Bristol Myers Squibb (BMY) -) shares slumped lower Monday after German drugmaker Bayer AG halted late-stage trials of a blood-thinning drug that could complicate the development of similar treatments.
Bayer shares plunged to a multidecade low in European trading following a late Sunday update that said its experimental anticoagulant, known as asundexian, was shown to be inferior to Eliquis, a blood-thinner made by Bristol Myers and Pfizer (PFE) -).
"This decision is based on the recommendation of the study’s Independent Data Monitoring Committee (IDMC) as part of ongoing surveillance which showed an inferior efficacy of asundexian versus the control arm," Bayer said in a statement.
"Although the results from this analysis do not support the continuation of the study, we will continue investigating asundexian and are currently reevaluating other indications in patients in need of antithrombotic treatment," Bayer added.
The scrapping of the study, however, has cast doubt on an upcoming Phase 3 trial of milvexian, a similar so-called FIX(a) inhibitor developed by Bristol Myers and Janssen Pharmaceuticals, a division of Johnson & Johnson (JNJ) -). That is designed to assess the drug's ability to treat patients with various cardio vascular diseases who are at risk to excessive bleeding.
The trial, known as Librexia, earlier this year was granted fast-track approval by the U.S. Food and Drug Administration. Bristol Myers had indicated that milvexian could ultimate generate around $5 billion in annual revenue, split with Johnson & Johnson, should it ultimately be approved.
"We are confident in our Phase 3 Librexia program, which is unrivaled as the most comprehensive anti-FXIa clinical development program today," Bristol Myers said in a statement emailed to TheStreet.
"We are currently focused on three core areas of high unmet need. Based on our Phase 2 data, and our ability to choose the optimal dose for each indication, we are confident that the Librexia AF trial is designed to potentially demonstrate benefit versus apixaban, hand-in-hand with a safer bleeding profile – which could open the door to treatment for millions of patients around the world, including many patients who are currently untreated or underdosed with available anticoagulants due to concerns about bleeding," the statement added.
Bristol Myers shares were marked 4.6% lower in early afternoon trading to change hands at $48.47 each, a move that would still leave the stock with a 25% gain over the past six months. Johnson & Johnson shares were marked 0.7% higher at $149.59 each.
Bayer shares, meanwhile, were marked 18.8% lower in mid-day Frankfurt trading to change hands at €33.60 each, the lowest levels in more than twelve years.
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