Zealand announces that Sanofi has published top-line results from the ELIXA cardiovascular safety outcomes study of Lyxumia® (lix-isenatide)The results support re-submission by Sanofi for regulatory approval of lixisenatide in the US in Q3 2015Copenhagen, 2015-03-19 07:09 CET --
19 March 2015 – Zealand Pharma (Nasdaq Copenhagen: ZEAL) (“Zealand”) informs that Sanofi today has announced top-line results of the ELIXA study. ELIXA is the Phase IIIb cardio-vascular safety outcomes trial, which compared lixisenatide (Lyxumia®) to placebo in a high-risk population of adults with Type 2 diabetes for the evaluation of cardiovascular safety.
The results from the study, which enrolled more than 6,000 patients, showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety.
Lixisenatide is a once-daily prandial GLP-1 receptor agonist, invented by Zealand and developed and marketed worldwide ex-US by Sanofi. Lixisenatide is not approved in the US.
The full results of ELIXA will be presented Monday, June 8, 2015, at the American Diabetes Association (ADA) 75th Scientific Sessions in Boston by the ELIXA steering committee, chaired by Dr. Marc Pfeffer. The results will also be included in the U.S. New Drug Application (NDA) of lixisenatide, which Sanofi announced to be on track for re-submission to the U.S. Food and Drug Administration in Q3 2015.
In a comment to this announcement, Britt Meelby Jensen, President and CEO of Zealand, said:
“We are extremely pleased about the top-line results from the ELIXA study, demonstrating there is no additional cardiovascular risk related to treatment with lixisenatide in a high-risk patient population. We see the results providing further support for the therapeutic benefits of Lyxumia® as a novel prandial GLP-1 agonist and very importantly, the route is now clear for regulatory re-submission of the product in the US by Sanofi in Q3 this year.”
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For further information, please contact:
Britt Meelby Jensen, President and Chief Executive Officer
Tel: +45 5167 6128, email: bmj@zealandpharma.com
Hanne Leth Hillman, Vice President and Head of IR & Corporate Communications
Tel: +45 5060 3689, email: hlh@zealandpharma.com
About ELIXA
ELIXA (Evaluation of cardiovascular outcomes in patients with Type 2 diabetes after acute coronary syndrome during treatment with lixisenatide) is the first event-driven cardiovascular outcomes study to provide data for a glucagon-like peptide-1 receptor agonist (GLP-1 RA). ELIXA was a randomized, double-blind, parallel group trial designed to evaluate cardiovascular risk, comparing lixisenatide to placebo in a high-risk population of adults with type 2 diabetes. More than 6,000 adults with type 2 diabetes and high CV risk (i.e., patients who have recently experienced a spontaneous acute coronary syndrome event) participated in the trial. The composite primary endpoint, which was evaluated for non-inferiority and superiority, comprised cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina. The global ELIXA study started in June 2010 and was completed in 2015.
About Zealand Pharma
Zealand Pharma A/S (“Zealand”) (Nasdaq Copenhagen: ZEAL) is a biotechnology company based in Copenhagen, Denmark. Zealand has leading expertise in the discovery, design and development of novel peptide medicines and possesses in-house competences in clinical trial design and management with a therapeutic focus on metabolic diseases and acute care indications. The company is advancing a proprietary pipeline of novel medicines alongside a partnered product and development portfolio.
Zealand’s first invented medicine, lixisenatide, a once-daily prandial GLP-1 agonist for the treatment of Type 2 diabetes, is marketed globally (ex-US) as Lyxumia® and in Phase III development as a single-injection combination with Lantus® (LixiLan), both under a global license agreement with Sanofi. US regulatory submission of Lyxumia® is planned for Q3 2015 and US/EU regulatory submissions for LixiLan in Q4 2015.
Zealand proprietary pipeline includes danegaptide (prevention of Ischemic Reperfusion Injury) and the stable glucagon product, ZP4207 (treatment of severe hypoglycemia) as well as several preclinical peptide therapeutics. Partnering represents an important component of strategy to leverage in-house expertise, share development risk in large clinical trials, provide funding and commercialize the company’s products. Zealand currently has global license agreements and partnerships with Sanofi, Helsinn Healthcare, Boehringer Ingelheim and Eli Lilly.
For further information: www.zealandpharma.com Follow us on Twitter @ZealandPharma
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