Novartis announced today that it has entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline plc (GSK). Ofatumumab, a fully human monoclonal antibody which targets CD20, is being developed for relapsing remitting multiple sclerosis (RRMS) and other autoimmune indications. Novartis previously acquired the rights to Ofatumumab for oncology indications and it is marketed under the brand name Arzerra®.
RRMS is thought to be associated with activation of B cells, a type of white blood cell in the immune system. Ofatumumab works by binding to the CD20 molecule on the surface of B cells and depleting them in lymphatic tissues. Positive phase IIa results for subcutaneous Ofatumumab demonstrated significant reduction of up to 90% in the cumulative number of new brain lesions in patients with MS between weeks 4-12 in the study. No unexpected safety findings were reported in the study. Since this was a dose finding trial, Ofatumumab is ready to begin phase III pivotal studies.
Multiple sclerosis (MS) is a chronic disorder of the central nervous system (CNS) that disrupts the normal functioning of the brain and spinal cord through inflammation and tissue loss. More than 2.3 million people worldwide are affected by MS, a disease that most often begins in early adulthood. The typical evolution of MS results in progressive loss of both physical and cognitive (e.g. memory) functions. People with MS can be diagnosed with relapsing forms of MS (RMS), which include relapsing remitting MS (RRMS) and secondary progressive MS (SPMS), or with primary progressive MS (PPMS).
