Dendreon wins FDA nod on production increase

Dendreon shares got a shot in the arm yesterday after the FDA signed off on a significant boost to its manufacturing capacity for the prostate cancer vaccine Provenge. Regulators OK'd an additional 36 work stations at Dendreon's New Jersey manufacturing facility, quadrupling its production of the personalized therapy and significantly adding to the Seattle-based biotech's ability to earn more revenue.

"This additional capacity really allows us to begin serving patients across the country in a more efficient manner," Dendreon CEO Mitchell Gold told Reuters. "The real effect of these additional work stations coming on line is going to effect us in Q2 and beyond."

The company has maintained its full year forecast for Provenge sales of $350 million to $400 million, Reuters reports. Half of that is expected to come in the fourth quarter as the biotech steadily ramps up production at facilities being built throughout the country. With the FDA's sign-off, the New Jersey plant will have 48 stations capable of turning out Provenge. Dendreon is looking for approval of 36 work stations at its Los Angeles plant in June; an additional 36-station approval is in the works for an Atlanta facility.

Meanwhile, the company is adding infusion centers around the country, with 225 expected to be ready for their first patients by the end of the second quarter, and a total of 500 by year's end.

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