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By Catherine Larkin

June 20 (Bloomberg) -- Takeda Pharmaceutical Co., Japan's biggest drugmaker, won U.S. approval to expand marketing of Velcade for patients with the blood cancer multiple myeloma.

Velcade was cleared as an initial treatment for multiple myeloma, widening its use beyond the previous approval for patients who failed to benefit from other treatments, Takeda said in a statement. Osaka-based Takeda acquired the medicine in its $8.8 billion purchase of Cambridge, Massachusetts-based Millennium Pharmaceuticals Inc. in May.

The broadened Food and Drug Administration approval will help Velcade gain ground on Celgene Corp.'s top-selling Revlimid, which isn't approved as an initial therapy. Velcade helped 35 percent of newly diagnosed multiple myeloma patients achieve remission in a study released in December.

``We are excited for patients with previously untreated multiple myeloma, who now can benefit from Velcade, including its ability to deliver a significant increase in overall survival,'' said Deborah Dunsire, president and chief operating officer, Millennium Pharmaceuticals, The Takeda Oncology Company, in the statement.

Multiple myeloma causes excess plasma cells to form tumors in bone marrow and hinders the body's ability to fight infections. Almost 20,000 new cases will be diagnosed this year in the U.S., and about two-thirds of patients will die within five years, according to the American Cancer Society.

$1 Billion

U.S. sales of Velcade, approved in 2003, rose 20 percent last year to $265 million. The intravenous drug won additional FDA approval in 2006 for patients with a rare, aggressive form of blood cancer called mantle cell lymphoma. Wider use and data from new studies may push U.S. sales to $1 billion within five to six years, said Yasuhiro Nakazawa, an analyst at Mitsubishi UFJ Securities, in a June 2 note to clients.

Johnson & Johnson, of New Brunswick, New Jersey, sells Velcade outside the U.S., where sales topped $500 million last year.

Revlimid capsules are the top-selling product for Summit, New Jersey-based Celgene, bringing in $774 million last year.

Takeda bought Millennium to gain new drugs and research capacity before its diabetes medicine Actos, its biggest seller, and the heartburn treatment Prevacid face competition from lower- cost generics within the next three years.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

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