- FDA approval triggers a $25 million milestone payment and double-digit percentage royalties of net sales of Soliqua(TM) to Zealand
- Sanofi plans to make Soliqua(TM) available in U.S. retail pharmacies in January 2017
- Zealand management will host a teleconference on Tuesday 22 November at 4pm CET
DK standard access +45 32 71 16 60UK and international +44 (0) 20 3427 1919 U.S. (free dial-in) +1 646 254 3362Kindly inform the operator of the following passcode: "Zealand Pharma" or 4119215. A live audio webcast of the call including an accompanying slide presentation will be available via the following link, http://edge.media-server.com/m/p/ykcwu3fn accessible also from the company's website ( www.zealandpharma.com). Participants are advised to register for the webcast approximately 10 minutes before the start. A replay of the event will be made available from the Investor section of Zealand's website following the call. Terms of the license agreement with Sanofi Under the terms of the license agreement between Sanofi and Zealand, which covers lixisenatide and any combination product that includes lixisenatide, Sanofi is responsible for all development and commercialization including the financing. The approval of Soliqua(TM) by the U.S. FDA triggers a milestone payment of $25 million to Zealand from Sanofi. Zealand is eligible to receive remaining milestone payments of up to $110 million as well as royalties on global sales. Royalties correspond to tiered, low double-digit percentages of Sanofi's global sales of Adlyxin TM/Lyxumia ® plus a fixed low double-digit percentage of global net sales of Soliqua TM/Suliqua TM. ***** For further information, please contact: Britt Meelby Jensen, President and Chief Executive Officer Tel.: +45 51 67 61 28, e-mail: email@example.com Mats Blom, Senior Vice President, Chief Financial Officer Tel.: +45 31 53 79 73 , e-mail: firstname.lastname@example.org About Soliqua (TM) Soliqua(TM) is a once-daily, titratable fixed-ratio combination of lixisenatide GLP-1 receptor agonist (Adlyxin(TM)/Lyxumia ®) and basal insulin glargine 100 units/ml (Lantus ®) for the treatment of adults with type 2 diabetes. 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 licence 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 analogue 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 basal insulin glargine (Lantus ®) and is approved as Soliqua(TM) in the United States, and in Europe a CHMP positive opinion recommendation was given on 11 November. Suliqua(TM) is the brand name in Europe.Zealand's proprietary pipeline includes: Dasiglucagon * (ZP4207) (single-dose rescue treatment) for acute, severe hypoglycaemia (Phase II); Glepaglutide* (ZP1848) for short bowel syndrome (Phase II); Dasiglucagon* (ZP4207) (multiple-dose version) intended for use in a dual-hormone artificial pancreas system for better hypoglycaemia 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).  Data on file: IMS Q_Global Q4/2015, V.Kircher Attachments: http://www.globenewswire.com/NewsRoom/AttachmentNg/7d8398d4-4cd2-48d2-9757-8bf64765762c