Bayer Halts Key Drug Trial Amid Performance Concerns, Faces Growing Challenges

Bayer announced the premature termination of a significant late-stage trial for an experimental anti-clotting drug. The trial was halted due to the drug's inferior performance when compared to Bristol-Myers Squibb and Pfizer's well-established Eliquis in preventing strokes among high-risk patients.

The development dealt a major blow to the embattled German pharmaceutical giant and raised concerns about the fate of its most promising medium-term project, observed Reuters.

Setback for Bayer Amidst Ongoing Challenges

The trial's halt, following the recommendation of independent trial supervisors, represents yet another setback for Bayer. Yahoo noted that the company has been grappling with a weak herbicide business, mounting debt, and the burden of U.S. lawsuits related to the alleged carcinogenic effects of its widely-used Roundup weedkiller.

Taking the helm as the new CEO, Bill Anderson intends to explore options to revitalize Bayer's battered share price. Efforts include potentially dividing the company into separate entities and streamlining management decision-making through the reduction of management positions.

Bayer will conduct a comprehensive analysis of the trial's data following its discontinuation. Known as OCEANIC-AF, the trial was initiated in August 2022.

The company stated that the trial's safety data remained consistent with prior studies. While this trial was halted, the independent supervisors recommended continuing a separate phase III trial named OCEANIC-STROKE.

This trial aims to evaluate the efficacy of asundexian in preventing recurring strokes among participants who have already experienced one.

Bayer’s Ambitious Goals and Implications

Bayer had set an ambitious goal for asundexian, aiming to generate over 5 billion euros in peak annual sales. This objective sought to compensate for declining revenue from one of Bayer's pharmaceutical best-sellers, the blood thinner Xarelto.

The patent protection for Xarelto in key European markets is set to expire in 2026. Consequently, the trial's termination also poses a setback for Stefan Oelrich, the head of Bayer's pharmaceutical unit. Oelrich had relied on asundexian's success to drive significant expansion in the United States market, the largest pharmaceutical market globally.

In contrast to its partnership on the Xarelto franchise, where Bayer shared development costs with Johnson & Johnson and ceded most of the U.S. market, Bayer embarked on the asundexian studies independently. The company had prepared to make substantial investments in U.S. marketing and distribution.

Bayer's stock price has fluctuated due to the challenges it faces, and concerns among shareholders have escalated.

Photo: Bayer Newsroom