Copenhagen, 2014-06-17 10:17 CEST (GLOBE NEWSWIRE) -- Press Release
No. 5/2014
- Lyxumia® (lixisenatide): Results from an 8-week head-to-head study versus liraglutide support lixisenatide’s differentiated profile as the first once-daily GLP-1 agonist with a pronounced lowering effect on meal-related blood sugar
- LixiLan: Results from a Phase IIb study of the fixed-dose combination of Lyxumia® with Lantus® show robust blood sugar reduction (HbA1c to 6.3%) with weight loss, no increased hypoglycemia versus Lantus® and a very low incidence of nausea (7.5%) and vomiting (2.5%)
- In an IR Conference call, Sanofi informed that resubmission of a US NDA for lixisenatide is expected in Summer 2015 and confirmed planned NDA submission for LixiLan as early as the end of 2015
Copenhagen, 17 June 2014 – Zealand Pharma A/S (“Zealand”) (NASDAQ OMX Copenhagen: ZEAL) provides a summary of new clinical data and information presented on Lyxumia® (lixisenatide) and on LixiLan, the fixed-ratio combination of Lyxumia® with Lantus®, during the American Diabetes Association’s 74th Scientific Sessions, held in San Francisco, 13 – 17 June 2014.
Lixisenatide is Zealand’s own-invented once-daily prandial GLP-1 agonist, developed and marketed globally by Sanofi (EURONEXT: SANF.CO).
Commenting on the new data and the prospects for Lyxumia® and LixiLan, David Solomon, President and Chief Executive of Zealand, said:
“The new data presented at ADA provide further positive evidence of the differentiated therapeutic profile of Lyxumia® which makes this medicine particularly well-suited for combination treatment with basal insulin. In this respect, we are also pleased to note the Phase IIb results on LixiLan, showing that the fixed-ratio combination of Lyxumia® and Lantus provides a solid reduction in blood glucose with weight loss, very low GI events and no increased hypos versus Lantus® alone. We look forward to following Sanofi’s continued progress towards regulatory filing for lixisenatide and LixiLan in the US.”
In an 8-week pharmaco-dynamic study head-to-head versus liraglutide, lixisenatide showed a significantly more pronounced lowering effect on post-prandial (after-meal) blood glucose (blood sugar) when both are added to optimally titrated Lantus® (insulin glargine).
In the study, lowering of post-prandial glucose was measured as change from baseline in incremental area under the glucose curve for 4 hours after a standardized solid breakfast, at week 8. Findings also showed that while both lixisenatide and liraglutide lowered blood glucose (HbA1c) when added to optimally titrated insulin glargine, lixisenatide treatment also resulted in significantly delayed gastric emptying vs liraglutide, fewer reports of gastrointestinal adverse events, a lower mean increase in heart rate and smaller increases from baseline to week 8 in pancreatic enzyme (amylase and lipase) levels. The most commonly reported adverse events in the study were symptomatic hypoglycemia and nausea.
Lyxumia® is approved in 40 countries, including Europe and Japan. Launched in the first countries in April 2013, the product is being rolled-out country by country by Sanofi. In the US, Sanofi plans for an NDA resubmission in summer 2015.
Results from the Phase IIb study on LixiLan showed that the fixed-ratio combination of Lyxumia® with Lantus® (insulin glargine) (2 units glargine/1 microgr lixisenatide) gave robust HbA1c reduction with weight loss and no increased hypoglycemia versus Lantus® and with very low gastro-intestinal adverse events in Type 2 diabetes patients inadequately controlled on metformin.
At week 24, mean HbA1c was reduced to 6.3% and 6.5% with LixiLan and Lantus® respectively, establishing statistical superiority of LixiLan, and 84%/78% achieved HbA1c <7%. Body weight was reduced with LixiLan (p< 0.0001) with no increase in hypoglycemia events compared to Lantus®, and no severe hypoglycemia. Incidence of nausea/vomiting was only 7.5%/2.5% with LixiLan.
Since January 2014, the LixiLan fixed-ratio combination of Lyxumia® with Lantus® is in Phase III development with expected US NDA submission as early as at the end of 2015.
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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 Communications
Tel: +45 5060 3689, email: hlh@zealandpharma.com
About Zealand Zealand Pharma A/S (“Zealand”) (NASDAQ OMX 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 a mature portfolio of therapeutic products, which are all based on internal inventions. The company’s focus lies in the field of cardio-metabolic diseases, diabetes and obesity in particular, and its lead product is lixisenatide, a once-daily prandial GLP-1 agonist for the treatment of Type 2 diabetes, marketed as Lyxumia® under a license agreement with Sanofi. Lyxumia® is approved in several countries globally, including Europe and Japan. In the US, submission of an NDA is expected in 2015, after completion of a cardiovascular outcome study, ELIXA. A once-daily single injection combination of Lyxumia® and Lantus® (LixiLan) is in Phase III development by Sanofi with planned first regulatory filing as early as at the end of 2015. 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
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