July 03, 2017

Not intended for U.S. and UK Media

Bayer starts Phase III study program with Vilaprisan in the treatment of symptomatic uterine fibroids

Berlin, July 3, 2017 - Bayer announced today that the first patient was
enrolled in a Phase III clinical study program ASTEROID which will investigate
vilaprisan in women suffering from uterine fibroids. Vilaprisan, discovered at
Bayer, is a novel oral, selective progesterone receptor modulator (SPRM) which
may allow for effective long-term treatment of uterine fibroids.

Uterine fibroids are the most common benign gynaecological tumors of women of
reproductive age. They are frequently characterised by heavy menstrual
bleeding, pain and bulk symptoms. Uterine fibroids are a leading cause of
hysterectomy (removal of the uterus) and their impact on a woman's life can be
significant. Approximately 5-10% of women of reproductive age have symptoms of
uterine fibroids and require treatment.

"Based on the promising results we have seen with vilaprisan in the Phase II
clinical study program, we are very excited about the start of the Phase III
trials that aims for a new symptom control for symptomatic uterine fibroids in
a long-term treatment option. While this condition impacts women in their
everyday life, current medical treatment options are not satisfactory," said Dr
Joerg Moeller, member of the Executive Committee of Bayer AG's Pharmaceutical
Division and Head of Development. "It is our ambitious goal that our research
efforts in this field result in a medical therapy that controls symptoms and
thereby significantly improves the quality of life for women with uterine
fibroids."

The planned ASTEROID Phase III clinical study program will include several
studies to investigate the efficacy and safety of vilaprisan 2mg in patients
with symptomatic uterine fibroids. The program aims at enrolling more than 3600
patients at about 900 centres in about 40 countries and it is anticipated that
it will take 3 years to complete the progam. Efficacy measures to be assessed
within the trial program will include the effect on heavy menstrual bleeding
(amenorrhea rate, controlled bleeding), reduction in fibroid size and
improvement in quality of life.

The design and dosing of the Phase III clinical study program was based on
results from the ASTEROID Phase II clinical study program (ASTEROID 1+2)
investigating vilaprisan in patients with symptomatic uterine fibroids.
ASTEROID 1 was a Phase IIb study that investigated the efficacy and safety of
four different doses of vilaprisan compared to placebo in patients with
symptomatic uterine fibroids; results were presented at the 72nd American
Society of Reproductive Medicine (ASRM) 2016 Scientific Congress & Expo in Salt
Lake City, UT, USA. ASTEROID 2 was a Phase IIb study that assessed the efficacy
and safety of vilaprisan in patients with symptomatic uterine fibroids compared
to placebo and ulipristal acetate (Esmya®). First results of ASTEROID 2 will be
presented at an upcoming scientific congress.

About Vilaprisan

Vilaprisan is a novel oral, highly potent and selective progesterone receptor
modulator (SPRM), which is currently in clinical development for the treatment
of symptomatic uterine fibroids as well as endometriosis. Modulation of the
progesterone receptor (PR) balances out the cycle-dependent, naturally
occurring hormonal fluctuations at the PR and inhibits activation of the
receptor via progesterone. As a result, menstrual bleeding is discontinued
leading to therapeutic amenorrhea (non-bleeding), a condition which can be
reversed with treatment cessation. Progesterone receptor modulation may allow
long-term treatment of uterine fibroids and endometriosis.

About Uterine Fibroids

Uterine fibroids (also known as leiomyomas or myomas) are the most common
benign gynaecological tumors of women of reproductive age. Approximately 5-10%
of women of reproductive age have symptoms of uterine fibroids and require
treatment. Fibroids consist of muscle cells and other tissues that grow in and
around the wall of the uterus, or womb. They are frequently characterised by
heavy menstrual bleeding, pain and bulk symptoms, and are a leading cause of
hysterectomy (removal of the uterus). The symptoms can range from mild to
severe and have the potential to impact a woman's day-to-day life. A
substantial proportion of women with symptomatic uterine fibroids experience
heavy menstrual bleeding (HMB), and/or prolonged menstruation, which can lead
to anemia, pelvic pressure and pain, as well as bladder, and reproductive
dysfunction. Uterine fibroids are among the leading causes of hospitalisation
for gynaecological disorders, and are a primary indication for hysterectomy.

About Gynecology at Bayer

Bayer is committed to delivering Science For A Better Life by advancing a
portfolio of innovative treatments. Women's health including family planning
and menopause management has been in the center of Bayer's gynecology franchise
for many years. 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. 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.

Bayer: Science For A Better Life

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 2016, the Group
employed around 115,200 people and had sales of EUR 46.8 billion. Capital
expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.7 billion.
These figures include those for the high-tech polymers business, which was
floated on the stock market as an independent company named Covestro on October
6, 2015. For more information, go to www.bayer.com.

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Forward-looking statements

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