Zealand reports Q4 2016 Lyxumia® royalty revenue

Company announcement - No. 3 / 2017

Zealand reports Q4 2016 Lyxumia® royalty revenue

Zealand receives royalty revenue of DKK 5.3 million / €0.7 million in Q4 2016 (and DKK 24.4 million / €3.3 million in full year 2016) from sales of Lyxumia® by Sanofi outside the United States.

Copenhagen, 8 February 2017 - Zealand Pharma (Zealand) reports royalty revenue from Sanofi's sales of Lyxumia® (lixisenatide) outside the United States of DKK 5.3 million / €0.7 million for Q4 2016. Zealand's annual royalty revenue in respect of Lyxumia® amounted to DKK 24.3 million / €3.3 million in 2016.

Lixisenatide is a once-daily prandial GLP-1 receptor agonist for the treatment of patients with type 2 diabetes and was invented by Zealand. Zealand licensed the global development and commercialization rights to lixisenatide to Sanofi. Lixisenatide is marketed under the brand name Lyxumia® in over 45 countries and was launched in the United States under the brand name Adlyxin(TM) in January 2017.

Sanofi has also developed a combination of lixisenatide and insulin glargine 100 units/mL (Lantus®), which was approved by: (i) the US Food and Drug Administration in November 2017 and is being marketed under the brand name Soliqua(TM)100/33 in the United States and (ii) the European Medicines Agency in January 2017 and is expected to be marketed in Europe under the brand name Suliqua(TM)[1].

Since January 2017, Soliqua(TM) 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) has been available by prescription in US pharmacies. Soliqua(TM) 100/33 is approved in the United States as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide alone. Sanofi has announced that it expects to launch marketing of Suliqua(TM) in certain EU countries in the second quarter of 2017.

For further information, please contact:

Britt Meelby Jensen, President and Chief Executive Officer
Tel: +45 51 67 61 28, email: bmj@zealandpharma.com

Mats Blom, Senior Vice President, Chief Financial Officer
Tel: +45 31 53 79 73, email: mabl@zealandpharma.com

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 that primarily target specialty diseases with significant unmet needs.

Zealand'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 Adlyxin(TM) in the US and Lyxumia® in the rest of the world. Lixisenatide has been developed in a combination with basal insulin glargine (Lantus®) and is marketed as Soliqua(TM) 100/33 in the US and has been approved as Suliqua(TM) in Europe.

Zealand's pipeline includes: dasiglucagon* (ZP4207, single-dose rescue treatment) for acute, severe hypoglycemia (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 hypoglycemia control and diabetes management (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).

[1] Approved in Europe in 2 doses (insulin 100 units/ml with lixisenatide 33 or 50 micrograms/ml)



Source: Zealand Pharma A/S