Billion dollar sales set for a shake up.

Billion dollar sales set for a shake up.

The performance of cholesterol lowering drugs continues to demand the attention of the pharmaceutical vanguard. Competition with the world’s top-selling cholesterol drug, Pfizer’s Lipitor, which generates a reported $10bn sales, could be about to get serious with news that a drug co-developed by Schering-Plough and Merck might be more effective than the market leader.

Its developers claim that the new product, Vytorin (ezetimibe/simvastatin), is the only drug of its kind to inhibit both cholesterol production in the liver and absorption in the intestine. Data presented at the American College of Cardiology in March suggest that the drug’s active ingredients trigger a greater cholesterol reduction than that measured with Lipitor treatment. Vytorin represents the marriage of two currently approved cholesterol drugs - Schering-Plough’s Zetia (ezetimibe) and Merck’s Zocor (simvastatin).

The drug will be shared 50-50 between the two companies, and hopes of success are high. ’Schering-Plough’s first quarter results reflect the serious challenges facing the company,’ said company chairman Fred Hassan in response to disappointing financial results released in April. ’We . continue to look forward to a turnaround that is expected to begin in 2005 and be driven by our cholesterol-lowering agent Vytorin.’ The FDA is in the process of reviewing the drug, with rumours it could be approved by August. It has already been approved in Mexico and Germany, where it is marketed under the name Inegy.

The approval of the drug in Germany represents the first approval in Europe and the first step towards seeking marketing approval throughout the EU under the EU’s mutual recognition procedure (MRP), said a spokesperson for Schering-Plough. If approved through the MRP process, the Inegy tradename will be used throughout the EU.

Meanwhile Pfizer continues to keeps a close eye on its market dominance, with the announcement that it has filed a lawsuit against an online company selling an unapproved copy of Lipitor manufactured in India. There seems little need to worry over challenge to its position from AstraZeneca’s troubled cholesterol drug Crestor, however, if reports are to be believed. The drug was re-launched recently in the US, but City analysts warn that widely-reported fears over long-term safety could continue to hamper AstraZeneca’s efforts.

Bea Perks