Zealand Pharma A/S Partner Sanofi SA Receives Marketing Authorization In Europe For Lyxumia (Lixisenatide)


Monday, 4 Feb 2013 01:56am EST 

Zealand Pharma A/S announced that its partner Sanofi SA has been granted a Marketing Authorization in Europe for Lyxumia (lixisenatide) by the European Commission. 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). 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. Under the license agreement with Sanofi, which covers lixisenatide and combination products, including lixisenatide, Zealand Pharma is eligible to receive remaining development, regulatory and sales payments of up to USD 215 million, which include USD 40 million for a depot formulation of Lyxumia not currently in active development 2. 

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