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

Rhea-AI Summary

BridgeBio grants Bayer exclusive license to commercialize acoramidis for ATTR-CM in Europe, receiving up to $310 million USD, royalties in low-thirties percent, and potential sales milestones. Positive Phase 3 trial results led to FDA and EMA acceptance, with Bayer's expertise enhancing commercialization efforts.

- 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.”

In July 2023, BridgeBio announced positive results from ATTRibute-CM, reporting a highly statistically significant result, demonstrated by a Win Ratio of 1.8 (p<0.0001) on the primary endpoint (a hierarchical analysis prioritizing in order: all-cause mortality, then frequency of cardiovascular hospitalization, then change from baseline in N-terminal prohormone of brain natriuretic peptide, then change from baseline in 6-minute walk distance). Acoramidis was well-tolerated, with no safety signals of potential clinical concern identified. BridgeBio has also presented analyses from ATTRibute-CM at the European Society of Cardiology Congress 2023 and at the American Heart Association Scientific Sessions 2023. In February 2024, BridgeBio shared positive results of a single-arm Phase 3 study of acoramidis in Japanese patients with ATTR-CM, including no mortality reported in the trial at 30 months.

“Bayer has a clear vision to transform cardiovascular care for patients and acoramidis complements our portfolio in specialty cardiology,” said Juergen Eckhardt, M.D., Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Business Development, Licensing & Open Innovation. “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."

About BridgeBio Pharma, Inc. 
BridgeBio Pharma (BridgeBio) is a commercial-stage biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn and Twitter.

BridgeBio Pharma, Inc. Forward-looking Statements 
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to expectations, plans, and prospects regarding the success of our exclusive license granted to Bayer to commercialize acoramidis as a treatment for patients with ATTR-CM in Europe and the payments we are eligible to receive under the license; the clinical, therapeutic and market potential of our clinical development program for acoramidis, including the statements in Mr. Sridhar’s and Dr. Eckhardt’s quotes regarding the potential US launch of acoramidis (if approved by the FDA) by us, the potential European launch of acoramidis (if approved by the EMA) by Bayer, the potential benefits to us of the partnership with Bayer, and the potential benefits of acoramidis to ATTR-CM patients; the statements related to the FDA’s planned actions regarding our NDA for acoramidis for the treatment of ATTR-CM; and the potential outcomes and expected timing of regulatory reviews by the FDA and the EMA, reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from our preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations our product candidates are designed to treat not being as large as anticipated, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, the FDA or such other regulatory agencies not agreeing with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of our collaborations, the success of our partnership with Bayer, our ability to obtain additional funding, including through less dilutive sources of capital than equity financings, potential volatility in our share price, uncertainty regarding any impacts due to global health emergencies such as COVID-19, including delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, increasing rates of inflation and rising interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of our most recent Annual Report on Form 10-K and our other filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Contact:
Vikram Bali
contact@bridgebio.com 
(650)-789-8220

What partnership was announced by BridgeBio and Bayer regarding acoramidis?

BridgeBio granted Bayer an exclusive license to commercialize acoramidis for ATTR-CM in Europe.

What financial benefits will BridgeBio receive from the partnership with Bayer?

BridgeBio will receive up to $310 million USD in upfront and near-term milestone payments, royalties in a tiered structure starting in the low-thirties percent, and additional undisclosed sales milestones.

What regulatory approvals have been obtained for acoramidis?

The US FDA has accepted BridgeBio's NDA for acoramidis with a PDUFA action date of November 29, 2024, while the EMA has accepted the MAA with expected EU approval in 2025.

What positive results were reported from the Phase 3 trial of acoramidis?

Positive results included a Win Ratio of 1.8 (p<0.0001) on the primary endpoint, demonstrating significant efficacy, with no safety concerns identified.

What was the outcome of the Phase 3 study of acoramidis in Japanese patients with ATTR-CM?

Positive results were shared, with no mortality reported in the trial at 30 months, indicating favorable outcomes.