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Generic-drug-maker admits to 'side agreements'


In court papers, Apotex said it had a secret deal with Bristol-Myers and Sanofi to delay its Plavix.
By Susan Decker
Bloomberg News

Apotex Inc., the generic-drug company that is selling a low-cost version of the blood thinner Plavix, admitted in court papers that it struck a "side agreement" with Bristol-Myers Squibb Co. and Sanofi-Aventis.

The drugmakers promised they would not put out an unbranded version of the medicine if Apotex agreed not to launch the generic drug until 2011. Bristol-Myers and Sanofi wanted that part of the agreement secret to ensure the settlement would be approved by the Federal Trade Commission and states that had the right to review the agreement under a 2003 consent decree, Apotex said in a court filing yesterday.

It is the first public statement of what prompted a criminal probe into the settlement. Bristol-Myers' board announced yesterday it had hired former federal prosecutor Mary Jo White to investigate what went wrong with the agreement, which handcuffed Bristol-Myers and Sanofi from preventing the launch of generic Plavix once the agreement was rejected.

The companies "have misled both federal and state government regulators to evade the restrictions of the consent decree in an effort to strengthen and extend their patent-based monopoly over a market worth approximately $4 billion per year," Apotex said in the court papers.

The companies are scheduled to appear in a New York courtroom today in which New York-based Bristol-Myers and Paris-based Sanofi will ask a judge to order Apotex to stop making the generic drug and recall anything that has entered the market. Apotex's statements came in court documents opposing such an order, called a preliminary injunction.

Bristol-Myers spokesman Tony Plohoros said the company had no comment on the filing. According to a transcript of a status hearing yesterday, Bristol-Myers attorney Evan Chesler said it was "absolutely untrue" that there were side agreements not disclosed to the FTC.