Bayer reveals key data to compete with Astellas in menopause market

Bayer is making significant strides with its OASIS program, which shows promise in the menopause treatment market. The German pharmaceutical giant has unveiled phase 3 data suggesting its drug, elinzanetant, could potentially compete with Astellas' recently approved Veozah. The data come from the OASIS 1 and 2 studies, which were successfully reported earlier this year, although the details were initially withheld.

The company presented this critical data at the 2024 American College of Obstetricians and Gynecologists annual meeting, focusing on the drug’s efficacy in reducing the severity and frequency of hot flashes over four and twelve weeks of daily oral doses. In the OASIS 1 study, Bayer reported a mean reduction in hot flash frequency by 3.29 at Week 4 and 3.22 at Week 12, compared to placebo. Similarly, in OASIS 2, the reductions were 3.04 at Week 4 and 3.24 at Week 12.

Astellas' Veozah had previously gained approval based on phase 3 trials that demonstrated placebo-adjusted reductions in hot flash frequency of 2.1 and 2.6 at Week 4, and 2.6 and 2.5 at Week 12. While comparing across different clinical trials can sometimes be misleading, the available data indicate that Bayer's elinzanetant could hold its own in the market.

For hot flash severity, Bayer’s data showed reductions versus placebo of 0.33 at Week 4 and 0.40 at Week 12 in OASIS 1, and 0.22 at Week 4 and 0.28 at Week 12 in OASIS 2. Astellas' Veozah reported reductions in severity of 0.2 and 0.3 at both Week 4 and Week 12, suggesting both drugs are comparable in efficacy.

Elinzanetant may have an advantage in treating sleep disturbances associated with menopause, which could distinguish it from Veozah. Unlike Veozah, which targets the neurokinin-3 (NK-3) receptor, elinzanetant acts on both NK-3 and NK-1 receptors. Research indicates that the NK-1 receptor might influence insomnia and mood disorders unrelated to menopause, and Bayer has reported significant improvements in sleep quality and overall menopause-related quality of life in their trials. Astellas has also shown positive results regarding sleep, but Bayer's dual mechanism could offer enhanced benefits.

With these positive results from three phase 3 trials, Bayer is gearing up to seek approval for elinzanetant. Bayer CEO Bill Anderson indicated that preparations to obtain market authorizations are progressing vigorously. This development is crucial for Bayer as it looks to strengthen its late-phase pipeline, especially in light of expected generic competition for its existing drugs, Eylea and Xarelto.

The move to file for approval of elinzanetant represents a strategic effort by Bayer to diversify and reinforce its product portfolio. Elinzanetant, acquired through Bayer's purchase of KaNDy Therapeutics, is positioned to be a key player in the menopause treatment market, potentially providing another option for women dealing with the challenging symptoms of menopause.

Overall, Bayer's continued advancements and strategic filings highlight their commitment to addressing unmet needs in women's health, potentially offering new hope and improved quality of life for those experiencing menopause.