February 20, 2015
Not intended for U.S. and UK Media

Adempas® Approved in Japan for the Treatment of Pulmonary Arterial Hypertension

Adempas® is the first drug to be approved in Japan for the treatment of two forms of pulmonary hypertension, a progressive, life-threatening disorder of the lungs and heart
Berlin, February 20, 2015 - Adempas® (riociguat) has received approval for the
treatment of patients with pulmonary arterial hypertension (PAH) by the
Ministry of Health, Labour and Welfare (MHLW) in Japan. Following the approval
of Adempas in January 2014 for the treatment of inoperable chronic
thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH
after surgery, Adempas is now the first drug approved in Japan to treat two
forms of pulmonary hypertension (PH). The development and commercialization of
riociguat is part of the worldwide strategic collaboration with Merck (through
a subsidiary) in the field of soluble guanylate cyclase (sGC) modulation. Merck
is known as MSD outside of the U.S. and Canada.

"PAH is a rare disease that usually presents with symptoms such as
breathlessness, dizziness and fainting. It severely impacts patients' daily
lives, and if untreated, PAH may be fatal," said Norifumi Nakanishi, M.D.,
Ph.D., Director of Endowed Department of Pulmonary Hypertension and Pulmonary
Vascular Medicine, National Cerebral and Cardiovascular Center Research
Institute, Osaka, Japan. "Physicians have been awaiting the approval of Adempas
in PAH as an additional indication. With its novel mode of action, we expect
Adempas may improve the symptoms of many patients with PAH whose prognosis has
remained poor despite the availability of several approved PAH therapies."

"In the pivotal PATENT-1 Phase III trial, riociguat demonstrated significant
clinical efficacy across multiple clinically relevant endpoints in patients
with PAH, either as a monotherapy or in combination with certain other
medicines used to treat PAH, such as endothelin receptor antagonists (ERAs) or
prostanoids," said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive
Committee and Head of Global Development. "Riociguat is an important new
treatment option for patients with PAH."

The approval of Adempas is based on results from the randomized, double-blind,
placebo-controlled, global Phase III study PATENT-1 as well as long-term data
from PATENT-2 available at the time. These assessed the efficacy and safety of
oral riociguat in the treatment of PAH. Results of PATENT-1 were published in
the New England Journal of Medicine (NEJM) in July 2013. One-year data from the
open-label long-term extension study PATENT-2 published in the European
Respiratory Journal demonstrate that the significant improvement in exercise
capacity was further improved, whilst the safety profile was sustained and
confirmed. An analysis of the PATENT-2 two-year data cut-off confirmed the
sustained improvements in patients with PAH after two years of treatment with

About Pulmonary Hypertension

Pulmonary hypertension (PH) is a severe, progressive, life-changing and
life-threatening disorder of the lungs and heart in which the blood pressure in
the pulmonary arteries is above normal, and which can lead to right heart
failure and death. People with PH develop a markedly decreased exercise
capacity and a reduced quality of life. The most common symptoms of PH include
shortness of breath, fatigue, dizziness and fainting, all of which are worsened
by exertion. As the symptoms of PH are non-specific, diagnosis can be delayed
by as much as two years. Early diagnosis and accurate identification of the PH
types are essential as a delay in treatment initiation of even a few months can
have a negative impact on survival. Continuous treatment monitoring by a PH
specialist is vital to ensure that patients are receiving optimal care for
their particular type and stage of disease.

There are five different types of PH; each can affect the patient in a
different way and every patient may have a different etiology of PH. For the
best chance of success patients need to be treated at a PH specialist center.

About Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH), one of the five types of PH, is a
progressive and life-threatening disease in which the blood pressure in the
pulmonary arteries is significantly increased due to vasoconstriction and which
can lead to right heart failure and death. PAH is characterized by
morphological changes to the endothelium of the arteries of the lungs causing
remodeling of the tissue and vasoconstriction. As a result of these changes,
the blood vessels in the lungs constrict, making it more difficult for the
heart to pump blood through to the lungs. PAH is a rare disease and affects an
estimated 15-52 people per million globally. It is more prevalent in women than
men. In most cases, PAH has no known cause, though it can sometimes be

In spite of several pharmacological treatment options for PAH having been
available for over a decade, the prognosis for these patients has remained
poor, resulting in the need for effective alternative treatment options.
Currently, mortality of PAH patients remains high and is still 15% at 1 year
and 32% at 3 years after diagnosis.

About Riociguat

Riociguat is a soluble guanylate cyclase (sGC) stimulator, the first member of
a distinct class of compounds discovered and developed by Bayer as an oral
treatment to target a key molecular mechanism underlying PH. Riociguat is being
investigated as a new and specific approach to treat different types of PH. sGC
is an enzyme found in the endothelial cells and the receptor for nitric oxide
(NO). When NO binds to sGC, the enzyme enhances synthesis of the signaling
molecule cyclic guanosine monophosphate (cGMP). cGMP plays an important role in
regulating vascular tone, proliferation, fibrosis, and inflammation.

PH is associated with endothelial dysfunction, impaired synthesis of NO and
insufficient stimulation of sGC. Riociguat has a dual mode of action - it
sensitizes sGC to endogenous NO by stabilizing the NO-sGC binding. Riociguat
also directly stimulates sGC via a different binding site, independently of NO.
Riociguat, as a stimulator of sGC, addresses the issue of NO deficiency by
restoring the NO-sGC-cGMP pathway, leading to increased generation of cGMP.

With its distinct mode of action, riociguat has the potential to overcome a
number of limitations of other approved therapies for PAH, including NO
dependence, and is the first drug which has shown clinical benefits in patients
with inoperable CTEPH or persistent or recurrent CTEPH after surgery, where
until the approval of riociguat no approved pharmacologic treatment was

Riociguat was approved under the name Adempas® in the US for use in inoperable
CTEPH or persistent or recurrent CTEPH after surgery and in PAH in October
2013. In the EU and US, riociguat has been granted orphan drug designation and
was approved by the European Medicines Agency (EMA) under the name Adempas® for
use in CTEPH and PAH in March 2014. In Japan, riociguat has been granted orphan
drug designation in the CTEPH indication and was approved in CTEPH in January

Since October 2014, the worldwide strategic collaboration with Merck & Co.,
Inc. (known as MSD outside of the U.S. and Canada) in the field of sGC
modulators brings together the two leading companies in this field, who both
have the stated intent to make full use of this promising novel class of
compounds and the potential it holds for the benefit of patients. Riociguat,
the first sGC stimulator approved and made available to patients, is the first
product which is part of this collaboration.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of
health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup
of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world's
leading, innovative companies in the healthcare and medical products industry
and is based in Leverkusen, Germany. The company combines the global activities
of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals
divisions. Bayer HealthCare's aim is to discover, develop, manufacture and
market products that will improve human and animal health worldwide. Bayer
HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is
represented in more than 100 countries. More information is available at

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