Bayer has announced a licensing agreement with BridgeBio Pharma to commercialise acoramidis as a treatment for patients living with transthyretin amyloid cardiomyopathy (ATTR-CM).
As part of the deal, Bayer will receive an exclusive license to commercialise acoramidis to treat ATTR-CM patients living in Europe.
Affecting around 500,000 people worldwide, ATTR-CRM is a rare and progressive condition that occurs when the transthyretin (TTR) protein becomes misshapen and builds up in various parts of the body, including the heart, resulting in cardiomyopathy, a disease of the heart muscle.
In exchange, BridgeBio will receive up to $310m in upfront and near-term milestone payments and will be eligible for additional undisclosed sales milestone payments.
Acoramidis is an investigational, orally administered, highly potent small molecule stabiliser of TTR that mimics the specific disease-protective action of a stabilising TTR mutation called T119M.
BridgeBio shared positive results from the phase 3 ATTRibute-CM study of acoramidis in adults with ATTR-CM. The trial met its primary endpoint and the company reported that the drug was well tolerated, with no safety signals of potential clinical concern identified.
Additionally, no mortality was reported in patients treated with acoramidis for 30 months.
The US Food and Drug Administration has already accepted BridgeBio’s New Drug Application for the investigational TTR for the treatment of ATTR-CM with a prescription drug user fee action date of 29 November 2024, while the European Medicines Association has accepted the marketing authorisation application for the drug with the potential of receiving EU approval in 2025.
Ananth Sridhar, senior vice president, corporate development, BridgeBio Cardiorenal, said: “This partnership… enables us, via substantial cost savings, to focus our resources on our wholly-owned geographies for acoramidis, including preparing for the US launch.”
Juergen Eckhardt, member of Bayer’s pharmaceuticals division executive committee and head of business developing, licensing and open innovation, said that Bayer “will work to make this new treatment available to patients as soon as possible, after a positive decision by the EU authorities”.
Most recently, AstraZeneca, which maintains an exclusive license with BridgeBio’s affiliate, Eidos Therapeutics, to develop and commercialise acoramidis in Japan, shared similar positive high-level results to BridgeBio’s ATTRibute-CM study, from a late-stage trial of the drug in ATTR-CM patients.