Seal Beach is set to play a big role in what could be a $1 billion drug to fight prostate cancer.
Seattle-based biotechnology drug developer Dendreon Corp. plans to open a plant in Seal Beach that’s set to produce Provenge, its prostate cancer vaccine.
Dendreon plans to open the Seal Beach plant in the second half of 2011.
In November, Dendreon is expected to submit an application for Provenge to the Food and Drug Administration, Chief Executive Mitchell Gold told analysts at a conference last week.
Dendreon said it expects action on the application by mid-2010. The FDA already has looked at Provenge and has indicated it could be approved.
A spokeswoman said “several hundred jobs” could be created in Seal Beach. The company’s current 290 employees could more than double by the time Provenge launches, she said.
Dendreon signed a 10.5-year lease valued at $13.6 million for 184,000 square feet of space in the Pacific Gateway Business Center business off the Garden Grove (22) Freeway.
Dendreon is leasing the building from developer Overton Moore Properties.
The Seal Beach plant and another being built in suburban Atlanta are expected to make $375 million to $750 million worth of Provenge yearly, said David Urdal, Dendreon’s chief scientific officer.
Dendreon also plans to make $500 million to $1 billion worth of Provenge at a New Jersey plant.
Provenge, Dendreon’s lead drug candidate, is meant for men whose prostate cancer is resistant to “chemical castration” hormone therapy, the traditional way to fight advanced forms of the disease.
Provenge works by harnessing a patient’s immune system and spurring his white blood cells to attack cancerous cells in the prostate. It works differently from traditional vaccines as it treats a disease, rather than prevents it.
Dendreon makes Provenge from white blood cells harvested from individual patients, Urdal told analysts. After cells are taken from patients, they are sent to a Dendreon plant where they are converted into the vaccine and then returned to the doctor’s office, he said.
Game Changer?
Provenge could be a game changer for Dendreon, which now has little in the way of revenue. A Citigroup Inc. analyst estimated the drug, if approved, could see sales of $900 million by 2014.
Prostate cancer is the second-leading cause of death among American men after heart disease and is diagnosed in one in every six men, Dendreon said.
Dendreon shares have skyrocketed, likely on investors’ expectations for Provenge.
Since January, the drug maker’s shares have risen nearly 500%, giving the company a market value of about $3 billion last week.
Provenge “continues to enjoy market support and interest,” said Aaron Reames, a senior biotechnology analyst with Wells Fargo Securities.
Dendreon also has been the subject of takeover talk.
The company has said it’s not interested in being bought and that it wants to keep the North American rights to Provenge.
Dendreon is looking to work with another company to market Provenge overseas.
The company is considered a development-stage drug maker. It reported a net loss of $126.7 million on revenue of $25,000 in the second quarter. Most of the loss was a $106 million non-cash charge associated with the revaluation of stock warrants.
Dendreon’s shareholders include BAM Capital LLC, a New York hedge fund that owns about 10% of the company.
Competitors include Abbott Laboratories of suburban Chicago, South San Francisco-based Cell Genesys Inc. and Northwest Biotherapeutics Inc. of Bethesda, Md.
Dendreon has attempted to get Provenge on the market for years with mixed results.
A FDA advisory panel recommended the drug for approval in 2007. But a pair of doctors on the panel wrote the FDA about concerns they had with the drug’s clinical trials.
Eventually, regulators said Provenge could be approved but asked Dendreon to do more trials involving more patients.
Dendreon said in April that the vaccine was shown to be safe and effective in a larger, late-stage trial.
Besides Provenge, Dendreon also has drugs in development that target breast cancer, ovarian cancer and colon cancer.
The company said that it plans to start a clinical trial of its Neuvenge drug for treating bladder cancer late next year.
Dendreon was started in 1992 as Activated Cell Therapy Inc. and previously was based in the Bay Area city of Mountain View before moving to Seattle.
