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Court Upholds Sanofi-Aventis Plavix Patent
Generic Clopidogrel from Apotex is Blocked; Apotex to Appeal Ruling

June 20, 2007 -- Patients who were hoping to be able to purchase a less-expensive generic version of Plavix (clopidogrel) will have to wait until 2011, according to Judge Sidney Stein of the U.S. District Court of the Southern District of New York. The patient trial, which took three weeks, ended yesterday with Judge Stein deciding against the Canadian pharmaceutical firm Apotex, stating that

"Sanofi has shown that it is likely to suffer irreparable price erosion, loss of goodwill, and a negative impact on the amount of research devoted to developing other medical uses for Plavix®."

Plavix is an antiplatelet drug which prevents blood from clotting and causing heart attacks or other coronary problems. It is routinely given to patients after stent implantation for 1-2 months following a bare metal stent, and for 6-12 months when the newer drug-eluting stent is used. However, because of the recent concerns about late stent thrombosis (clots occurring later than 6 months) there has been much controversy over how long Plavix should be given, with many cardiologists prescribing the drug for life. Plavix costs almost $5.00 US a day. The generic version from Apotex was selling at about 15% less. Plavix is the second-biggest-selling drug with worldwide annual sales of more than $6 billion.

Editor Burt Cohen of Angioplasty.Org noted last year in his blog that, according to the FDA, in non-emergency stent patients (the vast majority of stent recipients), the use of Plavix is technically "off-label" -- because studies have not been done by the drug manufacturers for this patient population. All the stent/Plavix studies were done by the device makers, like Cordis and Boston Scientific.

Cohen hopes that with this ruling, Sanofi-Aventis and Bristol-Myers Squibb, Sanofi's marketing partner in the U.S., will devote significant funds to researching the long-term outcomes of clopidogrel in non-emergency stent patients and that they will sponsor both randomized clinical trials to determine optimum length of antiplatelet therapy, and an education campaign to inform stent patients and physicians of the critical need to comply with Plavix and aspirin regimens.

But, alluding to the past actions of Sanofi-Aventis and Bristol-Myers regarding Plavix and stent patients, Dr. William O'Neill, a high-profile interventional cardiologist and Professor and Executive Dean for Clinical Affairs at the University of Miami's Miller School of Medicine, told Cohen last December:

"They haven't put a dime into clinical trials on the use of their drug in stents. They've piggy-backed onto the device makers and they haven't really needed to do the science. Like there's a real concern about Plavix resistance or hypo-responsiveness -- they haven't done squat on that.... They haven't had to act responsibly toward the use of their drug, the length of the time, and the potential premature termination. They could get it past a labeled indication if they did the proper trial, but they don't want to do it because they figure that they'll just make all the money with doctors using the drug off-label."

Apotex Chairman Barry Sherman vowed to appeal and continue the fight to bring generic clopidogrel to the marketplace and "once again make possible billions of dollars in savings for the public." According to the Wall Street Journal, analysts believe an appeal would not be likely, given the legal history of the case.