BERLIN (dpa-AFX) - Following a further study on the active substance elinzanetant, Bayer plans to apply for approval of the drug to treat certain menopausal symptoms. This non-hormonal treatment of vasomotor symptoms showed a statistically significant reduction in the frequency of moderate to severe hot flushes in the Phase III Oasis 3 study, as the Dax-listed company announced on Tuesday. A commercial success could help Bayer to at least slightly reduce an increasingly large revenue gap due to expiring patents for the billion-euro drugs Xarelto, a blood thinner, and Eylea, an eye medication. Nevertheless, a competitor, the Japanese company Astellas Pharma, launched a drug comparable to elinzanetant in the USA last year.

"Oasis 3 was designed to answer the important question about the long-term profile of elinzanetant," said Christian Rommel, Head of Pharma Research and Development at Bayer. The full study data should now be presented at medical conferences while the regulatory filing is being prepared.

If approved, elinzanetant would be an alternative for women who do not like hormone replacement therapy or are unable to use it for health reasons. Bayer added the drug to its development portfolio following the acquisition of the British biotech company Kandy Therapeutics in 2020. The drug candidate is currently also being tested on breast cancer patients in another study (Oasis 4). They often suffer from menopausal symptoms, as hormone-lowering therapies lead to lower oestrogen levels.

Analysts such as Richard Vosser from the bank JPMorgan rated the data from the two studies Oasis 1 and 2 as slightly positive in January. However, Vosser had written at the time that details on efficiency were needed in order to be able to estimate the possible sales potential. The expert had also pointed out that the US sales launch of rival drug Veozah from pharmaceutical company Astellas Pharma had been rather sluggish.

According to earlier statements, Bayer pharmaceuticals boss Stefan Oelrich believes that the drug Elinzanetant will become a blockbuster. This means peak annual sales of more than one billion euros./mis/nas