The Biggest Cholesterol Drop Ever?
Matthew Herper, 06.19.06, 9:15 AM ET [Forbes]
New York -
An AstraZeneca-funded study to be reported this week will show the biggest drop in bad cholesterol ever seen, according to the researcher who led the trial.
The result doesn't herald the coming of some dramatic new medical weapon against heart attacks, which kill 700,000 Americans each year. Rather, the study combined AstraZeneca's (nyse: AZN - news - people ) Crestor with rival pill Zetia in a clever marketing gambit to protect AstraZeneca's cholesterol-lowering drug, which has annual sales of about $1 billion, from a flood of cheap generic copies of Zocor from Merck (nyse: MRK - news - people ).
Patients in AstraZeneca's 239-person study, dubbed EXPLORER, received either Crestor alone or a combination of Crestor and Zetia, a medicine from Schering-Plough (nyse: SGP - news - people ) and Merck that boosts the effectiveness of other cholesterol-lowering pills. The combination lowered low-density lipoprotein (LDL), the bad cholesterol that leads to heart attacks and strokes, by 70%--an unprecedented amount, lead researcher Christie M. Ballantyne, of the Methodist DeBakey Heart Center in Houston said in a press release. Ballantyne will present the results Thursday at a medical meeting in Rome.
"We are very excited about the results of the EXPLORER trial," says an AstraZeneca spokeswoman. "This is very meaningful for a small group of patients, particularly those high-risk patients with very high [LDL] who are unable to achieve their guideline [LDL] goals on the maximum statin dose."
The $16 billion market for cholesterol-lowering drugs called statins is about to be hit by a giant broadside. Zocor, the first statin ever shown to prevent heart attacks and deaths, loses patent protection on Friday. Switching patients to cheap knockoffs of Zocor and Bristol-Myers Squibb's (nyse: BMY - news - people ) Pravachol, which went generic in April, represents one of the biggest money-saving opportunities ever for health insurers. Pharmacy benefits manager Express Scripts estimates that if every eligible patient were switched to a generic to treat their cholesterol, $10 billion could be saved.
Actual savings will most likely be smaller, but they will come directly out of the pockets of drug giants Pfizer (nyse: PFE - news - people ), Merck and AstraZeneca. In the months before the patent expiration, Zocor sales popped as insurers encouraged patients to switch to the drug, and Lipitor's market share dipped. The EXPLORER study gives AstraZeneca data it can use to help argue that health plans and patients should pay for Crestor.
Merck's own defense against the patent expiration has been to pair Zocor with Zetia in a combination pill. The combo pill, which goes by the brand name Vytorin, lowers cholesterol by 60%, 11 points more than Zocor alone. If health plans push patients to try Zocor first, switching to Vytorin allows those who are not helped to boost their efficacy without changing to a new drug. That's important because patients may experience side effects on one statin medicine, but not another. Zetia's side effects are usually mild.
Studies funded by Merck and Schering already show that the combination of Lipitor and Zetia is actually more effective at lowering cholesterol than Vytorin. But because Crestor was approved after Zetia, Merck and Schering never studied the two drugs in combination. The EXPLORER study is apparently an attempt to fix that--and to give Astra a potent marketing message: If patients can't get Crestor, they might not have the most powerful cholesterol-lowering regimen possible available to them.
The EXPLORER study does have shortcomings. Unlike studies of Zetia and other drugs, patients knew which treatment they were getting. And the study was done in patients with extremely high cholesterol, which could result in a bigger percentage drop in cholesterol. An AstraZeneca spokeswoman said that the results should not be affected by patients' knowledge of which treatment they received.
Despite a number of high-profile research failures in recent years, AstraZeneca is literally flying high. Shares hit a 52-week peak on Thursday, due to the strong performance of existing drugs like ulcer treatment Nexium and antipsychotic Seroquel. After three years on the market, Crestor is finally starting to gain against rivals like Lipitor on the strength of new data, including a study that showed it helped reduce the amount of plaque in the arteries. That study, too, had a scientific shortfall: It lacked a control group. But the result was unprecedented and could sell some doctors on the drug.
AstraZeneca's duel with Pfizer, which rakes in $12 billion annually from Lipitor, is likely to intensify. Sometime in the next six months, Pfizer is expected to announce results from studies of torcetrapib, its new drug to raise the good cholesterol, or HDL. If torcetrapib works, it is widely expected to be a huge advance in treating heart disease--and it could more than make up for any impact to Pfizer from generic Zocor.
But Astra has bought itself a spoiler, in the form of a drug called AGI-1067 from tiny startup Atherogenics. Like torcetrapib, the drug is designed to be added to statins to prevent even more heart attacks. Mid-stage data were muddy, but AstraZeneca signed a deal minimizing its risk. It paid Atherogenics only $50 million upfront, but could pay up to $1 billion if the pill proves effective. Results of a big phase III trial are expected in 2007. |
