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• Real-world evidence (RWE) research results on treatment utilization and pathways in women with menopausal symptoms via poster presentations on the CHAPTER natural menopause study, CHAPTER i-menopause study and REALISE study
• These poster presentations reinforce Bayer’s leadership and commitment to understanding and advancing women’s healthcare specifically for those who are experiencing menopause symptoms

Bayer will present the latest RWE research results which focuses on treatment utilization and pathways in women with menopausal symptoms at the upcoming Menopause Society Annual Meeting (formerly The North American Menopause Society). The Menopause Society Annual Meeting takes place from September 27 – 30, in Philadelphia, Pennsylvania, USA.

Key Highlights of Bayer’s presentations at The Menopause Society annual meeting 2023 are:

REALISE iVMS: What do women with breast cancer take for menopause symptoms? A real-world analysis of treatment utilization from the US and Europe

• Approximately 20% of women with vasomotor symptoms (VMS) induced by breast cancer treatment received hormonal therapy (HT).
• Regardless of severity of symptoms, women were prescribed HT at similar rates for their VMS.
• Evidence of HT prescribing, despite contraindications, suggests clinicians are seeking treatment options (indicating significant symptom burden) and an unmet need for non-HT options.

CHAPTER natural menopause: Characterizing treatment pathways for natural menopausal symptoms in US women

• Two-thirds of natural menopausal women did not receive treatment for menopausal symptoms, which might suggest undertreatment in this population.
• Paroxetine was prescribed to fewer women than other non-hormonal therapies , despite being the only non-HT approved for VMS in the US.
• Benzodiazepines were highly prescribed suggesting an unmet need for treatments for the management of menopause-associated sleep and mood disturbances.

CHAPTER i-menopause: Characterizing treatment pathways for endocrine therapy (ET)-related menopausal symptoms in US

• Only one-third of women initiating ET for breast cancer or high breast cancer risk received treatment for menopausal symptoms, which might suggest symptoms often go unrecognized and untreated.
• Benzodiazepines were the most common treatment prescribed, reflecting a requirement for management of menopause-associated sleep and mood disturbances.
• Despite being contraindicated, HT was prescribed to approximately 15% of women, suggesting an unmet need for effective, long-term non-HT management options for ET-related menopausal symptoms.

The research presented showcases the commitment of Bayer as a leader in women’s healthcare to broaden therapeutic choices and to increase awareness and education around menopausal symptoms. Additionally, as part of this commitment, the company is investigating new approaches, including elinzanetant, a late-stage investigational drug with a data readout expected in late 2023.

The official poster session will be held on Thursday, September 28, from 6:15 PM to 7:15 PM EST.

About Vasomotor Symptoms

Vasomotor symptoms (VMS; also referred to as hot flashes) are a result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons due to withdrawal of estradiol, which can result from progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.

VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.

Vasomotor symptoms may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. There are currently no treatment options available for these women.

About Menopause

By 2030, the world population of women in the menopause phase is projected to increase to 1.2 billion, with 47 million new entrants each year. Menopause is a natural phase in women’s lives, related to progressive decline of ovarian function, which usually occurs in women in their late 40s or early 50s. It can also be the result of surgical or medical treatment, for example for breast cancer. The decline in hormone production by the ovaries can lead to various symptoms, which can dramatically affect a woman’s health, quality of life, consumption of healthcare and work productivity. The most frequently reported and bothersome symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. For this reason, maintaining functional ability and quality of life is extremely relevant from both a healthcare and socio-economic perspective.

About Elinzanetant

Elinzanetant is an investigational, first, non-hormonal, orally administered, selective neurokinin-1,3 receptor antagonist currently in clinical development for the treatment of vasomotor symptoms (hot flashes) associated with menopause. Elinzanetant seeks to address vasomotor symptoms by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons), that due to the absence of estrogen, become hyperactive in menopausal women and consequently disrupt body heat control mechanisms resulting in hot flashes.

The clinical Phase III development program with elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. The OASIS 1,2 and 3 investigate the efficacy and safety of elinzanetant in women with vasomotor symptoms associated with menopause. The OASIS 4 study is an expansion of the clinical phase III program and investigates the efficacy and safety of elinzanetant in women with vasomotor symptoms by endocrine therapy for treatment or prevention of breast cancer.

The design and dosing of the Phase III clinical development program is based on the positive data from two Phase II studies (RELENT-1 and SWITCH-1). RELENT-1 was a Phase Ib/IIa study investigating the safety, pharmacokinetics and preliminary efficacy of elinzanetant. SWITCH-1 was a Phase IIb study, which investigated the efficacy and safety of four different doses of elinzanetant compared to placebo in patients with vasomotor symptoms. Full results of the study have been published in March 2023 in Menopause - The Journal of the Menopause Society (formerly the North American Menopause Society) and are available at: https://doi.org/10.1210/jendso/bvaa046.2071.

About Women’s Healthcare at Bayer

Bayer is a global leader in women’s healthcare with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

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Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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