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Schering-Plough warns
graphic December 21, 2001: 7:05 p.m. ET

Schering-Plough warns on 4Q, may have to pay regulators up to $500M.
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  • Drug sector in decline - Dec. 14, 2001
  • Schering president quits - June 27, 2001
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    NEW YORK (CNN/Money) - Drugmaker Schering-Plough warned on fourth-quarter earnings Friday and said it may have to pay up to $500 million to regulators to settle quality control issues at its New Jersey and Puerto Rico plants.

    But the company also announced it received approval from the U.S. Food and Drug Administration for Clarinex, the successor to blockbuster drug Claritin, and expect to launch the drug in January.

    Schering-Plough (SGP: Research, Estimates) said it is negotiating with the FDA for a consent decree to resolve manufacturing deficiency issues which have plagued the company since February.

    The company said it may have to pay as much as $500 million to the federal government, but stressed there are "a number of issues being discussed and no assurances can be given that a negotiated agreement will be reached or as to what the terms of any such agreement would be."

    Schering-Plough said because of the effect of the manufacturing issues on product sales, fourth-quarter earnings per share will be 7 percent below the 39 cents earned in the year-ago period, or 36 to 37 cents per share.

    Analysts surveyed by First Call are expecting the company to earn 41 cents per share.

    "For the 2002 fiscal year, we are expecting a percentage increase in earnings per share in the low double digits," said Richard Jay Kogan, Scherin-Plough chairman and CEO, in a statement.

    The company said the launch of Clarinex and potential inventory reductions of Claritin, whose patent expires at the end of next year, could affect 2002 earnings. graphic

      RELATED STORIES

    Drug sector in decline - Dec. 14, 2001

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