Biotech firm applies for FDA approval of treatment. Company plans to build a factory in Seal Beach
By Charles M. Kelly
The Seattle-based biotech firm that plans to open a 24-hour factory in Seal Beach announced Monday, Nov. 2, that it had submitted a license application to the federal government for a prostate cancer treatment.
If the application is approved, Dendreon would be allowed to manufacture and sell the cancer treatment. This would increase the likelihood that the planned Seal Beach factory would become a reality.
Dendreon Corporation announced that it has completed the submission of the amended Biologics License Application for Provenge (also known as sipuleucel-T), the company’s lead product, to the U.S. Food and Drug Administration.
Dendreon is seeking a license to sell Provenge to men with advanced prostate cancer. If approved by the FDA, Provenge would represent the first commercial product that uses the patient’s own immune system to fight a cancer.
According to a statement issued by the company, the amended BLA includes data from the Immunotherapy for Prostate AdenoCarcinoma Treatment trial, which demonstrated improvement in overall survival in men with advanced prostate cancer.
“With the BLA submission complete, we have taken an important step towards reaching our goal of bringing a new therapy to men with advanced prostate cancer,” said Mitchell H. Gold, MD, president and chief executive officer of Dendreon. “We look forward to working with the FDA to potentially make Provenge the first active cellular immunotherapy to be licensed in the United States.”
Not everyone agrees that Provenge significantly increases survival time for terminally ill men. However, Dendreon has cited studies that show Provenge adds a few months to a patient’s life with minimal side-effects.
Earlier this year, Dendreon officials announced plans to start a biotech factory in the Seal Beach area. The factory could create hundreds of job openings.
In an e-mail to the Sun Newspapers, Dendreon Senior Vice President Greg Schiffman said the factory would produce Provenge. However, the drug has not yet been approved for mass production. In fact, the FDA rejected the first Dendreon application to approve Provenge.
Schiffman said the FDA would have six months to review the company’s Biologics License Application.
Before his retirement, Lee Whittenberg, then director of Development Services for Seal Beach, said that Dendreon representatives had informed Seal Beach officials that the Dendreon plant would operate 24 hours a day. The Seal Beach code requires a conditional use permit to run a 24-hour business. That means the Dendreon plant project will require Planning Commission approval before it goes forward.
Schiffman said construction would start in late 2009 or early 2010. He said it would take 12 to 14 months to complete the construction project.
In related news, Dendreon management will hold a conference call on Wednesday, Nov. 11, to review third quarter 2009 financial results. Dendreon reported losing money in the first half of 2009. The company reported revenues of $55,000 and expenses of $37.9 million for that period.