Dendreon Gets FDA Nod for New LA Cancer Drug Factory
Seattle-based Dendreon (NASDAQ: DNDN) said today that it has won clearance from the FDA to start manufacturing its immune-boosting drug for prostate cancer at a new factory in the Los Angeles area. The manufacturing plant OK, which was widely expected by analysts, means that Dendreon now has its first new location to produce its treatment outside its original commercial factory in New Jersey.
The company is also seeking FDA clearance for a third facility in the Atlanta, GA area, which the company is hoping will get the green light by a regulatory deadline of August 28. The new capacity is important to Dendreon because it has been unable to meet all the demand from patients for its drug, sipuleucel-T (Provenge), in its first year on the market.
Getting FDA sign-off on the factories isn’t trivial. Dendreon’s first-of-its-kind manufacturing process is complicated, in that it requires running a patient’s own cells through a proprietary system to “teach” the cells to recognize hallmarks of prostate cancer cells, so that when they are re-infused into the patient, they should be able to start fighting the cancer cells like a virus. Getting all three factories running on schedule is critical for Dendreon if it is going to hit its sales forecast of $350 million to $400 million in sales of the treatment this year.