Novartis signed an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline. The fully human monoclonal antibody, which targets the CD20 molecule, 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. Ofatumumab works by binding to CD20 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, according to officials at Novartis. 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 will be responsible for the worldwide development, regulatory, and commercialization activities for Ofatumumab. The company will make an initial upfront payment of $300 million to GSK for the acquisition of the compound and a further payment of $200 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 $534 million may be made. Novartis will also pay royalties of up to 12% to GSK on any future net sales of Ofatumumab in auto-immune conditions.