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GlaxoSmithKline and Genmab Refocus Development Program for Ofatumumab in Autoimmune Indications

GlaxoSmithKline (GSK) and Genmab A/S (Copenhagen:GEN); Following the 1st July announcement by GSK and Genmab of an amendment to the collaborative agreement for ofatumumab in which GSK assumed development responsibility for autoimmune indications, GSK and Genmab announced today plans to refocus the development program of ofatumumab in autoimmune indications.

After review of the program's full development strategy, GSK will focus development efforts on the subcutaneous delivery of ofatumumab in autoimmune indications and will stop further development work on the intravenous route of administration in autoimmune disease.

Based on the positive results from the Phase I/II study in multiple sclerosis (MS) that were announced on 10th September, GSK plans to begin a Phase IIB dose ranging study in MS using the subcutaneous administration of ofatumumab in 2011following discussion with regulatory authorities. Further work in rheumatoid arthritis (RA) with a subcutaneous administration of ofatumumab is under review.

"Although the intravenous delivery of ofatumumab has previously demonstrated positive results in MS and RA studies, the autoimmune program is being refocused on the subcutaneous delivery of ofatumumab because GSK believes this route of administration has the potential to offer added convenience and improved tolerability," said Ian Tomlinson, SVP Biopharmaceuticals R&D, GSK.

"Genmab initiated the early development of ofatumumab in the autoimmune indications and we are pleased and highly supportive of GSK's continued commitment to the development of ofatumumab in these chronic diseases," said JanG. J. van de Winkel, Ph.D., President and CEO, Genmab.

Ofatumumab is currently not licensed for any autoimmune indications. GSK and Genmab will continue their development of ofatumumab in multiple oncology indications with the intravenous route of administration.
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