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 Assuming approval from the U.S. Food and Drug Administration, Amgen
Inc. will offer its drug, Repatha, as a biweekly 140 mg injection or
a monthly injection of 420 mg, while Praluent, from Regeneron
Pharmaceuticals Inc and Sanofi, will be offered in biweekly
injections of 75 mg or 150 mg.
The difference in dosages is likely to lead to very different sales
strategies for the two drugs, in what could be a fierce competition
for market share. Amgen's high-dose monthly injection could be seen
as more convenient and might appeal to doctors because of its higher
potency. Regeneron and Sanofi could enjoy a significant pricing
advantage with their low-dose option.
Both drugs belong to a new class of antibodies that target PCSK9, a
protein that maintains "bad" LDL cholesterol in the blood, and are
aimed at the millions of people who don't benefit from statins.
Statin pills, like Pfizer Inc's Lipitor, work very differently,
blocking the liver's production of LDL cholesterol.
Neither Amgen nor Regeneron/Sanofi would talk about possible pricing
of their new drugs, but some industry experts suggest that low-dose
Praluent will be priced significantly below Repatha to make it more
attractive to health insurers who have become increasingly
aggressive about keeping medication costs down.
Dr Jennifer Robinson, a University of Iowa epidemiologist and lead
researcher on clinical trials of Praluent, believes Sanofi and
Regeneron "would be crazy not to" price its 75 mg dose below the 150
mg option.
"Sanofi will say you can start off at this cheaper, lower dose,"
Robinson said. "If you don't reach the LDL goal, you can move up" to
a higher dose, at the higher price.
Sanford Bernstein analyst Geoffrey Porges predicts that lower-dose
Praluent will cost $5,000 a year, with the higher dose at $10,000.
He estimates Repatha's price at $10,000 per year for both the
biweekly and monthly versions. Manufacturers do not necessarily
charge less for lower doses of a medication.
Amgen's high-dose injections could be appealing in light of recent
clinical data that has shown that keeping LDL very low can better
protect against heart attack and stroke in high risk patients. Trial
data has shown that both drugs produce greater LDL reductions in
higher doses.
"It goes back to the patients we are trying to serve - patients with
elevated, very high LDL cholesterol," said Scott Wasserman, Amgen's
head of cardiovascular and metabolic therapies. "We didn't feel that
a low dose option would serve those patients."
The FDA is due to decide on approval for Praluent by July 24 and on
Repatha by Aug. 27. The agency, which has convened expert panels on
June 9 and 10 to review both drugs, could also issue a joint
decision.
The two PCSK9 drugs are each expected to generate about $2.5 billion
in annual sales by 2020, according to Wall Street estimates compiled
by Thomson Reuters Cortellis. Some predict total sales for the class
rising to $20 billion by 2026.
PRICE MATTERS
In March, new clinical trial data showed that both Repatha and
Praluent, combined with statins, reduced LDL levels dramatically,
cutting in half the risk for heart attack, stroke, and other major
cardiovascular problems. Sanofi/Regeneron and Amgen are conducting
larger trials to confirm the benefits of PCSK9 drugs in reducing
cardiovascular risks.
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Industry experts note that there are many unanswered questions about
the market for the drugs, including how widely the FDA will allow
them to be used, how aggressively cardiologists will seek to lower
LDL and whether other differences between them will emerge from the
larger trials that will yield results in 2017.
Some see Sanofi having an advantage purely due to its larger
marketing force among heart doctors. Another possible factor in
which drug will dominate the market is the success or failure of a
lawsuit Amgen has brought against Sanofi and Regeneron for alleged
patent infringement.
But in the meantime, with the main merits of the two drugs appearing
nearly equal, their comparative dose and price will become much more
important differentiators.
Health insurers "are likely to view this as a class, one is the same
as the other," said Les Funtleyder healthcare portfolio manager for
ESquared Asset Management, which does not own shares in any of the
three drugmakers. "You could have a case where if payers pay,
they'll only pay for one rather than the other."
Express Scripts Holding Co is the largest U.S. manager of pharmacy
benefit plans and successfully pressed for price reductions on novel
hepatitis C drugs earlier this year.
Its chief medical officer, Dr. Steve Miller, said in an interview
that $10,000 per year for a new cholesterol drug is "an
extraordinarily high price." As many as 15 million Americans are
estimated to have high cholesterol that cannot be controlled by
statins.
"We are bullish on the health benefits, but they have to bring
value," Miller said, adding that pricing would be a major factor in
recommending either Praluent or Repatha for coverage.
Dr Steven Nissen, chairman of the department of cardiovascular
medicine at the Cleveland Clinic, said he is most concerned about
effectiveness: "What counts is how much you can lower LDL
cholesterol," he said.
But he acknowledges that if the lower dose also had a lower price,
"there might be some people who find that appealing," Nissen said.
(Reporting by Deena Beasley, additional reporting by Bill Berkrot in
New York; Editing by Michele Gershberg and Sue Horton)
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