As reported in xconomy, Dendreon gave an update on its plans for marketing Provenge in Europe. The company said it will file an NDA with the EMA in last quarter 2011 or first quarter 2012. It expects to use the same clinical trial data that was submitted with it US application that gained approval in April 2010. Dendreon projects that it will receive approval to market the drug in Europe in 2013.
The European patient population for late stage prostate cancer is approximately 150,000-200,000 patinets or about 1.5 times that seen in the US. As a result, Dendreon plans to build another production facility in Germany that will mirror facilities it has built in Los Angeles and Atlanta in the US to produce Provenge. Right now, the company believes it can charge a similar price per treatment course in Europe as it charges in the US ($93,000).
Dendreon reported that it had revenues of $48 M on sales of Provenge in 2010 - more than half of which came in the final 3 months of the year. It predicts sales of $350-$400 M in 2011 - but also expects to lose between $310-$350 M dollars during the year as it continues to invest in marketing and manufacturing as well as in other therapeutic programs.
Posted by Bruce Lehr Jan 7th 2011.