Bayer issues pile up as blood thinner drug trial fails.
The company’s shares plummeted 16.4% to a 12-year low.
The drug was anticipated to generate annual sales exceeding 5 billion euros.
Bayer, Germany’s pharmaceutical giant, has terminated a significant late-stage trial for its new anti-clotting drug due to insufficient efficacy, casting uncertainty over its most promising development project.
The company’s shares plummeted 16.4% to a 12-year low following the announcement, compounded by a separate development involving a $1.56 billion order to pay in a recent U.S. lawsuit related to its widely used Roundup weedkiller.
The experimental anticoagulant, asundexian, was discontinued midway through a Phase III trial as it proved inferior to Bristol-Myers Squibb and Pfizer’s established Eliquis in preventing strokes among high-risk patients on Sunday.
The drug was anticipated to generate annual sales exceeding 5 billion euros ($5.5 billion) and potentially replace revenue from the pharmaceutical best-seller Xarelto, set to lose patent protection in key European markets by 2026.
This setback further challenges Bayer, already grappling with challenges in its herbicide business, substantial debt, and Roundup-related legal issues in the U.S.
The company’s new CEO, Bill Anderson, is exploring options to restructure the company, contemplating a separation of its divisions and streamlining decision-making processes by reducing management positions.
Analysts note the unexpected nature of the trial’s halt, calling it a “total surprise” and emphasizing the significant hurdles facing Bayer’s pharmaceutical business.
The discontinuation of asundexian development poses challenges for Bayer’s U.S. expansion plans, particularly for Stefan Oelrich, the head of Bayer’s pharmaceutical unit, who envisioned a major expansion in the lucrative U.S. pharmaceutical market with the drug.
Bayer stated that it would conduct further analysis of the trial data and highlighted the consistent safety data from the discontinued trial, known as OCEANIC-AF.
The company will continue a separate smaller phase III trial, OCEANIC-STROKE, testing asundexian’s efficacy in preventing strokes in participants who have already experienced one while this development is a blow to Bayer’s growth prospects.
The compound, belonging to the factor XI inhibitors drug group, faces competition from other pharmaceutical players like Novartis and Bristol-Myers Squibb.
Asundexian was one of four potential new drugs identified by Bayer with a combined peak sales potential exceeding 12 billion euros.