October 20, 2008 / 10:00 PM / 11 years ago

UPDATE 2-U.S. FDA withholds approval of Abbott painkiller

(Adds analyst comment)

By Ransdell Pierson

NEW YORK, Oct 20 (Reuters) - Abbott Laboratories (ABT.N) said on Monday that U.S. regulators have withheld approval of its experimental long-acting form of the painkiller Vicodin, leaving it unclear if and when the powerful narcotic might be approved.

But Abbott stuck to its earlier company earnings forecasts for 2008 and 2009 despite the uncertain fate of the pill, which it had expected to be approved in the fourth quarter and generate eventual peak annual sales of $500 million.

Like Vicodin, it contains the narcotic hydrocodone in combination with acetaminophen, an anti-inflammatory chemical that is the active ingredient in Tylenol. But it would be taken only once every 12 hours, compared with every 4 to 6 hours for Vicodin.

The Abbott product is the first slow-release formulation of Vicodin, a generically available medicine for chronic pain that is one of the most prescribed drugs in the United States.

Company spokeswoman Melissa Brotz declined to disclose the contents of the Food and Drug Administration’s so-called complete response letter, a document issued when the agency withholds approval until it receives information of some type.

Companies have discretion to reveal the contents of such letters.

Brotz declined to say whether the agency was seeking more clinical trial data or new clinical trials, or when the drug might be approved. She said Abbott would discuss the letter with the FDA and provide an update when appropriate.

“We are not speculating on the timing” of potential approval, she said. “But the timing is not relevant to our financial guidance for this year and next year,” Brotz said.

The company reaffirmed that it still expects full-year 2008 earnings of $3.31 to $3.33 per share, which would reflect growth of up to 17.2 percent from last year. It still expects double-digit earnings growth in 2009, Brotz said.

“It looks like we’re talking about an FDA delay here, not a complete derailment,” said Phillip Nalbone, an analyst with RBC Capital Markets. “I think it will be back on track at some point.”

The medicine demonstrated good safety and efficacy results in late-stage clinical trials, he said, and has potential “in every conceivable case where the body is wracked with chronic pain — fractures, back pain, underlying chronic medical conditions.”

The studies suggest the drug would offer significant medical and lifestyle advantages, Nalbone said. “You have fewer episodes of breakthrough pain, and you get a better night’s sleep because you have fewer of these pain episodes,” he said.

The FDA appears to be issuing more complete response letters as a way of buying the heavily burdened agency more time to complete its drug reviews, Nalbone said.

Shares of Abbott closed up $2.09, or 3.77 percent, at $57.55 on the New York Stock Exchange. (Reporting by Ransdell Pierson; editing by Susan Kelly)

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