BERLIN (dpa-AFX) - Bayer believes it is on course for possible approval following positive study data on the active substance elinzanetant for the treatment of certain menopausal symptoms. This non-hormonal treatment for vasomotor symptoms (hot flashes) during menopause achieved a statistically significant reduction in frequency in two pivotal Phase III trials, Bayer announced on Monday. Marketing authorization applications for the active substance are planned as soon as the data from the Oasis 3 study are available, which Bayer expects in the coming months. Nevertheless, the Leverkusen-based company is lagging far behind its Japanese competitor Astellas Pharma, which has been allowed to sell a comparable drug in the USA since May 2023.

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.

The Phase III studies Oasis 1 and 2 met all four primary endpoints and showed a statistically significant reduction in the frequency and severity of hot flushes compared to a placebo up to weeks 4 and 12, the Dax Group further announced. The secondary endpoints were also achieved: a statistically significant reduction in the frequency of hot flushes in week 1 as well as improvements in sleep disturbances and quality of life.

At the beginning of December, analyst Richard Vosser from the bank JPMorgan described a possible success in the trials as slightly positive for Bayer, as the drug is probably not yet included in the general market expectations in terms of sales development. However, Bayer would probably be one and a half years behind Astellas in the event of approval. According to Vosser, details on the comparative efficiency of elinzanetant are therefore important. Bayer intends to present such detailed results at medical conferences.

The sales launch of Astellas' rival drug Veozah was also rather sluggish. According to business figures from the beginning of November, the Japanese company generated 1.3 billion yen, the equivalent of 8.3 million euros, with the drug in the months following its market launch up to the end of September. Analyst Vosser believes that this makes it clear that elinzanetant will probably not be of particularly great economic significance for Bayer.

Bayer added elinzanetant to its development portfolio following the 2020 acquisition of the British biotech company Kandy Therapeutics. 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.

A year ago, Stefan Oelrich, head of Bayer's pharmaceutical division, announced that he expected peak sales of more than one billion euros for elinzanetant. This refers to the highest sales of a drug in one year. The commercial success of the drug could help Bayer to at least slightly reduce the revenue gap that is gradually opening up due to expiring patents for the billion-euro drugs Xarelto, a blood thinner, and Eylea, an eye medication./mis/he/men