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GSK leukemia treatment Arzerra filed for regulatory approval in Japan

Leukemia treatment Arzerra, developed by GlaxoSmithKline (NYSE:GSK) and drug partner Genmab (CSE:GEN), has been submitted for approval in Japan. Arzerra has currently received regulatory approval in the United States and Europe to treat chronic lymphocytic leukemia (CLL), a type of leukemia that progresses more slowly as it targets lymphocytes in the body’s immune system. CLL […]

Leukemia treatment Arzerra, developed by GlaxoSmithKline (NYSE:GSK) and drug partner Genmab (CSE:GEN), has been submitted for approval in Japan.

Arzerra has currently received regulatory approval in the United States and Europe to treat chronic lymphocytic leukemia (CLL), a type of leukemia that progresses more slowly as it targets lymphocytes in the body’s immune system. CLL is the most common type of leukemia in adults, according to the Mayo Clinic. Besides Arzerra, other drug therapies for treating CLL include Roche‘s (OTC:RHHBY) Rituxan. Rituxan generated $6.8 billion in 2011 sales for Roche. By comparison, Arzerra generated $71 million in 2011 global sales; $50 million in the United States. But approval of the Arzerra in other indications would boost the drug’s sales.

The GSK/Genmab partnership dates to 2006, when the companies entered an agreement to codevelop and commercialize ofatumumab, an antibody that targets the CD20 molecule. The agreement gave GSK exclusive worldwide rights to ofatumumab as well as any other antibodies that Genmab may develop that targets the molecule.

The U.S. Food and Drug Administration approved ofatumumab, now called Arzerra, in 2009. Arzerra is the first commercialized drug to emerge from Denmark-based Genmab’s drug pipeline. Britain-based GSK, which has its U.S. headquarters in Research Triangle Park, North Carolina, amended its partnership agreement with Genmab in 2010. The change gave GSK responsibility for developing ofatumumab in autoimmune indications. GSK continues to work with Genmab to develop the compound for other cancer indications.

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