Merck & Co. and Schering-Plough Corp. plan to dig more deeply into the lucrative market for cholesterol-lowering drugs by developing a pill that combines their drug Zetia with Lipitor, the world’s bestselling medicine.
Pfizer Inc.'s U.S. patent on Lipitor is expected to expire as soon as 2010, paving the way for other companies to make generic versions of the blockbuster drug. Pfizer is not involved in the deal.
Merck and Schering-Plough said the development program was timed so the combination product could be available when the patent expires for Lipitor, known generically as atorvastatin.
Analysts said the new product could replace the companies’ Vytorin, which combines Zetia with Merck’s slightly less-potent statin Zocor.
“Because Lipitor is more efficacious than Zocor ... in my view it would be the new combination pill that cardiologists would be comfortable in prescribing,” Edward Jones analyst Linda Bannister said.
Drug companies have increasingly turned to combination drugs for controlling cholesterol as medical recommendations for lowering levels of the artery-clogging substance have become more aggressive. High levels of bad cholesterol, or LDL, are a major risk factor for heart disease.
Through their joint venture, formed in 2000, Kenilworth, N.J.-based Schering-Plough and Whitehouse Station, N.J.-based Merck have developed both Zetia and Vytorin into products with annual sales each approaching $2 billion. Lipitor sales were $12.9 billion last year.
Lipitor, Zocor and other statin medicines work in the liver. Zetia, known generically as ezetimibe, blocks absorption of cholesterol in the intestines in a complementary fashion to statins. Zetia is currently approved for use by itself or with other statin drugs.
“Lipitor has high efficacy and is a well-understood product, so it is understandable we would look at that fixed combination,” said Fred Hassan, Schering-Plough’s chief executive.
“It will take some business from Vytorin, but the hope is the convenience of one good drug would spare patients from having two co-pays, and might offer us a new opportunity,” Hassan said.
Global sales of all cholesterol and lipid drugs rose 7.5% to $35.2 billion in 2006, according to pharmaceutical information company IMS Health Inc.
Lipitor prescriptions currently make up about 35% of the cholesterol market, while Vytorin makes up about 11% and Zetia 8%, according to analysts at Bear Stearns.
Vytorin cuts bad cholesterol by as much as 60%, compared with as much as 47% for Zocor alone. Lipitor can cut LDL by more than 50%.
Shares of Schering-Plough jumped 52 cents Monday to $25.14, Merck fell 38 cents to $44.07 and New York-based Pfizer rose a penny to $25.67.