by Jane Anderson
Sanofi S.A. is cutting its losses on its PCSK9 inhibitor,
exiting the U.S. market for the drug completely after various tactics,
including slashing prices and promoting value-based contracts to payers, failed
to spark sales for the high cholesterol treatment. But at the same time,
Novartis International AG is betting big on the PCSK9 market by acquiring the
manufacturer of an investigational PCSK9 that has strong Phase 3 results.
Sanofi, which had partnered with Regeneron Pharmaceuticals on
Praluent (alirocumab), will turn the U.S. marketing of Praluent over to
Regeneron beginning in the first quarter of 2020, and availability of the drug
is not expected to be affected.
The company’s decision points to the difficulty inherent in
pitting an expensive new product against long-standing successful drugs, in
this case statins and other cardiovascular therapies, one observer says. Both
Praluent and competitor Repatha (evolocumab) from Amgen have failed to catch on
in a big way.
"These products do have a place in therapy but to expect
them to be blockbusters isn’t realistic, since the class is satisfied with a
lot of cheaper generic alternatives," Mesfin Tegenu, R.Ph., president of
PerformRx, tells AIS Health.
However, Novartis is bucking the PCSK9 trend, betting that a
third PCSK9 therapy could become a blockbuster. Novartis announced plans on
Nov. 24 to purchase the Medicines Company for $9.7 billion, citing
"potentially transformational" potential for the company’s
investigational product inclisiran.
The Medicines Company has wrapped up Phase 3 studies and has
reported positive results. Inclisiran’s biologic mechanism enables twice-yearly
subcutaneous dosing, which the manufacturer says could improve adherence and
patient outcomes.
Inclisiran "could become one of the largest products by
sales in [the] Novartis portfolio," the company said. The firm also
previewed "flexible market access strategies and value-based
pricing," which it said "can enable broad access."
According to Novartis CEO Vas Narasimhan, "inclisiran is a
potentially transformational medicine that reimagines the treatment of
atherosclerotic heart disease and familial hypercholesterolemia. With tens of
millions of patients at higher risk of cardiovascular events from high LDL-C,
we believe that inclisiran could contribute significantly to improved patient
outcomes and help health care systems address the leading global cause of
death."
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