Regeneron Nabs Deal with White House, New Gene Therapy Will Be Free

Key Points

• Regeneron has reached an agreement with the U.S. government to lower certain drug prices in the U.S., including Medicaid pricing changes and pricing alignment for future medicines based on a defined group of other developed countries.
• The company said Praluent will be available for direct patient purchase through TrumpRx.gov, and Otarmeni, a newly approved gene therapy for a rare genetic hearing loss, will be provided for free in the U.S.
• Regeneron said the agreement also includes a three-year period of tariff relief and commitments tied to continued U.S. investment in R&D and manufacturing.

Agreement Terms

Regeneron has announced an agreement with the U.S. government covering drug pricing, patient access, and domestic investment. Under the deal, the company said it will lower Medicaid prices based on prices in other developed countries and align U.S. prices for future medicines with prices set in that same defined group of countries.

The company also said eligible patients will be able to directly purchase Praluent (alirocumab), a PCSK9 inhibitor for cardiovascular disease, through TrumpRx.gov at what it described as the most-favored-nation price.

Regeneron added that it will not be subject to future pricing mandates under the agreement and will receive tariff relief for three years through an arrangement with the U.S. Department of Commerce. Additional terms were not disclosed.

Otarmeni Access

Regeneron said it will provide Otarmeni (lunsotogene parvec-cwha) for free in the U.S. Otarmeni, formerly known as DB-OTO, was recently approved by the FDA to treat severe to profound and profound hearing loss caused by variants in the otoferlin gene.

The company positioned the free access program as part of the broader agreement announced with the government.

Company Remarks and Investment Plans

Regeneron also said it will continue investing in U.S.-based R&D and manufacturing. The company noted that it has already committed more than $9 billion in planned domestic manufacturing and R&D infrastructure investments in the coming years.

“For too long, American patients and taxpayers have shouldered a disproportionate share of the cost of biotechnology innovation — effectively subsidizing lower drug prices for other high-income nations that have not been paying their fair share,” said Dr. Schleifer, Board co-Chair, President and Chief Executive Officer of Regeneron. “Vilifying the biopharma industry has not produced lower prices for Americans, nor has it generated more innovation. For more than a decade, we have argued that the most direct path to meaningful relief for American patients depends on getting other high-income countries to finally contribute their fair share to the cost of the breakthroughs they rely on just as much as we do. We hope that today’s agreement, coupled with effective trade policy, will lead to closer equilibration of prices around the globe while preserving innovation and lowering prices for Americans.”

“Discovering and developing transformative new medicines is among the most challenging endeavors in all of science, and among the most consequential for addressing the cost and burden of disease. It demands that we invest deeply in the biotech ecosystem that has the power to push the boundaries of what is possible, not just incrementally, but boldly,” said Dr. Yancopoulos, Board co-Chair, President and Chief Scientific Officer of Regeneron. “Otarmeni, our first-of-its-kind gene therapy for a form of genetic hearing loss, is a powerful reminder of what becomes possible when brilliant minds have the resources and freedom to pursue difficult challenges. Our decision to provide Otarmeni for free in the United States serves to highlight our belief that the biopharmaceutical industry can be a genuine force for good in the world.”

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