In case you are not aware, the cost of a Dendreon treatment is $93,000.00 which is not cheap by any means they anticipate upon approval that the price would be around the same in Europe. So far sales have been $48 Million and they are working on getting factories opened in Los Angeles, New Jersey and Atlanta. Also, CMS has a couple studies and evaluations ongoing here. BD
CMS To Require Study For Off Label Use for Provenge to Evaluate Risk of Strokes as Well as On Label Use as Approved by FDA
Dendreon took a big leap ahead last year when its new immune-boosting therapy for prostate cancer hit the U.S. market. Now in 2011, it is mapping out plans to take this new mode of treatment into the European Union for the first time.
The Seattle-based biotech company (NASDAQ: DNDN) said today that it plans to put together a new drug application for the approval of sipuleucel-T (Provenge) in Europe by the end of 2011 or in early 2012. Based on preliminary talks with regulators there, the company said it expects the same 512-patient trial that clinched Provenge’s approval in the U.S. ought to be good enough to seek approval in the EU as well. Dendreon also plans to build its own factory in Germany to serve the European market, based on a distribution model similar to the one used by its plants under construction in Los Angeles and Atlanta. The drug could be cleared for sale in Europe by the first half of 2013, the company said.
Dendreon has talked to investors about the potential in Europe, and whether it might seek help from a partner there. That never happened. Dendreon, which owns 100 percent of the commercial rights to its cancer drug in the U.S., has been making signals for at least a year about how it has had its eye on taking its drug to Europe, potentially on its own.