Copenhagen, 2013-08-01 07:32 CEST (GLOBE NEWSWIRE) --
| Company Announcement No. 19/2013 |
? Lyxumia ® was approved in Europe in February 2013 and in Germany, the first EU country, where Sanofi has launched the product, Lyxumia ® has now gained +10% of the weekly GLP-1 market in volume after 18 weeks on the market
? Sanofi expects to continue the commercialization of Lyxumia ® to include additional markets in 2013
Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) informs that Sanofi (EURONEXT: SAN and NYSE: SNY) today in its quarterly release for Q2 2013 has provided an update on the commercial roll-out of Lyxumia ® . Lyxumia ® (lixisenatide) is a once-daily prandial GLP-1 receptor agonist invented by Zealand for the treatment of Type 2 diabetes with world-wide rights to develop and market the product licensed to Sanofi.
In February 2013, Lyxumia ® was granted approval in the Europe Union and since then it has been launched by Sanofi in the first European markets. In Germany, where Lyxumia ® was launched at the end of March, the product has gained 10.3% of the weekly GLP-1 market in volume after only 18 weeks on the market. Lyxumia ® has also been launched in some Scandinavian markets. In the United Kingdom, where Sanofi is introducing the product in a step-wise approach, full commercial launch is expected later this year. Based on Sanofi’s first net sales of Lyxumia ® in the first half of 2013, Zealand expects to report initial royalty revenues in connection with its Interim report for the 2 nd quarter 2013 planned for release on 29 August 2013.
Lyxumia ® has also been approved in Mexico and Australia and in June 2013 Lyxumia ® received approval in Japan, making Lyxumia ® the first GLP-1 receptor agonist approved in Japan for use in combination with basal insulin. Further commercial roll-out of the product is expected in 2013.
In the United States, the product is undergoing regulatory review by the Food and Drug Administration (FDA) following their acceptance in February 2013 of the New Drug Application (NDA) submitted by Sanofi.
Commenting on the update on Lyxumia ® , David Solomon, President and CEO of Zealand, said:
“We are delighted to see the continuous regulatory and commercial advances for Lyxumia ® as a new medicine to be offered patients with Type 2 diabetes. We are firm believers in the overall prospects for the GLP-1 receptor agonist class and we are convinced that Lyxumia ® has a strong product profile.
”In relation to the potential for GLP-1 based medicines, of which Zealand has more in its pipeline beyond Lyxumia ® , we are reassured by the recent communication of the EMA, with which the FDA has concurred, continuing to support the positive risk-benefit of these products.”
Financial outlook for 2013 and terms of the agreement with Sanofi
For the full year 2013, Zealand retains its financial outlook as announced in the company’s Q1 2013 Interim Report from 15 May 2013 (Company Announcement no. 14/2013), including expectations for revenue from royalties on first sales of Lyxumia ® .
Zealand will release its Q2 2013 Interim report on 29 August 2013.
Under the license agreement with Sanofi, covering lixisenatide (Lyxumia ® ) and any combination products including lixisenatide, Zealand is entitled to up to a total of USD 275 million in milestone payments, of which up to potentially USD 175 million are outstanding. Further, Zealand will receive tiered low double-digit percentage royalties on Sanofi’s global sales of Lyxumia ® and fixed low double-digit percentage royalties on global full net sales of the Lantus ® /Lyxumia ® combination product.
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For further information, please contact:
David Solomon, President and Chief Executive Officer – Tel: +45 22 20 63 00
Hanne Leth Hillman, Vice President, Head of Investor Relations & Corporate Communications – Tel: +45 50 60 36 89, email: hlh@zealandpharma.com
About Zealand
Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) is a biotechnology company based in Copenhagen, Denmark. Zealand specializes in the discovery, optimization and development of novel peptide drugs and has a broad and mature pipeline of drug candidates identified through its own drug discovery activities. The company’s focus lies in the field of cardio-metabolic diseases, diabetes and obesity in particular, and its lead drug invention is lixisenatide, a once-daily GLP-1 agonist, which is licensed to Sanofi for the treatment of Type 2 diabetes. Lixisenatide is approved in Europe, Japan, Australia and Mexico and marketed by Sanofi under the name of Lyxumia ® . Lixisenatide is under regulatory review in a large number of other countries globally, including in the US (NDA submission accepted in Feb 2013).
Zealand has a partnering strategy for the development and commercialization of its products and in addition to the collaboration with Sanofi in Type 2 diabetes, the company has partnerships with Boehringer Ingelheim in diabetes/obesity, Helsinn Healthcare in chemotherapy induced diarrhea and AbbVie in acute kidney injury.
For further information: www.zealandpharma.com .
@ZealandPharma
