Bayer, the German drugmaker, has stopped a large late-stage clinical trial for a new anti-clotting drug due to insufficient efficacy. The experimental anticoagulant, asundexian, was expected to generate annual sales of over €5 billion but was shown to be inferior to the established Eliquis drug from Bristol-Myers Squibb and Pfizer in preventing strokes in high-risk patients during a Phase III trial.
This is a significant setback for the company which is already facing several challenges. Bayer is currently facing lawsuits in the US over the alleged carcinogenic effect of its Roundup weedkiller and has a weak herbicide business along with high debt levels. The latest trial halt doubts Bayer’s most promising medium-term development project. The company’s new CEO, Bill Anderson, is considering breaking up the company to revive the share price. Bayer will analyze the data of the discontinued trial, known as OCEANIC-AF, which was initiated in August 2022.
However, the independent trial supervisors have recommended that a separate phase III trial, OCEANIC-STROKE, testing asundexian to prevent repeated strokes in participants who have already suffered one, should continue. The two OCEANIC studies would have involved up to 30,000 patients, as stated by Bayer last year in August. Bayer had set the goal for asundexian to generate more than €5 billion in peak annual sales, seeking to replace revenue from one of its pharmaceutical best-sellers, blood thinner Xarelto, which is set to lose protection from key European patents in 2026.
The trial halt is also a blow for the head of Bayer’s pharmaceutical unit, Stefan Oelrich, who had pinned hopes of a major expansion in the United States on asundexian. Unlike the Xarelto franchise, where Bayer shared development costs with Johnson & Johnson and ceded most of the US market to its partner, Bayer conducted the asundexian studies on its own and was prepared to spend heavily on US marketing and distribution. The German drugmaker Bayer has stopped a large late-stage clinical trial for a new anti-clotting drug due to insufficient efficacy.
The experimental anticoagulant, asundexian, was expected to generate annual sales of over €5 billion but was shown to be inferior to the established Eliquis drug from Bristol-Myers Squibb and Pfizer in preventing strokes in high-risk patients during a Phase III trial. This is a significant setback for the company which is already facing several challenges. Bayer is currently facing lawsuits in the US over the alleged carcinogenic effect of its Roundup weedkiller and has a weak herbicide business along with high debt levels. The latest trial halt casts doubt on Bayer’s most promising medium-term development project. The company’s new CEO, Bill Anderson, is considering breaking up the company in an attempt to revive the share price. Bayer will analyze the data of the discontinued trial, known as OCEANIC-AF, which was initiated in August 2022.
However, the independent trial supervisors have recommended that a separate phase III trial, OCEANIC-STROKE, testing asundexian to prevent repeated strokes in participants who have already suffered one, should continue. The two OCEANIC studies would have involved up to 30,000 patients, as stated by Bayer last year in August. Bayer had set the goal for asundexian to generate more than €5 billion in peak annual sales, seeking to replace revenue from one of its pharmaceutical best-sellers, blood thinner Xarelto, which is set to lose protection from key European patents in 2026.
The trial halt is also a blow for the head of Bayer’s pharmaceutical unit, Stefan Oelrich, who had pinned hopes of a major expansion in the United States on asundexian. Unlike the Xarelto franchise, where Bayer shared development costs with Johnson & Johnson and ceded most of the US market to its partner, Bayer conducted the asundexian studies on its own and was prepared to spend heavily on US marketing and distribution.