BridgeBio Pharma, Inc. and Bayer have announced a strategic partnership, granting Bayer an exclusive license to commercialize acoramidis for ATTR-CM (Transthyretin Amyloid Cardiomyopathy) in Europe. 

Under this agreement, BridgeBio is set to receive up to USD 310 million USD, including upfront and near-term milestone payments, along with additional undisclosed sales milestones. Additionally, BridgeBio will earn royalties in a tiered structure, starting in the low-thirties percent on sales of acoramidis in Europe.

Acoramidis represents a promising investigational treatment, being a next-generation, orally-administered, highly potent small molecule stabilizer of transthyretin (TTR). 

The United States Food and Drug Administration (FDA) has accepted BridgeBio’s New Drug Application (NDA) for acoramidis for the treatment of ATTR-CM, with a Prescription Drug User Fee Act (PDUFA) action date set for November 29, 2024. Furthermore, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for acoramidis, with potential approval in the European Union anticipated in 2025.

Ananth Sridhar, Senior Vice President of Corporate Development at BridgeBio Cardiorenal, expressed excitement about the partnership with Bayer, emphasizing their shared commitment to improving the lives of ATTR-CM patients. Sridhar stated, “We have a responsibility to the ATTR-CM community to make acoramidis available to as many patients as possible, as quickly as possible, and we believe that Bayer is the right collaborator for us in this mission.”

This collaboration capitalizes on Bayer’s established European cardiovascular infrastructure, enabling BridgeBio to focus resources on their wholly-owned geographies for acoramidis, including preparations for the U.S. launch, while realizing substantial cost savings.

The efficacy and safety profile of acoramidis has been demonstrated in various studies. In July 2023, BridgeBio announced positive results from the ATTRibute-CM trial, showcasing a highly statistically significant outcome. Moreover, BridgeBio presented analyses from ATTRibute-CM at prestigious medical congresses, including the European Society of Cardiology Congress 2023 and the American Heart Association Scientific Sessions 2023. 

In February 2024, positive results from a single-arm Phase 3 study of acoramidis in Japanese patients with ATTR-CM were shared, highlighting no mortality reported in the trial at 30 months.

Juergen Eckhardt, M.D., Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Business Development, Licensing & Open Innovation, affirmed Bayer’s commitment to transforming cardiovascular care. Eckhardt stated, “As a leading player in the field of cardiovascular diseases, we will work to make this new treatment available to patients as soon as possible, after a positive decision by the European authorities."

The partnership between BridgeBio and Bayer signifies a significant step forward in addressing the unmet medical needs of ATTR-CM patients in Europe, promising enhanced accessibility to innovative treatments and improved patient outcomes.