Adempas® now approved for second rare heart and lung disease, offering a new treatment option to improve patient care

 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)         (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.  Marija Mandic, 416-240-5376, marija.mandic@bayer.com  To view this news release in HTML formatting, please use the following URL:  http://www.newswire.ca/en/releases/archive/March2014/10/c2160.html  CO: Bayer Inc. ST: Ontario NI: CHM MTC HEA NP  
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