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Supply and demand — Dendreon accelerates development of manufacturing capacity for Provenge

Posted Jan 12 2010 12:00am

The signals from Dendreon in September last year were that it would take the company until at least the end of 2011 to be able to “ramp up” to full manufacturing capacity for its prostate cancer immunotherapeutic agent, sipuleucel-T (Provenge), even if the FDA does approve this product in May or June of 2010 — which is what most people are currently expecting.

However, according to CNNMoney, Dendreon CEO Mitchell Gold — speaking this morning at a big biotech investor conference in San Francisco — has now said he is hopeful that the new manufacturing plants in Atlanta and Los Angeles (currently both in development) would in fact come on line something like 6 months earlier than originally projected, and that Dendreon should therefore be capable of full manufacturing capacity for Provenge by mid-2011.

Since there is (presumably) significant pent-up demand for what will be the first “therapeutic vaccine” ever approved to treat any form of cancer in the USA, some people had been concerned that Dendreon might not be able to meet initial demand for Provenge when it got approved. If the company is able to ramp up to full production capacity by mid-2011, this may be less of a problem than might otherwise have been expected.

Of course we still have to wait to see if the FDA does, in fact, approve Provenge on the expected schedule, but so far there have been no signals from anywhere to suggest that this will not be the case. Futhermore, there have been no indications that the FDA expects to schedule an advisory committee meeting to review the results of the IMPACT trial. (It is on the results of the IMPACT trial, presented at the American Urological Association annual meeting in April 2009, that Dendreon’s hopes for a product approval lie.) So … The “New” Prostate Cancer InfoLink will continue to have a positive expectation that we shall be seeing Provenge on the market by June 2010 or very soon thereafter.

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