In a significant setback for Germany’s pharmaceutical giant Bayer, the company has halted a large late-stage trial testing its highly anticipated anti-clotting drug, asundexian, due to lack of efficacy. This blow comes at a challenging time for Bayer, with its shares plunging 16.4% to their lowest point in 12 years. It was after a recommendation by independent trial supervisors that operations were brought to a halt, landing a blow to the otherwise promising project.
Bayer, in a statement, revealed that asundexian showed inferiority to the established Eliquis, a joint product of Bristol-Myers Squibb and Pfizer, in preventing strokes among high-risk patients. The company had ambitious expectations for asundexian, aiming for annual sales exceeding 5 billion euros ($5.5 billion). In 2026, when Bayer loses out on some of its European patents for one of its best-sellers, Xarelto, this drug is expected to make up for the loss in revenue.
The abrupt halt to the trial represents another blow to Bayer’s new CEO, Bill Anderson, who is currently contemplating strategies to reinvigorate the company’s share price. Anderson is currently looking to break apart the diversified business, encompassing prescription drugs, crop chemicals, seeds, and consumer health products.
The impact of this setback extends beyond the financial realm, affecting Bayer’s hopes for a major expansion in the United States, the world’s largest pharmaceutical market. Bayer chose to go solo on asundexian studies, indicating a deviation in its risk management strategy, in the past the firm has been seen to share developmental costs with partners, as was the case with the Xarelto franchise where Johnson and Johnson bore the burden with Bayer. The development costs for asundexian, now deemed a failed risk management example, should have been shared, according to Manns.
and Bristol-Myers Squibb, working with Johnson & Johnson and Novartis, working with private equity firm Blackstone are some of teh other pharmaceutical giants that are interested in the class of drugs that Asundexian belongs to. These are referred to as factor XI inhibitors The compound was one of Bayer’s four new drug hopefuls with a combined peak sales potential exceeding 12 billion euros.
Bayer’s plans to position asundexian as a 5 billion euro ($5.5 billion) per year medicine have taken a hit. The drug’s inferior efficacy compared to Eliquis in the phase 3 trial has prompted Bayer to halt the study while still considering its advancement in another indication. Factor XIa inhibition, the mechanism targeted by asundexian, is considered a potential strategy to prevent blood clots without raising the risk of bleeding, providing an alternative to existing drugs like Eliquis.
Despite the setback, Bayer is committed to analyzing the data from the discontinued trial, OCEANIC-AF, started in August of last year with 18,000 participants. The company plans to reevaluate the design of another phase 3 trial, OCEANIC-AFINA, in light of the setback while continuing the OCEANIC-STROKE trial, testing asundexian in stroke prevention for patients who have already suffered one.
