You have to hand it to Dendreon ($DNDN): It knows drama. The company sent out a release this morning, announcing a conference call to talk about its plans for the closely watched cancer vaccine Provenge. A few tantalizing details were included--such as an expected date for European approval--but for more, we'd have to wait for the call.
Well, Dendreon is planing to file for European approval of the prostate vax late this year or early next, with approval expected in 2013. After meeting with regulators, the company believes it won't need any new data for the new application. Rolling out the product in Europe will require more manufacturing capacity--a factor Dendreon is already dealing with in the U.S.--so, it's planning to hire a contract manufacturer to supply the European market initially while it builds a plant in Germany. It's also going to need to raise some financing.
Dendreon figures the European market for Provenge is about the size of the U.S. market, Bloomberg reports. And in the U.S., Dendreon pulled in $48 million in Provenge revenue for 2010 and predicted 2011 sales of $350 million to $400 million, about half of that in the fourth quarter as new production plants come online. Deutsche Bank raised its price target on the stock to $54 on the news.
The question is whether European governments will be willing to hand over the $90,000 sticker price for Provenge treatment. The drug faced an unusual hearing before the Centers for Medicare and Medicaid Services, apparently for information on covering off-label uses. The CMS review decision sparked an outcry in the U.S., but it's the order of the day across the Atlantic. We'd love to know how Dendreon plans to price Provenge on the continent. But for that we'll probably have to wait for another conference call.