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FDA Advisory Panel Makes Favorable Recommendation for GlaxoSmithKline and Genmab's ARZERRA(TM) (ofatumumab)
Date:5/29/2009

matology 2008 annual meeting and will be presented at the American Society of Clinical Oncology 2009 annual meeting.

About CLL

CLL is the most common adult leukemia and one of the most common malignant lymphoid diseases. In the United States, about 90,000 people are living with CLL, with approximately 15,000 estimated new cases being diagnosed in 2009. Based on 2007 worldwide estimates, leukemia (all types) accounted for more than 330,000 new cases and more than 245,000 deaths.

CLL cells are malignant B-cells that have a low concentration of CD20 molecules on their surface. B-cells normally protect the body from invading pathogens by developing into plasma cells, which make antibodies. These antibodies directly inactivate pathogens or attach to pathogens to prepare them for destruction by other white blood cells.

About Ofatumumab

Ofatumumab is an investigational monoclonal antibody that targets a membrane-proximal (close to the cell surface), small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule on B-cells. Ofatumumab also binds to the large loop of the CD20 molecule. The CD20 molecule is a key target in CLL therapy because it is highly expressed in most B-cell malignancies.

Ofatumumab is being developed under a collaboration between Genmab and the GSK Oncology and BioPharm R&D Units.

Ofatumumab is not yet approved in any country.

About GlaxoSmithKline (GSK)

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 company information, visit GlaxoSmithKline at www.gsk.com.

GSK Oncology is dedicated to producing innovations in cancer that
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SOURCE GlaxoSmithKline
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