Bristol, Sanofi lawyer requests generic Plavix halt

NEW YORK, Aug 19 (Reuters) A lawyer for Bristol-Myers Squibb Co. and Sanofi-Aventis told a federal judge that the launch of a generic version of their blockbuster drug Plavix would cause ''irreparable injury'' if it did not stop.

The companies are seeking a preliminary injunction to halt sales by Canadian drug maker Apotex Inc., which last week shook up the industry by launching its generic of the 4 billion-dollars a-year blood-clot treatment far earlier than analysts had expected.

Yesterday hearing is part of the latest, and perhaps final, effort by Bristol-Myers to maintain its grip on its top-selling product, which accounts for an estimated 30 percent of profits.

The company and Sanofi-Aventis are locked in a battle with Apotex over the drug's patent.

''You can never put this Humpty Dumpty back together if it's not stopped,'' said Evan Chesler, a lawyer for Bristol-Myers and Sanofi-Aventis, as yesterday's hearing on the companies' request began in the US District Court for the Southern District in Manhattan.

Bristol-Myers and Sanofi-Aventis also asked to recall supplies of the generic already in the marketplace.

Without an injunction, Chesler said, US regulators will probably approve other generics waiting in the wings as soon as Apotex's 180-day exclusivity as the lone generic on the market lapses.

''They can enter the market and the product (Plavix) erosion will be much worse,'' Chesler said. ''They're destroying the (Plavix) franchise and creating price erosion from which we will never recover.'' Privately held Apotex, which launched its generic on Aug.

8, is believed to have shipped huge amounts of its product after a settlement between it and the two larger drug makers collapsed late last month.

''Apotex submits there are no irreparable damages,'' Robert Silver, a lawyer for Apotex, said in court. ''No other conclusion can be reached.'' He said the public ''overwhelmingly favors competition, and the dramatic benefit to consumers should be allowed to continue.'' Chesler said Bristol-Myers' risks are enormously higher as each day's supply of the generic hurts Plavix sales.

New York-based Bristol-Myers sells Plavix in the United States for Paris-based Sanofi-Aventis.

Under the collapsed settlement, Apotex would have delayed its launch for years in exchange for compensation from Bristol-Myers and Sanofi-Aventis, which still claim the generic infringes a Plavix patent.

The US Department of Justice began a criminal antitrust investigation of the settlement, including a raid on the office files of Bristol-Myers Chief Executive Peter Dolan, only days before the settlement fell through.

Bristol-Myers' board on Thursday issued a statement saying an ongoing investigation by the company's outside counsel ''has not found any evidence of unlawful conduct by Bristol-Myers employees.'' Amid claims by some investors that Bristol-Myers was outmaneuvered by Apotex, the board said in its statement that it was ''well aware of investor concerns'' and ''believes the company is executing the appropriate initiatives to protect the best interests of the company and its shareholders.'' Shares of Bristol-Myers were down 3 cents at 21.45 dollars in afternoon trading and are off about 17 per cent since the company announced the criminal investigation late last month.

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