(Repeats to widen distribution)
By Bill Berkrot
March 13 Data that should help unlock the sales
potential of a potent new cholesterol medicine will be unveiled
at the American College of Cardiology meeting this week as the
future of the only rival drug rests with the courts in an
ongoing patent dispute.
Highly anticipated results from a 27,500-patient trial of
Amgen Inc's Repatha will be presented on Friday at the
meeting in Washington, informing doctors and investors of just
how much the expensive injectable drug cut the risk of heart
attack, stroke and death in people with heart disease already
taking maximum doses of cholesterol-lowering statins, such as
Insurers and pharmacy benefit managers have been rejecting
some 75 percent of prescriptions written for the new medicines
while awaiting proof of their clinical value. They prefer to
keep patients on cheap, generic statins already shown to prevent
Repatha and a competing drug, Praluent from Regeneron
Pharmaceuticals Inc and Sanofi SA, have list
prices of over $14,000 a year, before discounts and rebates.
They belong to a class of medicines called PCSK9 inhibitors
that were approved on their ability to dramatically lower "bad"
LDL cholesterol. But with a raging debate over high U.S.
prescription drug prices, there has been pressure for hard data
to justify the cost of medicines that may have to be taken for
The high rejection rate has severely constrained sales of
the potential multibillion-dollar products, which were just $58
million for Repatha and $41 million for Praluent in the fourth
Rejections have frustrated cardiologists trying to get these
new drugs for patients whose cholesterol remains dangerously
high despite taking the most potent statins, and for those
unable to tolerate them.
"What I care about is there are patients for whom the PCSK9
is absolutely vital," said Dr. Leslie Cho, head of preventive
cardiology and cardiac rehabilitation at the Cleveland Clinic.
Industry analysts said they hope to see at least a 20
percent reduction of major adverse heart events from Repatha,
and that anything less might be viewed as disappointing to
Dr. Jorge Plutzky, director of the vascular disease
prevention program at Brigham and Women's Hospital in Boston,
said a risk reduction greater than 20 percent would be very hard
for insurers to ignore. But, he added, "any statistically
significant reduction in cardiovascular events would be
important to me."
Amgen shares rose 3 percent last month, when it announced
the Repatha trial had succeeded without providing details.
AWAITING APPEAL DECISION
Regeneron expects to have results from Praluent's large
cardiovascular outcomes trial by year end. Whether Praluent will
still be available depends on an appeal of a U.S. court ruling
that found it infringed Repatha patents.
Praluent was allowed to remain on the market pending the
appeal decision, which could take into account the benefit to
society of competition that lowers drug prices.
New prescriptions have been higher for Repatha since the
January court ruling. In the week ended March 3, there were
1,288 written for Repatha and 892 for Praluent, according to
data reported by analysts.
But interviews with physicians found they were not taking
Praluent's uncertain future into account when selecting which
Those decisions were driven by preferences of individual
patients' health insurer or PBM, they said. Insurers negotiate
discounts with each drugmaker and then offer the cheaper one to
patients with a lower co-payment.
Express Scripts Holding Co, the nation's largest
PBM, declined to speculate on how much clinical benefit must be
demonstrated before making it available to more patients.
(Reporting by Bill Berkrot in New York; Editing by Lisa