NEW YORK, March 31 (Reuters) - Merck & Co's (MRK) Cordaptive pill to raise "good" HDL cholesterol caused less facial flushing in a study than Abbott Laboratories Inc's (ABT) Niaspan treatment, but with certain increased side effects, researchers said on Monday. The results were described at the annual meeting of the American College of Cardiology in Chicago.
Merck's experimental drug contains an extended-release form of the vitamin niacin to raise levels of HDL. It also contains a chemical called laropiprant to stop flushing, a dilation of blood vessels that causes redness and an unpleasant burning sensation on the neck and face.
Flushing is a common side effect of niacin-based drugs, and the biggest reason many patients stop taking current products, including Niaspan. Results from the late-stage study of Cordaptive suggest the problem was largely averted and could boost interest in HDL-raising therapy, Merck said.
Although overall other side effects were similar among patients taking Cordaptive and Niaspan, those taking the Merck drug had elevations in liver enzymes -- a potential sign of toxicity -- and diabetics had to adjust their medicines due to an impact on their blood sugar.
Dr. Michael Koren, a Jacksonville, Florida, cardiologist who led the study, said none of the side effects was worrisome, although patients were taken out of the study if they developed elevated liver enzymes.
Elevated enzymes are a common side effect of cholesterol medicines and are typically managed by lowering the dosage of such drugs, Koren said.
"I think (Cordaptive) will be deemed as safe as niacin, but we will need to monitor it as we do statins," if it is approved, Koren said.
The phase 3 study involved 1,455 patients, aged 18 to 80, with either high levels of artery-clogging LDL cholesterol or blood fats called triglycerides, or low levels of heart-protective HDL.
One group of patients received Cordaptive, beginning with 1-gram doses of the niacin component for the first month, and taking the full recommended 2-gram dose of niacin for the remaining 12 weeks of the study.
Another group took Niaspan, starting with 500 milligram doses of the extended release form of niacin and graduating to the recommended 2-gram dose by week twelve. They continued to take that dose for the remaining four weeks. <<
[MK-0524B, a combination of Zocor, niacin, and laropiprant (MRK’s proprietary anti-flushing agent), was once one of the most touted drugs in MRK’s pipeline. MRK says the drug is being dropped for business reasons, which makes sense insofar as niacin-based products have taken a major hit following the 2011 failure of the NIH’s AIM-HIGH study (#msg-63617748). MRK says that the 2-drug combo known as Cordaptive/Predaptive/MK-0524A, which consists of niacin + laropiprant, is still on target for an FDA re-submission in 2014; MK-0524A was rejected by the FDA in 2008 due to LT safety concerns (#msg-28864222, #msg-28896504), although it was approved in the EU and other countries.]
Merck & Co. (MRK) said it has placed on hold its development of a combination cholesterol drug, citing "business reasons."
The Whitehouse Station, N.J., drug maker no longer plans to file for U.S. regulatory approval of the drug, code-named MK-0524B, in 2014 as it had previously planned. The combination drug was meant to help raise levels of good cholesterol while also lowering levels of bad cholesterol and a related substance implicated in heart disease.
Merck said in its quarterly report filed with the Securities and Exchange Commission that it placed the development program on hold in July for business reasons. A spokeswoman said the decision was part of Merck's "ongoing prioritization" of its drug research pipeline.
MK-0524B is a single-pill combination of three compounds: simvastatin, an widely used cholesterol-lowering drug that is now available as a generic drug; niacin, which lowers substances called triglycerides and raises good cholesterol; and laropiprant, a drug designed to alleviate reddening of the skin, which is a side effect of niacin.
Bernstein previously estimated MK-0524B would generate $248 million in sales for 2016.
Merck's single-pill combination of niacin and laropiprant is available in some countries outside the U.S. under the brand Tredaptive. Merck has said it plans to seek U.S. Food and Drug Administration approval of Tredaptive in 2013[the NDA was rejected in 2008]. The company is awaiting results of a large clinical trial known as HPS2-Thrive, which is testing Tredaptive's ability to prevent heart attacks and other cardiovascular outcomes.
Merck said its decision to place MK-524B on hold doesn't affect its plans for Tredaptive, also known as MK-0524A, or the HPS2-Thrive study.
Investor expectations for Merck's niacin-based drugs were tempered by last year's halt to a government-funded study which found that adding niacin to cholesterol-lowering drugs known as statins didn't significantly improve cardiovascular outcomes versus statins alone.‹
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