Positive results from pivotal Phase III clinical t

• Type 2 diabetes patients treated with iGlarLixi (formerly LixiLan) had significantly greater reductions in blood glucose (HbA1c) versus treatment with either lixisenatide or Lantus^®   
• Treatment with iGlarLixi also resulted in body weight reduction versus Lantus^®
• The positive Phase III results support Zealand’s potential for revenue growth from milestone payments and royalties on iGlarLixi, if approved
• Regulatory decisions by the U.S. FDA and by the EMA in Europe are expected in August 2016 and in Q1 2017, respectively

Copenhagen, 12 June 2016 – Zealand announces that Sanofi today has reported positive results of the pivotal Phase III LixiLan-O and LixiLan-L clinical trials with iGlarLixi (formerly LixiLan), intended for the treatment of type 2diabetes. iGlarLixi is an investigational titratable fixed-ratio combination of Lantus^® (basal insulin glargine 100 Units/mL) and GLP-1 receptor agonist lixisenatide for once-daily single injection. Lixisenatide was invented by Zealand and global development and commercial rights are licensed to Sanofi. The full Phase III results were presented in two oral sessions at the American Diabetes Association 76th Scientific Sessions in New Orleans, LA, U.S. Topline results from the trials were reported in Q3 2015.  

In the LixiLan-O trial, 1,170 patients with type 2 diabetes inadequately controlled on oral anti-diabetes medication received treatment with iGlarLixi, Lantus^® or lixisenatide over 30 weeks. Results showed that iGlarLixi gave significantly greater reductions in HbA1c (a measure of average blood sugar levels during the past three months) from a baseline of 8.1% and when compared to Lantus^® and to lixisenatide (-1.6%, -1.3%, -0.9%, respectively; p<0.0001). Treatment with iGlarLixi also resulted in a weight reduction compared to Lantus^® (difference of -1.4kg (p<0.0001)).

In the LixiLan-L trial, 736 patients with type 2 diabetes inadequately controlled on basal insulin received treatment with iGlarLixi or Lantus^® over 30 weeks. Results showed significantly greater reductions in HbA1c from a baseline of 8.1% and when compared to Lantus^® (-1.1%, -0.6%, respectively; p<0.0001). Treatment with iGlarLixi also resulted in a weight reduction compared to Lantus^® (difference of -1.4kg (p<0.0001)).

Commenting on the results of LixiLan-O and LixiLan-L, Britt Meelby Jensen, President and CEO at Zealand, said: “I am very happy that the full Phase III results reconfirm the therapeutic relevance of iGlarLixi and its potential to help people with type 2 diabetes better manage their disease. The presentation at ADA is an important event in the ongoing regulatory process for iGlarLixi in both the U.S. and Europe, following also the positive recommendation by the FDA Advisory Committee for a U.S. approval a couple of weeks ago. For Zealand, it confirms that we remain on track towards potential milestone payments and increasing royalty revenues under our license agreement with Sanofi. This is one of the elements in realizing our strategy of advancing our own product candidates and I look forward to the U.S. regulatory decisions on lixisenatide and iGlarLixi in Q3 2016.”

The results of the LixiLan-O and LixiLan-L trials have been included in regulatory submissions to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with regulatory decisions anticipated in August 2016 (FDA) and Q1 2017 (EMA).