By Ransdell Pierson
March 17 Amgen Inc said its
experimental new type of cholesterol-fighting drug met the
primary goal of a late-stage trial by slashing "bad" LDL
cholesterol levels in patients with a genetic tendency towards
high levels of the artery-clogging fat.
Amgen said on Monday patients given its injectable drug
evolocumab once a month, on top of standard daily statin
treatments, showed "clinically meaningful" improvement compared
with taking statins alone after 12 weeks of treatment. The drug
is also known as AMG-145.
The Phase 3 study, called TESLA, involved 49 adult and
adolescent patients with a rare condition called homozygous
familial hypercholesterolemia. The condition, seen in about one
in a million individuals, can cause a four-fold increase in
levels of LDL cholesterol, greatly raising the risk of heart
Evolocumab works by blocking PCSK9, a naturally occurring
protein that keeps LDL levels elevated in the bloodstream.
Other drugmakers, including Pfizer Inc, and a
partnership between Regeneron Inc and Sanofi,
are racing with Amgen to complete trials of potentially
lucrative anti-PCSK9 antibodies.
"You could have two or three drugs here, each with upwards
of $3 billion to $4 billion in annual sales," said Richard
Purkiss, an analyst with Atlantic Equities.
The PCSK9 inhibitors are one of the most closely followed
new classes of medicines, Purkiss said, even though they will
probably not be prescribed for the average patient with high
If approved, "they would be used mainly for very high-risk
patients, who have frustratingly high LDL despite statin
treatment," he said.
Purkiss said Regeneron and Sanofi had been ahead of the pack
in terms of completing clinical trials, but that Amgen's trials
had picked up speed and its drug could be the first to market.
In Amgen's now-completed TESLA study, the safety risk was
similar between those taking evolocumab in combination with
statins, and those taking statins alone, Amgen said, with the
most common adverse events including upper respiratory tract
infection, gastrointestinal inflammation and stuffy nose.
Data from the trial will be presented at a future medical
conference, Amgen said. The world's largest biotechnology
company noted that favorable results have previously been
reported in five other Phase III trials of its experimental
medicine, which involved different populations.
They have included trials among mainstream populations whose
high cholesterol is not due to serious genetic causes, as well
as trials among those who cannot tolerate statins and instead
take a different type of cholesterol fighter called Zetia
(ezetimibe) from Merck & Co.
In mid-stage studies, evolocumab has cut LDL levels by as
much as 60 percent more than with statins alone.
Such results have bolstered faith among doctors and industry
analysts that the drug and other PCSK9 inhibitors might be a
good option for patients who are unable to reach target LDL
levels with statins and other standard treatments.
Amgen shares were up 1.8 percent in midday trading on the
Nasdaq, amid a 1.5 percent gain for the NYSARC Biotech Index