-- Once-daily Lyxumia® demonstrates non-inferior reduction of blood glucose and good safety with less hypoglycemia versus exenatide twice daily in Type 2 diabetes patients
-- Once-daily Lyxumia® in combination with basal insulin improves glycemic control in Asian Type 2 diabetes patients
-- Four abstracts presented, including the full data from the Phase III GetGoal-X and GetGoal-L Asia studies
Copenhagen, 24 June 2011 – Zealand Pharma A/S (NASDAQ OMX: ZEAL), a biopharmaceutical company based in Denmark, announces that its partner Sanofi has published additional positive data from four studies with Lyxumia® (lixisenatide), a once-daily GLP-1 analogue, which is completing Phase III clinical development for the treatment of Type 2 diabetes. Lixisenatide was discovered by Zealand Pharma and global rights are licensed to Sanofi.
The data is being presented at the American Diabetes Association (ADA)’s 71st Scientific Sessions in San Diego, California and include the full results from GetGoal-X and GetGoal-L Asia, two clinical Phase III GetGoal-studies with Lyxumia® in Type 2 diabetes patients that are not adequately treated with oral therapies or with basal insulin alone. Top-line results from the two studies were announced in September 2010 and February 2011, respectively.
Commenting on this announcement, David Solomon, President and Chief Executive Officer of Zealand Pharma, said: “We are pleased that our partner Sanofi is successfully advancing Lyxumia® towards completion of Phase III and now is presenting these additional four sets of positive study findings at the 2011 ADA meeting. The data provides further confirmatory signs of the attractive potential of Lyxumia® as an effective and safe treatment of Type 2 diabetes. We are delighted that the program is progressing so well.”
“Lixisenatide once-daily demonstrated efficacy in blood glucose control and by meeting an endpoint of non-inferiority at week 24 in a head-to-head study versus exenatide twice daily,” said Julio Rosenstock, MD, director of the Dallas Diabetes and Endocrine Center at Medical City Dallas and lead investigator of the GetGoal-X trial;
Summaries of the four abstracts presented are highlighted below.
- Efficacy and Safety of Lixisenatide Once-Daily Versus Exenatide Twice-Daily in Type 2 Diabetes Inadequately Controlled on Metformin (GetGoal-X) - ABSTRACT 0033-LB
In the clinical Phase III GetGoal-X study, lixisenatide once daily achieved its primary endpoint of non-inferiority in HbA1c reduction from baseline with less symptomatic hypoglycemia (low blood sugar) and better gastrointestinal tolerability versus exenatide twice daily, as an add-on to metformin in patients with Type 2 diabetes.
GetGoal-X, a randomized, open-label, active-controlled, two-arm parallel-group, multicenter study, included a total of 634 patients who were randomized to receive 24-week treatment with either lixisenatide or exenatide. Both groups received a stepwise increase in dose, up to a maximum daily dose of 20µg. At baseline, the mean age in the trial was 57.4 years, mean diabetes duration 6.8 years, mean body mass index (BMI) 33.6 kg/m2 and mean HbA1c 8.0 percent.
- Lixisenatide Significantly Improves Glycemic Control in Asian Patients with Type 2 Diabetes Insufficiently Controlled on Basal Insulin ± Sulfonylurea (GetGoal-L Asia) - ABSTRACT 0278-OR
Data from the Phase III GetGoal-L Asia study showed that lixisenatide once-daily significantly improved glycemic control versus placebo at week 24 in combination with basal insulin. Lixisenatide also demonstrated a pronounced post-prandial glucose and fasting plasma glucose effect, and was well tolerated. The study included 311 Asian patients with Type 2 diabetes insufficiently controlled by basal insulin ± sulfonylurea.
- Cardioprotective Effect of the GLP-1 Receptor Agonist Lixisenatide on Ischemia-Reperfusion-Induced Injury in the Isolated Rat Heart - ABSTRACT 0968-P
In this pre-clinical study, data showed that lixisenatide once-daily protects against myocardial ischemia-reperfusion injury (tissue damage caused by restriction of oxygen-rich blood to the heart) in isolated rat hearts by significantly reducing myocardial infarct size (measurement of damage to the heart).
- Effect of the Once-Daily GLP-1 Receptor Agonist Lixisenatide on Gastric Emptying and Prandial Carbohydrate Utilization in Animal Models: A Comparison with Liraglutide - ABSTRACT 2267-PO
Data from several preclinical studies showed that treatment with lixisenatide was more effective in delaying gastric emptying and lowering prandial glucose excursions (change in glucose concentration after a meal) than liraglutide.
The agreement with Sanofi and financial outlook
Under the licence agreement between Sanofi and Zealand Pharma, Sanofi is developing lixisenatide both as monotherapy in the Phase III GetGoal program and in a combination with Lantus®, its best selling global insulin product. Zealand Pharma is eligible to receive remaining milestone payments of up to EUR 235 million and double-digit royalties on worldwide sales of both lixisenatide as monotherapy and of combination products that include lixisenatide.
The data to be presented for Lyxumia® at ADA does not change Zealand Pharma’s expectations in 2011 to receive a total of DKK 150 (€20) million of revenues and other income under the Boehringer Ingelheim agreement, nor the company’s guidance on total operating expenses of DKK 170 (€23) million for the full year.
For further information, please contact:
Zealand Pharma A/S
David Solomon, President and Chief Executive Officer
Tel: +45 4328 1200
Hanne Leth Hillman, Vice President for IR & Corporate Communications
Mobile: +45 5060 3689
About Lyxumia® (lixisenatide)
Lyxumia® (lixisenatide), a once-daily GLP-1 receptor agonist, is completing Phase III development for the treatment of patients with Type 2 diabetes. Lixisenatide was in-licensed from Zealand Pharma A/Sby Sanofi (EURONEXT: SAN and NYSE: SNY). Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is not currently approved or licensed anywhere in the world.
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 the GetGoal Phase III clinical program
The GetGoal Phase III clinical program will provide data for the efficacy and safety of lixisenatide in adults with Type 2 diabetes treated with various oral anti-diabetic agents or insulin. With nine trials in the program, GetGoal started in May 2008 and has enrolled more than 4300 patients. To date GetGoal-X, GetGoal-Mono, GetGoal-L Asia, GetGoal-S and GetGoal-L have reported and all with positive top-line results, offering clinical support for the efficacy and safety profile of lixisenatide. Further results from the GetGoal Phase III program are expected during 2011.
About Zealand Pharma
Zealand Pharma A/S is a public (NASDAQ OMX: ZEAL) biopharmaceutical company based in Copenhagen, Denmark with a mature and growing clinical pipeline of innovative peptide based drugs. The company’s lead product is Lyxumia® (lixisenatide), a once-daily GLP-1 agonist licensed to Sanofi, who is responsible for the late-stage Phase III development of Lyxumia® for the treatment of Type-2 diabetes. Zealand Pharma also has a collaboration with Boehringer Ingelheim covering glucagon/GLP-1 dual agonists, including ZP2929 for the treatment of diabetes and obesity, and a license agreement with Helsinn Healthcare on a clinical stage GLP-2 drug for the treatment of chemotherapy and radiotherapy induced diarrhea.
Zealand Pharma specializes in the discovery, optimization and development of novel peptide drugs with favorable therapeutic attributes, and all drug candidates in its pipeline have been identified through the company’s own drug discovery activities. Zealand Pharma’s products target 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 more information please visit www.zealandpharma.com
