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Generic Version of Plavix® (Clopidogrel) is Launched by Apotex

August 8, 2006 -- In a bold and risky move, the U.S. subsidiary of Canadian-owned drug manufacturer Apotex, has launched a generic version of the top-selling antiplatelet drug Plavix. The generic drug, clopidogrel bisulfate, was approved by the U.S. Food and Drug Administration in January. Plavix is a blood thinner, taken by millions of heart patients and prescribed for all drug-eluting stent patients to lower the possibility of "stent thrombosis", a serious and sometimes fatal clotting of blood inside of the stent.

The release is considered an "at risk launch" because of the complex legal situation over the validity of the Plavix patent -- a situation involving Apotex, Sanofi-Aventis, the manufacturer of Plavix, and Bristol-Myers, U.S. marketer of Plavix.

The stakes are high: Plavix is the world's second largest-selling drug with sales last year of $5.9 billion (that's close to the global sales for ALL drug-eluting stents). After the F.D.A. approved the generic version, Bristol-Myers and Sanofi-Aventis came to an agreement with Apotex to delay the launch of the generic drug until 2011, when the Plavix patent in dispute is scheduled to expire. However, that agreement was rejected on July 28 by the States' Attorneys General . Critics of the proposal said it was counter to the interests of consumers, delaying the substantial savings of a generic drug for years.

Once the agreement was rejected, Apotex decided to go ahead with its launch "at risk", meaning that if the Plavix patent is judged valid, Apotex would normally be liable to pay triple damages to Bristol-Myers and Sanofi-Aventis. Those companies are reportedly weighing their legal options and may ask for an injunction against sales of the generic. An interesting point is noted in a Reuters report: the rejected agreement, which was made public today, contained certain terms judged very favorable to Apotex, such as a clause that reduced damages to 50% of sales, as opposed to triple, a signal that Bristol-Myers and Sanofi-Aventis may not have felt that their patent would withstand the legal challenges. According to reports that portion of the agreement remains in effect. Bristol-Myers is also the subject of an anti-trust investigation around the Plavix agreement.

A 75mg tablet of Plavix (the daily dose for stent patients) currently sells for $4.00 -- estimates are that the generic version will retail for 30% less. The availability of a less expensive version of clopidogrel would seem a boon for stent patients in particular, some of whom are not able to afford Plavix and, according to many articles we've posted, stop taking the drug too soon, raising their risk of stent thrombosis.

The opposite view is taken by Bristol-Myers CEO Peter Dolan. In a letter written to his employees (as reported in the business publication Forbes) he argues that patent protection is critical so that companies can continue to develop medicines to treat serious diseases, and that weakening of that protection can negatively affect Research and Development and will "ultimately hurt patients."

The launch is expected to affect the bottom line of both Bristol-Myers and Sanofi-Aventis. Since last Thursday, when rumors about the generic launch began circulating, Bristol-Myers stock has dropped over 18%, Sanofi-Aventis almost 11%.

related stories:
Apotex Launches First Generic Plavix® -- Apotex Corp.

Generic of Bristol clot drug hits market -- Lewis Krauskopf and Ransdell Pierson, Reuters

Plavix Pain -- Matthew Herper, Forbes

Apotex Receives Approval for First Generic Plavix® -- Apotex Corp.

Plavix and Aspirin -- Discussion Forum -- Angioplasty.Org Cardiology Patients' Forum