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Biotech / Medical : MEDX ... anybody following? -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (1755)	6/18/2007 9:22:48 AM
From: nigel bates	Respond to of 2240

Genmab Announces Development Plans for Ofatumumab Monday June 18, 8:49 am ET Summary: Genmab Announces That Further Development Plans for Ofatumumab in Oncology and Autoimmune Disease Will be Described Today at GlaxoSmithKline's Oncology Seminar. COPENHAGEN, June 18 /PRNewswire-FirstCall/ -- Genmab A/S (CSE: GEN - News) announced that development plans for ofatumumab (HuMax-CD20®) will be described at GlaxoSmithKline's (GSK) Oncology Seminar today. Ofatumumab is currently in late stage development for chronic lymphocytic leukemia (CLL), follicular non-Hodgkin's lymphoma (NHL) and in Phase II for rheumatoid arthritis (RA) and is being developed under a worldwide co-development and commercialisation agreement between Genmab and GSK. A clear demonstration of the efficacy and safety of ofatumuamb in two late stage single-arm trials (CLL and follicular NHL), which are not routinely accepted as registration studies, could provide the initial regulatory applications. Genmab has received a Fast Track designation for the CLL study. Under these circumstances, ofatumumab could potentially enter the market in 2008 first for the treatment of refractory CLL and subsequently for rituximab-refractory follicular NHL. We furthermore expect to expand the ofatumumab program into new indications with the planned initiation of clinical studies in diffuse large B-cell lymphoma (DLBCL) by the end of 2007 and randomized Phase III studies in CLL and follicular NHL in the first half of 2008. In the autoimmune disease setting, we expect to initiate Phase III studies of ofatumumab in RA by the end of 2007. We also plan to expand the development program with initiation of a Phase II study in relapsing remitting multiple sclerosis (RRMS) in the first quarter of 2008. There is potential to pursue indications in a wide range of autoimmune disease settings.