CHOLESTEROL New drug Vytorin awaits approval

The new drug is expected to ignite a pricing and advertising battle.
NEW YORK (AP) -- The fight for market share in the world's largest drug category is about to intensify as a new cholesterol-lowering medicine called Vytorin joins the pack that includes Lipitor, Zocor and Crestor.
The introduction of Vytorin -- expected to win Food and Drug Administration approval later this month -- is likely to ignite a pricing and advertising battle.
Vytorin, a combination of two other cholesterol drugs, Zocor and Zetia, has been shown in studies to lower cholesterol better than market leader Lipitor. Zocor is from the class of drugs known as statins, and lowers cholesterol by cutting its production in the liver. Zetia, meanwhile, limits the absorption of cholesterol in the intestines.
The new drug, manufactured and marketed by a joint venture between Merck & amp; Co. Inc. and Schering-Plough Corp., is expected to provide tough competition for Pfizer Inc.'s Lipitor, which dominates the market with a 55-percent share of prescriptions and 49 percent of sales.
It's also likely to have a big impact on Crestor, a statin introduced last September that has fought Lipitor with studies demonstrating Crestor's superior cholesterol-lowering ability. There have been concerns about the drug's safety, however.
'An enviable position'
"Vytorin is in an enviable position. It has best-in-class efficacy without the safety hang-ups," said Tim Anderson, an analyst at Prudential Securities. He predicts Vytorin sales will hit $3.4 billion by 2008.
Vytorin, made by Merck/Schering-Plough Pharmaceuticals, is launching at a time when growth has slowed in the cholesterol-lowering market. Last year, combined sales of cholesterol-lowering medicines rose 11 percent to $13.85 billion, according to research firm IMS Health. That followed an increase of 14 percent in 2002, 21 percent in 2001 and 26 percent in 2000.
Analysts believe the recent stagnation may be a result of patients having to pay higher insurance copayments for their drugs.
But there are signs the market is gathering some momentum, with sales up 13 percent in the first five months of this year. Analysts suggest heavy advertising by AstraZeneca PLC to promote Crestor helped boost revenues.
New guidelines
Vytorin's expected approval coincides with the release last week of new guidelines that call for people who have had heart attacks or who are at high risk for heart disease to lower their LDL, or bad cholesterol, to 70 instead of 100 as previously recommended. The guidelines were released by the National Cholesterol Education Program, an initiative of the National Heart, Lung and Blood Institute, one of the National Institutes of Health.
Analysts expect the guidelines to help increase the market for cholesterol drugs.
There certainly is room for growth -- though an estimated 37 million Americans could benefit from the drugs, only around 14 million take them.
"Cholesterol drugs aren't like insulin," said Richard Evans, an analyst at Sanford C. Bernstein. "It's not like if you don't take them you are immediately going to die."
That's why doctors and analysts agree that pricing will be a major factor in Vytorin's success as insurers grow ever more vigilant about restraining drug prices. Lipitor is $2.58 or $3.75 a pill, depending on the dose. Crestor is $2.23 a pill for all doses.
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