Acoramidis is an investigational, next-generation, orally administered, highly potent and selective small molecule transthyretin (TTR) stabiliser, intended for the treatment of patients suffering from ATTR CM, which results in heart failure
Headquarters of Bayer Pharmaceuticals in Berlin. (Credit: Fridolin freudenfett/Wikipedia)
German pharmaceutical and biotechnology company Bayer has acquired the exclusive rights to market BridgeBio’s oral transthyretin (TTR) stabiliser Acoramidis in Europe, for up to $310m.
Acoramidis is an investigational, next-generation, orally administered, highly potent and selective small molecule transthyretin (TTR) stabiliser.
The drug is intended for the treatment of patients suffering from ATTR CM, a progressive mortal disease characterised by infiltrative, restrictive cardiomyopathy resulting in heart failure.
Under the terms of the agreement, BridgeBio and the affiliates will receive up to $310m in upfront and near-term milestone payments.
The affiliates include Eidos Therapeutics, BridgeBio International and BridgeBio Europe.
BridgeBio and affiliates are also eligible to receive additional undisclosed sales milestone payments plus tiered-royalties starting in the low-thirties percent.
Bayer pharmaceuticals division executive committee member and business development, licensing and open innovation head Juergen Eckhardt said: “Bayer has a clear vision to transform cardiovascular care for patients and acoramidis complements our portfolio in specialty cardiology.
“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 US Food and Drug Administration (FDA) has accepted BridgeBio’s new drug application (NDA) for Acoramidis to treat ATTR-CM with a prescription drug user fee act (PDUFA) action date of 29 November 2024.
In addition, the European Medicines Agency (EMA) has accepted the company’s marketing authorisation application (MAA) for Acoramidis and is expected to grant EU approval in 2025.
BridgeBio filed the MAA in January 2024, based on positive results from the Phase 3 clinical trial, in which Acoramidis showed statistically significant efficacy and good tolerability.
In a Phase 3 study, Acoramidis has met all clinical endpoints by significantly reducing hospitalisation, improving survival, preserving functional capacity and quality of life for patients.
BridgeBio Cardiorenal corporate development senior vice president Ananth Sridhar said: “We are excited to have found a like-minded partner in Bayer that shares our belief in the potential of acoramidis to ameliorate the lives of ATTR CM patients.
“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 partnership leverages Bayer’s established European cardiovascular infrastructure and enables us, via substantial cost savings, to focus our resources on our wholly-owned geographies for acoramidis, including preparing for the US launch.”