Click here to close now.


News Feed Item

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 Canadians2
  • 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)1,3

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 (CTEPH).1,4,5

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 treatment.22

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 dependence.23

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

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 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 Jul;30(1):104-9.

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 2013;369(4):319-329.

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?, 2013.

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 2009;30(20):2493-2537.

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 Drugs 2010;15(1):71-85.

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 2012;2(2):e000806.

16 Peacock AJ. Treatment of pulmonary hypertension. BMJ 2003;326(7394):835-836.

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., 2014.

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 2011;123(20):2263-2273.

SOURCE Bayer Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Apps and devices shouldn't stop working when there's limited or no network connectivity. Learn how to bring data stored in a cloud database to the edge of the network (and back again) whenever an Internet connection is available. In his session at 17th Cloud Expo, Ben Perlmutter, a Sales Engineer with IBM Cloudant, demonstrated techniques for replicating cloud databases with devices in order to build offline-first mobile or Internet of Things (IoT) apps that can provide a better, faster user e...
Microservices are a very exciting architectural approach that many organizations are looking to as a way to accelerate innovation. Microservices promise to allow teams to move away from monolithic "ball of mud" systems, but the reality is that, in the vast majority of organizations, different projects and technologies will continue to be developed at different speeds. How to handle the dependencies between these disparate systems with different iteration cycles? Consider the "canoncial problem"...
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ab...
With all the incredible momentum behind the Internet of Things (IoT) industry, it is easy to forget that not a single CEO wakes up and wonders if “my IoT is broken.” What they wonder is if they are making the right decisions to do all they can to increase revenue, decrease costs, and improve customer experience – effectively the same challenges they have always had in growing their business. The exciting thing about the IoT industry is now these decisions can be better, faster, and smarter. Now ...
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessi...
In his General Session at DevOps Summit, Asaf Yigal, Co-Founder & VP of Product at, explored the value of Kibana 4 for log analysis and provided a hands-on tutorial on how to set up Kibana 4 and get the most out of Apache log files. He examined three use cases: IT operations, business intelligence, and security and compliance. Asaf Yigal is co-founder and VP of Product at log analytics software company In the past, he was co-founder of social-trading platform Currensee, which...
There are over 120 breakout sessions in all, with Keynotes, General Sessions, and Power Panels adding to three days of incredibly rich presentations and content. Join @ThingsExpo conference chair Roger Strukhoff (@IoT2040), June 7-9, 2016 in New York City, for three days of intense 'Internet of Things' discussion and focus, including Big Data's indespensable role in IoT, Smart Grids and Industrial Internet of Things, Wearables and Consumer IoT, as well as (new) IoT's use in Vertical Markets.
Discussions of cloud computing have evolved in recent years from a focus on specific types of cloud, to a world of hybrid cloud, and to a world dominated by the APIs that make today's multi-cloud environments and hybrid clouds possible. In this Power Panel at 17th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the importance of customers being able to use the specific technologies they need, through environments and ecosystems that expose their APIs to make true ...
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Container technology is shaping the future of DevOps and it’s also changing the way organizations think about application development. With the rise of mobile applications in the enterprise, businesses are abandoning year-long development cycles and embracing technologies that enable rapid development and continuous deployment of apps. In his session at DevOps Summit, Kurt Collins, Developer Evangelist at, examined how Docker has evolved into a highly effective tool for application del...
In today's enterprise, digital transformation represents organizational change even more so than technology change, as customer preferences and behavior drive end-to-end transformation across lines of business as well as IT. To capitalize on the ubiquitous disruption driving this transformation, companies must be able to innovate at an increasingly rapid pace. Traditional approaches for driving innovation are now woefully inadequate for keeping up with the breadth of disruption and change facin...
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data...
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningf...
The cloud. Like a comic book superhero, there seems to be no problem it can’t fix or cost it can’t slash. Yet making the transition is not always easy and production environments are still largely on premise. Taking some practical and sensible steps to reduce risk can also help provide a basis for a successful cloud transition. A plethora of surveys from the likes of IDG and Gartner show that more than 70 percent of enterprises have deployed at least one or more cloud application or workload. Y...