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Radar On Market Access: Sanofi Backs Away From U.S. PCSK9 Market, While Novartis Bets Big With Inclisiran

Posted by Jane Anderson on Feb 6, 2020

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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, AIS Health reported.

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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Topics: Specialty, Market Access, Data & Analytics, Provider, Payer