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Dendreon has completed its U.S. regulatory submission for its closely watched experimental prostate cancer vaccine, the company said Monday, sending its shares up 5 percent.
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CNBC.com |
Dendreon previously said it expected to seek U.S. approval for Provenge in November, and expected regulators to respond by mid-2010.
"The submission came a little earlier than had been expected, which was in mid-November, so that is a positive," said Canaccord Adams analyst George Farmer, who estimated the product's sales potential at greater than $4 billion annually by 2020.
If approved, Provenge would be the first "therapeutic" cancer vaccine. While conventional vaccines prevent disease, Provenge treats the condition.
"With the (application) submission complete, we have taken an important step towards reaching our goal of bringing a new therapy to men with advanced prostate cancer," Dendreon Chief Executive Mitchell Gold said in a statement.
Dendreon in September said it will be able to make enough Provenge to generate potential sales of $60 million to $125 million in the second half of next year.
The company said it will steadily ramp up production until full capacity is achieved by late 2011 at plants in New Jersey, Atlanta and Los Angeles, together able to support potential annual sales of $1.2 billion to $2.5 billion.
Prostate cancer is diagnosed in one of every six American men and is the second-leading cause of cancer death among men.
Dendreon shares [DNDN
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], which have soared 10-fold since March, were up 5 percent in morning trading on Nasdaq.
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