BridgeBio Pharma and Bayer Announce European Licensing Agreement for Acoramidis in ATTR-CM

- BridgeBio grants Bayer exclusive license to commercialize acoramidis as a treatment for patients with transthyretin amyloid cardiomyopathy (ATTR-CM) in Europe

- BridgeBio to receive royalties according to a tiered structure beginning in the low-thirties percent, designed to provide BridgeBio the opportunity to maximally share in the blockbuster potential of acoramidis

- BridgeBio will also receive up to $310 Million USD in upfront and near-term milestone payments, and is eligible for additional undisclosed sales milestones

- BridgeBio’s New Drug Application (NDA) based on positive results from global Phase 3 ATTRibute-CM trial has been accepted by the US Food and Drug Administration (FDA) with a PDUFA action date of November 29, 2024; Marketing Authorization Application (MAA) for acoramidis has been accepted by the European Medicines Agency (EMA), with an expected approval in 2025

- Deal pairs Bayer’s commercial experience and long legacy of expertise in cardiovascular medicine with BridgeBio’s leadership in the emerging field of ATTR-CM

PALO ALTO, Calif. and BERLIN, March 04, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio) and Bayer today announced a partnership wherein BridgeBio grants Bayer an exclusive license to commercialize acoramidis for ATTR-CM in Europe. In exchange, BridgeBio will receive up to $310 million USD comprising of upfront and near-term milestone payments, as well as additional undisclosed sales milestones. 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 (TTR). The US FDA has accepted BridgeBio’s NDA for acoramidis for the treatment of ATTR-CM with a PDUFA action date of November 29, 2024; additionally, the EMA has accepted the MAA for acoramidis with potential EU approval in 2025.

“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,” said Ananth Sridhar, Senior Vice President of Corporate Development, BridgeBio Cardiorenal. “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.”