Quarterly update on the commercialization of Lyxum

Copenhagen, 2013-10-30 08:25 CET (GLOBE NEWSWIRE) --  

• Lyxumia ^® , invented by Zealand for the treatment of Type 2 diabetes and licensed globally to Sanofi, was launched in the first market in March 2013
• Sanofi is rolling out Lyxumia ^® commercially country by country in Europe and in other countries, where the product has now been approved
• In Japan, where Lyxumia ^® was recently launched, the product provides the first GLP-1 receptor agonist in the country approved for use in combination with basal insulin
• Revenue to Zealand based on initial sales of Lyxumia ^® in Q2 and Q3 2013 amount to DKK 3.3 (EUR 0.4) million

Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) informs that Sanofi (EURONEXT: SAN and NYSE: SNY) today in its Q3 2013 earnings release has provided an update on the commercialization of Lyxumia ^® including initial sales revenue for the period. Subsequently, Zealand hereby reports initial resultant royalty revenues of DKK 3.3 (EUR 0.4) million from Sanofi for Q2 and Q3 2013.

Lyxumia ^® (lixisenatide) is a once-daily prandial GLP-1 receptor agonist invented by Zealand for the treatment of Type 2 diabetes with global rights to develop and market the product licensed to Sanofi.

Following EU approval in February 2013, Sanofi has now launched Lyxumia ^® in a number of European countries including the UK, Germany and Spain. In Germany, the Gemeinsamer Bundesausschuss (GBA) earlier in the year concluded that Lyxumia ^® had demonstrated no additional benefits over GBA selected anti-diabetes therapies. Sanofi disagrees with the GBA’s decision, which is due to factors including lack of clinical study data versus these comparators, and is evaluating its options.

In addition to the EU, Lyxumia ^® has now been approved in Mexico, Australia, Japan, Brazil, Colombia and Chile and is under review in a number of other countries globally.

In Japan, Lyxumia ^® was approved in June and has now been launched by Sanofi, making this diabetes medicine the first ever GLP-1 receptor agonist available in the country for use in combination with basal insulin. 

Sanofi will continue to roll-out the product gradually country by country as price and reimbursement negotiations are being settled.

In September 2013, Sanofi withdrew the New Drug Application (NDA) for lixisenatide in the U.S, which included early interim results from the ongoing ELIXA cardiovascular outcome study. The decision followed discussions with the Food and Drug Administration (FDA) regarding its proposed process for the review of the interim results from the ELIXA study. Sanofi believes that potential public disclosure of early interim data, even with safeguards, could compromise the integrity of the ongoing ELIXA study. The withdrawal of the NDA was not related to safety issues or deficiencies in the NDA. Sanofi plans to resubmit the NDA for lixisenatide in 2015, after completion of the ELIXA CV study.

The withdrawal of the US NDA has not changed Sanofi’s plans to start Phase III studies with the Lyxumia ^® /Lantus ^® combination product in H1 2014.

Financial outlook for 2013 and terms of the agreement with Sanofi

Zealand retains its financial outlook for 2013 as announced on 12 September 2013 (Company Announcement no. 23/2013), including expectations for Lyxumia ^® sales based revenue. As Sanofi has given no guidance on expected Lyxumia sales in 2013, Zealand cannot provide further revenue guidance at this point in time.

The company will release its interim report for the first 9 months of 2013 on 15 November 2013.

Under the license agreement with Sanofi, covering lixisenatide (Lyxumia ^® ) and any combination products including lixisenatide, Zealand is eligible to up to USD 175 million in remaining milestones. 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 lixisenatide Lixisenatide is approved in Europe for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Lixisenatide is also approved in Mexico, Australia, Japan, Brazil, Columbia and Chile for the treatment of adults with type 2 diabetes. Lyxumia ^® is the proprietary name approved by the European Medicines Agency and other health authorities for lixisenatide. Lixisenatide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) invented by Zealand for the treatment of patients with type 2 diabetes mellitus. Global rights to develop and commercialize the product are licensed to Sanofi. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells. About Zealand Pharma 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 prandial GLP-1 agonist, which is licensed to Sanofi for the treatment of Type 2 diabetes.  Lixisenatide (marketed by Sanofi as Lyxumia ^® ) is approved in several countries, including Europe and Japan, and under regulatory review in a number of other countries globally. In the U.S., an NDA is planned to be submitted in 2015, after completion of the ELIXA CV outcome study. Zealand has a partnering strategy for the development and commercialization of its products and in addition to the license agreement with Sanofi in Type 2 diabetes, the company has partnerships with Boehringer Ingelheim in diabetes/obesity, Lilly in diabetes and obesity, Helsinn Healthcare in chemotherapy induced diarrhea and AbbVie in acute kidney injury.   For further information: www.zealandpharma.com .   @ZealandPharma