Dendreon wins green light for Provenge production
pharmafile | March 22, 2011 | News story | Manufacturing and Production | Cancer, Dendreon, FDA, Provenge, pharma manufacturing, prostate cancer vaccine, sipuleucel-T
US oncology specialist Dendreon has been boosted by the approval of additional production capacity for its therapeutic prostate cancer vaccine Provenge by the FDA.
Provenge (sipuleucel-T) was launched in the US as a treatment for advanced prostate cancer last year, 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.
The FDA has now given the go-ahead to 36 additional workstations at the company’s New Jersey facility, adding to the 12 already approved. The new capacity will be brought online in stages, said Dendreon in a statement.
The company is also ramping up production to other facilities in the USA, filing for approval last month to bring 36 workstations at its unit in Los Angeles online. A third production facility in Atlanta is also planned and could be producing Provenge by the summer. Once these are in play revenues could swell to $350-$400 million in 2011, it says.
Meanwhile, in anticipation of the availability of the additional workstations, Dendreon expects to have approximately 225 infusion centres prepared to treat their first patient by the end of the second quarter of this year. That will expand to around 500 centres by the end of 2011, added the firm.
Mitchell Gold, Dendreon’s president and chief executive, said: “With FDA approval of the additional NJ workstations, we now have significant capacity to make this important therapy available to the many men across the US who may benefit from it.”
Dendreon’s development programme for Provenge in Europe is running a little later than in the US, with a regulatory submission not expected until the end of this year at the earliest. In Europe the company is planning to rely on contract manufacturing to serve the initial demand while it constructs a dedicated facility in Germany.
Phil Taylor
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