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Genmab Rises After FDA Grants Breakthrough Therapy Status

May 2 (Bloomberg) -- Genmab A/S rose the most in almost two months after U.S. regulators granted “breakthrough therapy” designation to an experimental cancer drug the Danish company is developing with Johnson & Johnson.

Genmab surged 8.7 percent, the most since March 8, to close at 157 kroner in Copenhagen. That’s the highest price since August 2009.

Genmab’s daratumumab is being developed to treat multiple myeloma, a type of cancer that starts in the plasma cells in bone marrow. The designation by the U.S. Food and Drug Administration, announced late yesterday, may speed up the market introduction of the treatment to 2015 from 2017, Michael Novod, an analyst with Nordea in Copenhagen, said in a note.

Breakthrough therapy is “the strongest possible designation the FDA can award to highlight an unmet medical need and potentially speed up development times considerably,” Novod said. “Furthermore, we expect it to massively increase awareness about the project.”

The market for multiple myeloma is “set to grow rapidly,” approaching $9 billion in 2020 amid better diagnosis and treatment of the disease, Novod said in March.

Separately, Genmab yesterday also released results from a mid-stage study of its experimental treatment ofatumumab for chronic lymphocytic leukemia. The overall response rate was 95 percent in the 44 patients who hadn’t received treatment before, and 74 percent in the 53 patients whose disease had relapsed, Genmab said.

The results compare favorably with those observed with Roche Holding AG’s competing Rituxan therapy, Samir Devani, an analyst at Nomura Code Securities Ltd., said in a note today.

To contact the reporter on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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