As BridgeBio’s acoramidis inches closer to an FDA approval decision, Bayer on Monday inked a European licensing agreement for the transthyretin amyloid cardiomyopathy treatment.
Pictured: A view of a Bayer facility in Leverkusen, Germany/iStock, Fotofantastika
German pharma Bayer is paying BridgeBio $310 million upfront for an exclusive license in Europe for acoramidis, the biotech’s treatment for transthyretin amyloid cardiomyopathy, the companies announced on Monday.
Under the agreement, Bayer will receive an exclusive license to commercialize ceramides for transthyretin amyloid cardiomyopathy (ATTR-CM) patients in Europe. Besides the upfront $310 million payment, BridgeBio will also receive sales milestones and royalties starting at the low 30 percentage range on the drug’s European sales.
Bayer’s move comes as the drug showed positive Phase III data in August 2023, reaching its primary endpoint.
The FDA has set a PDUFA date for Nov. 29, 2025, while the marketing authorization application for acoramidis has also been accepted by the European Medicines Agency with a potential approval in the E.U. in 2025.
“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,” Ananth Sridhar senior vice president of corporate development at BridgeBio Cardiorenal said in a statement. “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 U.S. launch.”
Mizuho analyst Salim Syed in a Monday note said the deal makes “fundamental” and “operational” sense for BridgeBio as Bayer has a cardiovascular portfolio, and with Xarelto staring down a patent expiration in Europe this year, having acoramidis in Europe is a “structural motivator” for Bayer.
“Bayer has a clear vision to transform cardiovascular care for patients and acoramidis complements our portfolio in specialty cardiology,” Juergen Eckhardt, member of the executive committee of Bayer’s pharmaceuticals division and head of business development, licensing and open innovation, said in a statement. “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.”
BridgeBio has been on a dealmaking spree recently. In January 2024, it secured investment from Blue Owl Capital and the Canada Pension Plan, bringing the company’s total capital to $1.25 billion. Last month, Kyowa Kirin paid BridgeBio $100 million to nab the exclusive rights to develop and commercialize infigratinib for skeletal dysplasias in Japan.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
