Novartis To Acquire GSK MS Drug for Up to $1 Bn
Novartis has agreed 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. Ofatumumab is to enter Phase III development for the MS indication.
Novartis will be responsible for the worldwide development, regulatory, and commercialization activities for ofatumumab. Under the agreement, Novartis 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.
The Novartis multiple sclerosis portfolio includes Gilenya (fingolimod), approved in the US for the first-line treatment of relapsing forms of MS in adults and in the European Union for adult patients with highly active RRMS defined as either high disease activity despite treatment with at least one DMT, or rapidly evolving severe RRMS. Gilenya is also being developed for pediatric MS and chronic inflammatory demyelinating polyneuropathy. Extavia (interferon beta-1b for subcutaneous injection) is approved in the US for the treatment of relapsing forms of MS. In Europe, Extavia is approved to treat people with relapsing remitting MS, secondary progressive MS with active disease, and people who have had a single clinical event suggestive of MS. Investigational compounds include BAF312, currently in Phase III clinical development and being investigated as an oral therapy for secondary progressive MS (SPMS). Novartis is also exploring the IL-17 pathway in MS with CJM112. Additionally, the Sandoz Division of Novartis markets Glatopa, the first generic version of Teva’s Copaxone 20mg.