Updated on 21 August 2015
Ofatumumab works by binding to the CD20 molecule on the surface of B cells
Singapore: Novartis has proceeded to acquire all remaining rights of GSK's Ofatumumab, a fully human monoclonal antibody which targets CD20, 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 percent 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.
"Novartis is pleased to further reinforce our commitment to neuroscience and to add an exciting new treatment to our strong MS portfolio," said Mr David Epstein, head, Novartis Pharmaceuticals. "Our vision for patients with MS is to develop treatments that improve on current standards of care, meeting patients' needs at every stage of their disease with innovative and targeted drugs."
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.
Novartis will be responsible for the worldwide development, regulatory and commercialization activities for Ofatumumab. Under the terms of the agreement, Novartis will make an initial upfront payment of USD300 million to GSK for the acquisition of the compound and a further payment of USD200 million payable following the start of a phase III study in MS by Novartis. Upon completion of pre-determined milestones, contingent payments of up to USD534 million may be made. Novartis will also pay royalties of up to 12 per cent to GSK on any future net sales of Ofatumumab in auto-immune conditions.