Early this evening Dendreon received the nod from the FDA to use their new manufacturing plant in Seal Beach, California. The approval of this plant will allow the company to now service the men with advanced prostate cancer in Hawaii as well as more efficiently service those in Western United States with Provenge.
When coupling this approval with the recent approval of the extra workstations in their New Jersey plant Denfreon will be able turn out significantly more product, allowing more of us to obtain the treatment more quickly.
Dendreon says that they will be phasing in the new workstations over time, but our hopes are that they will be able to move quickly to train the additional techs. They will also need to expand their network of aphoresis sites.
The new California facility includes 36 workstations. With this FDA approval and the fully approved New Jersey facility, Dendreon now has total of 84 workstations available to manufacture Provenge. We urge Dendreon to dedicate some of this expanded capacity to opening more clinical trials for men with earlier state disease.
Additionally, Dendreon expects to continue expand their capacity through the anticipated licensure mid-year of one other manufacturing facility in Atlanta Georgia. The FDA has indicated an action date of August 28, 2011 on the Georgia plant.
In addition, Dendreon is hoping for CMS approval for national reimbursement through Medicare and Medicaid. The target date for that announcement is tomorrow, Thursday June 30.
Joel T Nowak, M.A., M.S.W.