Dendreon Corp. (DNDN) told Wall Street that its regulatory and launch plans for prostate cancer treatment Provenge, assuming its gets approved, remain on track as it plans for regulatory review.

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, it told Wall Street analysts Thursday. Although it didn't provide projections, Dendreon said Provenge's launch will occur as production capacity becomes available, supporting $1.2 billion to $2.5 billion in annual revenue after all of its manufacturing facilities come on line in 2011.

Dendreon shares recently traded down 3.8% to $27.21, after being down as much as 11%.

Production will begin 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.

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

Dendreon expects that first facility to be fully functional in the first half of 2011 and operations in Atlanta and Los Angeles to be available in the second half of that year.

In preparing for launch, the company expects to spend $150 million in 2009 and end the year with $200 million in cash. It currently has about 290 workers and plans to double that by the time the drug launches.

Dendreon expects to sell the drug in the U.S. while finding a partner for overseas markets, a plan that the company reiterated Thursday. It said it is in the process of hiring a chief operating officer that has "deep commercial experience."

In April, Dendreon reported Provenge 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.

Provenge uses a patient's own cells to prompt the body to fight the disease, leading many to call it a vaccine.

Dendreon had previously expected to file an amendment to its previously rejected marketing application by year-end. 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.

In transporting the product, the company will use a third-party service to transport the cells to its manufacturing facilities within 18 hours.

Dendreon will provide a tracking system, similar to that used by major shipping carriers, that allows patients and physicians to follow the progress of their cells in the process.

Although the company essentially froze its development of other products as the Provenge trial was being completed, it is now planning to study Provenge's effectiveness in earlier stages of prostate cancer, as well as the possibility of providing patients with a booster after their initial treatment.

The company expects to have one new immunotherapy in clinical trials every year for the next three years, beginning with beginning a study of Neuvenge in bladder cancer in late 2010 or early 2011.

The company expects to study Neuvenge in other cancers and has other cancer treatments in early development.

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