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The following news item has been released:
Not intended for U.S. and UK Media
Bayer Submits Investigational Drug Riociguat for Patients with Chronic
Thromboembolic Pulmonary Hypertension for Regulatory Approval in Japan
Berlin, May 17, 2013 - Bayer HealthCare has filed the oral investigational
drug riociguat for the treatment of chronic thromboembolic pulmonary
hypertension (CTEPH) for regulatory approval in Japan. CTEPH is a
progressive and life-threatening disease in which it is believed that blood
clots of pulmonary vessels gradually lead to an increased pressure in the
pulmonary arteries, resulting in an overload of the right heart.
"To date, there is no pharmacological treatment available for CTEPH. There
is an urgent unmet medical need for patients for whom surgery is not a
viable treatment option or whose disease persists or is recurrent after
surgery," said Kemal Malik, member of the Bayer HealthCare Executive
Committee and Head of Global Development. "We hope to be able to bring
riociguat to doctors and patients of this life-threatening disease in Japan
Riociguat is the first drug therapy that has shown clinical efficacy in the
treatment of inoperable CTEPH patients, or patients with persistent or
recurrent CTEPH after surgery. The submission is supported by data from the
randomized, double-blind, placebo-controlled pivotal, global Phase III
study CHEST-1. Results of the study were presented at the 2012 annual
meeting of the American College of Chest Physicians (ACCP) in Atlanta, USA.
Within CHEST-1 the primary endpoint, a change in exercise capacity, was
reached after 16 weeks: Compared to placebo, patients treated with
riociguat showed a statistically significant improvement (p<0.0001) from
baseline in the six-minute walk test (6MWT) after this time frame.
Riociguat was generally well tolerated, with a good safety profile.
Bayer HealthCare announced positive results of an interim analysis of the
on-going CHEST-2 trial, the open-label long-term extension of the pivotal
Phase III study CHEST-1 with riociguat at the 5th World Symposium of
Pulmonary Hypertension (WSPH) in Nice, France. The interim analysis shows
long-term safety and sustained clinical benefits in patients with
At the beginning of February, Bayer HealthCare submitted riociguat, the
first drug to demonstrate efficacy in two distinct forms of pulmonary
hypertension, namely inoperable 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
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
About Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
CTEPH is a rare and 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.
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
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
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