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Zealand Pharma Announces An Extension Of The Lixisenatide Global Licensing Agreement With Sanofi-Aventis K.K. For Type-2 Diabetes


6/8/2010 10:12:22 AM

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




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