Attn: Business/City Editors
August 31, 2006
For Immediate Release
Court Halts Sales of Generic Plavix®
Apotex to File Emergency Motion to Stay Injunction
Weston,
FL (August 31, 2006) — Apotex Corp. today
announced that the U.S. District Court of the Southern District of New
York has granted the request of Bristol Myers Squibb and Sanofi to issue
a preliminary injunction to prevent further sales of Apotex’s generic
version of Sanofi’s Plavix® (clopidogrel 75mg tablets). The Court denied
BMS and Sanofi’s request to force Apotex to recall product it has
already shipped.
Apotex will immediately appeal the decision and is filing an emergency
motion with the Court of Appeals for the Federal Circuit to stay the
injunction pending the appeal.
In granting the injunction, the Court has required BMS to post a $400
million bond to compensate Apotex for damages should it prevail in its
patent dispute with BMS and Sanofi over U.S. Patent No. 4,847,265 (the
‘265 patent). Apotex had asked the Court to set the bond at $4 billion.
Apotex began shipping clopidogrel on August 8. Launch of the product
followed the July 28th rejection by the States’ Attorneys General of a
proposed settlement of the patent dispute concerning the ‘265 patent,
which was submitted to the states and Federal Trade Commission by the
parties earlier this year.
Apotex Chief Executive Officer Dr. Barry Sherman said “We remain
steadfast in our belief that the ‘265 patent will be held invalid and
that the courts will find inequitable conduct on the part of Sanofi.
Today’s decision to stop Apotex from continuing to sell our generic
Plavix® is first and foremost a blow to consumers, patients, taxpayers,
and businesses. And the $400 million bond is grossly inadequate to
compensate Apotex for the damages we are now in jeopardy of incurring.
Apotex is moving immediately and aggressively to reverse the court’s
decision.”
“We launched this product at-risk because Apotex always strives to make
quality, affordable generic medicines accessible to those who need them
at the earliest possible time,” Sherman added. “With that commitment at
the forefront of our effort, we will do everything we can to swiftly
restore access to our quality, affordable generic version of this
important medicine for all the constituencies of the U.S. health care
system.”
Apotex's clopidogrel tablets are packaged in bottles of 30s, 90s, 1000s,
and 100 count unit dose blisters.
The Apotex Group manufactures more than 200 different high-quality
generic pharmaceuticals, used by millions of patients worldwide. Its
product line includes oral solids, liquids, injectables, nasal sprays,
opthalmics, and inhalation solutions.
Plavix® is a registered trademark of Sanofi-Aventis.
Apotex
Corp. is the U.S. subsidiary of Apotex Inc., the largest Canadian-owned
manufacturer of prescription drugs. Through its sales and marketing
headquarters in Weston, Florida and operations center in Indianapolis,
Apotex Corp. is committed to providing safe and affordable generic
medicines. Products manufactured and marketed by the Apotex Group are sold
in 115 countries around the world. For more information visit
www.apotexcorp.com.
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