Bayer, Algeta Win U.S. Approval for Prostate Cancer Drug

Bayer AG and Algeta ASA won U.S. approval for their drug to treat an advanced prostate cancer that doesn’t respond to standard testosterone-lowering therapy.

The Food and Drug Administration cleared the medicine more than three months early for patients whose disease has spread to their bones, the agency said today in a statement. The drug, Xofigo, is designed treat the secondary cancer that has settled in the bones. Prostate cancer is the most common cancer among men after skin cancer, according to the American Cancer Society.

The injection, also known as radium-223, has similar properties to calcium and is drawn to bones, Oslo-based Algeta said on its website. The injection may generate $802 million in sales in 2017, according to the average of six analysts’ estimates compiled by Bloomberg.

“Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues,” Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products, said in the statement. “Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer.”

The FDA approved Medivation Inc.’s Xtandi for prostate cancer Aug. 31.

Xtandi, Johnson & Johnson’s Zytiga and Dendreon Corp.’s Provenge are approved for men suffering from prostate cancer that is resistant to hormone therapy and has spread to other parts of the body.

Bayer Partnership

Algeta signed an agreement in 2009 for Leverkusen, Germany-based Bayer to develop the treatment. The companies will co-promote the drug and split profit from sales in the U.S., Algeta said in a statement in April 2012.

Bayer rose 0.6 percent to close in Frankfurt at 85.03 euros, the highest price since 1992. Algeta fell 1.8 percent to 207.80 kroner in Oslo.

Xofigo will be available for patient treatment in a few weeks, the companies said.

“Most men with castration-resistant prostate cancer develop bone metastases, which can decrease overall survival,” Oliver Sartor, medical director of the Tulane Cancer Center in New Orleans who worked on the main trial on the drug, said in the companies’ statements. “Xofigo has demonstrated an anti-tumor effect on bone metastases and will be an important addition to the treatment of this cancer.”

Patients who took radium-223 in a clinical trial survived a median of 14 months compared with 11.2 months for men who took a placebo, the FDA said. Prostate cancer will be diagnosed in 238,590 men and 29,720 will die from the disease this year in the U.S., the Atlanta-based cancer society said.

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