CHMP issues positive opinion recommending Suliqua(TM) (iGlarLixi) for approval in the EU

Company announcement - No. 44/2016

CHMP issues positive opinion recommending Suliqua(TM) (iGlarLixi) for approval in the EU

• Positive opinion based on data from two Phase III studies, LixiLan-O and LixiLan-L
• Final decision from the European Commission expected in the coming months

Copenhagen, Denmark, Nov. 11, 2016 -- Zealand Pharma (Zealand) today announced that Sanofi has received a positive opinion from the Committee for Medicinal Product for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of Suliqua(TM), the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. CHMP recommended the use of Suliqua(TM) in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.

The CHMP positive opinion is based on data from two Phase III studies, LixiLan-O and LixiLan-L, which enrolled more than 1,900 adults with type 2 diabetes worldwide to evaluate the efficacy and safety of the fixed-ratio combination when used in patient populations insufficiently controlled after OADs and after basal insulin therapy, respectively. Both studies met their primary endpoints, demonstrating statistically superior HbA1c reduction versus lixisenatide and insulin glargine 100 Units/mL in LixiLan-O,1 and versus insulin glargine 100 Units/mL in LixiLan-L.

Suliqua(TM) is the brand name in Europe for the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide.

The CHMP positive opinion will be forwarded to the European Commission, which has the authority to approve medicines for the European Union. A formal decision by the European Commission is expected in the coming months.

Once approved, Sanofi will make Suliqua(TM) available in the EU in two pre-filled SoloSTAR^® pens, providing different dosing options that will help answer individual market and patient needs. The differentiation between the pen strengths is based on the dose range of each pen. The 10-40 SoloSTAR^® pre-filled pen will deliver 10 to 40 dose steps of insulin glargine in combination with 5 to 20 micrograms of lixisenatide. The 30-60 SoloSTAR^® pre-filled pen will deliver 30 to 60 dose steps of insulin glargine in combination with 10 to 20 micrograms of lixisenatide.

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.
  
Britt Meelby Jensen, President and Chief Executive Officer of Zealand commented: "We are pleased that Sanofi received the positive opinion from the CHMP on Suliqua(TM) (iGlarLixi) in the EU. The opinion is supported by robust data from the LixiLan phase III program showing substantial benefits to patients with type 2 diabetes. Suliqua(TM) will be marketed by Sanofi and an approval is expected to provide significant revenue to Zealand in the years to come. We look forward to the European decision in the coming months as well as the upcoming FDA decision in the U.S."

This fixed-ratio combination is currently under review in a total of nine markets, including the United States, where a U.S. Food and Drug Administration decision is anticipated later this month. 

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For further information, please contact:

Britt Meelby Jensen, President and Chief Executive Officer
Tel: +45 51 67 61 28, email: [email protected]

Mats Blom, Senior Vice President, Chief Financial Officer
Tel: +45 31 53 79 73, email: [email protected]

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines. Zealand has a portfolio of medicines and product candidates under license collaborations with Sanofi, Boehringer Ingelheim and Helsinn and a pipeline of proprietary product candidates, which primarily target specialty diseases with significant unmet needs.

The company's first invented medicine, lixisenatide, a once-daily prandial GLP-1 analog for the treatment of type 2 diabetes, is licensed to Sanofi. Lixisenatide is marketed as Lyxumia^® outside the United States and approved as Adlyxin^TM in the United States. Lixisenatide has been developed in a fixed-ratio combination with Lantus^® (insulin glargine) which product is under regulatory review in the United States and in Europe. 

Zealand's proprietary pipeline includes: Dasiglucagon^* (ZP4207) as single-dose rescue treatment for acute, severe hypoglycemia (Phase II); Glepaglutide* (ZP1848) for treatment of short bowel syndrome (Phase II); Dasiglucagon* (ZP4207) multiple-dose version intended for use in a dual-hormone artificial pancreas system for better hypoglycemia control and diabetes management (in preparation for Phase II); and other earlier stage clinical and preclinical peptide therapeutics.

Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the company's business and activities, please visit www.zealandpharma.com or follow Zealand on Twitter @ZealandPharma.
* Dasiglucagon and glepaglutide are proposed International Nonproprietary Names (pINN)  

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