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Sanofi (France) (SAN.PA) Seeks Approval for Diabetes Drug in Japan

6/11/2012 6:55:40 AM

COPENHAGEN, Denmark, Jun 11, 2012 (GlobeNewswire via COMTEX) -- Zealand Pharma A/S (copenhagen:ZEAL) announces that its partner, Sanofi, has submitted a marketing authorization application for lixisenatide (Lyxumia(R)) to Japan's Ministry of Health, Labour and Welfare. Lixisenatide is a once-daily investigational GLP-1 agonist, invented by Zealand Pharma and licensed to Sanofi for the treatment of Type 2 diabetes.

The Japanese application is supported by data from the extensive global GetGoal Phase III clinical trial program, which has assessed the intended use of lixisenatide in the treatment of adults with Type 2 diabetes to achieve glycemic control in patients who are not adequately controlled on oral anti-diabetics and/or basal insulin. The application includes data from the GetGoal-L Asia study2 which has shown positive results on the efficacy and safety of lixisenatide versus placebo in Asian patients with Type 2 diabetes who were insufficiently controlled on basal insulin +/- sulfonylurea on top of diet and exercise.

Results from the GetGoal program provide clinical evidence for lixisenatide's good efficacy and safety profile in the treatment of Type 2 diabetes, demonstrating a significant reduction in HbA1c, and as expected from a GLP-1 agonist, a low risk of hypoglycemia and in terms of tolerability, mild and transient nausea and vomiting as the most commonly reported adverse events.

In total, the GetGoal program has enrolled more than 5,000 patients with Type 2 diabetes, including subjects in Japan, and has studied the highest number of patients in any Phase III program to evaluate a GLP-1 in combination with basal insulin3.

Commenting on the regulatory submission of lixisenatide in Japan, Zealand Pharma's President and CEO, David Solomon, said: "The regulatory filing by Sanofi in Japan marks a further important advance in the development of lixisenatide as a novel treatment for Type 2 diabetes. We are encouraged by this milestone, which follows a boast of supportive clinical and preclinical data on lixisenatide presented by Sanofi in 17 presentations at the ongoing ADA meeting in Philadelphia."

The submission to Japan's Ministry of Health, Labour and Welfare follows the acknowledged receipt of Sanofi's market authorization application filing for lixisenatide by the European Medicine Agency in November 2011. Sanofi expects that submission for regulatory approval of lixisenatide in the United States will take place in Q4 2012.

The first set of results from the various studies of the GetGoal program have been published in peer reviewed medical journals and others will be submitted for publication in the next few months.


-- Lyxumia is the proprietary name submitted to the EMA for the investigational once-daily GLP-1 agonist lixisenatide. The proprietary name for lixisenatide in the United States is under consideration. Lixisenatide is not currently approved or licensed anywhere in the world.

-- Seino Y et al, Diab Obes Metab., May 2012 (Epub ahead of print) date accessed 28/05/12

For further information, please contact:

Zealand Pharma A/S

David H. Solomon, President & CEO, Tel: +45 22 20 63 00

Hanne Leth Hillman, Vice President, Director of IR & Corporate Communication,

Tel: +45 50 60 36 89, email:

About lixisenatide (Lyxumia(R))

Lixisenatide (Lyxumia(R)) is a once-daily GLP-1 drug, invented by Zealand Pharma, and developed through a global license partnership with Sanofi both as a stand-alone product and in a combination pen with Lantus(R) (insulin glargine), Sanofi's world-leading basal insulin product. The GetGoal Phase III clinical program, which completed in February 2012, provided data for lixisenatide (Lyxumia(R)) 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 enrolled more than 5,000 patients.

Phase III studies of a lixisenatide and Lantus(R) combination drug based on a pen device allowing for flexible Lantus dosing with a fixed lixisenatide dose are on track to start in early 2013.

About GLP-1 receptor agonists

GLP-1 (glucagon-like peptide-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 to stimulate insulin secretion by pancreatic beta cells. GLP-1 receptor agonists are members of an established class of diabetes drugs approved by regulatory authorities and marketed globally as an add-on treatment for patients with Type 2 diabetes. Their use is endorsed by the European Association for the Study of Diabetes, the American Diabetes Association, the American Association of Clinical Endocrinologists and the American College of Endocrinology. Several novel GLP-1 receptor agonists are in development.

About Diabetes

Diabetes is a long-term disease that occurs either when the pancreas does not produce enough insulin (the hormone that regulates blood glucose concentrations), or when the body cannot effectively use the insulin it produces, or both. This results in raised blood glucose concentrations (hyperglycemia). Over time, uncontrolled hyperglycemia leads to the macrovascular and microvascular complications of diabetes. Macrovascular complications, which affect the large blood vessels, include heart attack, stroke and peripheral vascular disease. Microvascular complications affect the small blood vessels of the eyes (retinopathy), kidney (nephropathy) and nerves (neuropathy). The incidence of Type 2 diabetes is growing at an alarming rate. Over 310 million people worldwide is living with the condition today and the number is expected to increase to more than 550 million people in 2030.

About Sanofi Diabetes

Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services and devices, including innovative blood glucose monitoring systems. Sanofi markets both injectable and oral medications for people with type 1 or type 2 diabetes. Investigational compounds in the pipeline include an injectable GLP-1 agonist being studied as a single agent, in combination with basal insulin, and/or in combination with oral anti-diabetic agents.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris /quotes/zigman/187275 FR:SAN +0.73% and in New York /quotes/zigman/307926/quotes/nls/sny SNY +0.94% .

About Zealand Pharma

Zealand Pharma A/S (copenhagen:ZEAL) is a biotechnology company based in Copenhagen, Denmark. Zealand Pharma specializes in the discovery, optimization and development of novel peptide drugs and has a broad and mature pipeline of drug candidates identified through its own drug discovery activities. The company's lead drug invention is lixisenatide (Lyxumia(R)), a once-daily GLP-1 agonist, which is licensed to Sanofi for the treatment of Type 2 diabetes. In November 2011, Sanofi filed for registration of lixisenatide in Europe and regulatory filing in the United States is expected in Q4 2012.

Zealand Pharma has a partnering strategy for the development and commercialization of its products and in addition to the collaboration with Sanofi in Type 2 diabetes, the company has partnerships with Boehringer Ingelheim in diabetes/obesity, Abbott in acute kidney injury and Helsinn Healthcare in chemotherapy induced diarrhea. Zealand Pharma focuses its activities in 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.


This news release was distributed by GlobeNewswire,

SOURCE: Zealand Pharma A/S

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