PharmExec Blog

Merck Gets to the Heart of the Matter

Merck may have succeeded in making a molecule that increases “good cholesterol,” which is likely the only real breakthrough left in the anti-cholesterol and hypertension market.

It has long been known that elevated LDL cholesterol and reduced HDL cholesterol are major risk factors for developing cardiovascular disease. And while much ado has been made about a drug that can balance the level of both cholesterol types before—think Pfizer’s torceptrapib, which was found to increase deaths and heart disease events in a large clinical trial—Merck may be on to something with its new drug, anacetrapib.

Merck’s high hopes for the new compound could signal a revival of interest in the mass market primary care space, which has ceded ground in recent years to the perception that the industry’s future lies in high priced specialty medicines for small patient populations.

Because the drug not only lowers  “bad cholesterol” (LDL) but also raises “good cholesterol” (HDL), Merck hopes that where other drugs have failed, anacetrapib can “reduce patient risk and improve outcomes,” according to a story published by Forbes last week.

What we don’t know yet is whether the problems with Pfizer’s drug, torceptrapib, are inherent to the entire class of CETP inhibitor drugs—of which Merck’s compound is also a member—and if the same factors that caused Pfizer’s drug to lead to increased risks will turn up for Merck. So far, patients who used the drug showed no signs of raised blood pressure or any other safety risks that were present with Pfizer’s drug.

The study, titled Determining the Efficacy and Tolerability of CETP Inhibition with anacetrapib (DEFINE), for Merck’s anaceptrapib was presented last week to a plenary session at an American Heart Association meeting. Though the study was too small to detect modest harms or benefits, a small study to generate preliminary results was a milestone that needed to be passed in order for Merck to proceed with a large clinical trial.

While the new drug could mean potential big business for Merck, it could also eventually mean a big change in patients’ lives, and could lead to a time where medications, rather than cardiac stents, become the norm. In the 18-month, 1,623-person preliminary study, the drug diminished the number of such procedures in patients with (or at high risk for) coronary heart disease by 70 percent, and increased good cholesterol by more than 130 percent.

The next step for Merck is a five-year, 30,000 person study, led by Oxford University, to determine whether the drug can lower patients’ heart risks without causing other adverse effects.

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One Comment

  1. Morton Kaplan
    Posted April 29, 2011 at 4:48 pm | Permalink

    How do I become one of the 30K trial participants?

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