UPDATE:Dendreon Sees Up To $2.5 Billion In Provenge Revenue If OK'd
September 24 2009 - 10:30AM
Dow Jones News
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