Approval paves the way for launch by Sanofi of the first Zealand invented product in the U.S.
Triggers a $5 million milestone payment from Sanofi
FDA is currently reviewing iGlarLixi, the fixed-ratio combination of AdlyxinTM (lixisenatide) and Lantus® (insulin glargine), with regulatory decision expected in August 2016
Zealand is eligible to receive remaining milestone payments of up to $135 million as well as royalties on global sales
Copenhagen, 28 July 2016 - Zealand Pharma (Zealand), a biotechnology company, announces that the U.S. Food and Drug Administration (FDA) has granted approval of lixisenatide for the treatment of adults with type 2 diabetes. Lixisenatide, a once-daily prandial GLP-1 receptor agonist, was invented by Zealand and global development and commercial rights are licensed to Sanofi.
Lixisenatide has been approved in the U.S. under the brand name AdlyxinTM indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes, including in combination with oral anti-diabetes medication and/or basal insulin. There are an estimated 27.5 million adults with type 2 diabetes (American Diabetes Association, 2012) in the U.S., and the U.S market constitutes approximately 75% of the world market for GLP-1 receptor agonists (IMS, 2016).
Britt Meelby Jensen, President and Chief Executive Officer of Zealand commented: "Today is an important day for Zealand. With the FDA approval of AdlyxinTM we have successfully passed the final regulatory milestone for the first Zealand invented product to become available for diabetes patients in the significant U.S. market. We look forward to Sanofi's launch of AdlyxinTM, while awaiting the FDA's regulatory decision on iGlarLixi, the single product combination of AdlyxinTM and Lantus®, expected in August 2016."
For further information, please contact:
Britt Meelby Jensen, President and Chief Executive Officer
Tel: +45 51 67 61 28, email: firstname.lastname@example.org
Hanne Leth Hillman, Senior Vice President, Investor Relations and Communications
Tel: +45 50 60 36 89, email: email@example.com