EU approval for Novo Nordisk's Tresiba and Ryzodeg and for Novartis' for Bexsero

Following positive recommendations from the European Medicines Agency’s advisory committee, the European Medicines Agency’s Committee for Medicinal Products for Human (The Pharma Letter October 22, 2012), late yesterday Danish insulin giant Novo Nordisk (NOVN: N) announced that the European Commission has granted marketing authorizations for its once-daily Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) for the treatment of diabetes in adults. The authorizations cover all 27 European Union member states.

The European approval adds to that of Ryzodeg’s clearance in Japan last month (TPL December 27, 2012) and a recommendation for approval from a Food and Drug Administration advisory panel (TPL November 9, 2012). Novo Nordisk has touted the degludec products as having blockbuster potential, ie, annual sales of over $1 billion, and set to compete with Sanofi’s Lantus (insulin glargine), which holds some 80% of the global market for long-acting insulins and had sales of 3.92 billion euros (around $5 billion) last year. Analysts at Credit Suisse have a present net value for Tresiba and Ryzodeg in Europe of 14.76 Danish kroner per share (2% of total) and 7.74 kroner/share (1% of total), respectively, for Novo Nordisk.

Roll-out to start in UK and Denmark in first-half 2013