GlaxoSmithKline and Genmab refocus development programme for ofatumumab in autoimmune indications

Issued: London UK and Copenhagen, Denmark

Following the 1st July announcement by GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) 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 programme of ofatumumab in autoimmune indications. After review of the programme’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 10^th September, GSK plans to begin a Phase IIB dose ranging study in MS using the subcutaneous administration of ofatumumab in 2011 following 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 programme 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 Jan G. 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.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

Genmab A/S - is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer. Genmab’s world class discovery and development teams are using cutting-edge technology to create and develop products to address unmet medical needs. Our primary goal is to improve the lives of patients who are in urgent need of new treatment options. For more information on Genmab’s products and technology, visit www.genmab.com.