Judge blocks generic Plavix sale

By Bill Berkrot and Lewis Krauskopf

NEW YORK (Reuters) – A U.S. judge on Thursday granted a
request from Sanofi-Aventis and Bristol-Myers Squibb Co. to
block the sale of a generic form of their top-selling Plavix
blood thinner.

Shares of Bristol-Myers, for which Plavix accounts for an
estimated 30 percent of profit, jumped 9 percent in after-hours
trading to $23.70 following the announcement of the ruling.

However, the federal judge denied a motion seeking a recall
of the generic product that has already been distributed by
Canadian drug maker Apotex since its launch earlier this month.

Investors have been anxiously awaiting the decision on
Plavix, which has annual U.S. sales of about $4 billion and is
by far Bristol-Myers’ biggest product. New York-based
Bristol-Myers sells Plavix in the United States for Sanofi,
which is based in Paris.

Judge Sidney Stein of the U.S. District Court in Manhattan
handed down the preliminary injunction, saying in his ruling
that Sanofi had demonstrated a likelihood of success on the
merits of the case, and that Sanofi and Bristol-Myers would
suffer “irreparable harm” if the injunction was not granted.

Shaojing Tong, a pharmaceuticals analyst for Mehta
Partners, called the injunction a big step for Bristol-Myers.

“It shows the judge is convinced in the Plavix patent’s
validity, and this same judge will rule on the patent itself in
the trial,” he said.

The court ordered Sanofi to post a $400 million bond by
September 5, and said a patent infringement trial involving
Plavix would begin on January 22, 2007.

But Tong said the lack of a recall was “definitely
damaging,” noting analysts have speculated Apotex has already
shipped between six to 18 months supply of generic Plavix.

“Nobody knows how much generic Plavix is already in the
channel,” Tong said.

Tony Plohoros, a spokesman for Bristol-Myers, said the
company was “pleased” the injunction was granted, but that it
was too soon to gauge the financial impact of generic Plavix
sales.

“We’re currently trying to assess wholesaler supply and
determine the amount of product in the marketplace,” Plohoros
said.

Apotex could not immediately be reached for comment.

Privately held Apotex launched its generic on August 8, far
sooner than analysts had expected. The launch came after a
settlement deal with Bristol-Myers and Sanofi that would have
delayed generics until 2011 fell through.

Sales of the generic, known chemically as clopidogrel, have
posed a serious threat to Bristol-Myers’ earnings and its
ability to keep paying a hefty dividend to shareholders.

Bristol-Myers and Sanofi-Aventis on August 14 sought an
injunction to block Apotex’s sales and to recall supplies of
the generic already on the market.

(Additional reporting by Anna Driver and Ransdell Pierson)