Green light for antibody drug
Copenhagen – British pharma firm GlaxoSmithKline and Danish biotech company Genmab finally won European backing for their leukaemia drug Arzerra in January, after the green light for the medicine was given by US regulators in October last year.
Arzerra (Ofatumumab) is the first of Genmab’s drug candidates to reach the market. The European Medicines Agency recommended conditional marketing authorisation for the antibody as treatment for chronic lymphocytic leukaemia in patients who do not respond to Genzyme’s Campath or the chemotherapy drug fludarabine (see p. 12). However, the agency added it wants to see further clinical data about the long-term use of Arzerra, as well as data on a specific group of patients who don’t respond to fludarabine but can’t be given Campath. GlaxoSmithKline and Genmab are aiming to position Arzerra as a rival to Roche’s and BioGen Idec’s blockbuster treatment Rituxan. GSK bought the global rights to the substance in December 2006 in a deal worth up to US$2.1bn, a record sum for a biotech product at that time. The world’s second largest drugmaker is also banking on Arzerra working in other diseases beyond CLL. But hopes for its use in patients with non-Hodgkin’s lymphoma (NHL) declined last year when a clinical trial failed. According to Thomson Pharma, forecasts for Arzerra suggest annual sales will reach US$465m in 2013.