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Trial fails to enhance Inegy's prospects

Published on 04/04/08 at 03:49pm

Schering-Plough and Merck's much-touted anti-cholesterol combination Inegy has suffered a setback following a poor showing in the ENHANCE trial.

Inegy combines Ezetrol (ezetimibe) with Merck's off-patent former blockbuster simvastatin.

New trial results suggest there is no significant difference between using the two-in-one treatment and using simvastatin alone. In other words, patients were no better off when it came to the trial's pre-specified primary endpoint: a change in the thickness of carotid artery walls over two years as measured by ultrasound.

Inegy's disappointing results came despite the fact that the ezetimibe/simvastatin 10/80-mg dose significantly lowered LDL 'bad' cholesterol, as well as triglycerides and C-reactive protein (although Inegy is not indicated for the reduction of CRP), more than simvastatin 80-mg alone.

The global cholesterol-management market is a lucrative area - worth $32 billion in 2006, $22 billion of which was from the US - and currently dominated by Pfizer's Lipitor.

Combined sales of Inegy (marketed in the US as Vytorin) and Exetrol (marketed in the US as Zetia) reached $2.4 billion in the first half of 2007, up 40%.

However, it is also a sector under pressure: the launch of the generic simvastatin caused a slowdown, and the expected loss of US patent for Lipitor in three years' time will take a further chunk of value from the market.

In a further blow to Merck and Schering-Plough, there also were no significant differences between treatment with ezetimibe/simvastatin and simvastatin on the four pre-specified key secondary endpoints.

These were: percentage of patients manifesting regression in the average carotid artery intima-media thickness (CA IMT); proportion of patients developing new carotid artery plaques >1.3 mm; changes in the average maximum CA IMT; and changes in the average CA IMT plus in the average common femoral artery IMT.

The ENHANCE results will cheer AstraZeneca, whose planned head-to-head trial of Crestor against Inegy seems designed to prove to doctors that combining Ezetrol with Crestor will produce better results than Ezetrol with simvastatin. The trials were set to use a low dose of Crestor (10-mg or 20-mg) combined with Ezetrol versus simvastatin (40-mg or 80-mg doses) and Ezetrol.

Schering-Plough and Merck have begun to work on a new combination of Ezetrol and Lipitor (atorvastatin) in advance of the latter's patent expiry.

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