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FDA marks Pregabalin approvable but not for GAD

Posted by jrbecker on September 3, 2004, at 10:24:51

Associated Press
FDA Gives Pfizer Mixed Response on Drug
09.02.2004, 06:04 PM

The Food and Drug Administration has told Pfizer Inc. that it may approve the successor to its blockbuster epilepsy drug Neurontin for three conditions, but the agency is saying no to the drug as a generalized anxiety disorder treatment.

While Pfizer still has to make some minor changes in order to obtain a final OK, the agency told the company that the drug, called Lyrica, is "approvable" for treating the pain from nerve damage caused by diabetes, for a painful side effect of shingles and as treatment to cut down on seizures in epileptics.

New York-based Pfizer issued a statement on the regulatory status of Lyrica Thursday.

The company is in a scramble to get Lyrica on the market before sales of Neurontin, which were $2.7 billion in 2003, are hit by generic competitors.

Ivax Corp. recently launched a tablet form of the drug, which Pfizer sells as a capsule. Because Ivax's version isn't in the same form, the two aren't deemed perfectly interchangeable.

Many on Wall Street are speculating that the companies that are first in line to launch an interchangeable generic version of Neurontin may tie up their legal squabbles between each other and launch the official copycat version of the drug soon.

The FDA's decision could pressure sales estimates for the experimental drug.

"We had felt that the anxiety claim had promise and was part of our view that the drug could reach $2.3 billion by 2008," Goldman Sachs analyst James Kelly said of Lyrica in a Thursday research note. However, putting that in context, if the drug is approved for diabetic neuropathy (nerve damage caused by diabetes), it would have approval for an indication that the older Neurontin doesn't have, he added.

Prudential analyst Tim Anderson considers the pain indications the most important commercially. "The failure to get a (generalized anxiety disorder) indication is only a modest setback," he said. "More important is when (Pfizer) will launch the product." There is still no clarification from the company as to what's been requested by the FDA before the agency will approve the drug, he said.

Pfizer said it is continuing to work closely with the FDA during the ongoing regulatory review to resolve open issues on all indications and labeling.

Pfizer spokesman Paul Fitzhenry said that the company will continue to seek approval for the anxiety indication and is in talks with the agency about the approvable indications.

However, he said that Pfizer can't predict approval timelines.

Shares of Pfizer finished at $32.70 Thursday, up 35 cents, or 1.1 percent, on the New York Stock Exchange.




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