Genmab and GlaxoSmithKline initiated a Phase III program with ofatumumab to treat rheumatoid arthritis (RA). The program will begin with two studies (GEN410/OFA110635 and GEN411/OFA110634) in two patient populations. One study will include 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. Additional 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 the drug. The studies will include a 24-week double-blind period followed by a 120-week open-label period. 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 III 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 R&D, GSK. 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 antibodies currently available or in development.