Merck is betting heavily on heart medicines
By Susan Todd

The drugmaker’s investment in cardiovascular disease became evident last week when it released new study data supporting the continued development of an experimental drug for treating troublesome cholesterol levels.

Merck spent four years, an effort that ranged from detective-like research to a closely monitored patient study, trying to determine whether its drug contained some of the same flaws as a similar one Pfizer was forced to abandon in 2006 after it was blamed for causing patient deaths.

Luciano Rossetti, Merck’s senior vice president of global scientific strategy, said the company was intent on proving that its drug, which is named anacetrapib, was effective at managing cholesterol levels and safe.

"It was not an easy path forward," Rossetti said.

The work around anacetrapib, which is pronounced anna-se-tra-pib, is an illustration of Merck’s determination to pursue what Rossetti described as "compelling opportunities.’’

In fact, while some of its rivals, including Pfizer, have retreated from the high-stakes hunt for new medicines to treat heart disease, Whitehouse Station-based Merck has persevered, working on a half-dozen drugs for managing cholesterol and treating heart conditions such as atherosclerosis and thrombosis.

Anthony Butler, an industry analyst with Barclays Capital, said the development of cardiovascular drugs is fraught with risk.

"Rightly or wrongly, some companies might argue how much more can we innovate," he said.

Anacetrapib falls into a class of new drugs called CETP inhibitors that work by boosting levels of good cholesterol or HDL that flush fat deposits from the arteries to the liver, where they can be purged by the body.

To get a sense of the scope of the problem, consider that nearly 100 million Americans are believed to have a deficit of good cholesterol, which increases their risk of suffering a heart attack or stroke.

The data released last week from Merck’s study of the drug in 1,600 high-risk patients showed anacetrapib raised HDL, or good cholesterol, by an impressive 138 percent.

In patients already taking statins, cholesterol-lowering medicines such as Lipitor, Merck’s drug also reduced LDL, or bad cholesterol by 40 percent.

Merck’s work isn’t done yet, though. The drugmaker will move anacetrapib into a final phase of development, a clinical study involving 30,000 patients.

The study will show, among other things, whether the drug works to lower heart attacks and deaths.

Meanwhile, it also faces the prospect that if it succeeds in pushing anacetrapib onto the market, it will face immediate competition for sales.

The Swiss drugmaker Roche is also working on a CETP inhibitor, and industry analysts expect Roche could have its drug on the market two years ahead of Merck.

One sign of the uncertainty that remains: The stock market barely reacted to the results of the company’s study were announced at the American Heart Association’s conference in Chicago.

"You’re talking about something that’s five years ago," Butler said. "The market thinks it still might fail."

Anacetrapib isn’t considered Merck’s only promising prospect though.

Two other proposed medicines, a novel anti-clogging treatment called Vorapaxar and a cholesterol-fighter called Tredaptive, have the potential to be blockbusters — drugs that generate at least $1 billion in annual sales.

Vorapaxar, which Merck gained through its acquisition of Schering-Plough last year, is considered another break-through drug because it works differently than top-selling medicines such as Plavix.

The drug, which is in late-stage development, essentially interrupts the clotting process by inhibiting the behavior of a key protein.

Rossetti said the potential of Vorapaxar, like anacetrapib, has generated a high level of excitement. "It’s a major competitor within our own pipeline (to anacetrapib’s) crown jewel status,’’ he said.

Tredaptive, which combines good cholesterol-raising niacin with a bad cholesterol-lowering statin, is expected to grab market share, especially if it reduces flushing, a side effect that causes a patient’s skin to burn and itch.

"It will serve Merck quite well," said Graeme Green, an analyst with Decision Resources.

If Merck succeeds in getting approval for vorapaxar and tredaptive, Green is forecasting that the drugs could generate as much as $3.5 billion in revenues.

That projection doesn’t reflect potential sales from anacetrapib, which is expected to be approved sometime in 2016.

Yet, despite the blockbuster potential, Green said Merck will still have its business challenges.

For two of its most promising drugs, anacetrapib and vorapaxrar, Merck faces rivals in Roche and AstraZeneca.

"The pipeline may look good," Green said of Merck’s efforts, "but there’s going to be strong competition with each door that opens."

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