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GSK refocuses MS drug development

GlaxoSmithKline has decided to refocus development efforts for MS drug ofatumumab on an injectable rather than an intravenous formulation

GlaxoSmithKline (GSK) has decided to refocus development efforts for ofatumumab, a human monoclonal antibody being tested for multiple sclerosis (MS) and other autoimmune indications, on an injectable rather than an intravenous formulation. This is in order to maximise convenience and tolerability for patients.

GSK and the Danish firm Genmab restructured their collaborative agreement for the drug this summer in order to give GSK development responsibility for autoimmune indications. Following that change, GSK reviewed the development strategy and determined that it should focus on the subcutaneous delivery of ofatumumab in autoimmune indications.

GSK said it will stop development of the intravenous version in autoimmune disease in spite of clinical data showing efficacy for the formulation in MS and rheumatoid arthritis.

Earlier this month, the companies released positive phase I/II study data for ofatumumab in MS. GSK plans to begin a phase IIb dose ranging study in MS using the subcutaneous formulation next year. Further development of the subcutaneous drug in rheumatoid arthritis is under review, the company said.

The two companies continue to be jointly responsible for the development of an intravenous formulation of the product for oncology indications. A phase II trial of ofatumumab in combination with bendamustine in patients with indolent B-cell non-Hodgkin's lymphoma was initiated in early September.

16th September 2010

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