Regeneron Announces Agreement with U.S. Government to Help Lower Drug Costs for American Patients and Will Provide Innovative New Gene Therapy for Free in the U.S.
🤝 Regeneron has entered an agreement with the U.S. government to lower drug costs for American patients while providing a new gene therapy for free.
🎧 The company will offer Otarmeni™ (lunsotogene parvec-cwha), its newly approved gene therapy for ultra-rare genetic hearing loss, at no cost in the U.S.
💰 Medicaid prices for Regeneron's medicines will be reduced to align with those charged in other developed countries.
📉 Future U.S. medicine prices will be aligned with pricing set by a defined group of other high-income nations.
💊 Praluent ® (alirocumab) will become available for direct patient purchase via the TrumpRx.gov platform at most-favored nation pricing.
🏛️ CEO Dr. Leonard Schleifer stated that American patients should not subsidize lower drug prices in other high-income nations that do not contribute their fair share.
🔬 Regeneron's leadership joined President Donald J. Trump and his Administration at the White House to discuss the terms of this new agreement.
🏭 The company is exempt from future pricing mandates and will receive three years of tariff relief under a Commerce Department agreement.
💵 Regeneron has already committed over $9 billion in U.S.-based manufacturing and R&D infrastructure investments for coming years.
🚫 Specific additional terms of the agreement have been kept confidential between Regeneron and the government.
📰 Regeneron plans to continue its large-scale investment in domestic research and development despite the new commitments.
🧬 Otarmeni treats severe to profound hearing loss caused by variants of the otoferlin gene, marking Regeneron's first gene therapy for this condition.
🔒 The press release includes standard forward-looking statements regarding risks and uncertainties about future events and performance.
🌐 Regeneron remains a leading biotechnology company focused on life-transforming medicines for serious diseases across multiple therapeutic areas.
- Regeneron has agreed to provide its innovative gene therapy, Otarmeni™ (lunsotogene parvec-cwha), for free in the U.S. to treat patients with severe to profound genetic hearing loss.
- The company will lower Medicaid prices based on prices set in other developed countries, aligning future U.S. medicine prices with this defined group of countries.
- Praluent ® (alirocumab) will be available for direct patient purchase through TrumpRx.gov at the most-favored nation price.
- Regeneron is not subject to future pricing mandates and has secured three years of tariff relief through an agreement with the U.S. Department of Commerce.
- The company has already committed over $9 billion in U.S.-based manufacturing and R&D infrastructure investments in coming years, reinforcing its domestic capacity.
- Regeneron will continue to invest deeply in its biotech ecosystem and domestic innovation without being constrained by unfavorable pricing policies.
- Regeneron's commitment to provide Otarmeni™ gene therapy for free in the U.S. creates a significant opportunity cost as the company forgoes revenue from an approved, innovative treatment that could have generated substantial sales.
- The agreement requires Regeneron to lower Medicaid prices by aligning them with prices in other developed countries, potentially reducing profit margins on existing and future medicines in the high-cost U.S. market.
- Future pricing mandates for Regeneron are excluded from this agreement, but the reliance on confidential terms suggests potential uncertainty regarding long-term commercial terms or regulatory obligations.
- The company's assertion that 'viliying the biopharma industry has not produced lower prices' highlights ongoing political and public scrutiny that could lead to further price pressures beyond current commitments.