Drugmaker restarts race to boost 'good' cholesterol

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Merck & Co. is betting it can succeed where Pfizer Inc. failed, with a new type of drug to combat heart disease by raising good cholesterol levels.

New Jersey-based Merck will report results from an advanced trial of its drug next week, four years after Pfizer abandoned a similar pill linked to heart attacks.

The new treatments could be the biggest advance against heart disease in the two decades since the arrival of statins, a group of drugs led by New York-based Pfizer’s Lipitor. Results showing Merck’s pill doesn’t cause the same side effects that sidelined Pfizer’s good cholesterol pill may propel Merck into a $15 billion annual market, according to Decision Resources.

Merck’s study will be the first advanced research to emerge from the family of medicines known as CETP inhibitors since New York-based Pfizer’s pill torcetrapib failed. Indianapolis-based Eli Lilly and Co. and Swiss firm Roche Holding AG are testing similar pills.

Lilly is in the second of three stages of testing its drug in the same family of medicines, according to the U.S. website that tracks studies. Lilly spokeswoman Judy Moore said the company had no comment on its cardiovascular drugs in development.

Merck’s medication “is looking to be a very promising agent,” said Rory Collins, co-director of the University of Oxford’s Clinical Trial Service Unit in England. “If we can add benefits by raising HDL, we could see an enormous public health benefit. But it’s a big gamble.”

The new drug is in a family of medicines known as CETP inhibitors, designed to boost levels of HDL that flush fat deposits from arteries to the liver to be purged from the body. Statins work by decreasing levels of LDL, or bad cholesterol, that clogs arteries and leads to heart attacks.

Merck will present research on its drug, anacetrapib, next week at the American Heart Association meeting in Chicago, hoping to revive the race to treat heart disease by raising HDL.

Cardiovascular disease, the leading cause of deaths in the U.S., kills about 830,000 people a year, according to the American Heart Association. As many as 100 million Americans have a deficit of good cholesterol, increasing their risk for heart attacks and strokes, said Scott Wright, a cardiologist at the Mayo Clinic in Rochester, Minnesota, in a telephone interview.

“We’ve done all we can do with lowering LDL cholesterol, and the residual risk remains high,” Wright said. “Being thin, getting weight down, exercising and eating healthy are the best ways to raise HDL, but those are challenging for most people. We probably need medication to help the lifestyle changes.”

Four years ago, Pfizer abandoned a good-cholesterol drug it spent $1 billion to develop after a study found it caused deaths. An analysis found patients taking it were 60 percent more likely to die than those who didn’t receive it.

Pfizer’s pill failed because it unexpectedly increased levels of a hormone called aldosterone, linked to fatty plaque buildup and high blood pressure.

“Cardiovascular disease is largely preventable,” Pfizer spokesman Ray Kerins said in an e-mailed statement. “Pfizer’s current and future portfolio of medicines in this therapeutic area focuses on the control of the risk factors inherent in smoking, diet, physical inactivity and Type 2 diabetes.”

Merck paused its own research after Pfizer’s torcetrapib setback to scour ongoing studies for signals of hypertension and design a new safety trial, called Define. Merck’s anacetrapib is now in the third and final stage of tests generally needed for U.S. approval.

“With torcetrapib and the toxicity that was observed, the bar is raised in terms of having to really demonstrate a benefit,” said Yale Mitchel, Merck’s vice president of cardiovascular disease research, in a telephone interview.

Results next week are from the Define trial, which followed 1,800 people for 18 months to examine safety and ability to alter cholesterol levels. Based on this trial, Merck began planning its final study, and may seek U.S. approval after 2015.

“With the right kind of outcome, the market could be billions and billions of dollars,” said Barbara Ryan, an analyst with Deutsche Bank in New York, in a telephone interview.

Merck’s results will hint at the potential for Roche to succeed with dalcetrapib, in the same family of medicines. Roche has said it will release initial results next year from three final studies and may seek U.S. clearance in 2012.

“The CETP inhibitor is a potential game changer for this company,” with the potential to generate as much as Pfizer’s Lipitor, the best-selling drug in the world with $11.4 billion in sales last year, Roche Chief Executive Officer Severin Schwan, said during a July 22 conference call. “It has its risks, but we are fully committed.”

People with the highest levels of HDL are least likely to have heart attacks or die from cardiac disease, said Jorge Plutzky, director of the vascular disease prevention program at Brigham and Women’s Hospital in Boston.

Cutting LDL by 1 percent reduces heart disease risk by the same amount, he said. Boosting HDL 1 percent can curb risk by as much as 3 percent, potentially making this approach more effective, he said.

“It seems as if you get a bigger bang for the buck in changing HDL,” Plutzky said in a telephone interview. “We just haven’t been as successful as we would like in doing that. We ultimately just have to see where the data takes us.”


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