Bayer Starts Phase III Clinical Development Program OASIS With Investigational Product, Elinzanetant

Elinzanetant is a non-hormonal development compound investigated for the treatment of vasomotor symptoms during menopause

Bayer, a global leader in women’s healthcare, announced today that it started the Phase III clinical development program OASIS, which aims to evaluate the efficacy and safety of the investigational compound, elinzanetant for the treatment of vasomotor symptoms during menopause. elinzanetant is currently under development as a potential non-hormonal, once-daily, oral, dual neurokinin-1,3 receptor antagonist.

In September 2020, Bayer completed the acquisition of KaNDy Therapeutics Ltd., a UK clinical-stage biotech company, and fully integrated elinzanetant into its women’s healthcare development pipeline.

Vasomotor symptoms (hot flashes) are reported by up to 75% of women over the age of 50 at some point during the menopausal transition and the leading cause for seeking medical attention during this particular phase of a woman’s life.¹

“Based on the positive Phase II data, we are very pleased to now start the Phase III program with the investigational compound elinzanetant to help address vasomotor symptoms women experience during menopause. With our OASIS clinical development program, we are aiming to address an important unmet medical need in women,” said Yesmean Wahdan, Vice President of Medical Affairs for Bayer’s Women’s Healthcare. “Investing in new products for women’s health concerns reflects our “We’re For Her” mission and we are excited about this important milestone.”

The OASIS Phase III clinical development program is investigating the efficacy and safety of elinzanetant 120mg once daily in menopausal women with vasomotor symptoms. The program intends to enroll approximately 1,300 patients at more than 200 centers in over 20 countries.

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. Results have been presented at the 2020 virtual annual meeting of the North American Menopause Society (NAMS).

About Menopause

By 2030, the world population of menopausal and postmenopausal women is projected to increase to 1.2 billion, with 47 million new entrants each year.² Menopause marks the end of a women’s reproductive life, occurring in their late 40s or early 50s.² The decline in hormone production by the ovaries can lead to various symptoms, during the menopausal transition, including hot flashes, sleep disturbances and mood changes.² With increased longevity, menopause management is of growing importance.

About Elinzanetant

Elinzanetant is an orally administered investigational small molecule dual antagonist of both the neurokinin-1 and 3 receptors and is believed to address vasomotor symptoms by modulating a group of estrogen sensitive neurons in the hypothalamus in the brain, the kisspeptin/neurokinin B/dynorphin (KNDy) neurons that in menopausal women due to the absence of estrogen, become hyperactive and consequently disrupt body heat control mechanisms.

About Women’s Healthcare at Bayer

Bayer is a recognized leader in the area of 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. Today, Bayer’s research and development efforts focus on finding new treatment options for menopause as well as gynecological diseases and includes several compounds in various stages of pre-clinical and clinical development. Together, these projects reflect the company’s approach to research, which prioritizes targets and pathways with the potential to alter the way that gynecological diseases are treated. Additionally, Bayer intends to provide 100 million women 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 planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate 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 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 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.

¹ Menopause: The Journal of The North American Menopause Society Vol. 27, No. 5, pp. 498-505

² Reference: Hill, Maturitas 1996 Mar;23(2):113-27. doi: 10.1016/0378-5122(95)00968-x.”

PP-PF-WHC-US-0382- 1 August 2021

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Bayer starts Phase III development with investigative non-hormonal treatment option for vasomotor symptoms during menopause