Schering-Plough and Merck are facing several state investigations of their handling of Vytorin (ezetimibe/simvastatin) clinical trial data.

Schering-Plough reports in a May 6 quarterly filing with the Securities and Exchange Commission that it has received several subpoenas from State Attorneys General requesting information on the Merck-Schering ENHANCE trial, which compared Vytorin to simvastain alone in preventing atherosclerosis. In January, nearly two years after the trial was completed, the companies released the findings that Vytorin had no significant benefit over simvastatnin alone.

The states are also seeking information relating to the sale and promotion of Vytorin and the stock sales of corporate officers since April 2006 when the ENHANCE trial was completed. Carrie Cox, president of Schering-Plough's global pharmaceutical business, is named as one of the officers whose stock sales are under investigation.

Schering did not specify which states had issued subpoenas. A company spokesperson said the firm would not comment beyond what was in the SEC filing. The tally appears to at least include subpoenas from the attorneys general of New York, Connecticut and New Jersey (¹ Also see "Merck Revises Guidance To Include $700 Million Less In Vytorin/Zetia Sales" - Pink Sheet, 21 April, 2008.).

The House Energy and Commerce Committee, House Oversight and Investigations Subcommittee and Senate Finance Committee have initiated several investigations seeking similar Vytorin data.

Schering noted that since mid-January a number of civil class action lawsuits have been filed alleging common law and state consumer fraud claims in connection with the sale and promotion of Vytorin and Zetia (ezetimibe) and that it is facing several shareholder securities class action suits alleging false and misleading statements about ENHANCE trial results. Merck previously reported that 115 civil class actions have been filed over sales and promotion of Vytorin and Zetia and that a Merck shareholder had also filed suit.

-Brenda Sandburg (b.sandburg@elsevier.com)

States Subpoena Schering-Plough For Vytorin Documents

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