Launch on track — Mgmt indicated that first patient has been treated with Provenge. Recall that company estimated they would treat 2,000 pts within the first 12 months out of 50 sites. Company indicated that currently not all 50 sites have been in-serviced, however they expect to have all sites on line soon. Mgmt also commented that due to capacity constraints (recall that only 25 percent of the NJ facility is operational), sites will have a quota. If a site does not use up its quota, it will be provided to another site. The manufacturing facility will be operational 24/7.
Billing — Company noted they will be using a fiscal intermediary. Physicians’ offices will have 120 day payment terms, however McKesson will pay Dendreon in 45 days, less a modest financing discount. Company commented that McKesson will be bare the risk and deal with collections.
Europe — Company does not currently have a manufacturing site in Europe. However, mgmt noted they could do trials including bridging studies in Europe using third party manufacturers. But DNDN intends to have its own facilities in EU. They also indicated that they are unaware of any cross border blood product restrictions in Europe.
Japan — Mgmt commented that after Europe, their next focus will be Japan. They noted that the Japanese regulatory authorities will want to see a trial in their pt population prior to approval. Mgmt indicated they conducted a small trial 8-9 years ago, with product coming from a third party manufacturer.
