With the FDA currently mulling whether to approve BridgeBio’s acoramidis as a rival to Pfizer’s blockbuster heart disease drug Vyndaqel, Bayer has decided to pay out $310 million to scoop up the European rights.

That $310 million is split between upfront and near-term milestone payments, according to a premarket release March 4. There are also additional undisclosed sales milestones tied to the agreement, and BridgeBio is in line to receive tiered royalties “beginning in the low-thirties percent” on any European sales.

With the FDA set to decide on acoramidis’ U.S. approval in transthyretin amyloid cardiomyopathy (ATTR-CM) at the end of November and European regulators expected to deliver their verdict in early 2025, those sales may not be far away.

BridgeBio continued to tout the drug’s “blockbuster potential” in today’s release. The high expectations come off the back of phase 3 data from July 2023 that the Bay Area biotech hailed at the time as demonstrating a “highly statistically significant” improvement on a hierarchy of assessments that included all-cause mortality, cardiovascular-related hospitalization and a six-minute walk test, among others.

A deeper dive into the data a couple of months later underscored the TTR stabilizer’s ability to reduce cardiovascular-related deaths. This showed that the average annual hospitalization rate for patients on acoramidis was 0.29, close to the annual hospitalization rate for U.S. Medicare patients generally. The mean annual hospitalization rate for Pfizer’s Vyndaqel (PDF) was 1.00.

While analysts have warned that Pfizer is “quite entrenched” and “might be difficult to displace,” ATTR-CM is a large, growing market, and BridgeBio has previously forecast “billions of peak year sales” for acoramidis.

AstraZeneca, which owns the rights to acoramidis in Japan, reported positive top-line results from a phase 3 trial in that country last month.

“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,” Ananth Sridhar, senior vice president of corporate development, BridgeBio Cardiorenal, said in this morning’s release. “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.”

Bayer has “a clear vision to transform cardiovascular care for patients and acoramidis complements our portfolio in specialty cardiology,” Juergen Eckhardt, M.D., a member of the executive committee of Bayer’s pharmaceuticals division and head of business development, licensing and open innovation, added in the release. “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."

The announcement comes ahead of Bayer’s capital markets day tomorrow, when the company is set to map out a refreshed strategy, with investors hoping for clarity on the long-running question of whether Bayer will split its divisions. The German pharma giant kicked off the year by unveiling a major restructuring tied to “significant job cuts” under the overview of new CEO Bill Anderson.

Author: James Waldron

Publication: Fierce Biotech

Link: Bayer pays $310M for Europe rights to BridgeBio's Vyndaqel rival (fiercebiotech.com)