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New Tricks for Anticholesterol Drugs?

By Amy Tsao A new study has found that higher-than-usual doses of Zocor, a popular anticholesterol drug, provided no benefit to patients with extremely high risk for a heart attack. No doubt, Merck (MRK), which makes Zocor and paid for the study that was reported in an item on the Journal of the American Medical Association's Web site on Aug. 31, anticipated a different outcome in this attempt to find a new use for Zocor. Yet because the drug wasn't studied in otherwise healthy patients with high cholesterol, it isn't expected to harm sales of Zocor, which is Merck's single biggest revenue-producing drug.

Despite this unsuccessful outcome, drug companies are likely to keep financing more studies of these cholesterol-fighting drugs. Known as statins, they're the biggest-selling prescription pills in pharmaceutical history. In 2004, global sales will total $26 billion, figures Shao Jing Tong, analyst at New York City-based Mehta Partners. "For such a big category, the effort [to study other uses] is obviously more intensive than for other categories," Tong says.

And with the looming prospect of statins going generic, getting as much as possible out of sales is critical. A decline in statin sales for Merck and Bristol-Myers Squibb (BMY), the other key player in this market, is inevitable, so the motivation to find new uses is intense.

PRESSURE ON DOCTORS. In 2006, Merck's Zocor and Bristol's Pravachol will both lose patent protection in the U.S. How big are the stakes? Merck reported $6.3 billion in worldwide Zocor sales in 2003 and Bristol $2.8 billion for Pravachol. And the rest of the market - namely Pfizer's (PFE) Lipitor and Astra Zeneca's (AZN) Crestor - could also see sales slow as effective generics come out after competitors lose patent protection.

"There will be pressure for doctors to use Zocor and Pravachol when they become generic," says Hemant Shah, an individual industry analyst based in Warren, N.J. "That will put pressure on existing products." Pfizer reported $10.3 billion in Lipitor revenues in 2003, while Astra-Zeneca's Crestor, which was launched in 2003, is expected to be a multibillion-dollar drug in coming years.

Statins are already the subject of a variety of ongoing studies in cardiovascular-related ailments. Earlier-stage studies are testing the drugs' effectiveness in treating central-nervous-system disorders and autoimmune diseases.

DATA ADVANTAGE. In general, studies looking for alternative uses for approved drugs are undertaken as a calculated risk on the part of drug companies. They don't come cheaply, and it's always possible that results will be negative, as was the case with the recent Merck study. Another recent example in the statin field: In March, results of a study funded by Bristol-Myers Squibb comparing its Pravachol and Pfizer's Lipitor worked against Bristol.

Still, the potential upside outweighs the risks. And "one of the key benefits of having these studies, is it gets salespeople past the receptionist's desk [in the doctor's office]," says Sanford Bernstein analyst Richard Evans. Physicians often look to drug salespeople to "get up to speed on studies," he says. Certainly, companies are happier if the results of a study add to the case for prescribing one statin over another. But having have new data that doctors are curious about can give drug companies an edge.

The longer term hope, of course, is that statins may be found to be useful outside of cardiovascular-related disorders. Small studies have shown them to be effective in treating diseases such as multiple sclerosis, Alzheimer's, and Parkinson's. "Scientifically, it makes some sense," Tong says. "Statins decrease the cholesterol deposits in blood vessels, but that effect probably also happens in brain vessels and other areas."

GROWING BASE. The industry's ultimate goal is for new research to show ways of keeping the statin market growing. The government's recently lowered cholesterol guidelines will help by expanding the potential universe of people who might be prescribed the drugs. And sales could pick up if drugmakers figure out ways to reach the millions who should be but aren't yet taking statins. "The class can expand because only 30% of the patients who should be taking statins are doing it," Tong says.

At a minimum, it will take several years to fully test the drugs in new diseases. In the next two years, however, as the big names in the field become subject to generic competition, all of the statin makers will be busily trying to find the competitive edge. Tsao is a writer for BusinessWeek Online in New York

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