CHEST-2 STUDY SUPPORTS BENEFITS OF BAYER’S RIOCIGUAT (ENG)

     (The following press release from Bayer was received by e-mail. It was not 
confirmed by the sender.) 
Not intended for U.S. and UK Media - Long-term extension study of Riociguat
in patients with CTEPH:
Interim results from CHEST-2 study support benefits of Bayer’s Riociguat as
demonstrated in Phase III CHEST-1 study
Riociguat showed significant and sustained improvements in six minute
walking distance (6MWD) and WHO functional class (FC) in patients with
inoperable or residual chronic thromboembolic pulmonary hypertension
(CTEPH) (1) / Riociguat showed good long-term safety profile (1) 
Berlin, March 4, 2013 - Bayer HealthCare today announced positive data from
the interim analysis of the on-going CHEST-2 trial with riociguat, the
open-label long-term extension of the pivotal Phase III study CHEST-1, at
the 5th World Symposium of Pulmonary Hypertension (WSPH) in Nice, France.
The results of the CHEST-2 trial support the positive data of the pivotal
CHEST-1 trial, showing long-term safety and sustained clinical benefits in
patients with inoperable chronic thromboembolic pulmonary hypertension
(CTEPH) or with persistent or recurrent CTEPH after a surgical procedure
called pulmonary endarterectomy (PEA).(1) 
In the first interim analysis in CHEST-2, riociguat was shown to be well
tolerated with a good long-term safety profile in patients with CTEPH. The
most frequent drug-related adverse events were dizziness, dyspepsia and
hypotension.(1) 
After 12 weeks in CHEST-2, the six minute walking distance (6MWD) had
increased by 63 meters in former riociguat patients and 35 meters in former
placebo patients compared with baseline of the pivotal CHEST-1 trial. Also
WHO functional class (FC) had improved in both patient groups. Sustained
effects in 6MWD and WHO FC have been observed in a cohort of patients that
had reached one year of study treatment.(1) 
The lead author for the presentation of the data at the WSPH was Gérald
Simonneau, Professor of Pneumology and Head of the Department of Pulmonary
Disease at Hôpital Bicêtre, Le Kremlin-Bicêtre, University Paris-Sud,
France. 
"The interim results of CHEST-2 support the benefits of riociguat that were
seen in the CHEST-1 trial and we are confident that, together, these
results reinforce the role of riociguat, if approved, in treating this
life-threatening disease for which no approved drug treatment is
available," said Kemal Malik, member of the Bayer HealthCare Executive
Committee and Head of Global Development. 
About CHEST-2 interim results
CHEST-2 is the open-label long-term extension trial of the multi-center,
multi-national CHEST Phase III study program currently being conducted in
26 countries. In the randomized, double-blinded, placebo controlled pivotal
CHEST-1 trial, patients with inoperable CTEPH, or persistent or recurrent
CTEPH after surgery received over 16 weeks either placebo or riociguat.(2)
Approximately 90% of patients from CHEST-1 entered the CHEST-2 trial which
aimed to investigate the longer term safety profile of riociguat in CTEPH
patients as primary outcome. In addition the sustainability of the efficacy
results of CHEST-1 including 6MWD and WHO FC were measured as secondary
outcomes. 
The first interim analysis in CHEST-2 showed that riociguat was
well-tolerated with a good long-term safety profile in patients with
inoperable CTEPH and in those with persistent or recurrent disease after
PEA. Adverse events were reported in 173 (89%) of patients during CHEST-2,
of which 83 (43%) patients developed drug -related adverse events.The most
frequent drug-related adverse events (>5%) were dizziness (8%), dyspepsia
(7%) and hypotension (6%). Serious adverse events were reported by 59 (30%)
patients, of which eight (4%) were considered drug related by the
investigator.(1) 
After 12 weeks in CHEST-2, the 6MWD had increased by 63 meters (former
riociguat) and 35 meters (former placebo) against CHEST-1 baseline. In the
cohort of patients that have reached one year of study treatment the
increase in 6MWD was 48 meters compared with CHEST-1 baseline.(1) However,
this promising result must be interpreted with caution until the complete
1-year data set for the overall population in CHEST-2 is available. 
After 12 weeks in CHEST-2, improvement in WHO FC was observed in 41% and 38
% of former ricoguat and former placebo groups respectively. In the cohort
of patients that have reached one year of study treatment, WHO FC had
improved in 51%, stabilized in 47% and worsened in 2% of patients compared
with CHEST-1 baseline.(1) Again, this promising result must be interpreted
with caution until the complete 1-year data set for the overall patient
population is available. 
Improvements in 6MWD and WHO FC were seen consistently in both subgroups of
inoperable CTEPH patients and those with persistent or recurrent CTEPH
after PEA.(1) 
At one year, 97% of patients in CHEST-2 were still alive and 87% were free
from clinical worsening.(1) 
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 an oral agent being investigated as a new
approach to treating different types of pulmonary hypertension. Riociguat
is the first member of a novel class of compounds, the stimulators of
soluble guanylate cyclase (sGC).(3) sGC is an enzyme found in the
cardiopulmonary system. When nitric oxide (NO) binds to sGC, the enzyme
catalyzes synthesis of the signaling molecule cyclic guanosine
monophosphate (cGMP). cGMP plays an important role in regulating vascular
tone, proliferation, fibrosis, and inflammation.(3) 
Pulmonary hypertension is associated with endothelial dysfunction, impaired
synthesis of NO and thus insufficient stimulation of the NO-sGC-cGMP
pathway. Riociguat is believed to have a dual mode of action: sensitizing
sGC to endogenous NO and also directly stimulating sGC independent of
NO.(4) 
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. 
Our online press service is just a click away:
http://press.healthcare.bayer.com
More information about CTEPH, its diagnosis and management can be found at:
http://www.CTEPH.co 
http://www.epresspack.net/bayer-riociguat 
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. 
------------ 
(1) Simonneau G et al.Riociguat for the treatment of chronic thromboembolic
pulmonary hypertension (CTEPH): A Phase III long-term extension study
(CHEST-2). 5th World Symposium of Pulmonary Hypertension (WSPH) 2013, Nice,
France. Poster Presentation.
(2) Ghofrani, HA. et al. Riociguat for the treatment of inoperable chronic
thromboembolic pulmonary hypertension: a randomized, double-blind,
placebo-controlled study (CHEST-1). ACCP 2012, Atlanta, USA. Oral abstract
1462924.
(3) Ghofrani, HA. et al. Riociguat for pulmonary hypertension. Furture
Cardiol. 2010;6(10):155-166.
(4) Schermuly, R et al. Riociguat for the treatment of pulmonary
hypertension. Expert Opin Investig Drugs. 2011 Apr;20(4):567-76. 
This press release is available here:
http://www.baynews.bayer.de/baynews/baynews.nsf/id/2013-0143-e 
Yours BayNews Editorial Team 
Bayer AG
Communications
Building W11
51368 Leverkusen, Germany 
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