Dendreon Corp. (DNDN) believes it will have the production capacity to support $1.2 billion to $2.5 billion in annual revenue from its prostate cancer treatment Provenge after all its manufacturing facilities come on line in 2011.

The Seattle drug maker expects to file for marketing approval for Provenge in mid-November and hopes to get a regulatory decision in the middle of next year.

The production of the drug will start at a New Jersey facility that will initially operate at 25%, bringing up to $60 million to $125 million in revenue in the six months after launch, the company said at a presentation to Wall Street analysts Thursday.

Dendreon shares recently traded down 6.2% to $26.52.

Leerink Swann recently projected U.S. Provenge revenue of $1.6 billion for 2014.

The company reported in April that the drug successfully prolonged patients' lives, which could make it the first immunotherapy approved for cancer. The share price is up more than threefold since that data was reported.

It had previously predicted filing with the Food and Drug Administration by the end of the year. Dendreon expects to sell the drug in the U.S. while finding a partner for overseas markets.

Provenge uses a patient's own cells to prompt the body to fight the disease, leading many to call it a vaccine. Some observers on Wall Street expect it to eventually be a blockbuster drug.

In applying to the FDA, Dendreon filed an amendment to its previously rejected marketing application for Provenge. An FDA advisory recommended the approval of Provenge in 2007, but the agency requested more data.

Although Dendreon's data were performed under a special protocol assessment, the company still must get a cautious FDA's approval in bringing an entirely new type of therapy to the market, including the resolution of manufacturing questions.

Unlike making a pill, Provenge's production involves taking a patient's cells, shipping them to the company for processing, then returning them to a physician to be delivered via intravenous infusion. This entire process must be performed three times over four weeks.

The company said that it recently signed an agreement with the American Red Cross for patients to use the organization's cell collection, or apharesis, centers so that the needed cells can then be shipped to Dendreon's production facilities.

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com