Bristol, Sanofi Pledge To Defend Plavix Patent In Face Of Potential “At Risk” Launch
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA grants final approval to Apotex’ ANDA for the antithrombotic, fueling speculation over timing of generic entry.
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Bristol-Myers Squibb and Sanofi-Aventis said they will "vigorously" defend a patent protecting Plavix (clopidogrel) following FDA's Jan. 20 final approval of Apotex' ANDA for the antithrombotic. "We continue to believe the 2011 patent is valid and infringed, and with our partner Sanofi, we are vigorously pursuing the pending patent litigation," Bristol CEO Peter Dolan stated during an earnings call Jan. 25. The trial in the infringement case over Sanofi's patent no. 4,847,265 - which expires in 2011 - is scheduled to begin April 3. FDA's statutory 30-month stay expired on May 17, 2005, clearing the way for the agency's final approval of Apotex' ANDA for clopidogrel 75 mg tablets. Although patent litigation is still pending, the approval has sparked speculation that Apotex could launch the generic "at risk." Apotex said Jan. 25 that it "is not releasing details regarding the possible launch of the product at this time," and added that it is "committed to ensuring that the product comes to market as soon as the time is right." Plavix is Bristol's top-selling drug, accounting for more than 20% of the company's revenues. It generates roughly $5 bil. in sales worldwide for Bristol and Sanofi. Bristol recorded Plavix sales of $3.82 bil. in 2005, up 14.9%. Bristol has also been hit with other exclusivity losses; the company has been eyeing 2007 as its year to return to sales and earnings growth following the loss of exclusivity for Pravachol later this year (1 (Also see "Bristol On Track For Growth In 2007 Despite Pargluva Setback" - Pink Sheet, 28 Oct, 2005.)). Bristol CFO Andrew Bonfield noted a loss in the '265 patent case would not necessarily result in an immediate Plavix generic launch. "There are legal processes you continue to go through, including appeals," he said. "In the event of generic competition at that time, we would review all the financial and operating policies of the company." - Jessica Merrill |