With new data, Bayer readies rival to Astellas menopause drug

2024-03-19

并购临床3期

Dive Brief:

Bayer on Tuesday said it plans to seek regulatory approval of a drug for symptoms of menopause following positive results from a third Phase 3 trial.

The drug, dubbed elinzanetant, has already succeeded in two late-stage studies testing its ability to reduce the frequency of hot flashes and improve sleep in menopausal women with moderate-to-severe symptoms. The latest trial showed similarly supportive evidence of efficacy, as well as longer-term safety results.

Bayer intends to share the findings with global health authorities. If approved, it would compete with a similar, rival medicine from Astellas Pharma known as Veozah.

Dive Insight:

Unlike many of its pharmaceutical peers, Bayer has long maintained a presence in women’s health research, investment in which has become a focus of the Biden Administration. The company sells drugs for birth control and endometriosis, among other conditions, and has at times looked to business development to grow its portfolio.

One of those deals came in 2020, when Bayer bought a small biotechnology company called KaNDy Therapeutics for $425 million upfront. That acquisition gave Bayer the rights to elinzanetant, which has worked its way through clinical testing and is now on the verge of approval.

Bayer has since signaled a shift in its strategy, announcing last year it’d move away from women’s health and toward therapeutic areas such as rare diseases and immunology. That’s one of several changes underway under new CEO Bill Anderson, who is overhauling the company in response to sluggish performance.

Still, elinzanetant figures prominently in Bayer’s future plans. Earlier this month, the head of its pharmaceutical division, Stefan Oelrich, called elinzanetant a “potential blockbuster” in a presentation to investors, claiming the drug is “capable of transforming the way menopausal symptoms are treated.”

Bayer may have an uphill battle commercially, however. The drug will face competition from Veozah, which Astellas acquired in 2017 as part of an $850 million acquisition. Astellas has also struggled to sell the medication. Earlier this year, the company significantly cut Veozah’s sales forecasts for the 2023 fiscal year, citing lower-than-expected demand and issues with insurer reimbursement.

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