Copenhagen, 2013-05-02 07:38 CEST (GLOBE NEWSWIRE) -- Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) announces that its licensing partner Sanofi (EURONEXT:SAN and NYSE:SNY) today in its 2013 first quarter earnings report has provided an update on the status of the Lantus® (insulin glargine)/Lyxumia® (lixisenatide) single combination development program.
In the report, Sanofi stated: “Given a recent competitor setback in the United States and extended development timelines for a Fix-Flex device, priority has been assigned to a Fixed-Ratio combination of Lantus®/Lyxumia®, currently in Phase II. Development timelines will be shared at the time of the American Diabetes Association (ADA) meeting in June.”
Commenting on the update from Sanofi, David H. Solomon, President and CEO of Zealand, said: “We support the decision by Sanofi to prioritize the Fixed-Ratio combination and are very pleased that Sanofi’s ongoing commitment to the Lantus®/Lyxumia® single combination program is now publicly confirmed as an important part of its continued worldwide effort to meet the needs of people living with diabetes.
“We strongly believe in the rationale and potential for the combination of Lantus® and Lyxumia®. Lantus® is the world’s most prescribed basal insulin and has been demonstrated as safe and well tolerated in the ORIGIN (Outcome Reduction with Initial Glargine INtervention) trial conducted by Sanofi in over 12,500 patients, spanning 40 countries worldwide, while the clinical profile of Lyxumia® makes this product particularly relevant to better control blood sugar in combination with basal insulin, including Lantus®. We look forward to the next progress update from Sanofi in June at the ADA meeting.”
Lyxumia®, discovered by Zealand and licensed to Sanofi, was approved in Europe in February and has been launched by Sanofi in the UK and Germany among the first countries. The European roll-out is expected to continue through 2013, and the product is under regulatory review in the United States and a large number of other countries globally. Lyxumia® is indicated for the treatment of adults with Type 2 diabetes, including as add-on therapy to basal insulins, including Lantus®. To further advance the therapeutic rationale for a combination of Lyxumia® and Lantus®, as previously communicated, Sanofi is evaluating a Fix-Flex single product to allow for full flexible dosing of Lantus® combined with a fixed dose of Lyxumia® and in parallel a Fixed-Ratio combination product. Given a technical issue encountered during the last development steps of the Fix-Flex product, Sanofi earlier this year stated that Phase III development timelines were being re-assessed. In a Phase IIb study of the Fixed-Ratio combination product, the enrollment of 323 patients has been completed.
Financial guidance for 2013 and the terms of the Sanofi agreement
The announced decision by Sanofi to assign development priority to the Fixed-Ratio combination product does not change Zealand’s financial guidance for 2013 as stated in the company’s Full Year release and Annual Report for 2012 (Company Announcement 08-13). This includes expected revenues in 2013 from royalties on first sales of Lyxumia® (lixisenatide) and potential success based milestone payments from its collaboration partners. However, no revenue guidance is provided at this point in time, as Sanofi has not yet given guidance on the expected sales of Lyxumia® and as the timing of milestone based payments is largely outside Zealand’s control. Net operating expenses for the year are expected at a range of DKK 210-240 million (EUR 28-32 million).
Under the license agreement with Sanofi, which covers lixisenatide and combination products, including lixisenatide, Zealand is entitled to tiered low double-digit percentage royalties on global net sales of Lyxumia® and fixed low double-digit percentage royalties on full net sales of combination products including lixisenatide1.
Further, Zealand is eligible to receive remaining development, regulatory and sales milestone payments of up to USD 215 million, which include USD 40 million for a depot formulation of lixisenatide not currently in active development 1.
References
- Zealand Pharma pays 13% to Alkermes (former Elan) and 0.5% to SIP® technology inventor on all income from lixisenatide.
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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 Communication
Tel: +45 50 60 36 89, email: hlh@zealandpharma.com
About lixisenatide (Lyxumia®)
Lixisenatide (Lyxumia®) is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with Type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to stimulate glucose-dependent insulin secretion by pancreatic beta cells and suppress glucagon secretion from pancreatic alpha cells.
Lixisenatide was invented by Zealand Pharma and global rights to the product are licensed to Sanofi. Lixisenatide is approved in Europe (February 2013) under the name of Lyxumia®, and is currently under regulatory review in a large number of other countries globally, including in the US (filed in December 2012) and Japan (filed in June 2012).
About ZealandZealand 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 diabetes/metabolic diseases, 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 (February 2013) under the name of Lyxumia®, and under regulatory review in a large number of other countries globally, including in the US (NDA filed in Dec 2012) and Japan (NDA filed in June 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
