Frankfurt The Bayer Group announced one of its largest clinical study programs to date over the weekend. The goal: to develop a successor product for the current bestseller Xarelto. The anticoagulant will lose patent protection in a few years.
To this end, the Leverkusen-based group intends to start two large phase 3 clinical trials with its product candidate Asundexian in the current year, in which up to 30,000 participants are to be included. Bayer wants to test the new development on the one hand to prevent strokes in patients with atrial fibrillation and on the other hand in certain patients who have already suffered a stroke. In some cases, Bayer wants to test its new development in a direct comparison with the current market leader in the field of anticoagulants, the drug Eliquis from the US company Bristol-Myers Squibb (BMS).
The two studies are likely to require development investments in the hundreds of millions. And they could have significant implications for the longer-term prospects of the group’s pharmaceuticals division. In this case, Bayer is concerned with defending its position in a very lucrative segment of the pharmaceutical market or, in the best case, even expanding it.
With the decision in favor of an extensive Phase 3 program, Bayer management is showing confidence that it can keep up with its own new development in the field of stroke prevention, especially compared to its main competitor BMS, which is working on a similar substance called Milvexian.
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Both active ingredients are so-called factor XIa inhibitors and therefore molecules that interfere with blood coagulation at a different point than the established agents. “Our clear goal is to develop a new treatment option that prevents thrombotic events,” explained Christian Rommel, Head of Bayer Pharmaceutical Research and Development.
Studies have not fully met expectations
Both companies presented new data on their projects at the Congress of the European Society of Cardiology in Barcelona on Sunday. The results so far from phase 2 studies are considered by the companies to be encouraging for larger studies, even if they have not fully met all expectations in either case. The previous phase 2 studies have not yet been able to show that Asundexian prevents thrombotic events such as strokes just as well as the established drugs.
In a study of patients who had previously had a heart attack, the number of thrombotic events treated with Asundexian was similar to that in the placebo group. Another study showed a 60 percent reduction in a certain type of stroke.
However, according to Bayer, the studies were not designed to prove the prophylactic effect, but primarily to determine the dose and safety. John Alexander, a Duke University cardiology professor and one of the lead investigators in the previous studies, pointed out that the overall number of thrombosis cases was relatively small in the tests, which limits the statistical power in this regard.
Nevertheless, investors were rather disappointed with the results for Asundexian. The shares of the pharmaceutical company fell by a good two percent on Monday morning.
Bayer manager Rommel, however, spoke of another paradigm shift that the new substance is aimed at. “The underlying knowledge of FXIa and the Phase 2 data, particularly demonstrating the safety of Asundexian, give us confidence in advancing the investigational drug to Phase 3.”
Anticoagulants such as Xarelto, Eliquis or Pradaxa are prescribed across the board, especially for older people who have an increased risk of stroke or other events caused by vascular occlusion, for example due to certain cardiac arrhythmias or after knee and hip operations.
The active ingredients developed in the last decade are also referred to as new oral anticoagulants (NOAC). They reduce the blood’s ability to coagulate and thus also the risk of dangerous clotting in the veins, but at the same time are associated with a certain risk of bleeding.
Bayer and BMS are hoping for billions in sales
With their new developments Asundexian and Milvexian, Bayer and BMS are primarily aiming to significantly reduce this risk of bleeding and thus improve the safety profile compared to Xarelto and other anticoagulants. Both companies are dealing with a multi-billion market.
In Germany alone, more than 600 million daily doses of these NOACs are prescribed at a total cost of more than 1.7 billion euros, of which Xarelto accounts for around 40 percent. The drugs recently achieved annual sales of around 28 billion dollars worldwide. The market is led by the active ingredient Eliquis, which BMS sells together with the industry leader Pfizer.
Bayer recently posted annual sales of 4.7 billion euros with Xarelto, which means that the anticoagulant is currently by far the most important sales driver for the Bayer pharmaceuticals division. The US sales partner Johnson & Johnson also achieved sales of around 2.4 billion dollars with the product.
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The key challenge for both Bayer and its US competitor BMS is that the patents on the active ingredients will expire in 2026. Then the way is clear for inexpensive imitation products, so-called generics.
Bayer and BMS have therefore been in a race to find improved successor products for several years, which will be able to cushion the impending loss of sales of the older products from the middle of the decade. The US group is also working intensively on a factor XIa inhibitor and has also already indicated plans to enter a phase 3 study with its product candidate Milvexian.
In these studies, it will be important for both Bayer and BMS to show that the new active ingredients can actually prevent strokes just as well as the established drugs, while significantly reducing the number of dangerous bleeding episodes. Results are unlikely to be available before 2025.
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