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 between pharmaceutical companies Merck & Co. and Schering-Plough Corp. late Friday won Food and Drug Administration approval for Vytorin as a supplement to dieting - an approval crucial for both companies.
Schering-Plough, of Kenilworth, has been struggling through four straight losing quarters, falling sales due to increased competition and a host of legal and regulatory problems. Whitehouse Station-based Merck reported flat profits last quarter, saw four promising drugs fail in mid- to late-stage testing last year and is facing generic competition for Zocor, its biggest seller, in 2006.
During conference calls with industry analysts and reporters on Monday, company officials said Vytorin does a better job of lowering LDL, or so-called bad cholesterol, than competitor Pfizer Inc.'s top-selling Lipitor or Merck's Zocor, the No. 2 cholesterol drug in the $15 billion U.S. market.
"We believe Vytorin will be a very strong competitor in the United States," said Adam Schechter, vice president and general manager of the joint venture, Merck/Schering-Plough Pharmaceuticals.
The new drug is likely to benefit from new national guidelines calling for more aggressive cholesterol lowering, with recommendations that patients at highest risk of heart attack and stroke get their LDL level below 100.
Vytorin combines Zocor, at one of four different doses, with 10 milligrams of Zetia, the first cholesterol drug produced by the joint venture.
"Vytorin is the first and only product approved to treat the two sources of cholesterol in one pill," said Dr. Rick Veltri, group vice president for worldwide clinical development for Schering-Plough Research Institute.
Zocor and Lipitor are part of the hugely popular drug class called statins, which reduce cholesterol production in the liver. Zetia, the only drug in a class called cholesterol absorption inhibitors, prevents cholesterol absorption in the intestines.
More cholesterol is produced by the body than what comes from foods so a low-fat diet won't lower cholesterol levels enough for some patients.
Vytorin outperformed both Lipitor and Zocor in testing sponsored by the joint venture. At the recommended Vytorin starting dose, 10 milligrams of Zetia and 20 of Zocor, LDL cholesterol levels fell an average of 50 percent, versus 44 percent for 20 milligrams of Lipitor. In a second study, the starting dose of Vytorin cut LDL level by 52 percent, compared with 34 percent for 20 milligrams of Zocor.
In another study, within five weeks 83 percent of patients taking the Vytorin starting dose reached their cholesterol goal of below 100, compared with 46 percent of patients on 20 milligrams of Zocor.
Schechter said the joint venture hopes to officially launch the new drug before Labor Day.
It is planning extensive marketing, through ads aimed at consumers, sales representatives visiting and giving free samples to doctors and efforts to get Vytorin listed on managed care companies' formularies of preferred drugs.
Vytorin will have a wholesale price of $2.34 for each of its four doses _ 10 milligrams of Zocor combined with 10, 20, 40 or 80 milligrams of Zetia.
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 early afternoon trading on the New York Stock Exchange, Merck shares fell 1 percent, or 46 cents, to $44.70, while Schering-Plough shares rose 42 cents to $19.17.
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