Novartis Acquires Remaining Rights to Ofatumumab by GSK for Multiple Sclerosis and Other Autoimmune Diseases

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by Patricia Silva, PhD |

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Pharmaceutical giant Novartis recently announced it has signed an agreement with GlaxoSmithKline for exclusive rights to GSK’s investigational CD20-specific monoclonal antibody, Ofatumumab, indicated for relapsing remitting multiple sclerosis (RRMS) and other autoimmune diseases. Novartis had previously acquired rights to the drug for its indications in oncology, effectively marketing it under brand name Arzerra®.

In multiple sclerosis, the immune system’s B cells are hyperactive and become destructive. The drug works by binding to CD20 molecules found on the surface of B cells, thereby facilitating these cells’ clearance from the lymphatic tissues. According to findings from a Phase IIa study of Ofatumumab administered via subcutaneous route, the drug is able to reduce the total number of new brain lesions in MS patients by up to 90% in 4-12 weeks. In light of these positive findings, the drug is now ready to proceed to Phase III trials.

“Novartis is pleased to further reinforce our commitment to neuroscience and to add an exciting new treatment to our strong MS portfolio,” said David Epstein, Head of 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.”

Under the newly signed agreement, Novartis will be overseeing the drug’s global activities for development, regulation and commercialization. GSK will be entitled to an upfront payment worth $300 million, followed by $200 million upon the launch of Ofatumumab’s Phase III studies. The agreement also stipulates milestone and contingent payments of up to $534 million, with Novartis paying GSK royalties of up to 12% on future net sales of the drug for autoimmune diseases.

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Novartis is already recognized as a leader in developing and commercializing multiple sclerosis therapies, with Gilenya and Extavia being the company’s two main FDA-approved drugs. Now the company will seek to further develop Ofatumumab into a viable FDA-approved RRMS therapy as well.

In other recent MS news, a survey of 97 neurologists conducted in June 2015 revealed specialists within the field of neurology are increasingly avoiding prescribing injectables to patients suffering from multiple sclerosis, as orally-available disease modifying-agents (DMAs) continue to gain in popularity.The survey was conducted and reported by Spherix Global Insights, a newly established business intelligence and market research company headquartered in Zug, Switzerland with US offices in Cambridge, MA. The company’s mission is to apply commercial experience and unique relationships within core specialty markets to translate data into insight, enabling clients to make smarter business decisions. Through their RealTime Dynamix large-scale primary market research service, Spherix was able to identify that a majority of both physicians’ and patients ‘ experience with oral DMAs has been positive, which bodes well for other products under this method of treatment.

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