Bayer (BAYRY) Acquires BridgeBio's Cardiovascular Drug
Bayer BAYRY announced that it has acquired the exclusive marketing rights for cardiovascular candidate acoramidis in Europe from BridgeBio BBIO. The rights were acquired from Eidos Therapeutics Inc., BridgeBio International GmbH and BridgeBio Europe B.V.
Acoramidis is an investigational, next-generation, orally-administered, highly potent small molecule stabilizer of transthyretin (TTR). It is being evaluated for the treatment of patients suffering from transthyretin amyloid cardiomyopathy (ATTR-CM).
In a placebo-controlled phase III study, acoramidis met all clinical endpoints by significantly reducing hospitalization burden, improving survival and preserving functional capacity and quality of life for patients in need.
A new drug application (NDA) for acoramidis has been filed with the FDA, and the regulatory body has set a target action date of Nov 29, 2024, for the same. A marketing authorization application is also under review with the European Medicines Agency. A potential approval in the EU is expected in 2025.
Per the terms of the agreement, BridgeBio and the affiliates will receive an upfront payment of $310 million from Bayer. BBIO and the affiliates are also entitled to near-term milestone payments, and additional undisclosed sales milestone payments and tiered royalties beginning in the low 30% range.
However, shares of BridgeBio were down on the news.
On the other hand, Bayer has a cardiovascular drug Xarelto in its portfolio, even though it is facing generic competition.
The addition of acoramidis to the company’s portfolio will act as a tailwind.
Upon a potential approval, acoramidis will compete with Pfizer’s PFE Vyndaqel.
Vyndaqel (tafamidis meglumine) 20 mg was first approved in 2011 in the EU for the treatment of transthyretin amyloid polyneuropathy (ATTR-PN), in adult patients with stage 1 symptomatic polyneuropathy, to delay peripheral neurologic impairment.
Sales of Vyndaqel totaled $3.3 billion in 2023.
Pfizer also has a blood thinner drug Eliquis (apixaban) in its portfolio, for which the company has a collaboration with Bristol Myers Squibb.
Shares of BAYRY have lost 43.1% in the past six months against the industry’s growth of 15.4%.
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Bayer earlier stopped the late-stage study, OCEANIC-AF, investigating asundexian compared with direct oral anticoagulant Eliquis in patients with atrial fibrillation and at risk for stroke due to the lack of efficacy.
The decision to stop the study was based on the recommendation of the study’s Independent Data Monitoring Committee (IDMC) as part of the ongoing surveillance, which showed an inferior efficacy of asundexian versus the control arm. This was a major setback, given the candidate’s potential.
Nevertheless, IDMC recommends continuing the phase III OCEANIC-STROKE study as planned.
The ongoing glyphosate litigation in the United States is also an overhang on BAYRY’s shares.
Zacks Rank & a Stock to Consider
Bayer currently has a Zacks Rank #4 (Sell).
A better-ranked stock in the drug/biotech industry is ADMA Biologics ADMA, which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased by 8 cents to 22 cents. The consensus estimate for 2025 EPS is pegged at 50 cents. Over the past year, shares of ADMA have jumped 70.7%.
ADMA beat on earnings in three of the trailing four quarters and met the mark in one, delivering an average surprise of 85%.
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