Friday, May 24, 2013

Algeta is declared the winner FDA approval for new treatment of prostate cancer - Boston Globe.

Norwegian drug maker Algeta ASA, which set up a US commercial business office in Cambridge's Kendall Rectangular in September, won Food and Illegal drug Administration approval Wednesday to market a new treatment for prostate cancer that's spread to the osseins.

Algeta's drug, called Xofigo, snacks castration-resistant prostate cancer, a disease that afflicts tens of thousands of men in the United States and much more worldwide. The drug works by releasing targeted alpha-particle-emitting radiation within the bones, killing cancer cells but doing limited trouble for surrounding healthy tissue, stretching out patients' lives.

"In however long it takes, what we're trying to complete is improve the patients' total well being, " said Jeff Albers, the Cambridge-based president of the company's Algeta US division.

Algeta will comarket Xofigo to US urologists and oncologists using German pharmaceutical giant Bayer AG. Bayer, which filed the completely new drug application with the FDA in addition to with European regulators, has exclusive rights to market Xofigo outside the u . s. The drug was developed in Oslo by Algeta, that struck a partnership by means of Bayer. The parties expect the drug to get approved in Europe by year's end.

Albers, some 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 in lieu of in Europe because "it's much easier to build a commercial footprint" available as one country. The company has on the subject of 80 employees in Norway and 80 in the united states, including about 20 in Cambridge, where its USA commercial, marketing, medical important affairs, and general operations tend to be based.

Wednesday's FDA approval came three months before the agency was scheduled to act on the US app in what already was deemed important review. In a proclamation, the agency said Algeta's treatment "demonstrates an capacity extend the survival of men with metastatic prostate cancers. " About 30, 000 die from the condition each year in the country.

Albers said the US sales arm eventually hopes promote other Algeta cancer drugs being developed in Norwegian. "Our vision is not to copromote this product, " he said. "Our vision is being a worldwide oncology company. We'll grow as time passes, but we're the right size now. "

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