Zealand Pharma announces new results on lixisenatide (Lyxumia®1)) for Type 2 diabetes presented by Sanofi at the 21st World Diabetes Congress
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®) 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).
1) Lyxumia® is the intended trademark for lixisenatide
2) QD = once-daily dosing
“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®). Submission for regulatory approval of lixisenatide in the United States is expected in Q4 2012.
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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: email@example.com
Posted: December 2011