Sanofi and BMS deal over Plavix runs into trouble

The Antitrust division of the US Department of Justice is conducting a criminal investigation regarding the proposed settlement between drug multinationals Sanofi-Aventis and Bristol-Myers Sqibb (BMS) and Canadian generics producer Apotex over the blood thinning therapy Plavix (clopidogrel bisulfate).

Plavix is currently worth more than US$5bin in annual sales, but in January 2006, Apotex announced that it had received final approval of its aNDA for clopidogrel bisulfate from the FDA, enabling it to launch a generic clopidogrel product.

In an out-of-court settlement BMS and Sanofi-Aventis agreed to pay Apotex to not to begin selling its generic version of Plavix until June 2011, the year the primary patent protecting Plavix expires.

Apotex would receive a reimbursement payment from the companies for certain short dated inventories of Apotex's clopidogrel bisulfate product. The amount, has not been quantified but any payment to Apotex will be paid 50% by Sanofi-Aventis and 50% by BMS, both of which have put US$20m in reserve.

However, the deal has failed to receive required antitrust clearance. It requires both the Federal Trade Commission and the States Attorney General approval to become effective.

When the two multinational announced the settlement on March 21, 2006, the companies said that there was a significant risk that required antitrust clearance would not be obtained.