Dendreon Gets FDA Green Light for NJ Factory

Xconomy Seattle — 

Seattle-based Dendreon (NASDAQ: DNDN) said today it has won FDA clearance to quadruple the output from the New Jersey factory where it makes its lone product, sipuleucel-T (Provenge).

The drug, for men with advanced forms of prostate cancer, was first cleared for sale in the U.S. last April, at a time when Dendreon had extremely limited manufacturing capabilities, with just 12 workstations, as opposed to the 48 that are now approved by the FDA.

Dendreon still has a long way to go in its manufacturing build-out. It hopes to win additional FDA clearances by the middle of this year to start producing Provenge at facilities in the Los Angeles and Atlanta metro areas. Dendreon has said it expects to sell $350 million to $400 million of Provenge this year as it scales up manufacturing. The company generated $48 million in revenue in 2010.

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2 responses to “Dendreon Gets FDA Green Light for NJ Factory”

  1. I am not so sure that the NJ expansion will result in a higher share price. Dendreon Corporation’s stockholders have witnessed DNDN share price rise and fall over the past several years. Though DNDN shares are currently priced well above its historical lows, many feel that is well below where it should be.