(new: Analysts' comments from Barclays and JPMorgan, statements by Bayer's pharmaceuticals chief)

BERLIN (dpa-AFX) - Bayer believes it is on course for a 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 well behind its Japanese competitor Astellas Pharma, which has been allowed to sell a comparable drug in the USA since May 2023.

The Bayer share price closed almost unchanged at the start of the week. The news was positive, but also expected, said analyst Emily Field from UK-based Barclays Bank.

If approved, elinzanetant would be an alternative for women who do not like hormone replacement therapy or cannot 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.

In an initial reaction, analyst Richard Vosser from the bank JPMorgan assessed the results as slightly positive. Nevertheless, details on efficiency are needed in order to be able to estimate the possible sales potential. In addition, a competing product is already on the market.

The US sales launch of the rival drug Veozah from the pharmaceutical company Astellas Pharma 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.

One reason could still be uncertainties about reimbursements by health insurers in the USA. With a view to a possible approval of elinzanetant, Bayer's pharmaceuticals boss Stefan Oelrich sees a good chance that it will become a reimbursable product in the USA, as he said in an interview with the financial news agency dpa-AFX. With regard to China, he also sees quite good chances, but for Europe it is uncertain. Nevertheless, Oelrich still believes that the product will become a blockbuster. This means a peak annual turnover of more than one billion euros.

Bayer added elinzanetant 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.

As Bayer announced on Monday, the clinical development program for elinzanetant is also being expanded. The phase II study Nirvana is intended to clarify efficacy and safety in women with menopausal sleep disorders.

A 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/he