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Merck Won’t Seek U.S. Approval for Drug After Trial Fails

Merck & Co. won’t seek U.S. marketing approval for its good cholesterol drug Tredaptive after a key study showed it ineffective and potentially harmful.

The therapy, sold in 70 countries, combines the vitamin niacin and the experimental medicine laropiprant, added to reduce a face-flushing effect of the drug. Tredaptive was designed to raise levels of HDL, or “good” cholesterol.

The findings call into question the benefits of raising good cholesterol, one of the main methods pharmaceutical companies including Eli Lilly & Co. and Whitehouse Station, New Jersey-based Merck are pursuing in their efforts to develop heart drugs. The pill, which generated less than $20 million in 2012, could have hit sales of $1.1 billion in 2020, said Tim Anderson, an analyst at Sanford C. Bernstein in New York. He removed all sales expectations for the drug from his model.

“There are millions of people taking this drug, niacin,” said Steven Nissen, chairman of cardiology at the Cleveland Clinic in Ohio. “Those people are going to be calling their doctors today. This result certainly undermines the likelihood that any benefit from niacin will ultimately be proven.”

Abbott Laboratories sells an extended-release form of niacin called Niaspan, which generates about $900 million a year, Anderson wrote today in a note. Niaspan failed to prevent heart attacks and may have boosted stroke risk in a U.S. government-funded study last year.

In a statement today, Merck said no one should start taking Tredaptive, though the company stopped short of telling people not to use it.

Other Approaches

Nissen said he would wait until the full results of the study were available before recommending any change to how patients are treated. He also said that other approaches to raising good cholesterol may still be effective, since they work differently. He is leading a study of Indianapolis-based Lilly’s evacetrapib, from a new class of experimental cholesterol medications that includes Merck’s anacetrapib. The drugs are designed to boost good cholesterol that sweeps fatty lipids out of the arteries.

Merck fell 3.4 percent to $42.16 at 4:03 p.m. in New York trading. The shares have gained 14 percent in the past 12 months.

In the study of 25,673 patients, Tredaptive failed to cut heart attacks, strokes, the need for artery-clearing procedures or death from cardiovascular disease more than cholesterol-lowering statin drugs. Patients given Tredaptive plus statin drugs alone or with Zocor were more likely to develop serious, though not life-threatening, side effects, the company said.

Additional Information

Additional information on the side effects won’t be available until after the study’s full results are analyzed, Pamela Eisele, a Merck spokeswoman, said in a telephone interview. The trial was from the third and final stage of testing typically needed for U.S. marketing approval. The full results will be presented in the first quarter of 2013.

“We are disappointed in these results,” said Peter Kim, president of Merck Research Laboratories. The company will work with regulators to figure out next steps for the drug, Kim said in the statement.

Doctors shouldn’t extrapolate the findings with Tredaptive to patients who are taking niacin alone, said Garret FitzGerald, director of the University of Pennsylvania’s Institute for Translational Medicine & Therapeutics. A study led by FitzGerald published in April suggested that adding laropiprant may undermine the benefits of niacin or carry its own health risk.

Careful Assessment

“Given the information we have at the moment, we have to be cautious,” he said in a telephone interview. “The absence of a control group with niacin alone, even with all the information, will make it difficult for us to know how to generalize the results of this trial to patients taking niacin.”

Merck originally filed for U.S. Food and Drug Administration approval of the medicine based on its similarity to niacin, which has been on the market for decades. The experimental drug laropiprant is used to reduce levels of flushing, a known side effect of niacin. It wasn’t thought to have any interaction with the cardiovascular system.

The drug, previously named Cordaptive, was given a “non-approvable” letter in 2008 and regulators insisted the company conduct larger and longer studies to determine whether the combination drug was safe and offered clear health benefits.

The agency also rejected the proposed trade name of Cordaptive for the drug. The company renamed it Tredaptive, the brand name in Europe.

Questions Abound

The study called HPS2-Thrive was designed to look only at the combination drug and leaves other questions unanswered, said Allen Taylor, chief of cardiology at Georgetown University Hospital. Bundling together niacin and laropiprant makes it difficult to evaluate the risks and benefits of each, he said.

“This is a shame,” said Taylor, who is a consultant for Abbott Park, Illinois-based Abbott. “I am open to the hypothesis that niacin doesn’t work, but you have to have a clean trial to answer the question.”

The study was also conducted mostly overseas, he said. It’s not clear how relevant the results would be to Americans and their unique cardiovascular risk, he said in a telephone interview.

“The trial design is such that we are going to be left with some questions,” he said. “If the results were positive, you would have had the same problem. Fortunately, it’s not a drug on the U.S. market right now. It probably has little relevance in the U.S., except the potential to cause some confusion.”

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