Bristol-Myers Squibb has reached an agreement in principle with the US Department of Justice to resolve the criminal investigation regarding its best-selling heart drug, Plavix.
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Bristol-Myers Squibb will plead guilty to criminal charges which relate to false statements to a government agency, carrying an aggregate statutory maximum fine of $1 million.
The charges relate to a claim by generics firm Apotex that the Plavix patent was invalid and therefore unenforceable. The companies agreed a settlement but this fell through when state attorneys general refused to sign off the agreement. As a result, a criminal investigation was launched by the antitrust division of the US Department of Justice into the proposed settlement with Apotex.
“Full compliance with all of the laws and regulations governing our company remains the highest priority for our leadership team, and for me personally,” said James Cornelius, CEO of Bristol-Myers Squibb. “As we move forward with our plans to grow our business and build shareholder value, compliance is an essential pillar that will support all of our goals.”
Bristol-Myers Squibb said that it does not believe this resolution of the investigation should have a material impact on its ability to participate in federal procurement or health care programs, although there can be no assurance of this.
The agreement in principle is contingent upon the parties’ assent to the terms of a final agreement and acceptance of the plea by the court in which it is entered.
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