Genmab A/S announced that the European Medicines Agency (EMEA) has confirmed the Marketing Authorization Application (MAA) for Arzerra (ofatumumab) for the treatment of chronic lymphocytic leukaemia (CLL) is valid and that the review procedure started on February 25, 2009.
If approved, ofatumumab would be indicated for the treatment of patients with CLL who have previously failed, or are inappropriate for, standard therapies. The MAA was submitted on February 5, 2009.
The acceptance of the MAA will trigger a milestone payment from GlaxoSmithKline to Genmab of DKK 58 million (approximately USD 10 million).
"We are excited to reach this important milestone so soon after submitting the Arzerra MAA to the European regulatory authorities," said Lisa N. Drakeman, chief executive officer of Genmab.
Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells. This epitope is different from the binding sites targeted by other CD20 antibodies currently available. The CD20 molecule is a key target in CLL therapy because it is expressed on most B-cells in CLL patients. In Europe, ofatumumab has been granted orphan designation for CLL as it affects approximately 3.5 in 10,000 persons in the European Union.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.