Commercial-stage biopharmaceutical company BridgeBio Pharma, Inc. (BBIO) announced Monday that it has granted German pharmaceutical and life sciences major Bayer (BAYZF.PK,BAYRY.PK,BYR.L) an exclusive license to commercialize acoramidis for patients with transthyretin amyloid cardiomyopathy or ATTR-CM in Europe.
In exchange, BridgeBio will receive up to $310 million, comprising of upfront and near-term milestone payments, as well as additional undisclosed sales milestones.
Under the partnership, BridgeBio will also receive royalties in a tiered structure beginning in the low-thirties percent on sales of acoramidis in Europe.
Acoramidis is an investigational, next-generation, orally-administered, highly potent small molecule stabilizer of transthyretin or TTR. The US FDA has accepted BridgeBio's New Drug Application or NDA for acoramidis for the treatment of ATTR-CM with a PDUFA action date of November 29, 2024.
In addition, the European Medicines Agency or EMA has accepted the Marketing Authorization Application for acoramidis with potential EU approval in 2025.
Ananth Sridhar, Senior Vice President of Corporate Development, BridgeBio Cardiorenal, said, "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."
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