Zealand Pharma announces a status update from Sanofi on the Lyxumia®/Lantus® combination programsCopenhagen, 2013-02-07 08:06 CET --
Zealand Pharma (NASDAQ OMX Copenhagen: ZEAL) announces that its licensing partner Sanofi (EURONEXT: SAN and NYSE: SNY) has today provided an update on the status of the Lyxumia® (lixisenatide) /Lantus® (insulin glargine) combination programs. In its 2012 full year earnings report, Sanofi stated that, owing to a recent technical issue encountered during the development of the Fix-Flex combination device, Phase III development for the combination of Lantus®/Lyxumia® will not be initiated in 2013, as previously planned.
Lyxumia® is a new, once-daily GLP-1 agonist invented by Zealand Pharma and licensed to Sanofi globally. Sanofi is responsible for the development and commercialization of the product, and is developing it for the treatment of Type 2 diabetes both as a stand-alone product and in combination with Lantus®, Sanofi’s world-leading basal insulin product.
Sanofi has filed for regulatory approval of lixisenatide in a large number of countries globally, including in the US, where an NDA was filed with the FDA in December 2012.
On Monday, 4 February 2013, Zealand Pharma along with Sanofi announced that Lyxumia® had been granted Marketing Authorization in Europe for the treatment of adults with Type 2 diabetes. The Marketing Authorization, which covers the 27 EU countries as well as Norway, Iceland and Lichtenstein, was granted on the basis of results from Sanofi’s international GetGoal Phase III program, involving more than 5,000 patients with Type 2 diabetes in 11 clinical studies. Regulatory approval for lixisenatide has also been granted in Mexico.
For the Lantus®/Lyxumia® combination product, Sanofi is developing the Fix-Flex device to allow for flexible dosing of Lantus® together with a fixed dose of Lyxumia®. In H2 2012, Sanofi entered industrialization, validation, usability and manufacturing phases with the Fix-Flex device in preparation for Phase III clinical studies of the combination product. In parallel, Sanofi is evaluating a Fixed-Ratio combination device; patient enrollment in a Phase IIb study of the Fixed-Ratio combination has been completed and study results are expected to be presented at a medical congress in 2013.
As part of the GetGoal program, a large number of patients were studied for an evaluation of the effects of Lyxumia® in combination with basal insulin, including Lantus® (706 patients treated with a free combination of Lyxumia® and Lantus® in three trials: GetGoal-L, GetGoal-L Asia and GetGoal Duo 1). Results from the GetGoal program demonstrate the clinical rationale for Lyxumia® as an add-on treatment to Lantus®. Zealand Pharma believes that having demonstrated a pronounced effect on post-prandial glucose, the combination of Lyxumia® with Lantus® can offer significant benefits in the treatment of diabetes.
Sanofi is currently reassessing timelines for the Lyxumia®/Lantus® combination development programs and an update is expected in due course.
Commenting on the update from Sanofi, David Solomon, President and CEO of Zealand Pharma, said: "While a delay by our global partner Sanofi to the timelines for start of Phase III studies of the Lantus®/Lyxumia® combination product is disappointing, the development is continuing and we look forward to further progress and the resolution of any technical issues. We also look forward to European launch of Lyxumia®, which we believe will provide further evidence of the key therapeutic benefits and unique positioning of this GLP-1 product for use in combination with Lantus®."
Financial guidance for 2013 and the terms of the Sanofi agreement
Zealand Pharma will provide financial guidance for 2013 in connection with the release of its 2012 full-year announcement on 14 March 2013.
Under the license agreement with Sanofi, which covers lixisenatide and combination products, including lixisenatide, Zealand Pharma 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, the company 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 Lyxumia® not currently in active development1.
References
1. 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 H. Solomon, President and Chief Executive Officer
Tel: +45 2220 6300
Hanne Leth Hillman, Vice President and Head of IR & Corporate Communication
Tel: +45 5060 3689, 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 is invented by Zealand Pharma and global rights to the product are licensed to Sanofi. Lyxumia® is the proprietary name approved by the European Medicines Agency (EMA) for the GLP-1 RA lixisenatide.
About Zealand Pharma
Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) is a biotechnology company based in Copenhagen, Denmark. Zealand Pharma 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 (Lyxumia®), a once-daily GLP-1 agonist, which is licensed to Sanofi for the treatment of Type 2 diabetes. Lyxumia® is approved in Europe (February 2013), and under regulatory review in a large number of other countries globally. In the US, a decision on NDA filing acceptance is expected from the FDA in Q1 2013.
Zealand Pharma 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. Zealand Pharma focuses its activities in disease areas where existing treatments fail to adequately serve patient needs and where the market potential for improved treatments through the use of peptide drugs is high. For further information: www.zealandpharma.com
About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services and devices, including innovative blood glucose monitoring systems. Sanofi markets both injectable and oral medications for people with Type 1 or Type 2 diabetes.
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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