Merck heart drug
surprises with positive result; questions linger
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[June 28, 2017] By
Bill Berkrot
(Reuters) - Merck & Co said on Tuesday its
experimental cholesterol drug from a class with a history of consistent
failure lowered deaths and heart attacks in a large trial, but the
company has yet to decide whether to seek approval despite the surprise
success.
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The drugmaker reported only that the drug, anacetrapib, met the main
goal in the 4-year trial of about 30,000 high-risk heart patients
already on cholesterol-lowering statins. It showed a statistically
significant reduction in the combined risk of heart attacks,
heart-related death and need for repeat artery-clearing procedures.
While announcing the positive result few had expected, given the
checkered past of similar medicines, Merck said it plans to review
the data with external experts and consider whether to file
applications seeking approval.
"When they make a statement that we haven't decided whether to file
a new drug application it sends a very strong message," said Dr.
Steven Nissen, chief of cardiology at the Cleveland Clinic, who has
studied other drugs in the class known as CETP inhibitors. "The fact
that they're hedging their bets ... suggests that the treatment
effect may have been relatively small."
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Full details of the trial will be presented at a major European
heart meeting on Aug. 29.
Merck shares, which initially rose more than 2 percent in pre-market
trading, were up just 3 cents at $65.95 as uncertainty over the
medicine's future weighed on investors.
"We believe it is more prudent to wait for the full data release
before drawing broad conclusions on the product’s commercial
potential," Credit Suisse analyst Vamil Divan said.
A little over a decade ago, CETP inhibitors were hailed as the next
big heart drug due to their ability to dramatically raise HDL, the
so-called good cholesterol.
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Pfizer had been banking on its torcetrapib to replace lost revenue
when Lipitor, then the world's top-selling medicine, lost patent
protection. Analysts had forecast more than $10 billion in eventual
annual sales.
But it became the most expensive failure in pharmaceutical history
in late 2006, when Pfizer had to pull the plug on its $800 million
Phase III program over an imbalance in deaths and other safety
issues.
CETP inhibitors from Roche and Eli Lilly and Co subsequently failed
due to lack of sufficient efficacy, and other drugs that raise HDL
by other mechanisms also failed to show benefit.
Merck's anacetrapib does also lower "bad" LDL cholesterol, which has
proven to cut heart attacks and deaths.
(Additional reporting by Akankshita Mukhopadhyay in Bengaluru;
Editing by Sriraj Kalluvila and Dan Grebler)
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