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Merck and Schering-Plough Developing Cholesterol-Lowering Combination
Malorye Allison, PharmaWeek

March 27, 2007--The race to deliver the next breakthrough in cholesterol-lowering is changing dramatically. Just recently, Pfizer stumbled in its attempt to develop a combination based on its super blockbuster Lipitor (atorvastatin) and a new compound called torcetrapib, a cholesteryl ester transfer protein (CETP) inhibitor. Now, Merck and Schering-Plough have announced plans to develop yet another new combination. 

The new product will combine ezetimibe (Merck/Schering-Plough’s Zetia) and atorvastatin (Pfizer’s Lipitor).  The pill will be launched as atorvastatin’s patent expires, which will be around 2010.  It will be marketed by a joint venture called Merck/Schering-Plough, formed in 2001 to develop and market new cholesterol and respiratory disease products in the US.  The joint venture already markets ezetimibe and a pill that combines that drug with simvastatin (Merck’s Zocor).

Combination products are seen as possibly the next potential breakthrough for treating atherosclerosis.  Although this is already the world’s largest therapeutic market, worth about $32 billion, better therapies are needed. The statins, such as atorvastatin and simvastatin, target LDL levels (the bad cholesterol). Despite aggressive statin therapy, however, many patients do not lower their LDL level enough to prevent progress of their disease.   

Pfizer’s torcetrapib was tested in combination with atorvastatin, which has been the world’s top-selling drug for the last several years.  With atorvastatin edging toward patent expiration, Pfizer had sought to extend the old drug’s life at the same time it was bringing the new drug — torcetrapib — to market.  But trial results showed the combination not only failed to impact disease as anticipated, it also led to higher blood pressure in some patients. 

Ezetimibe works by inhibiting cholesterol absorption in the digestive track.  The ezetimibe/simvastatin combination (Vytorin) is already a big success, reaping over $2 billion in sales annually.  By introducing an ezetimibe/atorvastatin combination, Merck/Schering-Plough could not only gain a nice new slice of the cholesterol-lowering market, it will also be taking a share that Pfizer had its eye on.

For more on combination therapies, see PharmaWeek Strategic Briefing: “Finding the Magic in Fixed Combinations.” 

Copyright 2007, Cambridge Healthtech Institute. All Rights Reserved.

 

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