Norwegian drug maker Algeta ASA, which set up a US commercial office in Cambridge’s Kendall Square in September, won Food and Drug Administration approval Wednesday to sell a new treatment for prostate cancer that has spread to the bones.
Algeta’s drug, called Xofigo, treats castration-resistant prostate cancer, a disease that afflicts tens of thousands of men in the United States and many more worldwide. The drug works by releasing targeted alpha-particle-emitting radiation into the bones, killing cancer cells but doing limited damage to surrounding healthy tissue, extending patients’ lives.
“In the long term, what we’re trying to do is improve the patients’ quality of life,” said Jeff Albers, the Cambridge-based president of the company’s Algeta US division.
Algeta will comarket Xofigo to US urologists and oncologists with German pharmaceutical giant Bayer AG. Bayer, which filed the new drug application with the FDA as well as with European regulators, has exclusive rights to market Xofigo outside the United States. The drug was developed in Oslo by Algeta, which struck a partnership with Bayer. The parties expect the drug to be approved in Europe by year’s end.
Albers, a veteran of Cambridge biotechnology firm Genzyme Corp., joined Algeta a year and a half ago. He said Algeta chose to set up its own sales force here rather than in Europe because “it’s easier to build a commercial footprint” in a single country. The company has about 80 employees in Norway and 80 in the United States, including about 20 in Cambridge, where its US commercial, marketing, medical affairs, and general operations are based.
Wednesday’s FDA approval came three months before the agency was scheduled to act on the US application in what already was deemed a priority review. In a statement, the agency said Algeta’s treatment “demonstrates an ability to extend the survival of men with metastatic prostate cancer.” About 30,000 die from the condition each year in the United States.
Albers said the US sales arm eventually hopes to market other Algeta cancer drugs being developed in Norway. “Our vision is not just to copromote this product,” he said. “Our vision is to become a worldwide oncology company. We’ll grow over time, but we’re the right size now.”