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FDA Advisory Panel Makes Favorable Recommendation for GlaxoSmithKline and Genmab's ARZERRA(TM) (ofatumumab)
Date:5/29/2009

ORLANDO, Fla., May 29 /PRNewswire-FirstCall/ -- GlaxoSmithKline [NYSE: GSK] and Genmab A/S [OMX: GEN] today announced that the United States Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to three that the ARZERRA(TM) (ofatumumab) data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab. Ofatumumab is an investigational treatment.

"The committee's positive vote in support of ofatumumab is a potential milestone for patients with CLL. While current initial treatments for CLL can provide prolonged remissions, some patients will progress rapidly and relapse, which highlights the need for new therapies," said Debasish Roychowdhury, M.D., Senior Vice President and Head, Medicines Development, GlaxoSmithKline Oncology. "We look forward to working with the FDA towards an approval for ofatumumab."

CLL is the most common form of adult leukemia in the Western world, and the treatment of patients with relapsed disease remains a significant challenge. Patients who have not responded to current standard therapies, or whose disease has returned following prior treatments, typically experience poorer clinical outcomes such as infections and death. Less than 25 percent of CLL patients who are resistant to current treatments respond to available therapies.

"The positive vote by ODAC confirms that ofatumumab may offer a new treatment option for patients who have received prior therapies with this type of CLL," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "Today's vote is positive affirmation for this medicine, which is a result of years of dedicated research and collaboration between Genmab and GSK."

The advisory committee made its decision based on an interim analysis of a pivotal trial that was presented at the American Society of He
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SOURCE GlaxoSmithKline
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