,
the American Diabetes Association, 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, includes ten studies and has enrolled more than 4,500 patients.

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, which 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 licence 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 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.