Dendreon to make sipuleucel-T available in Germany, the UK


According to a media release issued earlier today, Dendreon is planning to make sipuleucel-T (Provenge) available in Europe, beginning with Germany and the United Kingdom. However, the media release is short on any precision regarding the dates of such availability.

According to the public statement from Dendreon, the company will initially make sipuleucel-T “commercially available to patients within the approved label through Centers of Excellence using its Contract Manufacturing Organization, PharmaCell.”

The statement goes on to state that,

Following the implementation of automation, which will enable Dendreon to manufacture more cost effectively, the Company will explore opportunities to make PROVENGE more broadly available in Europe and other world markets.

Dendreon had actually received approval to market sipuleucel-T from the European Commission in September 2013 — for the treatment of men with asymptomatic or minimally symptomatic metastatic (non-visceral) castration-resistant prostate cancer for whom chemotherapy is not yet clinically indicated. In theory, this allows commercialization of sipuleucel-T in all 28 countries of the European Union, as well as Norway, Iceland, and Liechtenstein. What is also not so clear, however, is whether individual national regulatory agencies are going to be willing to facilitate access to this treatment, or to cover the costs of sipulecucel-T. We assume that this is a “work in progress.”

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