Québec First Province to List Adempas® for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

MONTREAL, April 24, 2014 /CNW/ - Bayer Inc. announced today the Québec public formulary, Régie de l'assurance maladie du Québec (RAMQ), has listed Adempas® (riociguat) for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are inoperable or have persistent or recurrent CTEPH after surgical treatment. Québec is the first province to provide public access to Adempas® for this rare heart and lung disease.

Adempas® was added as an Exceptional Medication to the List of Medications as monotherapy for treatment of chronic thromboembolic pulmonary hypertension of WHO functional class II or III that is inoperable, or persistent or recurrent after surgical treatment.  Persons must be evaluated and followed up on by physicians currently working in designated centres specializing in the treatment of pulmonary arterial hypertension. This listing is effective immediately, and follows after an Institut national d'excellence en santé et en services sociaux (INESSS) priority evaluation.

"CTEPH is a life-threatening disease.  It is a type of pulmonary hypertension in which blood clots lodge in the pulmonary vessels, leading to increased blood pressure in the pulmonary arteries, and resulting in an overload of the right heart," says Dr. David Langleben, Professor of Medicine at McGill University and Director of the Center for Pulmonary Vascular Disease at the Jewish General Hospital in Montreal.  "The availability of Adempas represents a major advance in the treatment of CTEPH patients who are not suitable for surgery to remove the clots, or who have persistent or recurring pulmonary hypertension after surgical clot removal. Adempas is the first and only medical therapy indicated for this disease."

"PHA Canada applauds the Québec Government for its leadership in recognizing the severity and unmet medical need for patients with CTEPH," says Angie Knott, National Manager, Pulmonary Hypertension Association of Canada.  "We would like to see this treatment available to all Canadians who need it in the very near future."

Adempas® was approved in 2013, as the first drug indicated to treat inoperable, or persistent/recurrent CTEPH after surgery in adults with WHO Functional Class II or III pulmonary hypertension.  Health Canada approved a second indication for Adempas® in March 2014 for the treatment of pulmonary arterial hypertension (PAH). 

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.i, ii Adempas® is being investigated as a novel and specific approach to treat different categories of PH.i, ii 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.iii

PH is associated with endothelial dysfunction, impaired synthesis of NO and insufficient stimulation of sGC.i 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.i,ii, iii 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.i

With its novel mode of action, Adempas® has the potential to overcome a number of limitations of currently approved PAH therapies, including NO dependence.i It is also the first drug which has shown clinical benefits in CTEPH, where no indicated pharmacological treatment was previously available.iv, v

About Bayer Inc.
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.

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i Ghofrani HA, Voswinckel R, Gall H et al. Riociguat for pulmonary hypertension. Future Cardiol 2010; 6(2):155-166.

ii 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.

iii Stasch JP, Pacher P, Evgenov OV. Soluble guanylate cyclase as an emerging therapeutic target in cardiopulmonary disease. Circulation 2011; 123(20):2263-2273.

iv Adempas® Product Monograph, April 7, 2014.

v Mayer E. Surgical and post-operative treatment of chronic thromboembolic pulmonary hypertension. Eur Respir Rev 2010;19(115):64-67.

SOURCE Bayer Inc.

For further information: Communicaitons Contacts: Liana Del Medico, Bayer Inc., 416-248-3017, liana.delmedico@bayer.com; Jennifer Runza, beSPEAK Communications, 416.319.0014, jennifer@bespeakcommunications.com