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GlaxoSmithKline sharpens ofatumumab's autoimmune focus

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Barely three months after GlaxoSmithKline took full responsibility for developing Genmab's ofatumumab in autoimmune indications, the company announced plans Sept. 16 to focus only on subcutaneous delivery of the anti-CD20 antibody because of the potential for added convenience and improved tolerability. Genmab announced July 1 that it had reworked its co-development and commercialization deal with GSK, turning over development of ofatumumab to GSK in that therapeutic area. The partners are proceeding together to develop ofatumumab in oncology indications, where it has entered the market as Arzerra. GSK will contribute heavily to those R&D costs in return for cutting back on Genmab's potential milestone payments down the road. On the autoimmune front, GSK plans to launch a Phase IIb dose-ranging study in multiple sclerosis in 2011 based on positive results from a Phase I/II study announced in September, and it is considering further work in rheumatoid arthritis with the sub-q formulation. In the 38-patient cross-over study in MS, repeated MRI scans showed a sustained reduction in brain lesions for up to 48 weeks in 26 patients treated with ofatumumab followed by placebo, while 12 patients who received placebo first showed similar 24-week results. Genmab found no dose-limiting toxicities and no unexpected safety findings

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