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Genmab and GlaxoSmithKline Initiate Ofatumumab Rheumatoid Arthritis Phase III Program
Date:11/20/2007

Summary: Genmab and GSK Have Announced the Initiation of the Phase III

Program With Ofatumumab to Treat Rheumatoid Arthritis.

COPENHAGEN, Denmark, November 20 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) and GlaxoSmithKline (LSE and NYSE: GSK) announced today the initiation of the Phase III program with ofatumumab to treat rheumatoid arthritis (RA). The program will commence with two studies (GEN410/OFA110635 and GEN411/OFA110634) which will be conducted outside the US, in two distinct patient populations. One study will be in patients who have had an inadequate response to methotrexate therapy and the other in patients who had an inadequate response to TNF-alpha antagonist therapy. Further studies to support the program are planned for 2008.

Each study will evaluate the efficacy of ofatumumab in reducing the clinical signs and symptoms in RA patients after a single course of ofatumumab and are comprised of a 24 week double-blind period followed by a 120 week open-label period during which re-treatment will be studied. The primary endpoint in each study is ACR20 at 24 weeks.

"This brings us closer to our goal of broadening the treatment options for patients with this painful and debilitating disease," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "From the data to date, we believe that ofatumumab has real potential. Now that Phase 3 studies are underway in multiple indications, we are moving closer to realizing this potential and bringing this important treatment to patients."

"We are very pleased that our collaboration with Genmab has progressed so that we can now move to the next step of the clinical trial program," said Dr. Moncef Slaoui, Chairman of Research and Development, GlaxoSmithKline. Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of B-cells. This epitope is different than other anti-CD20 a
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SOURCE Genmab A/S
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