Keywords: Bristol-Myers Squibb, Plaxiv, Sanofi-Aventis, blood thinner

Bristol-Myers Squibb says USPTO to review Plavix patent

Article | 20 August 2009

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US drug major Bristol-Myers Squibb says that its lead drug, Plavix (clopidogrel), the blood thinner co-marketed under an agreement with its originator, French giant Sanofi-Aventis, will be reviewed by the US Patent and Trademark Office (PTO).

Sales of Plavix in the second quarter of this year were $1,539 million, up 11%, while turnover in 2008 increased 18% to $5.6 billion, making it one of the world’s best-selling pharmaceutical products.

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The patent of the antiplatelet blood thinner is expected to expire in November 2011, although the companies might win a six-month extension for conducting pediatric studies. Canada-based Apotex has requested the USPTO to review the patent as the company is looking to bring generic versions of the drug to the market before 2011.

Meanwhile, comment analysts at Zacks Equity Research, Plavix will face new competition from Eli Lilly, which recently received Food and Drug Administration approval for its drug Effient (prasugrel). Phase III data comparing Effient to Plavix shows that Effient is more effective in reducing major adverse cardiovascular events. However, there is an increased bleeding risk to Effient, so we believe that Plavix use and sales of the drug should remain strong until the patent expiration in 2011.

In order to compensate for the loss in revenues once Plavix loses exclusivity, Bristol-Myers is working on bringing new products to market. Additionally, management is working hard to reduce costs and shed less profitable and non-core businesses.

The recently announced $1 billion extension in cost cuts in 2012-2013, the extension of the Abilify agreement with Otsuka, and the potential acquisition of Medarex, which has cleared the regulatory review recently, are the latest examples that management is taking meaningful steps to prepare for the loss of exclusivity of Plavix, says the Zacks team, which has an outperform rating on B-MS.

$125 million settlement approved

Prior to the B-MS announcement, a judge gave initial approval to settlements of shareholder litigation arising out of the drug major’s efforts in 2006 to end its long-running patent dispute with Apotex over Plavix.

In an order, US District Judge Paul Crotty granted preliminary approval to an agreement in principle in which B-MS and its former chief executive would pay $125 million to settle a consolidated shareholder action over disclosures regarding its efforts to settle the Plavix litigation in 2006. The pact was reached in May.