Welcome!

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 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 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? http://www.phassociation.uk.com/what_is_ph, 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. http://www.phacanada.ca/en/patients/clinical-directory, 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
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
910Telecom exhibited at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and exchanges.
Whether you like it or not, DevOps is on track for a remarkable alliance with security. The SEC didn’t approve the merger. And your boss hasn’t heard anything about it. Yet, this unruly triumvirate will soon dominate and deliver DevSecOps faster, cheaper, better, and on an unprecedented scale. In his session at DevOps Summit, Frank Bunger, VP of Customer Success at ScriptRock, discussed how this cathartic moment will propel the DevOps movement from such stuff as dreams are made on to a practic...
As software becomes more and more complex, we, as software developers, have been splitting up our code into smaller and smaller components. This is also true for the environment in which we run our code: going from bare metal, to VMs to the modern-day Cloud Native world of containers, schedulers and micro services. While we have figured out how to run containerized applications in the cloud using schedulers, we've yet to come up with a good solution to bridge the gap between getting your contain...
The modern software development landscape consists of best practices and tools that allow teams to deliver software in a near-continuous manner. By adopting a culture of automation, measurement and sharing, the time to ship code has been greatly reduced, allowing for shorter release cycles and quicker feedback from customers and users. Still, with all of these tools and methods, how can teams stay on top of what is taking place across their infrastructure and codebase? Hopping between services a...
Niagara Networks exhibited at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. Niagara Networks offers the highest port-density systems, and the most complete Next-Generation Network Visibility systems including Network Packet Brokers, Bypass Switches, and Network TAPs.
Zerto exhibited at SYS-CON's 18th International Cloud Expo®, which took place at the Javits Center in New York City, NY, in June 2016. Zerto is committed to keeping enterprise and cloud IT running 24/7 by providing innovative, simple, reliable and scalable business continuity software solutions. Through the Zerto Cloud Continuity Platform™, organizations can seamlessly move and protect virtualized workloads between public, private and hybrid clouds. The company’s flagship product, Zerto Virtual...
WebRTC is about the data channel as much as about video and audio conferencing. However, basically all commercial WebRTC applications have been built with a focus on audio and video. The handling of “data” has been limited to text chat and file download – all other data sharing seems to end with screensharing. What is holding back a more intensive use of peer-to-peer data? In her session at @ThingsExpo, Dr Silvia Pfeiffer, WebRTC Applications Team Lead at National ICT Australia, looked at differ...
Without a clear strategy for cost control and an architecture designed with cloud services in mind, costs and operational performance can quickly get out of control. To avoid multiple architectural redesigns requires extensive thought and planning. Boundary (now part of BMC) launched a new public-facing multi-tenant high resolution monitoring service on Amazon AWS two years ago, facing challenges and learning best practices in the early days of the new service. In his session at 19th Cloud Exp...
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
"Plutora provides release and testing environment capabilities to the enterprise," explained Dalibor Siroky, Director and Co-founder of Plutora, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Security, data privacy, reliability and regulatory compliance are critical factors when evaluating whether to move business applications from in-house client hosted environments to a cloud platform. In her session at 18th Cloud Expo, Vandana Viswanathan, Associate Director at Cognizant, In this session, will provide an orientation to the five stages required to implement a cloud hosted solution validation strategy.
SYS-CON Events announced today that CA Technologies has been named "Platinum Sponsor" of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and 21st International Cloud Expo, which will take place in November in Silicon Valley, California.
The security needs of IoT environments require a strong, proven approach to maintain security, trust and privacy in their ecosystem. Assurance and protection of device identity, secure data encryption and authentication are the key security challenges organizations are trying to address when integrating IoT devices. This holds true for IoT applications in a wide range of industries, for example, healthcare, consumer devices, and manufacturing. In his session at @ThingsExpo, Lancen LaChance, vic...