Zealand announces that Sanofi has informed of results from GetGoal Duo-2, showing advantages of Lyxumia(r) versus rapid-acting insulin as add-on to Lantus(r) for the treatment of Type 2 diabetes

  • Zealand-invented lixisenatide shows statistically superior weight change compared to rapid acting insulin with similar blood sugar control when both are added to basal insulin for the intensified treatment of Type 2 diabetes
  • Results will be presented at ADA and shared by Sanofi with health authorities worldwide, and will also be included in the US regulatory application for lixisenatide, on track to be resubmitted in Q3 2015

COPENHAGEN, Denmark, June 6, 2015 (GLOBE NEWSWIRE) -- Zealand Pharma A/S ("Zealand") (Nasdaq Copenhagen: ZEAL) announces that Sanofi today reported results from a clinical Phase IIIb trial, GetGoal Duo-2, with Lyxumia(r) (lixisenatide). GetGoal Duo-2 has evaluated the efficacy and safety of once-daily lixisenatide as an add-on to basal insulin for the treatment of Type 2 diabetes patients poorly controlled on basal insulin, versus the addition of rapid acting insulin once daily at main meal (basal-plus) or three times daily at meal-times (basal-bolus).

In the trial, lixisenatide was shown to be non-inferior to both comparator insulin regimens for reduction in blood sugar (HbA1c), and statistically superior to the basal-bolus regimen for body weight change, as co-primary endpoints. Further results from the study showed that in the lixisenatide group of patients, documented hypoglycemia was numerically lower than in the group receiving rapid insulin once daily and significantly lower than in the group receiving rapid insulin three times daily.

Britt Meelby-Jensen, President and Chief Executive Officer of Zealand Pharma, commented: "The results from the GetGoal Duo-2 study reconfirm the therapeutic benefits of Lyxumia(r) as a novel prandial GLP-1 agonist. For Type 2 diabetes patients treated with basal insulin, effective control of meal-related (prandial) blood sugar is often challenging. It is great news that Lyxumia(r) offers some advantages over short-acting insulin in terms of both efficacy and safety as intensification treatment for patients on insulin."

The results from GetGoal Duo-2 will be presented at the 75th Scientific Sessions of the American Diabetes Association (ADA), taking place 5 - 9 June 2015 in Boston, MA, US under the following title:

" Advancing Basal Insulin Glargine with Prandial Lixisenatide QD vs Insulin Glulisine QD or TID in T2DM: The GetGoal Duo-2 Evidence-Based Trial (NCT01768559) , Rosenstock et al. Poster presentation 107-LB, Sunday June 7, 2015.

Sanofi has informed that following the presentation of results at ADA, data from GetGoal Duo-2 will be shared with health authorities worldwide and be included also in the regulatory application for lixisenatide in the US, which is on track for re-submission in the third quarter of 2015.

Analysis of results from GetGoal-Duo II

The 26-week, randomized, open-label study compared the addition of once-daily lixisenatide (20 ug) to optimally titrated insulin glargine with/without metformin versus the addition of one daily injection (basal-plus) or three daily injections (basal-bolus) of insulin glulisine with or without metformin. The study included 894 patients with Type 2 diabetes, who were predominantly obese and who had been poorly controlled on basal insulin +/- oral anti-diabetics (OADs) for at least 6 months prior to the study.

Lixisenatide was shown to be non-inferior to both comparator insulin regimens for reduction in blood sugar (HbA1c) (LS mean difference [95% CI]: -0.05% [-0.17 to 0.06] vs. basal-plus; 0.21% [0.10 to 0.33] vs. basal-bolus; mITT n=890), and superior to basal-bolus for body weight change (LS mean difference [95% CI]: -2.0kg [-2.6 to -1.4kg], p<0.0001 vs. basal-bolus). In addition, post-prandial glucose (PPG) was measured in patients treated before breakfast, and was significantly reduced with lixisenatide compared with both insulin glulisine regimens (LS mean difference [95% CI]: -37mg/dL [-59 to -15mg/dL] vs. basal-plus; -40md/dL [-61 to -19mg/dL] vs. basal-bolus).

Documented hypoglycemia was numerically and statistically lower with lixisenatide than with basal-plus and basal-bolus, respectively (estimated rate ratio [95% CI]: 0.8 [0.5 to 1.1], p=0.123 vs. basal-plus; 0.5 [0.3 to 0.7], p<0.0001 vs. basal-bolus; safety n=894). Nausea events were higher with lixisenatide (25% of patients receiving lixisenatide experienced one or more nausea event, 2% of patients on basal-plus regimen, and 1% of patients on basal-bolus).Patients receiving lixisenatide also reported vomiting (9%) and diarrhea (7%).

For further information, please contact:

Britt Meelby Jensen, President and Chief Executive Officer

Tel: +45 51 67 61 28, email: bmj@zealandpharma.com

Hanne Leth Hillman, Senior Vice President for Investor Relations & Communications

Tel: +45 50 60 36 89, email: hlh@zealandpharma.com

About Lixisenatide

Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.

Lixisenatide is invented by Zealand with worldwide development and marketing rights with Sanofi (SANF.PA). The product is currently approved in 50 countries worldwide for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Commercial launches have taken place in +35 countries including in most EU countries, Japan, Brazil, Mexico and other markets.

Lyxumia(r) is the proprietary name approved by the European Medicines Agency and other health authorities for the GLP-1 RA lixisenatide. Lixisenatide is an investigational product in the U.S. It will be resubmitted to the Food & Drug Administration (FDA) in the third quarter of 2015. The proprietary name in the U.S. is under consideration.

About Zealand Pharma

Zealand Pharma A/S ("Zealand") (Nasdaq Copenhagen: ZEAL) is a biotechnology company based in Copenhagen, Denmark. Zealand has leading expertise in the discovery, design and development of novel peptide medicines and possesses in-house competences in clinical trial design and management with a therapeutic focus on metabolic diseases and acute care indications. The company is advancing a proprietary pipeline of novel medicines alongside a partnered product and development portfolio.

Zealand's first invented medicine, lixisenatide, a once-daily prandial GLP-1 agonist for the treatment of Type 2 diabetes, is marketed globally (ex-US) as Lyxumia(r) and is in Phase III development as a single-injection combination with Lantus(r) (LixiLan), both under a global license agreement with Sanofi. US regulatory filing for Lyxumia(r) is planned for Q3 2015 and filing for LixiLan is planned for Q4 2015 in the US and Q1 2016 in Europe.

Zealand's proprietary pipeline includes danegaptide (prevention of Ischemic Reperfusion Injury) and two stable glucagon products, ZP4207 (one for treatment of severe hypoglycemia and the other for mild to moderate hypoglycemia) as well as several preclinical peptide therapeutics. Partnering represents an important component of strategy to leverage in-house expertise, share development risk in large clinical trials, provide funding and commercialize the company's products. Zealand currently has global license agreements and partnerships with Sanofi, Helsinn Healthcare and Boehringer Ingelheim.

For further information: www.zealandpharma.com Follow us on Twitter @ZealandPharma

Source: Zealand Pharma A/S