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Firms fighting to block generic Plavix

BMS and S-A say sale of cheaper version of blood-thinner is causing them 'irreparable' harm
The recent launch of a generic version of sanofi-aventisí (S-A) and Bristol-Myers Squibbís (BMS) blockbuster, Plavix, will cause both companies ìirreparableî harm, they have told a US federal judge.

The two firms were in a New York federal court on August 18, trying to convince Judge Sidney Stein to issue a preliminary injunction that would block sales of generic Plavix and recall packs of the drug that have already been shipped.

Canadian generics firm, Apotex, launched the generic version of the blood-thinner on August 8, triggering a renewal of patent litigation between the firms, which first started four years ago. It is believed to have shipped substantial amounts of its product after a settlement between it and the two larger drug manufacturers collapsed last month after failing to gain US antitrust clearance.

The deal would have delayed the introduction of generic Plavix until 2011 but before the patent expiration claimed by S-A and BMS.

ìWe are being irreparably injured and it will get worse with each passing week,î BMS attorney, Evan Chesler, told the judge during the two-day hearing. He accused Apotex of ìflooding the marketî with generic Plavix so it could quickly lock in profits in case an injunction was issued.

Without an injunction, Chesler added, US regulators would more than likely approve other generics as soon as Apotexís 180-day exclusivity as the first generic version of Plavix on the market elapses.

Apotex attorney Robert Silver countered that S-A and BMS have not been irreparably harmed, because they have already agreed to a cap on damages in the event they win the patent infringement trial. He also said Apotex would be harmed financially if an injunction were granted because the company had incurred costs to develop and build up its manufacturing capacity.

The outcome of the case is crucial to S-A and BMS. Plavix is the worldís second biggest-selling drug after Pfizerís Lipitor, with global sales of $5.9bn in 2005.

According to Verispan LLC, which collects prescription data, the generic version of Plavix has wasted no time in grabbing market share from the branded version.

For the week ended August 18, generic Plavix had captured 60.2 per cent of the total prescriptions written for the drug and 74 per cent of new prescriptions.

Apotex is selling the drug for about $124 for 30 pills, compared with $148 for a monthís supply for the branded version. BMS and S-A have offered to discount Plavix for major purchasers to maintain market share.

BMS is currently the focus of a US Justice Department investigation into the settlement. The Manhattan office of chief executive, Peter Dolan, was raided on July 26 and FBI agents seized documents.

In a statement, the board of BMS said it was taking the investigation with ìthe highest degree of attention and seriousnessî.

30th September 2008

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