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.
"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."
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. More than 2.3 million people worldwide are affected by MS, a disease that most often begins in early adulthood. The typical evolution of MS results in progressive loss of both physical and cognitive (e.g. memory) functions. People with MS can be diagnosed with relapsing forms of MS (RMS), which include relapsing remitting MS (RRMS) and secondary progressive MS (SPMS), or with primary progressive MS (PPMS).
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 $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 per cent to GSK on any future net sales of Ofatumumab in auto-immune conditions.
About Novartis in Multiple Sclerosis
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 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. Gilenya® is also being developed for pediatric MS and chronic inflammatory demyelinating polyneuropathy (CIDP). 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(TM), the first generic version of Teva's Copaxone® 20mg.
Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world.