The group needs high-revenue supplies in the drug business.
(Photo: dpa)
Dusseldorf Bayer AG has achieved another important success in the development of one of its greatest pharmaceutical hopes. The American health authority has granted the so-called fast-track status to the potential means of stroke prevention in a second area of application, as Bayer announced on Tuesday. This beckons the group to have a faster approval process.
Bayer is currently testing the preparation, called Asundexian, in a large-scale patient study to prevent thrombosis. A good 30,000 people take part worldwide. If brought to market successfully, it could become the new blockbuster in Bayer’s pharmaceuticals portfolio. According to the latest information, the group estimates the top sales potential at five billion euros.
The drug is traded as the successor to Bayer’s current bestseller, the anticoagulant Xarelto. With this drug, which is also used to prevent thrombosis, the group achieved sales of 4.5 billion euros last year. In the coming years, however, the patents for Xarelto will expire worldwide.
Bayer is therefore urgently dependent on supplies. The group has already brought some new drugs onto the market, such as the cancer drug Nubeqa and the kidney drug Kerendia. For the future of the pharmaceuticals division, however, it is important that Bayer can present a strong new drug in the treatment of cardiovascular diseases.
Fast track status for Asundexian is another step in that direction. The FDA grants this designation to potential drugs that it believes have a high unmet medical need in certain applications. The current case is about the prevention of strokes and systemic embolisms in patients with atrial fibrillation. Bayer already has this status for another special therapeutic approach.
“Fast track status allows for more frequent interactions with the FDA on the investigational drug’s development plan and, if the relevant criteria are met, expedited approval and priority review,” Bayer said in a statement. According to earlier information, Bayer expects to start an approval process in 2025 or 2026.
It is likely to be one of the major and most important projects of the new CEO Bill Anderson, who will succeed CEO Werner Baumann at the beginning of June. Anderson has to bring Bayer’s pharmaceutical division back to the front. In the first quarter, the division’s adjusted profit had shrunk 20 percent, which didn’t sit well with the stock market at all.
China’s authorities are pushing down pharmaceutical prices
After the quarterly figures were presented on Thursday last week, the share lost ten percent in value. The sharp fall in the price of the weed killer glyphosate also contributed to this.
The analysts at Berenberg Bank do not rule out a profit warning from Bayer in the course of the year. On Tuesday, after the FDA decision became known, the price rose by two percent.
High costs for the marketing of new products as well as for research and development depress the profit of the pharmaceutical division. That was expected. However, business in China also had a surprisingly heavy impact on the result. China is not the largest single market for Bayer’s pharmaceutical division. But the price pressure in the country is particularly high.
The Chinese government uses so-called tender procedures. Provinces and municipalities are joining forces to become bulk buyers of medicines and pushing down prices. This particularly affected Bayer’s top revenue generator Xarelto and the heart drug Adalat.
More: Bayer shares collapse – glyphosate depresses profits