FDA Holds Up Wyeth Drug

Last week, Wyeth issued strong quarterly results and raised its full-year earnings forecast.

"Wyeth remains committed to the development of Pristiq as a potential treatment for moderate-to-severe vasomotor symptoms associated with menopause," said Dr. Gary Stiles, executive vice president and chief medical officer for Wyeth's prescription drug business, in a prepared statement.

"We will work with the agency to satisfy its requests for additional data and move the medicine forward in the FDA review process."

Merrill Lynch analyst David Risinger cut his rating to hold from buy, telling clients that Pristiq probably wouldn't be available for treating menopause symptoms until the first quarter of 2010. He doesn't own shares, but his firm has had a noninvestment banking relationship.

"For all intents and purposes, this indication is dead," says Barbara Ryan, of Deutsche Bank Securities, in a note to clients.

She had sounded an early warning about Pristiq's prospects, saying before that the consensus view of Pristiq as a $1 billion- to $2 billion-a-year menopause drug was "highly unrealistic." Her peak annual forecast had been $650 million.

Ryan, who has a hold rating, doesn't own shares. Her firm does or seeks to do business with companies mentioned in research reports.

Pristiq has been viewed by Wyeth as a way to expand its women's health care offerings and to shore up sales for its Premarin and Prempro treatment for menopause. These drugs achieved sales of $1.05 billion last year and are among Wyeth's biggest products.