Bayer Secures European Rights to Acoramidis for ATTR-CM with $310 Million Deal; Regulatory Submissions Under Review in US and EU

Mar 05, 2024 07:31 CST Updated 07:31

BridgeBio

Pharmaceutical R&D Developer

Bayer

Pharmaceutical Product R&D Developer

▎WuXiEdited by Kant Content Team

BridgeBio Pharma and Bayer announced a partnership today,BridgeBio Grants Bayer Exclusive License to Commercialize Acoramidis for the Treatment of Transthyretin-Mediated Amyloidosis with Cardiomyopathy (ATTR-CM) in EuropeBridgeBio will receive up to $310 million in upfront payments and near-term milestones.

Acoramidis is a next-generation, orally administered, highly potent small molecule stabilizer of transthyretin (TTR). It is designed to mimic the function of the protective TTR T119M mutation, maintaining the normal tetrameric conformation of TTR protein and preventing the formation of toxic amyloid proteins.The U.S. FDA has accepted BridgeBio's New Drug Application (NDA) for acoramidis for the treatment of ATTR-CM, with a PDUFA action date set for November 29, 2024. Additionally, the European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for acoramidis.

In July 2023, BridgeBio announced the ATTRibute-CM trialPositive Results, The clinical results of the 30th month of the study include:

Primary endpoint achieved highly statistically significant improvement(The hierarchical analysis prioritizes all-cause mortality, followed by the frequency of cardiovascular disease-related hospitalizations, then the change in N-terminal pro-brain natriuretic peptide from baseline, and finally the change in 6-minute walking distance from baseline), with a Win Ratio of 1.8 (p<0.0001). This result differs from those observed in previous transthyretin stabilizer trials.At 30 months, a consistent reduction in the risk of cardiovascular-related hospitalizations was observed across all predefined patient subgroups.

The time-to-first-event curves for all-cause mortality and cardiovascular-related hospitalization began to separate at Month 3 and continued to diverge through Month 30, with a hazard ratio of 0.645 (p=0.0008).

In February 2024, BridgeBio shared the results of a single-arm Phase 3 clinical trial conducted in Japan among ATTR-CM patients.Positive Results, including no reported deaths within the 30 months of the trial.

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References:

[1] BridgeBio Pharma and Bayer Announce European Licensing Agreement for Acoramidis in ATTR-CM . Retrieved March 4, 2024, from https://www.globenewswire.com/news-release/2024/03/04/2839242/0/en/BridgeBio-Pharma-and-Bayer-Announce-European-Licensing-Agreement-for-Acoramidis-in-ATTR-CM.html

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