COPENHAGEN, Denmark, Feb. 4, 2013 (GLOBE NEWSWIRE) -- Zealand Pharma (NASDAQ OMX Copenhagen: ZEAL) announces that its partner Sanofi (EURONEXT: SAN and NYSE: SNY) has been granted a Marketing Authorization in Europe for Lyxumia® (lixisenatide) by the European Commission.
Lyxumia®, the once-daily prandial GLP-1 receptor agonist, was invented by Zealand Pharma and licensed to Sanofi, which holds global commercial rights for the drug. Lyxumia® has been indicated for the treatment of Type 2 diabetes in adults to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.
The European Commission's decision to grant Marketing Authorization in Europe for Lyxumia® is based on results from Sanofi's international GetGoal Phase III program, involving more than 5,000 patients with Type 2 diabetes in 11 clinical studies. As part of the program, a large number of patients were studied for an evaluation of the effects of Lyxumia® in combination with basal insulin (706 patients treated with Lyxumia® in three trials) 1.Results from GetGoal have enabled Lyxumia® to become the first once-daily GLP-1 receptor agonist with a predominantly prandial glucose lowering effect to be indicated for use on top of basal insulin and in combination with oral anti-diabetic medications. The results showed that treatment with Lyxumia® gave significant HbA1c reductions, a pronounced lowering of post-prandial glucose (after meal blood sugar levels) and a beneficial effect on body weight in adult patients with Type 2 diabetes. GetGoal results also showed that Lyxumia® had a favorable safety and tolerability profile in most patients, with mild and transient nausea and vomiting, the most common adverse events observed in the GLP-1 receptor agonist class, and a limited risk of hypoglycemia. Commenting on this announcement, David Solomon, President and CEO of Zealand Pharma, said: "The European approval of Lyxumia® is a key milestone for Zealand Pharma. The achievement of commercial status is the ultimate endorsement of Lyxumia's therapeutic potential and a validation of Zealand Pharma's peptide drug discovery and development capabilities. We are extremely gratified that our first discovered product, lixisenatide – branded as Lyxumia® by Sanofi, will soon be available for diabetes patients throughout Europe." "In clinical practice today, there is a strong need for more differentiated diabetes treatments. Patients with Type 2 diabetes are not all alike and the availability of additional GLP-1-based drugs with new pharmacological profiles is important to ensure a more effective management of diabetes," said Dr Filip K. Knop, MD, PhD, of Gentofte Hospital, University of Copenhagen. "One issue is that patients treated with basal insulin often move away from their target HbA1c despite well-controlled fasting plasma glucose. Adding a short acting GLP-1 receptor agonist with a pronounced effect on post-prandial glucose like once-daily Lyxumia® may be a good way of getting these patients back at target without increasing the risk of hypoglycemia." "With the European approval of Lyxumia®, we now have a simple new tool to help patients with Type 2 diabetes further reduce HbA1c, with the benefit of weight loss and limited risk of hypoglycaemia. This well-tolerated therapy is of specific interest to patients who are on oral treatments and / or basal insulin and do not manage to maintain their HbA1c targets," said Pierre Chancel, Senior Vice-President, Global Diabetes at Sanofi in a press release from Sanofi today . "With a single daily injection and only one step to maintenance dose, Lyxumia® is a positive addition to the Sanofi portfolio, and represents another step forward in our efforts to advance scientific excellence and develop new therapeutic solutions that improve outcomes for people with diabetes, an area of significant unmet medical need." Marketing Authorization for Lyxumia® in Europe is applicable to the 27 Member States of the European Union, as well as Iceland, Lichtenstein and Norway, and follows the positive recommendation issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency on 15 November 2012.