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Superpills with a One-Two Punch

By Amy Tsao This summer, the esteemed British Medical Journal published a report arguing the case for a "superpill" comprising a statin (a type of cholesterol-cutting drug), three hypertension drugs at low doses, folic acid, and aspirin. After dissecting hundreds of studies, British researchers concluded that if such an amalgamation were given to all people over the age of 55, it would result in stunning declines in the industrialized world's biggest killer -- heart disease.

Multifunction superpills aren't nearly as farfetched as they may sound. And reducing such serious risks to heart health as soaring cholesterol, diabetes, and high blood pressure potentially could save many lives and be highly lucrative for drug companies. A combo pill from Pfizer (PFE) of its hypertension drug Norvasc and cholesterol-lowering agent Lipitor "could have huge potential," says Shaojing Tong, analyst at Mehta Partners. "Offering two functions in one pill itself is a huge convenience."

FIRST WAVE. Several companies have superpills aimed at fighting heart disease in the pipeline, but Pfizer, which filed with the Food & Drug Administration this spring, is the furthest along. Its new drug could reach the market as early as 2004. Merck (MRK) says it will file an FDA application before yearend for a pill that combines the anticholesterol drugs Zocor and Zetia. Bristol-Myers Squibb (BMY) has said it's developing a single-pill version of aspirin and Pravachol, its statin drug, as a heart protector.

These fused pills are the latest twist in "product life-cycle management," aimed at offsetting an expected period of lackluster growth in the drug industry. "It's sort of a bridge mechanism that companies use to smooth growth when new products might be decelerating," says analyst Rich Watson of William Blair & Co. "This is not innovation."

If Norvasc-Lipitor is a commercial and clinical hit, however, it could easily be at the cutting edge of a trend. Analysts figure Pfizer could come out with other variations on the theme -- such as adding a second cholesterol drug to make the superpill even more powerful. "This is the first wave of products," says Watson. "How well they do will dictate whether this becomes more of a trend."

PICKING UP SLACK. If such pills catch on, they could generate significant revenues for drug companies. In Pfizer's case, the goal is to transfer as many qualified patients as possible to the combo pill. Norvasc's patents expire in 2007, but Pfizer could avoid losing all its revenues from the drug at once if it were part of a superpill. Sena Lund, an analyst at Cathay Financial, sees Pfizer selling $4.2 billion worth of Norvasc-Lipitor by 2007. That would help take up the slack for falling sales of Lipitor, which he projects will drop to $5 billion in 2007, down from $8 billion last year. (He projects sales of Norvasc will actually rise slightly, from $3.8 billion last year to $4.1 billion in 2007.)

Analyst figure combos from Bristol-Myers and Merck could be big sellers as well, though they aren't quite as ambitious as Pfizer's drug, which treats two distinct diseases. Bristol-Myers declined to provide more details. Analysts have speculated that Merck and partner Schering-Plough's (SGP) pill combining Zocor and Zetia would be targeted at patients with stubbornly high cholesterol levels and could emerge as a multibillion-dollar drug when introduced in late 2004 or early 2005.

Pfizer argues that addressing two distinct and serious cardiovascular risk factors in one pill has advantages. People with both hypertension and high LDL cholesterol (the "bad" kind) number around 27 million in the U.S., notes Craig Hopkinson, medical director for dual therapy at Pfizer, and only 2% of that population reaches adequate treatment goals. Taking two treatments in one will increase the number of patients who take the medications properly and "assist in getting patients to goal," he says. For one thing, Hopkinson says, research suggests that starting treatment for both diseases at the same time results in greater patient adherence to therapy than when treatments are begun separately.

"YOU'RE STUCK." Doctors also may be quick to adopt Norvasc-Lipitor, Pfizer figures, because it's made up of two well-studied drugs, which many physicians are already familiar with. But Dr. Stanley Rockson, chief of consultative cardiology at Stanford University Medical Center, says fixed-dose combination pills represent "an interesting crossroads" for physicians, who are typically trained to "approach each individual problem with care." Combining treatments would challenge doctors to approach heart disease differently. But better patient compliance is important enough, says Rockson, that he expects doctors to be open to trying the combined pill.

Some other physicians are more skeptical. "If you want to change dosage on one [of the new pill's two drugs], you're stuck," fears Dr. Irene Gavris, professor of medicine at Boston University School of Medicine. She says she would feel most comfortable trying the combination pill on patients who "have been on the drugs for a while" and are thus unlikely to need changes in dosage.

As usual, economics could tip the scales. Patients now taking both Lipitor and Norvasc "could cut their [insurance] co-pay in half" by switching to the combo drug, Gavris notes. That's a key advantage. Controlling hypertension, for instance, can require three or more drugs, and the financial burden on patients mounts quickly. If patients also benefit -- as Pfizer and other drug companies contend -- making the switch to superpills could be advantageous for everyone. Tsao covers biotechnology issues for BusinessWeek Online. Follow her Biotech Beat column only on BusinessWeek Online

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