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 The results marked the third successful Phase III
test of the drug evolocumab reported by Amgen in recent months — this one in a patient population among the most in need of
alternative therapies.
An estimated 5 to 20 percent of heart patients are intolerant of statin medications for lowering cholesterol due to side effects such
as muscle weakness or fatigue, Amgen said.
Evolocumab belongs to a class of medicine called PCSK9 inhibitors
that work by blocking a protein that reduces the liver's ability to
remove LDL cholesterol from the blood.
Based on dramatic LDL lowering demonstrated by Amgen and other
companies in earlier studies, PCSK9 inhibitors could be the most
important new heart drugs to come along in several years with
multibillion-dollar sales potential.
The injected medicines are likely to be used in high-risk heart
patients unable to lower their LDL levels sufficiently with high
doses of widely used statin drugs, such as Pfizer's Lipitor, and in
those unable to take statins.
Many patients remain at high risk of heart attack and stroke
"despite the use of all available therapies," Amgen research and
development chief Sean Harper said in a telephone interview.
"The ability to treat those individuals with a completely distinct
mechanism and see this very large effect size of dropping LDL
cholesterol by roughly 50 percent, that's a pretty big deal for
those patients," Harper said.
The company expects during the current quarter to have results of
its final two Phase III studies — one in patients already taking
high doses of statins and one in patients genetically predisposed to
dangerously high cholesterol levels.
Amgen will provide details of its latest 307-patient Phase III
study, called GAUSS-2, which compared evolocumab to Merck & Co's
Zetia (ezetimibe), at an upcoming medical meeting.
However, the world's largest biotech company said the percentage of
cholesterol lowering was consistent with those observed in a
similar, smaller Phase II trial. In that study, evolocumab led to 51
percent reduction in LDL levels and 63 percent when combined with
Zetia versus a 15 percent reduction seen with Zetia alone.
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"It's very unusual to have a therapeutic that addresses one of the
underlying factors that drive the greatest mortality risk that
exists in Western countries, and increasingly in developing
countries — cardiovascular disease driven by atherosclerosis,"
Harper said.
The company anticipates that some of its global filings seeking
approval of the drug will occur this year.
"We don't come across therapeutics like this very often in this
industry," Harper said. "It is very exciting, and as we get each
data set our confidence slowly builds that we have the efficacy and
the safety profile that will make this an important medicine."
Regeneron Pharmaceuticals Inc, in partnership with Sanofi, is also
in Phase III testing of a rival drug. Pfizer is developing its own
PCSK9 inhibitor.
Amgen shares were down about 0.6 percent at $123.55 on Nasdaq,
roughly in line with declines in the broader market.
(Reporting by Bill Berkrot; editing by
Stephen Powell)
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