B-MS resolves Plavix antitrust probe

US drug major Bristol-Myers Squibb says it has reached an agreement in principle to resolve the previously-disclosed Antitrust Division of the Department of Justice's criminal investigation regarding the proposed settlement deal between the company, its product partner, Sanofi-Aventis and Apotex Inc and Apotex Corp. The proposed settlement agreement was related to the Plavix (clopidogrel) patent litigation, which is pending before the US District Court for the Southern District of New York.

As part of the agreement with the DOJ, B-MS or a subsidiary, will plead guilty to criminal charges consisting of two counts of violating Section 1001 of US Code Title 18 (relating to false statements to a government agency), carrying an aggregate statutory maximum fine of $1.0 million. The charges relate to representations made by a former B-MS senior executive during the renegotiation of the proposed settlement agreement in May 2006 that were not disclosed to the Federal Trade Commission.

B-MS says it has advised the US Attorneys Office for the District of New Jersey of this agreement in principle which, in turn, has told the company that it believes it has cured resulting breaches of the deferred prosecution agreement (DPA) entered into between the drugmaker and the USAO by terminating the employment of certain former senior officers, as well as by taking other actions to prevent the recurrence of the issues and events that led to this matter. The USAO has also advised B-MS that, assuming resolution of the investigation in accordance with the agreement in principle and the company's compliance with the DPA between now and June 15, it is the USAO's intention to terminate the DPA that day.