Zealand Pharma A/S
05.12.2011 07:00
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Copenhagen, 5 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 new results on lixisenatide
(Lyxumia(r)) will be presented by the company's partner Sanofi at the
International Diabetes Federation's 21st World Diabetes Congress, 5 - 8
December 2011 in Dubai, United Arab Emirates. Lixisenatide is an
investigational new GLP-1 agonist for once-daily dosing, discovered by Zealand
Pharma and developed by Sanofi for the treatment of Type 2 diabetes.
In a poster session today at 2:00 - 3:00 pm Dubai local time (11:00 am - 12:00
noon CET), Sanofi will present three posters with titles and conclusions as
follows:
'Pharmacodynamic characteristics of lixisenatide QD 2) versus liraglutide QD in
patients with T2DM inadequately controlled with metformin' (Abstract D-0740)*
Conclusion: Lixisenatide QD had a significantly greater post-prandial glucose
lowering (PPG) effect than liraglutide QD in patients with Type 2 diabetes
(-129% versus -41%, respectively), accompanied by significant decreases in
insulin, C-peptide and glucagon and a better gastro-intestinal tolerability
profile.
* This is a 4-week Phase II study
'Post-meal pharmacodynamic profile of lixisenatide once daily versus placebo in
T2DM insufficiently controlled on SU +/-metformin (GetGoal-S)' (Abstract
D-0743)
Conclusion: Add-on treatment with lixisenatide (once-daily) provided a marked
significant improvement in postprandial glycemic control over 24 weeks in Type
2 diabetes patients insufficiently controlled on SU +/- metformin. Lixisenatide
also reduced glucagon and pro-insulin and thus improved glucose homeostasis.
The GetGoal-S study is part of the GetGoal Phase III clinical program with
lixisenatide, and positive top-line results from the study were reported by
Sanofi and announced by Zealand Pharma in April 2011 (Company Announcement no.
5/2011, 12 April 2011).
'Comparison of the Once-Daily GLP-1R Agonists Lixisenatide and Liraglutide on
Prandial Carbohydrate Utilization in Animal Models' (Abstract D-0737)
Conclusion: In the present animal studies, lixisenatide and liraglutide had a
different impact on post-prandial carbohydrate utilization, with lixisenatide
having a stronger prandial effect than liraglutide.
This potent effect of lixisenatide on post-meal glucose control might result in
improvement of glucose control in Type 2 diabetes, allowing more patients to
reach their HbA1c target with body weight loss.
Further, in two oral presentations scheduled for presentation at the congress
on Thursday, 8 December at 10:45-12:45 local time (7:45-9:45 CET), Sanofi will
present results from two studies under the GetGoal Phase III program with
lixisenatide: top-line results from the GetGoal-M study and additional results
from the GetGoal-F1 study , from which study positive top-line results were
reported by Sanofi at EASD 2011 and announced by Zealand Pharma mid-September
2011 (Company Announcement no. 15/2011, 12 September 2011). The two oral
presentations are titled as follows:
'Efficacy and safety of lixisenatide QD morning and evening injections versus
placebo in T2DM inadequately controlled on metformin (GetGoal-M)' (Abstract
O-0591)
'Long-term (up to 2 years) safety of lixisenatide once daily versus placebo in
T2DM insufficiently controlled on metformin (GetGoal-F1)' (Abstract O-0595)
In November 2011, the European Medicines Agency (EMA) accepted Sanofi's
marketing authorization application filed for lixisenatide (Lyxumia(r)).
Submission for regulatory approval of lixisenatide in the United States is
expected in Q4 2012.
1. Lyxumia(r) is the intended trademark for lixisenatide
2. QD = once-daily dosing
# # #
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(r))
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(r) 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 to date enrolled more than 4,500 patients. So far top-line results
have been reported for the GetGoal-X, GetGoal-L, GetGoal-L Asia, GetGoal-Mono,
GetGoal-S and GetGoal-F1 studies, all supporting potential efficacy and safety
for lixisenatide. Further Phase III results are expected in 2011 and 2012.
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(r) 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(r)) in Europe. Submission
for regulatory approval of lixisenatide in the U.S. 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(r) is the intended trademark for lixisenatide
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Language: English
Company: Zealand Pharma A/S
Denmark
Phone:
Fax:
E-mail:
Internet:
ISIN: DK0060257814
WKN:
End of Announcement DGAP News-Service
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DGAP-Adhoc: Zealand Pharma announces new results on lixisenatide (Lyxumia(r)1)) for Type 2 diabetes presented by Sanofi at the 21st World Diabetes Congress
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