SOURCE: Zealand Pharma

September 20, 2010 06:22 ET

Positive Study Findings from Lixisenatide in First Phase III GetGoal Trial for Type 2 Diabetes

COPENHAGEN, DENMARK--(Marketwire - September 20, 2010) -


Zealand Pharma A/S

("Zealand Pharma" or "the Company")

~ Presented by sanofi-aventis at European Association for the Study of Diabetes 46th Annual Meeting ~

Copenhagen: 20 September - Zealand Pharma A/S, the biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs, is pleased to announce that the positive study findings from the first Phase III GetGoal clinical trial program with lixisenatide will be presented by Zealand Pharma's partner, sanofi-aventis, at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden.

The study has assessed the efficacy and safety of lixisenatide, a once- daily GLP-1 receptor agonist invented by Zealand Pharma, as a monotherapy in patients with type 2 diabetes. The trial was designed as a 12-week, randomized, double-blind, multicentre, phase 3 study with 361 patients participating in total. The full Phase III GetGoal clinical program includes 10 trials and more than 4,000 patients.

Highlights of the Lixisenatide announcement issued by sanofi-aventis today are:

* Significant improvement in glycemic control versus placebo with a pronounced postprandial effect

* Significant reduction in A1C levels versus placebo (p < 0.0001)

* Mean decreases in body weight observed in all groups

* Well tolerated and acceptable safety profile (only one serious treatment-emergent adverse event (TEAE) occurred in the lixisenatide group versus five in the placebo group. Nausea was the most frequent TEAE with lixisenatide

* Study investigator said results demonstrate lixisenatide as a once daily GLP-1 agent and that the data provided a rationale for investigating the combined effect of lixisenatide and long acting insulins in patients with type 2 diabetes


To view the full announcement issued by sanofi-aventis today, please Visit http://www.sanofi-aventis.com.

Commenting on the announcement David Solomon, Chief Executive Officer and President of Zealand Pharma, said: "We are delighted that lixisenatide has shown significant efficacy as well as safety data in this GetGoal Phase III clinical trial. These study findings demonstrate the potential of lixisenatide for the treatment of type-2 diabetes. Zealand Pharma's scientists are pioneers in peptide drug innovation and development and we look forward to further clinical trial read-outs from the GetGoal study."

# # #

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 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 to 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. Sanofi-aventis is also investigating the use of Lixisenatide as part of a combination product with Lantus (insulin glargine).

* 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#1445301]

Press Release in PDF:

http://hugin.info/136974/R/1445301/388717.pdf


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Source: Zealand Pharma via Thomson Reuters ONE

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