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Dendreon will outsource first Provenge production in EU

Published on 11/01/11 at 09:43am

US oncology specialist Dendreon has decided to hire a contract manufacturer for its cell-based cancer therapy Provenge in Europe to handle initial demand while it builds a dedicated facility in Germany.

Provenge (sipuleucel-T) was launched in the US as a treatment for advanced prostate cancer last May, and became the first autologous cellular immunotherapy - a patient's own antigen-presenting cells to stimulate the body's immune system against cancer - anywhere in the world.

The product brought in $48 million in its first few months on the market, despite being held back by manufacturing capacity constraints which have led to long waiting lists for patients eager to get treatment with the therapy.

Dendreon has been working hard to ramp up US production by bringing new production lines online at its existing plant in New Jersey, and additional facilities due to start production in Los Angeles and Atlanta in the middle of this year will help it achieve a 'tenfold' increase in capacity. That should help boost sales to $350 million to $400 million in 2011, the firm said.

The company seems determined to avoid any such hold-ups in Europe, particularly as it now believes it will be able to use data from its US registration dossier in its EU marketing authorisation application. That means it could be in a position to seek approval in the EU in late 2011 or early 2012, with a green light expected in the first half of 2013.

The company announced its European plans on a conference call on Friday, but did not disclose either the cost of building the German manufacturing plant, or how long construction is expected to take.

Dendreon did say however that it will need to raise additional funding to carry out the European expansion programme.

The company also reported progress with its other autologous cell immunotherapy projects, noting that it filed for approval to start phase II trials of its candidate bladder cancer therapy DN24-02 in December.

Phil Taylor

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