Monday, December 31, 2007

Plavix: The beggining of the end of a blockbuster

Plavix (Clopidogrel) is an anti-platelet agent manufactured by Sanofi-Aventis and co-marketed with Bristol-Myer Scribb. It is the anti-platelet agent of today, having been found to be safe and very effective in preventing cardiovascular events, in patients with established coronary artery disease and also in subjects at high risk of CAD.

This role was initially reserved for aspirin for many years between the seventies to the nineties. The gastrotoxicity of aspirin prove to be it's demise. Ticlopidine was a substitute for aspirin in the nineties but proved unpopular because of the 4% incidence of agranulocytosis, which in high risk groups, including elderly females, proved to potentially fatal.

So, Sanofi, also the manufacturer of Ticlopidine, brought out Clopidogrel (Plavix) as a good substitute for aspirin (plavix has no gastrotoxicity) and also ticlopidine (plavix very rarely caused agranulocytosis). It became the number one anti-platelet agent, despite it's high cost. It proved to be more effective than aspirin in the primary and secondary prevention of CAD and also proved very effective when combined with aspirin in the secondary prevention of CAD. Plavix also became the indispensable agent for the prevention of stent thrombosis when drug-eluting stents are used. For all these reasons, for the third quater of 2007, the total sales of Plavix topped USD1.2billion. Well, that is all wonderful and good for Sanofi-Aventis. Sadly, early signs of the end of the blockbuster sales of plavix is beginning to show. Plavix was FDA aproved in 1998 and its patent in USA may expire in 2011.

This year has seen the release of two clinical trials (TRITON and PRINCIPLE). Both these trials pitted Prasugrel against Clopidogrel, head to head. The second trial (PRINCIPLE - TIMI 44) was published in the on-line edition of Circulation on Dec 3rd. Both the trials showed that Prasugrel was superior to Clopidogrel in terms of anti-platelet effects. Looks like the correct dose of Prasugrel have yet to be determined. I am sure that Sanofi will be hoping that Eli Lily (maker of Prasugrel), will take a long time to find the right dose. The present dose of Prasugrel was associated with a significant rate of bleeding. Well Sanofi and plavix, take note, competition is around the corner.

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