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Pfizer Insomnia Drug Fails to Win FDA Nod

Posted on: Wednesday, 17 May 2006, 21:04 CDT

By Anthony Cronin, The Day, New London, Conn.

May 17--The federal Food and Drug Administration withheld initial approval Tuesday of a new extended-release insomnia drug, a setback for Pfizer Inc.'s San Diego-based partner that is developing the pharmaceutical.

The agency, however, did offer initial approval letters for Neurocrine Biosciences' indiplon drug in 5- and 10-milligram capsules. The agency did not offer such a letter for the 15-milligram extended-release tablet version of the insomnia-and-sleep treatment. An approval letter is an essential part of the FDA approval process. The California biosciences company is developing the drug; Pfizer would serve as the marketing partner.

Shares of Neurocrine plummeted 62 percent during the day's trading on the Nasdaq electronic stock exchange, closing the day at $20.76 a share, down $33.87. Pfizer's shares were little affected by the regulatory news, closing the day's trading at $24.90 a share, about even with the previous day's closing price. Some industry analysts have forecast that the insomnia-and-sleep drug could become a billion-dollar blockbuster.

So far this year, Pfizer has gained federal approval for four new drugs, including Exubera, the world's first inhaled insulin drug, and Chantix, its new smoking-cessation drug. The New York-based pharmaceutical company, a major employer in southeastern Connecticut, expects to receive two more drug approvals this year. Last year, Pfizer had four drugs approved by the FDA.

Gary Lyons, president and chief executive officer of Neurocrine, said the company was disappointed with the FDA's action but said his firm "would move forward expeditiously to address FDA's outstanding questions" regarding the 15-milligram tablets.

He said his company was heartened by the approval of the 5- and 10-milligram capsule dosages and that the biosciences firm is "dedicated to working with the agency" concerning issues surrounding its stronger tablet version.

The lower dosages of the proposed drug would be used by those who have trouble falling asleep or staying asleep.

The extended-release version of the drug would be used to quickly induce sleep in those with insomnia and then allow them to remain asleep.

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Copyright (c) 2006, The Day, New London, Conn.

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PFE, NBIX,

Source: The Day

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