Positive Top-line Results From Phase III GETGOAL Clinical Trial Using Once-Daily Lixisenatide in Combination With Basal Insulin

COPENHAGEN, September 30, 2010 /PRNewswire/ -- Zealand Pharma A/S, the biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs, is pleased to note that its partner, sanofi-aventis, has today announced positive top-line results of the Phase III GETGOAL-L-ASIA trial which assessed the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist discovered by Zealand Pharma, in combination with basal insulin. Results of the study showed that lixisenatide, when dosed once-daily in combination with basal insulin (with or without sulfonylurea), significantly improved glycaemic control and that there were no specific safety concerns with lixisenatide in patients with Type-2 Diabetes.

Commenting on today's announcement, David Solomon, Chief Executive Officer and President of Zealand Pharma, said: "We are very encouraged by the Phase III clinical trial data which demonstrates the positive effects of combining basal insulin, including the world's leading long-acting insulin, Lantus(R), with Zealand's lixisenatide. Based on this research such a combination could have the potential to provide Type-2 Diabetes patients with significant clinical and convenience benefits."

The GETGOAL-L-ASIA study was a 24-week, double-blind, placebo-controlled, two-arm parallel-group, multicenter trial and it assessed the safety and efficacy of lixisenatide as an add-on therapy in a total of 311 Asian patients with Type-2 Diabetes insufficiently controlled with basal insulin (with or without sulfonylurea). Patients in the study had baseline glycated hemoglobin (A1C) levels between 7 and 10%; were 20 years of age or older, and were diagnosed with Type-2 Diabetes for at least one year before the screening visit. They were randomised to add either lixisenatide once-daily, or placebo to their existing treatment regimen. Sixty percent of patients were taking Lantus(R) (insulin glargine) as their basal insulin.

The study met its primary endpoint and the addition of lixisenatide once daily to the basal insulin significantly reduced A1C levels by 0.88% versus placebo (p<0.0001). The full study findings will be submitted to a medical congress for presentation.

As per the press release issued by sanofi-aventis earlier today, Marc Cluzel, M.D., PhD, Executive Vice President, Research & Development, sanofi-aventis, said: "The results of this study show that lixisenatide once-daily in combination with basal insulin provides a significant reduction in A1C. Adding lixisenatide, a new GLP-1 with a strong post-prandial glucose effect, to a basal insulin may offer patients a new treatment approach to better control glucose and prevent long-term complications."

Positive study findings from the first GETGOAL MONO study with lixisenatide were presented on 20 September 2010 by sanofi-aventis at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden. The results showed that lixisenatide, when dosed once-daily as a monotherapy, had a significant effect on postprandial blood

glucose control and A1C levels with mean decreases in body weight observed in all dose groups.

The GETGOAL Phase III clinical trial program encompasses multiple clinical trials and will assess the efficacy and safety of lixisenatide in adult patients with Type-2 Diabetes mellitus treated with various oral antidiabetic agents or insulin. The GETGOAL program started in May 2008 and enrolled more than 4,000 patients at the time that enrollment was completed at the end of 2009. The next results of the GETGOAL program are expected to be released in Q2 2011.

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 emerged from Zealand Pharma's own drug discovery. Currently in the diabetes portfolio, Zealand Pharma has the following drugs in development:

Lixisenatide, a glucagon-like peptide-1 agonist (GLP-1), is in development for the treatment of patients with Type 2 Diabetes mellitus. Lixisenatide was in-licensed by sanofi-aventis from Zealand Pharma A/S. The efficacy and safety of lixisenatide once-daily is being assessed in the GETGOAL Phase III clinical trial program. The GETGOAL clinical trial program, which started in May 2008 and has enrolled more than 4,000 patients, will assess efficacy and safety of lixisenatide in adult patients with Type 2 Diabetes mellitus treated with various oral antidiabetic agents or insulin. Enrolment in the GETGOAL clinical trial program was completed at the end of 2009 and the next results of the program are expected to be released in Q2 2011.

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: http://www.zealandpharma.com.

About GLP-1 Receptor Agonists

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 EASD, the American Diabetes Association, the American Association of Clinical Endocrinologists and the American College of Endocrinology.

    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.

    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: [email protected]

    M:Communications
    Mary-Jane Elliott / Emma Thompson
    Tel: +44(0)20-7920-2300, E-mail: [email protected]

SOURCE Zealand Pharma A/S