Jul 26, 5:18 PM EDT
New Cholesterol Drug May Make Splash
LINDA A. JOHNSON
TRENTON, N.J. (AP) -- 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. The drug is crucial for both companies.
Schering-Plough, of Kenilworth, has been struggling through four straight losing quarters, falling sales and a host of legal and regulatory problems. Whitehouse Station-based Merck reported flat profits last quarter and saw four promising drugs fail in advanced testing last year.
Company officials told industry analysts and reporters Monday that Vytorin lowers LDL, or 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 percent, but research to show how much it prevents heart attacks and other problems won't be finished for years.
"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.
Sales are 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 70 instead of the old goal of 100.
"I think it's going to be a big seller," said pharmaceuticals analyst Mike Krensavage of Raymond James & Associates. "You have a drug that is good or better than anything else, priced at or below competing drugs."
Krensavage said he expects Vytorin to take market share from Lipitor as well as Zocor, which is Merck's No. 1 drug at 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.
"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 prevents cholesterol absorption in the intestines - the only drug to do so.
More cholesterol is produced by the body than what comes from foods, so a low-fat diet rarely cuts cholesterol levels more than 30 percent.
Vytorin outperformed both Lipitor and Zocor in testing ponsored 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.
Dr. Muhamed Saric, director of echocardiography at University of Medicine and Dentistry of New Jersey in Newark, said he thinks many doctors will prescribe Vytorin for patients who can't get down to their goal, even at the highest statin dose.
He's concerned because there are no studies longer than a few years on long-term effects of statins, which can cause liver and muscle damage; Zetia is not known to cause any additional problems.
"There's a possibility a lot of my patients will be on cholesterol drugs 25 or 30 years," Saric said.
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 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.
Jen Leone, spokeswoman for Medco Health Solutions, which manages prescription benefits for about 60 million Americans, said the company hasn't decided whether to cover Vytorin.
In trading on the New York Stock Exchange, Merck shares closed down 16 cents at $45, while Schering-Plough shares jumped 81 cents, or 4.3 percent, to $19.54.
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(AMs. Retransmitting to fix slug. SUBS graf 6, 'Sales are ... ' to CLARIFY; SUBS graf 22, 'Vytorin will ... ' to correct order of Zetia and Zocor; ADDS comment, details; UPDATES stock movement.)
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