New Anti-Cholesterol Drug to Be Priced Competitively

Vytorin, the first pill to lower cholesterol in two ways, should hit pharmacy shelves within weeks, the makers said Monday as they promised heavy marketing and a discounted price to battle the top-selling competition.

A joint venture of pharmaceutical companies Merck & Co. and Schering-Plough Corp. won Food and Drug Administration approval late Friday for Vytorin. The drug is crucial for both companies.

Schering-Plough of Kenilworth, N.J., has been struggling through four straight losing quarters, falling sales and a host of legal and regulatory problems. Whitehouse Station, N.J.-based Merck reported flat profit for last quarter and saw four promising drugs fail in advanced testing last year.

Company executives said Monday that Vytorin lowers LDL, also known as bad cholesterol, more than competitor Pfizer Inc.’s top-selling Lipitor or Merck’s Zocor, the No. 2 cholesterol drug in the $15-billion U.S. market. At the highest dose, Vytorin reduced LDL up to 60%. But research to show how much it prevents heart attacks and other problems will take years to finish.

“We believe Vytorin will be a very strong competitor,” said Adam Schechter, vice president and general manager of the joint venture, Merck/Schering-Plough Pharmaceuticals.

Sales are likely to benefit from new national guidelines calling for more aggressive cholesterol lowering. Patients at highest risk of heart attack and stroke are now urged to get their LDL level below 70 instead of the old goal of 100.

“I think it’s going to be a big seller,” said pharmaceutical analyst Mike Krensavage of Raymond James & Associates. “You have a drug that is as good as or better than anything else, priced at or below competing drugs.”

Krensavage said he expected Vytorin to take market share from Lipitor as well as Zocor, which as Merck’s No. 1 drug generates about $5 billion in annual sales but faces generic competition in 2006.

Vytorin combines Zocor, at one of four different doses, with 10 milligrams of Zetia, the joint venture’s first drug.

Schechter said the joint venture hoped to officially launch the drug before Labor Day.

Vytorin will have a wholesale price of $2.34 for each of its four doses: 10 milligrams of Zetia combined with 10, 20, 40 or 80 milligrams of Zocor.

By comparison, Pfizer’s Lipitor sells for $2.10 wholesale for a 10 milligram pill and $3 for an 80 milligram pill. Zocor sells for $2.20 for a 10 milligram pill and $3.83 for the three higher doses. Zetia sells for $2.16 per pill.

In New York Stock Exchange trading, Merck shares sank 16 cents to $45, while Schering-Plough rose 81 cents to $19.54.