Bayer's menopausal relief drug succeeds in late-stage trial

[January 08, 2024]  By Ludwig Burger

FRANKFURT (Reuters) - Bayer said its menopausal relief drug eased hot flashes and improved sleep in two late-stage trials, much-needed good news for the German group's pharmaceuticals unit that is reeling from a recent development setback.

Germany's Bayer said in a statement on Monday that its elinzanetant drug candidate met the main goal in two Phase III trials of reducing the frequency and severity of vasomotor symptoms, also known as hot flashes, in postmenopausal women.

The read-out marks a slight turn of fortune for embattled Bayer, which in November aborted a large late-stage trial testing a new anti-blood-clotting drug due to lack of efficacy, throwing its most promising development project into doubt.

Prior to the setback, Bayer had estimated the blood-thinning drug could have peak annual sales of more than 5 billion euros ($5.5 billion), while elinzanetant was given the potential of about a billion dollars or more per year. Among secondary trial goals, the drug was also shown to ease sleep disturbances and improve menopause-related quality of life. Further details of the trials would be presented at as yet undisclosed medical conferences, it added.

New Bayer CEO Bill Anderson is weighing options to break apart the maker of prescription drugs, consumer health products, crop chemicals and seeds, in a bid to revive a battered share price.

The 120 metres high Bayer Cross, logo of German pharmaceutical and chemical maker Bayer AG, consisting of 1710 LED glass bulbs is seen outside the industrial park "Chempark" of the chemical industry in Leverkusen, Germany, September 23, 2023. REUTERS/Wolfgang Rattay/ File photo

In the race for non-hormonal menopausal symptoms relief drugs, Bayer is behind Japan’s Astellas, which last year won U.S. and European approval for similar treatment Veoza, also known as fezolinetant.

Yet another similar compound, developed by Acer Therapeutics, failed to ease hot flashes in a mid-stage trial last year.

Bayer added that the results of a third Phase III study testing its elinzanetant are expected in the coming months and that it plans to submit data from all three trials to seek approval from health authorities thereafter.

($1 = 0.9106 euros)

(Reporting by Ludwig Burger in Frankfurt; Editing by Matthew Lewis)

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