- Lixisenatide (Lyxumia ® ) demonstrated to be safe versus placebo on all cardio-vascular safety parameters in a high-risk population of adults with Type 2 diabetes
- No signal for increased risk of heart failure, pancreatitis, pancreatic cancer or severe symptomatic hypoglycemia
- Results will be included in Sanofi’s US NDA for lixisenatide, which is on track for re-submission in Q3 2015
- The results further validate Lyxumia ® as a Zealand-invented peptide medicine and provide further support for the value proposition to Zealand of also the LixiLan single-injection combination of Lyxumia ® with Lantus ®
Copenhagen, 8 June 2015 – Zealand Pharma A/S (“Zealand”) (Nasdaq Copenhagen: ZEAL) announces that today, in a keynote symposium at the 75 th Scientific Sessions of the American Diabetes Association (ADA) in Boston, data from the ELIXA Cardiovascular Safety Outcome Trial on lixisenatide was reported and discussed. The discussions were led by the ELIXA steering committee.
ELIXA was a randomized, double-blind, parallel group trial which evaluated cardiovascular risk, comparing lixisenatide to placebo in more than 6,000 high-risk adults with Type 2 diabetes.
Previously reported top-line results from ELIXA showed that the pre-specified criterion of non-inferiority, but not superiority, on cardiovascular safety was met for lixisenatide versus placebo. This was measured on the composite primary endpoint of MACE+, including evaluation of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for unstable angina. Additional safety findings included no signal for lixisenatide on increased risk of heart failure, pancreatitis, pancreatic cancer or severe symptomatic hypoglycemia. Lixisenatide was generally safe and well tolerated; nausea and vomiting, which are known side effects of the GLP-1 RA class, were observed more frequently with lixisenatide.
Britt Meelby Jensen, President and Chief Executive Officer of Zealand Pharma, commented :
“ We are very pleased to see the results from the ELIXA study as reported today, placing Lyxumia ® as the first and only GLP-1 receptor agonist with cardiovascular safety proven in a long-term outcome study.
The results are an important milestone for Zealand as they further validate lixisenatide as a Zealand-invented peptide medicine as well as the value of our license agreement with Sanofi. The route is now clear for Sanofi to re-submit for US regulatory approval of lixisenatide in the US in Q3. We also see ELIXA supporting the value proposition of LixiLan, as a single injection combination of Lantus ® and Lyxumia ® , which is planned for US regulatory filing in Q4 2015, pending the Phase III results expected in Q3.”
Lixisenatide is a Zealand-invented prandial GLP-1 receptor agonist for once-daily administration. Global development and commercial rights are licensed to Sanofi who is marketing the product worldwide ex-US as Lyxumia ® for the treatment of adults with type 2 diabetes. In the US, Sanofi plans to submit a New Drug Application for regulatory approval of lixisenatide in Q3 2015, substantiated by the results of ELIXA. Sanofi is also developing a single-injection combination of Lyxumia ® with Lantus ® in Phase III with results expected in Q3 2015 followed by planned US regulatory submission in the US Q4 2015 and in the EU in Q1 2016.
ELIXA results
Lixisenatide met the pre-specified criterion of non-inferiority versus placebo for the composite primary endpoint of MACE+: CV death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for unstable angina (Hazard Ratio [95% confidence interval (CI)]: 1.017 [0.886 to 1.168]). The trial did not show superiority over placebo the composite primary endpoint, since the upper bound of the 95% CI was >1.0.
The CV safety of lixisenatide was also confirmed by further analyses, including on MACE Hazard Ratio [95% CI]: 1.02 [0.887 to 1.172]. No signal for increased risk of heart failure (HF) was observed (Hazard Ratio [95% CI]: 0.96 [0.75 to 1.23]).
Additional safety measures showed no increase in pancreatitis (0.2% with lixisenatide and 0.3% with placebo), pancreatic cancer (<0.1% with lixisenatide and 0.3% with placebo), severe symptomatic hypoglycemia (0.3 events per 100 patient-years with lixisenatide; 0.6 per 100 patient-years with placebo), malignancy (2.9% with lixisenatide and 2.6% with placebo), or drug-related allergic reactions (0.2% with both lixisenatide and placebo).
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For further information, please contact:
Britt Meelby Jensen, President and Chief Executive Officer
Tel: +45 51 67 61 28, email: bmj@zealandpharma.com
Hanne Leth Hillman, Senior Vice President, Investor Relations & Corporate Communications
Tel: +45 50 60 36 89, 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 is in Phase III development as a single-injection combination with Lantus ® (LixiLan), both under a global license agreement with Sanofi. US regulatory filing for Lyxumia ® is planned for Q3 2015 and filing for LixiLan is planned for Q4 2015 in the US and Q1 2016 in Europe.
Zealand’s proprietary pipeline includes danegaptide (prevention of Ischemic Reperfusion Injury) and two stable glucagon products, ZP4207 (one for treatment of severe hypoglycemia and the other for mild to moderate hypoglycemia) as well as several preclinical peptide therapeutics. Partnering represents an important component of strategy to leverage inhouse 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 and Boehringer Ingelheim.
For further information: www.zealandpharma.com Follow us on Twitter @ZealandPharma
