BAYER TO PRESENT RIOCIGUAT DATA ON ATS MAY 17-MAY 22 (ENG)

     (The following press release from Bayer was received by e-mail. It was not 
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News-Release 
Not intended for U.S. and UK Media - The American Thoracic Society
International Conference 2013:
Bayer to Present Data on Pulmonary Hypertension Research at the ATS
International Conference 2013 in Philadelphia
Interim Analysis from Long-Term Extension Study PATENT-2 Phase III /
Hemodynamic data and clinical correlation from CHEST-1 Phase III / New Data
Sets from Pivotal PATENT-1 Phase III 
Berlin, May 8, 2013 - Bayer HealthCare announced today that new data on
treatments for patients with pulmonary hypertension will be presented at
the American Thoracic Society (ATS) International Conference 2013, May
17-22 in Philadelphia, USA. Within the official program of the ATS, these
data will be shared in oral presentations at a mini symposium dedicated to
pulmonary hypertension at the Pennsylvania Convention Center on May 20th.
The annual ATS International Conference brings together the latest
information on clinical, basic and translational science in pulmonary,
critical care and sleep medicine. 
The studies to be presented include the latest data on Bayer’s oral
investigational drug riociguat from the Pulmonary Arterial Hypertension
sGC-Stimulator Trial (PATENT) and Chronic Thromboembolic Pulmonary
Hypertension sGC-Stimulator Trial (CHEST) trial programs. 
"We are dedicated to promoting the scientific understanding of pulmonary
hypertension and are committed to developing new treatment options for
patients with this life-threatening condition", said Kemal Malik, MD, Head
of Global Development and Member of the Bayer HealthCare Executive
Committee. "We look forward to sharing new data from studies of our oral
investigational drug riociguat demonstrating robust safety and efficacy in
two pulmonary hypertension indications." 
The studies presented include: 
Hemodynamic Assessment Phase III CHEST-1 Clinical Trial Data:
Hemodynamic Assessment of Patients with Inoperable Chronic Thromboembolic
Pulmonary Hypertension (CTEPH) in the Phase III CHEST-1 Study
May 20th, 2013, 2:30 p.m. - 2:45 p.m., Abstract A3529 
Interaction Study PATENT PLUS Phase II Clinical Trial Data:
A Placebo-Controlled, Double-Blind Phase II Interaction Study to Evaluate
Blood Pressure Following Addition of Riociguat to Patients With Symptomatic
Pulmonary Aterial Hypertension (PAH) Receiving Sildenafil (PATENT PLUS)
May 20th, 2013, 2:45 p.m. - 3:00 p.m., Abstract A3530 
Interim Analysis PATENT-2 Phase III Clinical Trial Data:
Riociguat for the Treatment of Pulmonary Arterial Hypertension (PAH): A
Phase III Long-Term Extension Study (PATENT-2)
May 20th, 2013, 3 p.m. - 3.15 p.m., Abstract A3531 
Response to Treatment in PATENT-1 Phase III Clinical Trial Data:
Baseline Characteristics and Response to Treatment in Pretreated Versus
Treatment-Naïve Patients with Pulmonary Arterial Hypertension (PAH) in the
Phase III PATENT-1 Study
May 20th, 2013, 3:15 p.m. - 3:30 p.m., Abstract A3532 
Efficacy in the Subgroups of PATENT-1 Phase III Clinical Trial Data:
Efficacy of Riociguat in Pretreated Versus Treatment-Naïve Patients with
Pulmonary Arterial Hypertension (PAH) in the Phase III PATENT-1 Study
May 20th, 2013, 3:45 p.m. - 4:00 p.m., Abstract A3534 
All presentations will be held in Room 118 A-B-C (100 Level), Pennsylvania
Convention Center. 
At the beginning of February, Bayer HealthCare submitted riociguat, the
first drug to demonstrate efficacy in two distinct forms of pulmonary
hypertension (inoperable chronic thromboembolic pulmonary hypertension
(CTEPH) and pulmonary arterial hypertension (PAH) ) for regulatory approval
in the United States and in the European Union. In April, the U.S. Food and
Drug Administration (FDA) granted priority review to the New Drug
Application (NDA) in both indications. 
Riociguat was discovered by Bayer and represents the first member of a
novel class of compounds, the stimulators of soluble guanylate cyclase
(sGC). 
About Pulmonary Hypertension
Pulmonary hypertension (PH) is a severe, progressive and life-threatening
disorder in which the pressure in the pulmonary arteries is significantly
increased and which can lead to heart failure and death. Patients with PH
develop a markedly decreased exercise tolerance and 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 is essential as a delay in treatment initiation can
have a negative impact on survival. Continuous treatment monitoring is then
vital to ensure that patients are receiving optimal care for their
particular type and stage of disease. 
According to the clinical classification of PH (Dana Point), there are five
different types of PH based on underlying causes which are: pulmonary
arterial hypertension (PAH), pulmonary hypertension owing to left heart
disease (e.g. PH-LVD), pulmonary hypertension owing to lung disease and/or
hypoxemia (e.g. PH-COPD or PH-ILD), chronic thromboembolic pulmonary
hypertension (CTEPH) and pulmonary hypertension with unclear multifactorial
mechanisms. Currently available pharmacological treatments are only
approved to treat one of the five types of PH, pulmonary arterial
hypertension. As a result, there is a strong need for more research to
improve understanding of how all five types of PH can be treated
effectively. 
About Pulmonary Arterial Hypertension (PAH)
PAH is a rare but life-threatening disease in which the pressure in the
pulmonary arteries is above normal. PAH is characterized by morphological
changes to the endothelium of the arteries of the lungs causing remodeling
of the tissue, vasoconstriction and thrombosis-in-situ. As a result of
these changes, the blood vessels in the lungs are narrowed, making it
difficult for the heart to pump blood through to the lungs. PAH affects an
estimated 52 people per million globally. It is more prevalent in younger
women than men. In most cases, PAH has no known cause and, in some cases,
it can be inherited. 
Despite the availability of several approved therapies, the prognosis for
patients with PAH remains poor. 
About Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
CTEPH is a rare but life-threatening disease in which it is believed that
thromboembolic occlusion (blood clots) of pulmonary vessels gradually lead
to an increased pressure in the pulmonary arteries, resulting in an
overload of the right heart. CTEPH may evolve after prior episodes of acute
pulmonary embolism, but the pathogenesis is not yet completely understood.
The standard treatment for CTEPH is pulmonary endarterectomy (PEA), a
surgical procedure in which the blood vessels of the lungs are cleared of
clot and scar material. However, a considerable number of patients with
CTEPH are not operable and in some patients the disease persists or
reoccurs after PEA. Currently, there are no approved pharmacological
treatments available for CTEPH. 
About Riociguat
Riociguat (BAY 63-2521) is a soluble guanylate cyclase (sGC) stimulator,
the first member of a novel class of compounds being investigated as a new
and specific approach to treat different types of PH. sGC is an enzyme
found in the cardiopulmonary system 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 unique 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 NO
deficiency by restoring the NO-sGC-cGMP pathway, leading to increased
generation of cGMP. 
With its novel mode of action, Riociguat has the potential to overcome a
number of limitations of currently approved PAH therapies, including NO
dependence, and is the first drug which has shown clinical benefits in
CTEPH, where no pharmacological treatment is approved. 
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 18.6 billion (2012), 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 55,300 employees (Dec
31, 2012) and is represented in more than 100 countries. More information
at http://www.healthcare.bayer.com. 
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Find more information at http://www.bayerpharma.com. 
Forward-Looking Statements
This release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup 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 http://www.bayer.com. The
company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments. 
Contact:
Pharmaceuticals
Daniela Esser, Tel. +49 30 468-15805
E-Mail: mailto:daniela.esser@bayer.com 
This press release is available here:
http://www.baynews.bayer.de/baynews/baynews.nsf/id/2013-0248-e 
Yours BayNews Editorial Team 
Bayer AG
Communications
Building W11
51368 Leverkusen, Germany 
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