Reuters and WAll Street Journal report today that Dendreon plans to seek US FDA approval for Provenge prostate cancer vaccine in November. Dendreon “expects regulators to act on the application by the middle of next year, the company said on Thursday.”

To start from an updated report in the Wall Street Journal, which adds this information to Reuters’ coverage of Dendreon ‘s share prices today. The points are excerpted and reordered:

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.

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.

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.

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.

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.

The Reuters report posted here earlier today focuses mainly on share prices:

Shares of Dendreon fell more than 3 percent in morning trading after the timetable, which was provided at a company meeting with industry analysts and was in line with previous company forecasts.

Dendreon has been in talks with potential partners to market Provenge outside the United States, but had not yet mentioned the partnership efforts during the analyst meeting.

Provenge would be the first approved ‘therapeutic’ cancer vaccine. While conventional vaccines prevent diseases, Provenge treats the condition, which is diagnosed in one of every six American men and is the second-leading cause of death among that population.

The Seattle biotechnology company previously said it would submit an application for Provenge in the fourth quarter.

Shares of Dendreon have exploded 10-fold this year following the release of data in April that showed Provenge prolonged lives of patients about four months. That compares to a two-to-three month survival extension in separate studies for Sanofi-Aventis’ (SASY.PA) Taxotere, the current standard of care.

Dendreon on Thursday noted that Taxotere, a chemotherapy, can cause harsh side effects that were not seen with Provenge — a potential big selling point as well as an advantage to patients.

Shares of Dendreon fell 93 cents, or 3.3 percent, to $27.34 in morning trading on Nasdaq.

(Reporting by Ransdell Pierson and Lewis Krauskopf, editing by Dave Zimmerman)

Sources

Wall Street Journal 2nd UPDATE: Dendreon Says Provenge Launch, Filing On Track
http://www.reuters.com/article . . .