Date: 2015-12-21
Type of information: Product acquisition
Compound: ofatumumab
Company: Novartis (Switzerland) GSK (UK)
Therapeutic area: Autoimmune diseases
Type agreement: product acquisition
Action mechanism: monoclonal antibody. Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. The drug has been developed under a co-development and commercialization agreement between Genmab and GSK. On March 2, 2015, Genmab announced that GSK and Novartis Pharma AG (Novartis) have announced that the definitive agreement in which Novartis agreed to acquire GSK's oncology products including ofatumumab has been completed. As a result, the agreement Genmab entered with GSK and Novartis to transfer the ofatumumab collaboration from GSK to Novartis in November 2014 is now effective.
Disease: relapsing remitting multiple sclerosis (RRMS) and other autoimmune diseases
Details: * On December 21, 2015, GSK announced the completion of its transaction to divest its rights to ofatumumab for auto-immune indications to Novartis Pharma. Income generated from the divestment will be treated as non-core in line with the accounting policies outlined in the third quarter financial results announcement of 28 October 2015. * On August 21, 2015, Novartis announced that it has entered into an agreement to acquire all remaining rights to ofatumumab from 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®. Novartis will be responsible for the worldwide development, regulatory and commercialization activities for ofatumumab. 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. This acquisition strenghtens Novartis multiple sclerosis portfolio. This portfolio already includes Gilenya®(fingolimod), approved in the US for the first-line treatment of relapsing forms of MS in adults and in the EU for adult patients with highly active relapsing-remitting MS (RRMS) defined as either high disease activity despite treatment with at least one DMT, or rapidly evolving severe RRMS, Extavia® (interferon beta-1b for subcutaneous injection) 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 (siponimod), 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.
Financial terms: Under the terms of the agreement, the consideration payable by Novartis to GSK may reach up to $1,034 million and comprises a series of milestone payments as follows: • $300 million paid at closing
• $200 million payable subject to the start of a phase III study in relapsing remitting multiple sclerosis by Novartis
• further contingent payments of up to $534 million payable on the achievement of certain other development milestones.
Novartis Pharma will also pay royalties of up to 12 per cent to GSK on any future net sales of ofatumumab in auto-immune indications.
Latest news: * On March 8, 2016, Genmab announced an update on development plans for ofatumumab in autoimmune indications focusing on relapsing multiple sclerosis following the transfer of the rights to ofatumumab in this disease area from GSK to Novartis at the end of 2015. Phase III studies are expected to be initiated by Novartis with the subcutaneous formulation of ofatumumab as therapy for patients with relapsing multiple sclerosis during the second half of 2016. The Phase III study of the subcutaneous formulation of ofatumumab in pemphigus vulgaris, which was started by GSK will be discontinued to focus on relapsing multiple sclerosis. The decision to discontinue the trial was not related to any safety or tolerability concerns. There are no current plans to develop ofatumumab in neuromyelitis optica. * On December 21, 2015, Genmab announced that the agreement under which GSK grants Novartis the remaining rights to ofatumumab, including rights in autoimmune diseases, is now effective. The agreement was announced in August 2015 and was subject to certain closing conditions, which have now been met. Novartis will be responsible for the development and commercialization of ofatumumab for all indications going forward.
