Dive Brief:
- BridgeBio Pharma is licensing some of the rights to a closely watched experimental medicine for a rare heart condition, agreeing on Monday to a partnership with German pharmaceutical giant Bayer.
- Per deal terms, BridgeBio will receive $310 million in upfront and near-term payments for rights in Europe to the drug, which is known as acoramidis and is being developed for the rare disease transthyretin amyloidosis cardiomyopathy. Bridge is also eligible for future milestone payments as well as at least a “low thirties” percent royalty on sales in Europe.
- Acoramidis succeeded in Phase 3 testing last year and is currently being reviewed by drug regulators in the U.S. and Europe. A verdict from the Food and Drug Administration is expected by Nov. 29. The European Medicines Agency could follow with a decision in 2025.
Dive Insight:
The BridgeBio deal with brings Bayer into a coming commercial battle with billions of dollars at stake.
The disease acoramidis treats,TTR cardiomyopathy, has quickly become one of the more competitive areas of drug research. The condition is caused by the buildup of a misfolded protein that corrodes heart tissue, potentially causing heart failure and death. The only drug available, Pfizer’s Vyndamax, generated $3.3 billion in sales last year. BridgeBio is now leading a group of other developers, including Alnylam Pharmaceuticals, Ionis Pharmaceuticals and Intellia Therapeutics, that aim to come up with better options.
Like Vyndamax, acoramidis is designed to stop the key protein involved in the disease — transthyretin or TTR — from misfolding. In preclinical testing, it did so more effectively than Vyndamax, raising expectations it might have a stronger effect on the disease. And last year, the drug helped keep patients in a Phase 3 trial alive and out of the hospital longer than a placebo.
BridgeBio hasn’t tested its drug against Pfizer’s, making it difficult to compare the two drugs. The biotech might also soon face competition from Alnylam, which expects Phase 3 results later this year for a different type of TTR cardiomyopathy medicine that some experts believe could be more potent. “Future market share for acoramidis is hard to predict given various moving parts,” wrote Stifel analyst Paul Matteis in a research note in January.
In an email to BioPharma Dive, Ananth Sridhar, BridgeBio’s senior vice president of corporate development, said the company expects acoramidis to be used in the “first-line care setting.” He added that transthyretin “stabilization,” the mechanism by which BridgeBio’s drug works, is the only strategy so far that’s proven to improve outcomes.
Some industry watchers believe acoramidis is a blockbuster-to-be. Consensus estimates have the drug pulling in about $2 billion in peak yearly sales, but that figure “could be larger,” Mizuho Securities analyst Salim Syed wrote last month. BridgeBio has already struck multiple deals ahead of its launch. In addition to the Bayer agreement, it secured $500 million in January by selling a small share of royalties. AstraZeneca also owns rights to acoramidis in Japan through a deal its Alexion Pharmaceuticals subsidiary forged five years ago.
Assuming the drug is approved, the partnership with Bayer should “accelerate the accessibility” of acoramidis in Europe, Sridhar wrote. BridgeBio is preparing to commercialize the drug in the U.S., where it holds full drug rights.
“Given the expense and operational lift of building EU commercial infrastructure to support the ... launch, engaging a pharma partner with global cardiology sales muscle makes sense to us,” wrote Leerink Partners analyst Mani Foroohar in a Monday note to clients.