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Genmab and GSK start phase III for ofatumumab for RA

Danish biotech Genmab and GlaxoSmithKline have begun a phase III programme with ofatumumab to treat rheumatoid arthritis.

Danish biotech Genmab and GlaxoSmithKline (GSK) have begun a phase III programme with ofatumumab (HuMax-CD20) to treat rheumatoid arthritis (RA).

Two studies will be conducted outside the US. One 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 are planned for 2008.

The studies 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.

The initial study will be followed by a 120-week open-label period during which re-treatment will be studied. The primary endpoint in each study is a greater than or equal to 20 per cent improvement in rheumatoid arthritis signs and symptoms, according to American College of Rheumatology criteria at 24 weeks.

In June 2007, Genmab reached the first development milestone for ofatumumab under the terms of its collaboration with GSK, which resulted in a payment of DKK 116.3m (USD 20.8m), triggered by positive efficacy results in the phase II RA
study. The payment did not influence Genmab's financial guidance for FY07.

Genmab licensed exclusive worldwide rights to co-develop and commercialise ofatumumab to GSK in December 2006. Genmab received a license fee of DKK 582m, while GSK invested DKK 2bn in Genmab shares. Genmab will be entitled to receive tiered double digit royalties on global sales of ofatumumab and further milestone payments.

30th September 2008

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