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 Lilly on Monday said it was halting a 12,000-patient study of its
drug, evacetrapib, an oral medication. In earlier studies, the
treatment cut "bad" LDL cholesterol by 30 to 35 percent and doubled
the levels of "good" LDL cholesterol. But the influence on
cholesterol levels did not ultimately improve patients' health,
dashing hopes for this approach to treating heart disease.
Merck's anacetrapib is now the only drug in a novel class known as
CETP inhibitors that remains in late-stage trials. Data from a
30,000-patient study is expected by 2017 to show whether it reduces
the incidence of heart attack and strokes. Wall Street analysts have
estimated the drug could reap eventual annual sales of up to $10
billion, if approved.
But with the outlook dimmed for CETP inhibitors, Wall Street
analysts on Monday predicted a boost to a competing class of drugs
just approved for the U.S. market that work by sharply lowering LDL
cholesterol. Shares in Amgen Inc and Regeneron Pharmaceuticals rose
on expectations the Lilly decision removed a competitive threat to
sales of their injectable drugs, which block a protein called PCSK9.
"CETP inhibitors as legitimate drug targets are dead as of today,"
said Dr. P.K. Shah, director of atherosclerosis research at
Cedars-Sinai Heart Center in Los Angeles, referring to Lilly's
setback. "For cardiologists looking for heart protection, these
drugs were a dream, but they haven't come true."
Dr. Steve Nissen, head of cardiology for the Cleveland Clinic, noted
that Lilly's failure follows the demise of two other high-profile
drugs in the same class. Pfizer's Inc's torcetrapib was discontinued
in 2006 due to safety worries, while Roche Holding AG's dalcetrapib
was terminated in 2012 for lack of benefit.
"In baseball you don't get four strikes," he said of prospects for
Merck's candidate. Nissen was chairman of the halted Lilly study,
which involved trials at 540 sites in 37 countries.
Merck, in an emailed statement, said it looks forward to better
understanding Lilly's decision to pull the plug on evacetrapib, but
remains confident in its own drug's potential success.
CETP inhibitors block a protein that transfers HDL cholesterol to
LDL cholesterol, resulting in higher levels of HDL and lower LDL
levels. Statins, by contrast, work by reducing the liver's
production of cholesterol.
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Amgen and Regeneron's treatments work by blocking a protein named
PSCK9 whose normal function in the body is to maximize the presence
of LDL cholesterol that enters the bloodstream.
However, investors are still waiting for proof that PCSK9 inhibitors
actually reduce heart attacks and strokes, and don't just reduce
cholesterol. Data from such an "outcomes" trial for Regeneron's
Praluent are expected by late 2016, while those from Repatha's trial
are due in 2017.
Dr. Allen Taylor, chief of cardiology at MedStar Heart and Vascular
Institute in Washington, D.C., said it would be unwise to assume the
PCSK9 inhibitors are heart-protective just because they slash LDL
levels.
"Until you see the trial results, all bets are off," he said.
Should Merck's own outcomes data for anacetrapib prove positive, the
pill could be a much preferred method for patients over the
injections required for PCSK9 treatments.
Lilly shares closed down 7.8 percent on Monday. Merck slipped 0.5
percent. Regeneron shares jumped 4.5 percent, while its PCSK9
partner, Sanofi SA, rose 1.3 percent in Paris. Amgen shares rose 2.4
percent.
(Reporting by Ransdell Pierson; Editing by Michele Gershberg and
Leslie Adler)
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