EC conditionally approves Arzerra

The European Commission granted conditional approval to an MAA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Arzerra ofatumumab to treat chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab. Partner Genmab A/S (CSE:GEN) said full approval is contingent on the submission of data from an open-label study evaluating Arzerra vs. physician's choice and a Phase IV observational study. The approval triggers a DKK87 million ($15.8 million) milestone payment to Genmab from GSK, which has exclusive, worldwide rights from the biotech to co-develop and commercialize the mAb against CD20. Arzerra already has accelerated approval in the U.S. for the indication. Genmab, which made the announcement after market close, was down DKK0.55 to DKK66.80 on Monday. ...