ANALYSTS: RULING ON DAPOXETINE A SETBACK TO J&J'S PIPELINE
The FDA has declared Johnson & Johnson's (J&J) experimental premature
ejaculation (PE) drug dapoxetine "not approvable," dealing a potentially
significant setback to the firm's pipeline, analysts said.
J&J subsidiary Alza did not disclose any details about the FDA's decision,
saying only that it received a not approvable letter from the agency regarding
dapoxetine. Alza received the letter one day ahead of the dapoxetine user fee
deadline. Alza's new drug application (NDA) had been closely watched because
there are currently no drugs approved in the U.S. to treat PE, a condition that
may affect as many as 25 percent of men worldwide.
Although J&J maintained that it did not anticipate immediate approval of
the drug, the FDA's decision caught financial analysts off guard, including
Standard & Poor's Equity Research analyst Robert Gold, who called the letter
"a significant blow" to J&J's pipeline.
"Although the company says it will address these concerns and continue
developing the drug, we are surprised by the FDA action and believe removal
of this compound impacts our revenue growth forecast starting in 2007,"
Gold writes in a recent research note.
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