GLOSTRUP, DENMARK--(Marketwire - June 08, 2010) -
Copenhagen, 08 June 2010
Announcement no. 5, 2010
Zealand Pharma A/S
("Zealand Pharma" or "the Company")
Zealand Pharma Announces An Extension of The Lixisenatide Global Licensing
Agreement with sanofi-aventis for Type-2 Diabetes
Zealand Pharma A/S, the biopharmaceutical company dedicated to the
discovery and
development of innovative peptide-based drugs, is pleased to announce
that the
global licensing agreement with sanofi-aventis has been amended to
provide for
the development and commercialization of Lixisenatide
(AVE0010/ZP10) in
combination with Lantus®, sanofi-aventis' recombinant human insulin
analog.
Lixisenatide is a Zealand-invented GLP-1 (glucagon-like-peptide-1)
receptor
agonist for the treatment of Type-2 Diabetes, and uses Zealand's
proprietary
SIP™ (structure inducing probe) peptide modification technology.
Lantus®
is sanofi-aventis' number one brand with 2009 sales of more than EUR3
Billion. In
April 2010, sanofi-aventis reported positive Phase III results from the
first of
nine clinical studies within the Lixisenatide GetGoal Phase III program.
Filing
of Lixisenatide is expected to take place in H2 2011 in Europe & H2 2012
in the
US.
The Phase III clinical program for the Lantus® + Lixisenatide
combination
product is expected to commence in 2010. Zealand knows of no similar
Type-2
Diabetes product that is as advanced in clinical testing.
The companies restructured the financial terms of the agreement to
provide
Zealand with payments for the achievement of development, regulatory, and
sales
milestones for the Lantus® + Lixisenatide combination product. Zealand
expects
to receive a part of such payments in 2010 as the combination product
advances
into Phase III. Royalties (low double digits) to Zealand for
Lixisenatide and
the Lantus® + Lixisenatide combination product as well as other non-
disclosed
provisions of the agreement have been further amended providing value for
both
companies.
Commenting on today's announcement David Solomon, Chief Executive
Officer and
President of Zealand Pharma, said: "We are delighted that sanofi-aventis,
one of
the world's leading diabetes care companies, has reinforced its
long and
successful relationship with Zealand Pharma. This agreement not only
strengthens
Zealand's financial position, allowing us to progress our other
pipeline
programs, but also provides significant excitement globally around a
superior
treatment for patients suffering with Type-2 Diabetes. We look forward
to the
ongoing clinical development of Lixisenatide and of the Lantus® +
Lixisenatide
combination product. Our focus at Zealand continues to be to build
shareholder
value through the development of leading peptide-based drugs."
For further information please contact:
Zealand Pharma A/S
David Solomon, President and Chief Executive Officer
Zealand Pharma A/S, Smedeland 36, DK-2600 Copenhagen, Denmark
Tel: +45 4328 1200, Fax: +45 4328 1212, E-mail: info@zp.dk
M:Communications
Mary-Jane Elliott / Emma Thompson
Tel: +44(0) 20 7920 2300, E-mail: Zealandpharma@mcomgroup.com
Notes for Editors
About Diabetes and Type-2 Diabetes (Source: WHO)
· More than 220 Million people worldwide have diabetes
· In 2005, an estimated 1.1 Million people died from diabetes
· Almost 80% of diabetes deaths occur in low- and
middle-income
countries
· Almost half of diabetes deaths occur in people under the
age of 70
years; 55% of diabetes deaths are in women
· WHO projects that diabetes deaths will double between 2005
and 2030
· Healthy diet, regular physical activity, maintaining a
normal body
weight and avoiding tobacco use can prevent or delay the onset of diabetes
Type-2 Diabetes results from the body's ineffective use of insulin.
Type-2
Diabetes comprises 90% of people with diabetes around the world, and is
largely
the result of excess body weight and physical inactivity. Symptoms
may be
similar to those of Type 1 diabetes, but are often less marked. As a
result, the
disease may be diagnosed several years after onset, once complications
have
already arisen. Until recently, this type of diabetes was seen only in
adults
but it is now also occurring in children.
About Lantus®
Lantus®, a recombinant human insulin analog, is sanofi-aventis'
number one
brand with 2009 sales over EUR3 Billion. Lantus® is indicated for
once-daily
subcutaneous administration in the treatment of adult patients with
Type-2
Diabetes who require basal (long-acting) insulin for the
control of
hyperglycemia and for adult and pediatric patients (6 years and older) with
type
1 diabetes mellitus. Lantus® is described by sanofi-aventis as
providing a
steady 24-hour release of insulin for blood sugar control with one shot a
day at
the same time each day, with no pronounced peak. For more information,
please
visit www.lantus.com.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and
distributes therapeutic solutions to improve the lives of
everyone.
Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
For more information please visit www.sanofi-
aventis.com.
About Zealand Pharma A/S
Zealand Pharma A/S is a biopharmaceutical company dedicated to the
discovery and
development of innovative peptide-based drugs. Zealand Pharma is a
leader in
peptide drug development, a growing market with significant drug
development
activities including treatment of diabetes, obesity, gastro-
intestinal,
metabolic and cardiovascular diseases. All of Zealand Pharma's products
target
diseases and indications with significant unmet clinical need and
commercial
potential.
Since 1999, Zealand Pharma's scientists have built a pipeline that includes
five
compounds in clinical development, four of which have been out licensed,
three
of these two major pharmaceutical companies (sanofi-aventis, Wyeth (now
part of
Pfizer) and Helsinn Healthcare). All of Zealand Pharma's compounds emerge
from
Zealand Pharma's own drug discovery. Currently in the diabetes
portfolio,
Zealand Pharma has the following drugs in development:
* Lixisenatide (AVE0010/ZP10), a pharmaceutical agent for the treatment
of
Type-2 Diabetes, has been out-licensed to sanofi-aventis, the world's
third
largest pharmaceutical corporation with a strong Diabetes franchise.
Phase
III clinical trials for Lixisenatide in monotherapy are being conducted
by
sanofi-aventis. The Phase III clinical program for the Lantus® +
Lixisenatide combination product is expected to start in 2010.
* ZP2929 is a novel, potent, long-acting dual Glucagon-GLP-1 agonist
aiming to
provide a novel treatment option for people with Type-2 Diabetes and
obesity. ZP2929 entered preclinical development in 2009 and has
already
demonstrated improved glycaemic control as well as significant and
sustained
body weight loss in pre-clinical pharmacology models.
In addition, Zealand Pharma has a rich and broad peptide
portfolio of
pre-clinical projects targeting a variety of disease areas, including
Type-1
Diabetes and Type-2 Diabetes.
Zealand Pharma A/S is based in Copenhagen. The Company's investors
include,
Sunstone Capital, Allianz Private Equity, CDC Innovation, LD Pensions,
Dansk
Erhvervsinvestering and LSP.
For more information please visit Zealand Pharma's web site:
www.zealandpharma.com.
[HUG#1422247]
Press Release in PDF: http://hugin.info/136974/R/1422247/371384.pdf
