Sanofi submits MAA for lixisenatide
Copenhagen/Paris - The cooperation between Danish biopharmaceutical company Zealand Pharma and French drugmaker Sanofi has borne its first fruit. Sanofi has submitted a marketing authorisation application for Lyxumia (lixisenatide) in Europe. Submission for regulatory approval in the USA is expected at the end of 2012. Lixisenatide is a once-daily GLP-1 receptor agonist discovered by Zealand Pharma and licensed to Sanofi, which is completing Phase III development of the drug as a monotherapy and as an add-on to existing diabetes type 2 treatments, preferably Sanofi's Lantus. According to analysts, the Lyxumia-Lantus combination will commence Phase III trials in early-2013. The actual filing is based on the phase III GetGoal study, comprising data from nine studies and more than 4,300 patients. Under the agreement with Sanofi, Zealand Pharma is eligible to receive remaining milestone payments of up to EUR 170m covering different formulations and combinations of lixisenatide. For Zealand Pharmaceuticals, founded in 1998, the deal is hugely important. Zealand chief executive David Solomon said the European submission "represents a transformational milestone" for the company. Lixisenatide, synthesized in the company's first year, is the most advanced compound in the pipeline.