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FDA experts spurn Abbott drug
Advisory panel recommends full agency not approve atrasentan, a treatment for prostate cancer.
September 13, 2005: 2:46 PM EDT
By Aaron Smith, CNN/Money staff writer

NEW YORK (CNN/Money) - An FDA expert panel voted unanimously Tuesday not to recommend atrasentan, an Abbott Laboratories drug candidate that the company says would stop the spread of prostate cancer and fight bone pain.

FDA panelists were not satisfied with late-stage clinical testing for atrasentan hydrochloride, also know by its brand name Xinlay. Analysts said they had expected a negative vote, adding that it was already priced into Abbott stock.

The Food and Drug Administration usually follows the recommendation of its advisory panels in deciding whether to approve new drug applications. Abbott is expecting a decision in October.

"The FDA believes that the level of certainty is not where it needs to be for them to feel comfortable," said Dr. Eugene Sun, vice president of global pharmaceutical clinical development for Abbott. "They encouraged us to move forward. We would like to proceed on getting more data on this drug."

On Monday, FDA staff members issued a report saying that Abbott Labs (down $0.15 to $45.08, Research) did not provide clear enough data on the effectiveness of atrasentan, sending a signal to investors that the drug would probably not get a green light on Tuesday.

"It was very clear going into the meeting that the panel was predisposed against the drug," Phillip Nalbone, analyst for RBC Capital Markets, said after the vote. "From my perspective it was a disappointment. We felt there is a lot of evidence here that this drug can help a lot of men with prostate cancer."

Some analysts have portrayed atrasentan as a potential blockbuster, since 30,000 men die of prostate cancer in America every year, and another 232,000 are diagnosed.

But other analysts have been more conservative. Bruce Cranna, analyst for Leerink Swann, projected $40 million in sales for 2006, so the impact of the "nay" vote on Abbott would be slight.

"It sounds like the scales have tipped somewhat towards nonapprovable," said Cranna prior to the vote. "[The FDA staffers] certainly went out of their way to point out there were some risk signals, especially with cardiovascular."

Based in Abbott Park Ill., Abbott raked in $19.7 billion in annual sales.

The analysts quoted in this story do not own Abbott stock.

To read more about FDA experts and their recent votes on drugs, click here.  Top of page

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