Zealand announces new timelines for a U.S. FDA decision on iGlarLixi, the fixed-ratio combination of lixisenatide (AdlyxinTM) and Lantus®, for the treatment of type 2 diabetes

• The FDA had requested updated information on the pen delivery device for iGlarLixi as part of its New Drug Application, which has been submitted by Sanofi   
• Consequently, the FDA has extended their review time by three months
• A regulatory decision on iGlarLixi in the U.S. is now expected at the end of November 2016
• Zealand's financial guidance for 2016 remains unchanged

Copenhagen, 20 August 2016 - Zealand Pharma (Zealand) announced today that Sanofi has submitted updated information on the pen delivery device for iGlarLixi to the U.S. Food and Drug Administration (FDA) as part of the New Drug Application (NDA) for the product. IGlarLixi is a once-daily, fixed-ratio combination of lixisenatide (Adlyxin^TM) and insulin glargine 100 Units/mL (Lantus^®) for the treatment of adults with type 2 diabetes. The submission of the additional information, requested by the FDA, constitutes a Major Amendment to the NDA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) goal date by three months. A U.S. regulatory decision on iGlarLixi is now expected before the end of November 2016.

Zealand invented lixisenatide, a once-daily prandial GLP-1 receptor agonist, for the treatment of type 2 diabetes and granted global development and commercial rights to the product, including for use in combinations, to Sanofi. On 27 July 2016, lixisenatide was approved by the U.S. FDA under the brand name Adlyxin^TM for the treatment of adults with type 2 diabetes. Lixisenatide is approved and marketed globally by Sanofi outside the U.S. under the brand name Lyxumia^®.

Sanofi submitted the NDA for iGlarLixi to the FDA in December 2015, and on 25 May 2016, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recommended, by a vote of 12 to 2, its approval.

Britt Meelby Jensen, President and Chief Executive Officer of Zealand commented: "The extension of FDA's review time for iGlarLixi by three months to November 2016 is related to a request for additional information on the pen device. IGlarLixi is a combination of two already FDA approved diabetes medicines and has in clinical trials demonstrated significant benefits for adults with type 2 diabetes. The combination received a convincing positive recommendation for approval by an FDA advisory committee in May, and Sanofi believes that the additional information submitted will result in an offering that will serve the patient needs."   

Sanofi submitted the fixed-ratio combination of lixisenatide (Adlyxin^TM/Lyxumia^®) and basal insulin glargine 100 Units/mL (Lantus^®) for regulatory review by the European Medicines Agency (EMA) in March 2016. A regulatory decision is expected in Q1 2017.

Financial guidance for 2016 remains unchanged

The extension of the FDA review time for Sanofi's NDA for iGlarLixi in the U.S. by three months does not change Zealand's financial guidance for 2016.

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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, Investor Relations and Communications
Tel: +45 50 60 36 89, email: hlh@zealandpharma.com

Vedhæftede filer:

32-16_0820 Company announcement_Extension of FDA decision on iGlarLixi - ENG_Final.pdf