Copenhagen, 2012-09-26 08:00 CEST (GLOBE NEWSWIRE) --
Press Release
No. 6/2012
-- One oral and two poster presentations of clinical data on Lyxumia®1 (lixisenatide), an investigational new once-daily GLP-1 agonist, filed by Sanofi for registration in Europe and Japan with filing in the US expected in December 2012
-- One oral and one poster presentation of preclinical data on Zealand Pharma’s proprietary investigational novel GLP-1-gastrin dual agonist, ZP3022
Copenhagen, Denmark – 26 September 2012 – Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), a Danish biotechnology company dedicated to the discovery and development of peptide drugs, informs that a series of clinical data will be presented on lixisenatide (Lyxumia®) at the European Association for the Study of Diabetes (EASD) 48th Annual Meeting on 1-5 October 2012 in Berlin, Germany, supporting the potential of this investigational new once-daily GLP-1 agonist as a new treatment for Type 2 diabetes. Lixisenatide was invented by Zealand Pharma and global rights are licensed to Sanofi (EURONEXT: SAN and NYSE: SNY), who has filed for registration of the product in Europe and Japan and expects filing in the US in December 2012.
Further at EASD, Zealand Pharma will present data from preclinical studies of ZP3022, a proprietary novel compound from the company’s program on dual acting GLP-1-gastrin peptide agonists.
Highlights of the clinical data to be presented on lixisenatide (Lyxumia®) are as follows (abstracts have been posted on the EASD website):
“Effects of lixisenatide once daily on gastric emptying and its relationship to postprandial glycaemia in type 2 diabetes mellitus” [Abs 808-EASD] – POSTER presentation
When: Wednesday 3 October, 12:00pm – 1:00pm CET
Presenter: M. Lorenz, Sanofi-Aventis Deutschland GmbH
Location: Berlin Fair Exhibition Halls, Poster Hall
“Efficacy and safety of once-daily lixisenatide in type 2 diabetes insufficiently controlled with basal insulin ± metformin: GetGoal-L2 study” [Abs 3-EASD] – ORAL presentation
When: Tuesday 2 October, 11:15am – 11:30am CET
Presenter: R. Aronson, LMC Endocrinology Centres, Toronto, Canada
Location: Berlin Fair Exhibition Halls, Langerhans Hall
“Once-daily lixisenatide added on to consistently titrated insulin glargine plus oral agents in type 2 diabetes: the GetGoal-Duo 13 study” [Abs 807-EASD] – POSTER presentation
When: Wednesday 3 October, 12:00pm – 1:00pm CET
Presenter: J. Rosenstock, Dallas Diabetes and Endocrine Center at Medical City, Dallas, U.S.A.
Location: Berlin Fair Exhibition Halls, Poster Hall
Highlights of the preclinical data to be presented on ZP3022 are as follows (abstracts have been posted on the EASD website):
“The novel GLP-1-Gastrin dual agonist ZP3022 improves glycemic control in ZDF rats” [Abs 823-EASD] – POSTER Presentation
When: Wednesday 3 October, 1:15pm – 2:15pm CET
Presenter: Jolanta Skarbaliene, M.Sc (Pharm.), Scientist, Ph.D. Student, Zealand Pharma A/S, Copenhagen, Denmark
Location: Berlin Fair Exhibition Halls, Poster Hall
”The GLP-1-gastrin dual agonist ZP3022 increases beta cell mass via an increase in mean islet mass in db/db mice” [Abs 177-EASD] – ORAL Presentation
When: Thursday 4 October, 10:15am – 11:45am CET, in session “Beta cell function in vivo”
Presenter: Dorthe L. C. Almholt, M.Sc, Ph.D, Scientist, Zealand Pharma A/S, Copenhagen, Denmark.
Location: Berlin Fair Exhibition Halls, Rubner Hall
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 for IR & Corporate Communication,
Tel: +45 50 60 36 89, email: hlh@zealandpharma.com
References
1. Lyxumia is the proprietary name submitted to the EMA for lixisenatide, an investigational once-daily GLP-1 agonist, invented by Zealand Pharma and licensed to and developed by Sanofi for the treatment of Type 2 diabetes. The proprietary name for lixisenatide in the United States is under consideration. Lixisenatide is not currently approved or licensed anywhere in the world.
2. GetGoal-L (NCT00715624 www.clinicaltrials.gov)
3. GetGoal Duo 1 (also known as EFC 10781) (NCT00975286 www.clinicaltrials.gov)
About lixisenatide (Lyxumia®)
Lixisenatide (Lyxumia®) is a once-daily GLP-1 agonist, invented by Zealand Pharma. The global rights to lixisenatide are licensed to Sanofi, who is developing the product for the treatment of Type-2 diabetes, both as a stand-alone drug and in a combination device with Lantus® (insulin glargine), Sanofi’s world-leading basal insulin product. The GetGoal Phase III clinical program, which completed in February 2012, has provided data for lixisenatide (Lyxumia®) in adults with Type 2 diabetes treated in monotherapy, with various oral anti-diabetic agents or in combination with basal insulin. The GetGoal program has enrolled more than 5,000 patients.
Sanofi filed for registration of lixisenatide in Europe in November 2011 and an opinion from the Committee for Human Medicinal Products under EMA is expected in Q4 2012. Lixisenatide was filed for registration in Japan in June 2012 and a filing with the FDA in the US is expected in December 2012.
Phase III studies of a lixisenatide and Lantus® combination drug based on a pen device allowing for flexible Lantus® dosing with a fixed lixisenatide dose are planned for initiation in mid-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 gastrin and the GLP-1-gastrin dual agonists ZP3022
Gastrin is a naturally-occurring peptide hormone that is released from the gastrointestinal tract during meal ingestion, stimulating the secretion of gastric acid and the secretion of digestive enzymes from the pancreas. Furthermore, it has been suggested that gastrin plays a role in pancreatic development.
ZP3022 is a compound from Zealand Pharma’s preclinical drug discovery program on dual acting GLP-1-gastrin peptide agonists, acting on both the GLP-1 and the gastrin receptors. In preclinical disease models of diabetes (db/db mice and Zucker Diabetic Fatty (ZDF) rats), ZP3022 has been shown to increase beta cell mass (insulin producing cell mass) to a greater extent than liraglutide. ZP3022 has also been shown to significantly improve glycemic control in rodents both during treatment and in a follow up period after treatment stop.
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 Zealand Pharma
Zealand Pharma A/S (NASDAQ OMX 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 focus lies in the field of diabetes/metabolic diseases, and its lead drug invention is lixisenatide (Lyxumia®)1, 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 December 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.
For further information: www.zealandpharma.com.
