Image: (Reuters)
In addition to another setback in the glyphosate trials in the USA, the company is now also suffering a bitter defeat in research with its most important drug hope, Asundexian. The share price suffered its biggest fall in decades on Monday.
Bayer announced on Monday night that it would prematurely terminate a crucial phase 3 study with the anticoagulant Asundexian due to lack of effectiveness on the recommendation of an independent control committee. In the study involving 18,000 participants, the drug was examined in comparison to the anticoagulant Eliquis from competitors Bristol-Myers Squibb and Pfizer in patients with atrial fibrillation and at risk of stroke. The effectiveness of Asundexian was shown to be inferior compared to the control arm of the study. The company wants to further analyze the data to better understand the result.
Investors reacted with shock
Investors on the stock market reacted with shock. Bayer shares in Germany’s leading DAX index fell almost 19 percent in early trading to a 14-1/2-year low of 33.72 euros. This is the biggest price fall in at least 32 years. As a result, the aspirin manufacturer’s market value shrank by around 7.6 billion euros.
“This is a severe setback for Bayer. Asundexian was the pearl in Bayer’s pharmaceutical pipeline and without the active ingredient, the pharmaceutical division is left without sustainable growth,” said fund manager Markus Manns from major shareholder Union Investment. “Designing a new beginning will be a herculean task for CEO Bill Anderson.”
For Bayer, the new anticoagulant is the greatest hope in its pharmaceutical research. According to previous information, the company believes that Asundexian alone has a peak sales potential of more than 5 billion euros, more than any of its other medications. Bayer did not want to comment on this forecast when asked on Monday. The drug should be ready for market in 2026 and, according to initial data, led to significantly lower bleeding rates than the competing product Eliquis.
Patents for the classics Xarelto and Eylea are expiring
It was only at the beginning of November that Bayer expanded the study program with the drug, which includes a total of almost 30,000 patients in over 40 countries. Recruitment of participants for this study for patients with atrial fibrillation without current treatment options with currently available anticoagulant tablets has not yet begun. It was actually intended to complement the study that has now been aborted. The phase 3 Stroke study with 9,300 test subjects, in which Asundexian is being tested for the prevention of ischemic stroke, will continue.
Replenishment from the pharmaceutical pipeline is essential for the German company, as the patents on its blockbusters – the anticoagulant Xarelto and the eye drug Eylea – expire in the middle of the decade. For a long time, analysts considered the pipeline to be too weak to be able to absorb the loss of sales after the top drugs’ patents expired. But with Asundexian the mood had changed. The now announced premature termination of the study comes as a complete surprise. Bayer’s pharmaceutical business is therefore facing considerable challenges, explained the analysts at Barclays.
Bad news from the agricultural sector
There was more bad news from Bayer’s agricultural division at the weekend, as the company lost its fourth lawsuit in a row because of the alleged carcinogenic effects of its weed killer glyphosate. A jury in the US state of Missouri sentenced the company to pay a total of 1.56 billion dollars (1.43 billion euros) to four plaintiffs. Bayer announced that it would appeal. “Unlike previous cases, the courts in the recent cases improperly allowed plaintiffs to misrepresent the regulatory and scientific facts.”
Bayer had already suffered three defeats in a row in trials in October, after Leverkusen had previously won nine trials in a row. Bayer has always rejected the allegations against glyphosate. Authorities worldwide have classified the drug as non-carcinogenic. The World Health Organization (WHO) cancer research agency IARC, however, rated the active ingredient as “probably carcinogenic” in 2015. Most recently, agreements were still pending for 52,000 of the total of around 165,000 registered claims.
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Source: Nachrichten
