Bayer Acquires European Rights to BridgeBio’s Acoramidis for ATTR-CM Therapy

- BridgeBio Pharma grants Bayer an exclusive license to commercialize acoramidis, a treatment for transthyretin amyloid cardiomyopathy (ATTR-CM), in Europe.
- Under the agreement, BridgeBio receives up to $310 million USD consisting of upfront and near-term milestone payments, along with royalties starting in the low-thirties percent on European sales of acoramidis.
- Acoramidis showed promising Phase 3 data in July 2023, with a highly statistically significant result, and the drug was well-tolerated.
- The U.S. Food and Drug Administration (FDA) has accepted BridgeBio's New Drug Application (NDA) for acoramidis, with a Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024; similarly, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for acoramidis, anticipating a potential EU approval in 2025.
- Bayer aims to leverage its established European cardiovascular infrastructure to facilitate the availability of acoramidis to patients and will work towards making the therapy accessible upon a favorable decision by European authorities.