GSK to sell its multiple sclerosis treatment drug to Novartis for $1 bn

Britain's biggest drugmaker GlaxoSmithKline (GSK) yesterday struck a deal to sell its experimental multiple sclerosis treatment drug to Swiss pharmaceutical giant Novartis Pharma AG for up to $1 billion.

Novartis had earlier acquired the oncology indications for ofatumumab (Arzerra) as part of the major three-part transaction between GSK and Novartis that completed earlier this year. After completion of the transaction announced yesterday, Novartis will own rights to ofatumumab in all indications.

Under the terms of the deal, Novartis' payment to GSK may reach up to $1.3 billion comprising $300 million payable at closing, $200 million payable subject to the start of a phase III study in relapsing remitting multiple sclerosis by Novartis and further contingent payments of up to $534 million payable on the achievement of certain other development milestones.

Novartis will also pay royalties of up to 12 per cent to GSK on any future net sales of ofatumumab in auto-immune indications.

"Novartis is pleased to further reinforce our commitment to neuroscience and to add an exciting new treatment to our strong MS portfolio," David Epstein, head of Novartis Pharmaceuticals, said in a statement.

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 is marketed under the brand name Arzerra.

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 per cent 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 was ready to begin phase III pivotal studies.

Epstein said, "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 commercialisation activities for Ofatumumab. Novartis will pay royalties of up to 12 per cent to GSK on any future net sales of Ofatumumab in auto-immune conditions.