The co-developers of a new drug in the same class as Plavix say it has outperformed the drug in a number of small-scale head-to-head trials.

Co-developers Sankyo and Eli Lilly have reported positive results from three parallel phase I studies of the drug, prasugrel, saying trial data showed it prevents blood-clotting more effectively than Plavix (clopidogrel).

Sanofi-Aventis' Plavix is the rising star among global pharmaceutical brands, its sales growing 31% in 2004 to $5 billion. Further growth in the number of licensed indications in worldwide markets means it is set to become the second biggest selling drug in the world after Pfizer's Lipitor in 2005.

Sankyo and Eli Lilly's challenger  is already in a phase III head-to-head trial with Plavix, and the companies hope the early indications of superiority will translate into clear benefits for patients and for sales of the rival product.

Commenting on the phase I results, John Brand, a senior physician at Eli Lilly said: "A more consistent, faster and greater level of platelet inhibition could have important implications for patient care."

But prasugrel has a considerable challenge on its hands ­ Plavix has firmly established itself on the back of a large body of evidence, and Sanofi-Aventis and co-marketer Bristol-Myers Squibb have unveiled new data which looks set to maintain its growth.

Unveiled at the same cardiology meeting in Florida as the prasugrel data, two new large-scale studies showed Plavix could save lives in patients who have suffered the most serious heart attacks.  

Patients with acute ST-elevation myocardial infarction (STEMI) who received Plavix in addition to aspirin and fibrinolytics saw their chances of suffering another blocked artery or second heart attack drop 36% after one week in hospital.

A second study was conducted along similar lines and involved 46,000 patients at over 1,000 sites in China, making it one of the largest ever clinical trials in heart disease.

This study showed the relative risk of patients dying fell 7% in patients receiving clopidogrel as well as standard therapy, and a 9% reduction in either recurrent heart attack, stroke or death.

Lilly says it expects to file prasugrel for acute coronary syndrome in late 2006 and plans to file another major drug, ruboxistaurin, for diabetic microvascular complications, in the second half of this year.

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Plavix leads the way in UK sales growth 

Thursday , January 20, 2005

pharmafocus@wiley.co.uk