Adempas® now approved for second rare heart and lung disease, offering a new
treatment option to improve patient care
-- Bayer's Adempas (riociguat tablets) approved for the treatment
of pulmonary arterial hypertension (PAH)(1), which affects up
to 2000 Canadians(2)
-- Adempas provides novel and specific approach to treat different
types of pulmonary hypertension (PH), a serious condition of
the heart and lungs
-- Only drug in Canada indicated to treat two rare types of PH -
PAH and chronic thromboembolic pulmonary hypertension (CTEPH)
TORONTO, March 10, 2014 /CNW/ - Bayer Inc. announced today the approval of
Adempas® (riociguat tablets) for treating patients with a form of heart and
lung disease called pulmonary arterial hypertension (PAH).(1 )Adempas is
currently the only treatment approved for use in two rare types of pulmonary
hypertension (PH) - PAH and chronic thromboembolic pulmonary hypertension
PAH is a rare form of PH, a severe, progressive and life-threatening heart and
lung condition affecting up to 2000 Canadians.(2 )Patients with PH develop
high blood pressure in the arteries of the lungs, which causes breathlessness
and fatigue, hindering their ability to work and carry out everyday
activities, like walking - even a short distance - in some cases.(6,7,8,9,10)
"It is important to have effective options to treat complex and rare diseases
like pulmonary hypertension. Adempas provides us with a novel treatment option
for patients that has a proven efficacy and safety profile," said Dr. David
Langleben, Cardiology Division, Jewish General Hospital and Director, Centre
for Pulmonary Vascular Disease. He added, "Adempas also introduces a new class
of drugs to the market, providing progress in the treatment of a disease that
continues to see high mortality rates."
Prognosis for patients suffering from PAH is poor despite the availability of
three other classes of approved PAH therapies.(11,12) Mortality rates remain
high at 15% within one year of diagnosis, while one third (32%) of patients
die within three years of diagnosis.(11 )
In a pivotal trial (PATENT), Adempas demonstrated statistically significant
efficacy in the treatment of PAH, taken alone or in combination with other PAH
therapies. Adempas showed improvements in exercise capacity, in a range of
disease related symptoms, in the speed of disease progression and in markers
of disease severity.(5)
"We are pleased that patients will have another option to manage this
devastating and rare disease. As new therapies come to market, it is paramount
that we also ensure patients have access to these life-saving medicines," said
Roberta Massender, Vice-Chair of the Pulmonary Hypertension Association of
Canada and President of the British Colombia Pulmonary Hypertension Society.
Results from another major clinical trial (CHEST) showed that Adempas is the
first ever drug to provide statistically significant clinical improvement in
patients with inoperable CTEPH or persistent or recurrent CTEPH after surgical
treatment at the end of 16 weeks of treatment. Improvements were seen in a
range of disease-related measures such as reduction in patients' resistance to
blood flow in the arteries of the lungs, and in markers of disease severity.(4
)Adempas also significantly improved exercise capacity measured by a
six-minute walk distance (6MWD).(4 )
Long-term trials of Adempas in PAH and CTEPH are ongoing, and interim results
show that safety and tolerability as well as efficacy (change in 6MWD) are
sustained over one year.(13,14)
About Pulmonary Hypertension (PH) PH is a severe, progressive, life-changing
and life-threatening disorder of the heart and lungs in which blood pressure
in the pulmonary arteries is above normal, and which can lead to heart failure
and death.(6,7 )Patients with PH develop a markedly decreased exercise
capacity and a reduced quality of life.(10 )The most common symptoms of PH
include shortness of breath, fatigue, dizziness and fainting, all of which are
worsened by exertion.(8,9 )As the symptoms of PH are non-specific, diagnosis
can be delayed by as much as two years.(10,15,16) Early diagnosis and accurate
identification of the PH category is essential as a delay in treatment
initiation can have a negative impact on survival.(10,17) Continuous treatment
monitoring is vital to ensure that patients receive optimal care for their
particular PH category and stage of disease.(10 )
There are five different PH categories and each can affect the patient in a
different way. Every patient may have a different etiology and manifestation
of PH.(10,18,15) For the best chance of success, patients need to be treated
at an expert PH centre.10,19 In Canada, there are 15 recognized expert PH
centres across the country.(20)
About Pulmonary Arterial Hypertension (PAH) PAH, one of the five categories 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 heart failure and death.(6,10 )PAH is characterized by
morphological changes to the endothelium of the artery of the lungs causing
remodeling of the tissue and vasoconstriction. 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.(6,7 )PAH is a rare disease and affects an
estimated 15 to 52 people per million.(6,7,2 )It is more prevalent in younger
women than men.(2 )In most cases, PAH has no known cause and, in some cases,
it can be inherited.(9,2 )
In spite of several pharmacological treatment options for PAH having been
available for over a decade, the prognosis for these patients has remained
poor and new treatment options are needed. Currently, mortality of PAH
patients remains high and is still 15% within one year of diagnosis and 32%
within three years of diagnosis.(11 )
About Chronic Thromboembolic Pulmonary Hypertension (CTEPH) CTEPH is a rare,
progressive and life-threatening disease and a category of PH in which it is
believed that thromboembolic occlusion (organized blood clots) of pulmonary
vessels gradually lead to increased blood pressure in the pulmonary arteries,
resulting in an overload of the right heart.(10,18 )
CTEPH may evolve after prior episodes of acute pulmonary embolism, but the
mechanism is not yet completely understood.(18 )The standard and potentially
curative treatment for CTEPH is pulmonary endarterectomy (PEA), a surgical
procedure in which the blood vessels of the lungs are cleared of clot and scar
tissue.(18 )However, a considerable number of patients with CTEPH (20%-50%)
are inoperable and in up to 35% of patients, the disease persists or recurs
after PEA.(18,21,22 )These patients need an effective pharmacological
About Adempas® Adempas (riociguat) is a soluble guanylate cyclase (sGC)
stimulator, the first member of a novel class of compounds developed by Bayer
to target a key molecular mechanism underlying PH.(23,24) Adempas is being
investigated as a novel and specific approach to treat different categories of
PH.(23,24 )sGC is an enzyme found in the cardiopulmonary system and the
receptor for nitric oxide (NO). When NO binds to sGC, the enzyme enhances
production of the signaling molecule cyclic guanosine monophosphate (cGMP).
cGMP plays an important role in regulating vascular tone, proliferation,
fibrosis, and inflammation.(25)
PH is associated with endothelial dysfunction, impaired synthesis of NO and
insufficient stimulation of sGC.(23 )Adempas has a unique mode of action - it
sensitizes sGC to endogenous NO by stabilizing the NO-sGC binding. Adempas
also directly stimulates sGC via a different binding site, independently of
NO.(23,24,25 )Adempas, as a stimulator of sGC, addresses the issue of NO
deficiency by restoring the NO-sGC-cGMP pathway, leading to increased
generation of cGMP.(23)
With its novel mode of action, Adempas has the potential to overcome a number
of limitations of currently approved PAH therapies, including NO
It is also the first drug which has shown clinical benefits in CTEPH, where no
indicated pharmacological treatment was previously available.(1,3 )
About Bayer in Canada Bayer Inc. is a Canadian subsidiary of Bayer AG and the
corporate headquarters for the Canadian operations. Founded in 1863, Bayer AG
is an international research-based group with core businesses in healthcare,
crop science and innovative materials committed to creating a better life for
all through science.
In Canada, Bayer operates its healthcare business - Pharmaceuticals, Consumer
Care, Diabetes Care, Animal Health and Radiology & Interventional - from its
headquarters in Toronto, ON, and Bayer CropScience Inc. operates out of its
head office in Calgary, AB. Together with its material science business, Bayer
improves the quality of life for Canadians through products that fight
disease, protect crops and animals, and provide high-performance materials for
numerous daily life uses.
With more than 1,300 employees across the country, in 2013, Bayer had sales of
$1.6 billion and invested $61 million in research and development in Canada.
Globally, Bayer AG had sales of €40.2 billion and invested €3.2 billion in
research and development.
For more information about Bayer, please visit www.bayer.ca.
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 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) Adempas® Product Monograph,
March 04, 2014
(2) Peacock AJ, Murphy NF, McMurray JJ, Caballero L, Stewart S. An
epidemiological study of pulmonary arterial hypertension. Eur Respir J. 2007
(3) Mayer E. Surgical and post-operative treatment of chronic thromboembolic
pulmonary hypertension. Eur Respir Rev 2010;19(115):64-67.
(4) Ghofrani HA, D'Armini AM, Grimminger F et al. Riociguat for the treatment
of chronic thromboembolic pulmonary hypertension. N Engl J Med
(5) Ghofrani HA, Galie N, Grimminger F et al. Riociguat for the treatment of
pulmonary arterial hypertension. N Engl J Med 2013;369(4):330-340.
(6) Rosenkranz S. Pulmonary hypertension: current diagnosis and treatment.
Clin Res Cardiol 2007;96(8):527-541.
(7) Macchia A, Marchioli R, Marfisi R et al. A meta-analysis of trials of
pulmonary hypertension: a clinical condition looking for drugs and research
methodology. Am Heart J 2007;153(6):1037-1047.
(8) McKenna SP, Doughty N, Meads DM, Doward LC, Pepke-Zaba J. The Cambridge
Pulmonary Hypertension Outcome Review (CAMPHOR): a measure of health-related
quality of life and quality of life for patients with pulmonary hypertension.
Qual Life Res 2006;15(1):103-115.
(9) PHA UK. What is pulmonary hypertension?
(10) Galie N, Hoeper MM, Humbert M et al. Guidelines for the diagnosis and
treatment of pulmonary hypertension: the Task Force for the Diagnosis and
Treatment of Pulmonary Hypertension of the European Society of Cardiology
(ESC) and the European Respiratory Society (ERS), endorsed by the
International Society of Heart and Lung Transplantation (ISHLT). Eur Heart J
(11 )Benza RL, Miller DP, Barst RJ, Badesch DB, Frost AE, McGoon MD. An
evaluation of long-term survival from time of diagnosis in pulmonary arterial
hypertension from the REVEAL Registry. Chest 2012;142(2):448-456.
(12) Girgis RE. Emerging drugs for pulmonary hypertension. Expert Opin Emerg
(13) Simonneau G, D'Armini AM, Ghofrani HA et al. Riociguat for the treatment
of chronic thromboembolic pulmonary hypertension (CTEPH): a phase III
long-term extension study (CHEST-2). 5th World Sympsoium on Pulmonary
Hypertension, Nice, France, 27 February - 1 March; 2013.
(14) Rubin LJ, Galie N, Grimminger F et al. Safety and efficacy of riociguat
for the long-term treatment of pulmonary arterial hypertension (PAH) in the
phase III PATENT-2 long-term extension study. American Thoracic Society
International Conference, Philadelphia, PA, USA, 17-22 May; 2013.
(15) Armstrong I, Rochnia N, Harries C, Bundock S, Yorke J. The trajectory to
diagnosis with pulmonary arterial hypertension: a qualitative study. BMJ Open
(16) Peacock AJ. Treatment of pulmonary hypertension. BMJ
(17) Vachiery JL, Yerly P, Huez S. How to detect disease progression in
pulmonary arterial hypertension. Eur Respir Rev 2012;21(123):40-47.
(18) Ali JM, Hardman G, Page A, Jenkins DP. Chronic thromboembolic pulmonary
hypertension: an underdiagnosed entity? Hosp Pract (1995) 2012;40(3):71-79.
(19) Ghofrani HA, Distler O, Gerhardt F et al. Treatment of pulmonary arterial
hypertension (PAH): updated Recommendations of the Cologne Consensus
Conference 2011. Int J Cardiol 2011;154 Suppl 1:S20-S33.
(20) PHA Canada. Canadian Medical Centres Specializing in the Treatment of PH.
(21) Condliffe R, Kiely DG, Gibbs JS et al. Improved outcomes in medically and
surgically treated chronic thromboembolic pulmonary hypertension. Am J Respir
Crit Care Med 2008;177(10):1122-1127.
(22) Freed DH, Thomson BM, Berman M et al. Survival after pulmonary
thromboendarterectomy: effect of residual pulmonary hypertension. J Thorac
Cardiovasc Surg 2011;141(2):383-387.
(23) Ghofrani HA, Voswinckel R, Gall H et al. Riociguat for pulmonary
hypertension. Future Cardiol 2010;6(2):155-166.
(24) Grimminger F, Weimann G, Frey R et al. First acute haemodynamic study of
soluble guanylate cyclase stimulator riociguat in pulmonary hypertension. Eur
Respir J 2009;33(4):785-792.
(25) Stasch JP, Pacher P, Evgenov OV. Soluble guanylate cyclase as an emerging
therapeutic target in cardiopulmonary disease. Circulation
SOURCE Bayer Inc.
Marija Mandic, 416-240-5376, email@example.com
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