Zealand Pharma Announces That Once-Daily Lyxumia(R)1 (Lixisenatide) Has Received CHMP Positive Opinion for the Treatment of

Zealand Pharma Announces That Once-Daily Lyxumia(R)1 (Lixisenatide) Has
Received CHMP Positive Opinion for the Treatment of Adults With Type 2
Diabetes in the EU

COPENHAGEN, Denmark, Nov. 16, 2012 (GLOBE NEWSWIRE) --

Company Announcement
No. 21/2012

Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) announces that its partner,
Sanofi (EURONEXT: SAN and NYSE: SNY), has received a positive opinion from the
Committee for Medicinal Products for Human Use (CHMP) under the European
Medicines Agency (EMA), recommending the approval of once-daily Lyxumia(r)
(lixisenatide) for the treatment of adults with Type 2 diabetes to achieve
glycaemic control in combination with oral glucose-lowering medicinal products
and/or basal insulin when these, together with diet and exercise, do not
provide adequate glycaemic control. The CHMP positive opinion will now be
forwarded to the European Commission, which has the authority to approve
medicines for the European Union. A formal decision by the Commission is
expected in the coming months.

Lyxumia(r) (lixisenatide), a once-daily GLP-1 agonist with a pronounced
post-prandial glucose lowering effect, was invented by Zealand Pharma and with
global rights licensed to Sanofi. Sanofi has evaluated the efficacy, safety
and tolerability profile of lixisenatide in the extensive global Phase III
clinical trial program, GetGoal, which comprised 11 clinical trials involving
more than 5,000 patients with type 2 diabetes. GetGoal included a large number
of patients studied to evaluate a GLP-1 receptor agonist in combination with
basal insulin (706 patients in three trials).2

The CHMP positive opinion is based on results from the GetGoal Phase III
program, which showed that once-daily lixisenatide significantly reduced HbA1c
- glycated haemoglobin - in patients with Type 2 diabetes (primary endpoint)
and showed an associated significant reduction in post-prandial glucose and a
beneficial effect on body weight. The GetGoal program also showed that
lixisenatide was well-tolerated overall, with only mild and transient adverse
effects (primarily nausea, vomiting, and diarrhea) ) and a limited risk of
hypoglycaemia.

Commenting on today's announcement, David Solomon, CEO and President of
Zealand Pharma, said: "We are very pleased by today's news that the European
CHMP has given our drug invention, Lyxumia(r) (lixisenatide), a positive
recommendation for market approval. This event may represent a watershed
moment in time for Zealand Pharma, and together with our partner, Sanofi, we
now look forward to a formal decision by the European Commission in the coming
months. Following the CHMP positive opinion and an additional 11 regulatory
applications filed for lixisenatide by Sanofi during 2012, we also await the
planned filing in the US in December this year."

"We have great confidence in the therapeutic potential of lixisenatide, and in
particular in the commercially strong hands of Sanofi do we expect this new
once-daily GLP-1 drug to provide a substantial added benefit to the global
management of Type 2 diabetes."

In a press release from Sanofi today, Pierre Chancel, Senior Vice-President,
Global Diabetes at Sanofi, commented;
"The CHMP positive opinion for Lyxumia marks an important milestone in the
development of this compound and brings us one step closer to serving even
more patients by expanding the Sanofi Diabetes product portfolio. This
recommendation validates our belief that Lyxumia, a once-daily GLP-1 receptor
agonist with a pronounced post-prandial glucose lowering effect, is a
promising medicine that can be combined with other treatments, such as basal
insulin, to help patients with Type 2 diabetes achieve target HbA1c levels. We
look forward to receiving the European Commission decision."
In addition to the European Union, lixisenatide has been submitted for
regulatory approval in 11 countries. Submission of a New Drug Application to
the United States Food and Drug Administration (FDA) is planned for December
2012.

Financial guidance for 2012 and the terms of the Sanofi agreement

As earlier announced, there is no milestone payment to Zealand Pharma
associated with an approval of lixisenatide in Europe, and Zealand Pharma
retains its financial guidance for 2012. As presented in the Interim Report
for the first nine months of 2012 (Company Announcement no. 20/12 of 13
November 2012) the company guide for revenues of DKK 224 (EUR 30) million with
related royalty expenses of DKK 16 (EUR 2) million and a positive net result
for the year of DKK 30-40 (EUR 4-5) million.

Under the agreement between Sanofi and Zealand Pharma, Zealand Pharma is
eligible to receive remaining development and sales milestone payments of up
to USD 215 million, including USD 40 million for a depot formulation of
lixisenatide. Further, the company is entitled to tiered low double-digit
percentage royalties on global net sales of lixisenatide and fixed low
double-digit percentage royalties on full net sales of lixisenatide-Lantus(r)
combination products.

References
1. Lyxumia is the proprietary name submitted to the EMA for lixisenatide. The
proprietary name for lixisenatide in the United States is under consideration.
Lixisenatide is not currently approved or licensed anywhere in the world.

2. http://clinicaltrials.gov/ct2/results?term=GetGoal. Date accessed: October
2012
For further information, please contact:

David H. Solomon, President and Chief Executive Officer
Tel: +45 2220 6300

Hanne Leth Hillman, Vice President and Head of IR & Corporate Communication
Tel: +45 5060 3689, email: hlh@zealandpharma.com

About lixisenatide (Lyxumia(r))

Lixisenatide (Lyxumia(r)) is a once-daily GLP-1 receptor agonist, invented by
Zealand Pharma, and developed under a global license partnership with Sanofi
for the treatment of patents with Type 2 diabetes, both as a stand-alone
product and in a fix-flex combination pen with Lantus(r) (insulin glargine),
Sanofi's world-leading basal insulin product. The global GetGoal Phase III
clinical program provides data for lixisenatide (Lyxumia(r)) 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 5,000 patients, with results serving as support for
applications for regulatory approval of lixisenatide as a stand-alone product.

Phase III studies of a lixisenatide and Lantus(r) combination product in a
fix-flex pen device allowing for flexible Lantus dosing with a fixed
lixisenatide dose are planned for start in mid-2013.

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 are members of 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 Diabetes

Diabetes is a chronic disease that occurs as Type 1 diabetes, which is a
genetic autoimmune disease characterized by the lack of insulin (the hormone
that regulates blood glucose concentrations) production by the pancreas, and
Type 2, a metabolic disorder in which there are two main biological defects: a
deficient production of insulin and reduced ability of the body to respond to
the insulin being produced. Type 1 and Type 2 diabetes are characterised by an
increase in blood glucose concentrations (hyperglycaemia). Over time,
uncontrolled hyperglycaemia leads to the macrovascular and microvascular
complications of diabetes. Macrovascular complications, which affect the large
blood vessels, include heart attack, stroke and peripheral vascular disease.
Microvascular complications affect the small blood vessels of the eyes
(retinopathy), kidney (nephropathy) and nerves (neuropathy).

More than 18 million people worldwide are living with Type 1 diabetes, and the
incidence of Type 2 diabetes is growing at an alarming rate, with nearly 348
million people worldwide living with the condition today.1

1. IDF Diabetes Atlas, 5th Edition (2012)

About Zealand Pharma
Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) is a biotechnology company
based in Copenhagen, Denmark. Zealand Pharma 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 diabetes/metabolic
diseases, and its lead drug invention is lixisenatide (Lyxumia(r)), a
once-daily GLP-1 agonist, which is licensed to Sanofi for the treatment of
Type 2 diabetes. In November 2012, lixisenatide was given a CHMP positive
opinion in Europe and a regulatory filing in the United States is expected in
December 2012.

Zealand Pharma 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, Abbott in acute kidney injury and Helsinn
Healthcare in chemotherapy induced diarrhea. Zealand Pharma focuses its
activities in 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

About Sanofi Diabetes

Sanofi strives to help people manage the complex challenge of diabetes by
delivering innovative, integrated and personalized solutions. Driven by
valuable insights that come from listening to and engaging with people living
with diabetes, the Company is forming partnerships to offer diagnostics,
therapies, services and devices, including innovative blood glucose monitoring
systems. Sanofi markets both injectable and oral medications for people with
type 1 or type 2 diabetes. Investigational compounds in the pipeline include
an injectable GLP-1 receptor agonist being studied as a single agent, in
combination with basal insulin, and/or in combination with oral anti-diabetic
agents.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs. Sanofi has core
strengths in the field of healthcare with seven growth platforms: diabetes
solutions, human vaccines, innovative drugs, consumer healthcare, emerging
markets, animal health and the new Genzyme. Sanofi is listed in Paris
(EURONEXT: SAN) and in New York (NYSE: SNY)
 
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