December 20, 2018
Not intended for U.S. and UK Media

Bayer receives approval in China for endometriosis treatment Visanne™

Berlin, December 20, 2018 - Bayer announced today that Visanne™ has been approved by the Chinese regulatory authorities for the treatment of endometriosis. Visanne is a once-daily oral tablet containing dienogest 2 mg that has been developed specifically for the treatment of this chronic gynecological disease. A number of international clinical studies have proven that Visanne relieves endometriosis pain with high efficacy, reduces endometriosis lesions and demonstrates a favorable safety and tolerability profile.

For Bayer this is the fourth product approval in China within the last 12 months, following approvals for Eylea™ in two indications and for Kovaltry™.

"With this approval we will be able to offer women in China a treatment option which can reduce the substantial burden of endometriosis," said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development. "Currently women often need to use different combinations of the available treatment options which are not approved for long-term use or in some cases even repeatedly undergo surgical procedures. Visanne has the potential to help women with this chronic disease as it has proven its suitability for long-term use in clinical studies."

The symptoms of endometriosis, which include severe menstrual cramps, painful intercourse, painful urination or bowel movements, and lower back or abdominal pain, take a toll on a woman's emotional and overall quality of life.

Outside of China, Visanne has been approved in more than 70 countries - amongst them Canada as well as countries in Europe and Asia.


About Endometriosis
Endometriosis is a chronic estrogen-dependent gynecological disease defined by the presence of endometrium-like tissue outside the uterus, which induces a chronic, inflammatory reaction. The endometrium is a layer of mucous tissue, which lines the uterus cavity and undergoes hormone-dependent changes during the menstrual cycle. Endometriosis is a common disease among women of reproductive age. The prevalence is estimated to be up to 10% in women of childbearing age worldwide. Lower abdominal and pelvic pain, cramping menstrual pains (dysmenorrhea), painful sexual intercourse (dyspareunia) and infertility are well recognized symptoms of endometriosis.

About Gynecology at Bayer
Bayer's gynecological franchise has focused for many years on how to improve women's health. Today, our research efforts focus on finding new treatment options for gynecological diseases with a high medical need such as uterine fibroids and endometriosis, which affect a large number of women in our society. The gynecology pipeline at Bayer includes several investigational compounds in various stages of preclinical and clinical development.

About Bayer
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2017, the Group employed around 99,800 people and had sales of EUR 35.0 billion. Capital expenditures amounted to EUR 2.4 billion, R&D expenses to EUR 4.5 billion. 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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