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Bayer to Present Data on Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension at ATS 2015 International Conference
Date:5/15/2015

WHIPPANY, N.J., May 15, 2015 /PRNewswire/ -- Bayer HealthCare will present data investigating pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) in scientific forum at the American Thoracic Society (ATS) International Conference, which takes place May 15-20 in Denver, Colorado.

"At the American Thoracic Society meeting, we will share Bayer's recent, extensive research in the field of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, including new data from ongoing study of Adempas® (riociguat)," said Dario Mirski, MD, Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.

The studies Bayer will present are:

  • Early Access Study (EAS) of Riociguat in Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH): Baseline Characteristics and Comparison with Registry Data
    • Poster # P666
    • Presentation: Tuesday, May 19, 2015; 11:30 a.m. – 1:15 p.m.; Colorado Convention Center; Area F, Hall A-B (Upper Level)
  • Early Access Study (EAS) of riociguat in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH): Exploratory Interim Safety Assessment
    • Poster # P677
    • Presentation: Tuesday, May 19, 2015; 11:30 a.m. – 1:15 p.m.; Colorado Convention Center; Area F, Hall A-B (Upper Level)
  • Characterization of Chinese Patients With Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH): Baseline Characteristics from the PATENT-1 and CHEST-1 Studies and Comparison With Other Studies
    • Poster # P672
    • Presentation: Tuesday, May 19, 2015; 11:30 a.m. – 1:15 p.m.; Colorado Convention Center; Area F, Hall A-B (Upper Level)
  • Efficacy and Safety of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Associated With Connective Tissue Disease: Results From PATENT-1 and PATENT-2
    • Oral Presentation
    • Presentation: Sunday, May 17, 2015; 2:15 p.m. – 4:00 p.m.; Colorado Convention Center; Bellco Theatre Section 1 (Street Level)
  • Health Outcome Assessment in Pulmonary Arterial Hypertension (PAH) Patients Treated with Riociguat: 2-Year Results from the PATENT-2 Long Term Extension Study
    • Poster # P601
    • Presentation: Tuesday, May 19, 2015; 11:30 a.m. – 1:15 p.m.; Colorado Convention Center; Area F, Hall A-B (Upper Level)
  • Health Outcome Assessment in Chronic Thromboembolic Pulmonary Hypertension (CTEPH)Patients Treated with Riociguat: 2-Year Results from the CHEST-2 Long Term Extension Study
    • Poster # P675
    • Presentation: Tuesday, May 19, 2015; 11:30 a.m. – 1:15 p.m.; Colorado Convention Center; Area F, Hall A-B (Upper Level)

About Pulmonary Arterial Hypertension (PAH)
PAH, a form of PH, is characterized by elevated blood pressure in the pulmonary arteries. It is a chronic and life-changing disease that can lead to heart failure. PAH produces symptoms such as shortness of breath, dizziness and fatigue, and the severity of symptoms usually correlates with the progression of the disease.1

About Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
CTEPH is a form of pulmonary hypertension in which blood clots and thromboembolic occlusion of the pulmonary vessels leads to increased pressure in the pulmonary arteries.  The standard treatment for CTEPH is pulmonary endarterectomy, a surgery that clears clots and scar material from the blood vessels of the lung. However, 20-40 percent of patients have inoperable CTEPH and the disease persists in up to 35 percent of those who do undergo surgery.2,3,4,5

About Riociguat
Riociguat, licensed in the U.S. as Adempas (riociguat), is a stimulator of soluable guanylate cyclase (sGC) and is the only treatment approved in the U.S. for use in two types of pulmonary hypertension (WHO Groups 1 and 4).

Adempas is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class.

Adempas is also indicated for the treatment of adults with pulmonary arterial hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening*.

Efficacy was shown in patients on Adempas monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness of riociguat included predominately patients with WHO functional class II–III and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (25%).

*Time to clinical worsening was a combined endpoint defined as death (all-cause mortality), heart/lung transplantation, atrial septostomy, hospitalization due to persistent worsening of pulmonary hypertension, start of new PAH-specific treatment, persistent decrease in 6MWD and persistent worsening of WHO functional class.

Pulmonary hypertension is associated with endothelial dysfunction, impaired synthesis of nitric oxide (NO) and insufficient stimulation of the NO-sGC-cGMP pathway. Adempas sensitizes sGC to endogenous NO by stabilizing the NO-sGC binding. Adempas also directly stimulates sGC via a different binding site independently of NO. Adempas stimulates the NO-sGC-cGMP pathway and leads to increased generation of cGMP with subsequent vasodilation.

The development and commercialization of riociguat is part of the worldwide strategic collaboration between Merck & Co., Inc (through a subsidiary) and Bayer AG in the field of soluble guanylate cyclase (sGC) modulators. Merck is known as MSD outside of the U.S. and Canada.

Established in October 2014, this collaboration brings together the two leading companies in this field, who both have the stated intent to make full use of this promising  class of compounds. Riociguat, the first sGC stimulator approved and made available to patients, is the first product which is part of this collaboration.

INDICATIONS

  • Adempas (riociguat) tablets are indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class.
  • Adempas is indicated for the treatment of adults with pulmonary arterial hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening.*

Efficacy was shown in patients on Adempas monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness included predominantly patients with WHO functional class II–III and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (25%).

*Time to clinical worsening was a combined endpoint defined as death (all-cause mortality), heart/lung transplantation, atrial septostomy, hospitalization due to persistent worsening of pulmonary hypertension, start of new PAH-specific treatment, persistent decrease in 6MWD and persistent worsening of WHO functional class.

IMPORTANT SAFETY INFORMATION

WARNING:  EMBRYO-FETAL TOXICITY 

 

Do not administer Adempas (riociguat) tablets to a pregnant female because it may cause fetal harm.

 

Females of reproductive potential:  Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment.  Prevent pregnancy during treatment and for one month after stopping treatment by using acceptable methods of contraception.

 

For all female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program.

 

Contraindications

Adempas is contraindicated in:

  • Pregnancy. Adempas may cause fetal harm when administered to a pregnant woman. Adempas was consistently shown to have teratogenic effects when administered to animals. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus
  • Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form.
  • Concomitant administration with specific phosphodiesterase-5 (PDE-5) inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE inhibitors (such as dipyridamole or theophylline).

Warnings and Precautions

Embryo-Fetal Toxicity. Adempas may cause fetal harm when administered during pregnancy and is contraindicated for use in women who are pregnant. In females of reproductive potential, exclude pregnancy prior to initiation of therapy, advise use of acceptable contraception and obtain monthly pregnancy tests. For females, Adempas is only available through a restricted program under the Adempas REMS Program.

Adempas REMS Program.  Females can only receive Adempas through the Adempas REMS Program, a restricted distribution program.

Important requirements of the Adempas REMS program include the following:

  • Prescribers must be certified with the program by enrolling and completing training.
  • All females, regardless of reproductive potential, must enroll in the Adempas REMS Program prior to initiating Adempas. Male patients are not enrolled in the Adempas REMS Program.
  • Female patients of reproductive potential must comply with the pregnancy testing and contraception requirements.
  • Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive Adempas.

Further information, including a list of certified pharmacies, is available at www.AdempasREMS.com or 1-855-4ADEMPAS.

Hypotension. Adempas reduces blood pressure. Consider the potential for symptomatic hypotension or ischemia in patients with hypovolemia, severe left ventricular outflow obstruction, resting hypotension, autonomic dysfunction, or concomitant treatment with antihypertensives or strong CYP and P-gp/BCRP inhibitors. Consider a dose reduction if patient develops signs or symptoms of hypotension.

Bleeding. In the placebo-controlled clinical trials, serious bleeding occurred in 2.4% of patients taking Adempas compared to 0% of placebo patients. Serious hemoptysis occurred in 5 (1%) patients taking Adempas compared to 0 placebo patients, including one event with fatal outcome. Serious hemorrhagic events also included 2 patients with vaginal hemorrhage, 2 with catheter site hemorrhage, and 1 each with subdural hematoma, hematemesis, and intra-abdominal hemorrhage. 

Pulmonary Veno-Occlusive Disease.  Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Therefore, administration of Adempas to such patients is not recommended. Should signs of pulmonary edema occur, the possibility of associated PVOD should be considered and if confirmed, discontinue treatment with Adempas.

Most Common Adverse Reactions

  • The most common adverse reactions occurring more frequently (>3%) on Adempas than placebo were headache (27% vs 18%), dyspepsia/gastritis (21% vs. 8%), dizziness (20% vs 13%), nausea (14% vs 11%), diarrhea (12% vs 8%), hypotension (10% vs 4%), vomiting (10% vs 7%), anemia (7% vs 2%), gastroesophageal reflux disease (5% vs 2%), and constipation (5% vs 1%).
  • Other events that were seen more frequently in Adempas compared to placebo and potentially related to treatment were: palpitations, nasal congestion, epistaxis, dysphagia, abdominal distension and peripheral edema.

For important risk and use information, please see the full Prescribing Information, including Boxed Warning at www.adempas-us.com.

About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Bayer® and the Bayer Cross® are registered trademarks of Bayer. 

Intended for U.S. Media Only

Forward Looking Statement
This news 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 Web site 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 Pulmonary Hypertension Association. About Pulmonary Hypertension. Available at: http://www.phassociation.org/AboutPH. Accessed March 25, 2015.

2 Ali, JM et al. Chronic thromboembolic pulmonary hypertension: An underdiagnosed entity? Hosp Pract 2012;40:71–9

3 Condliffe, R et al. Improved outcomes in medically and surgically treated chronic thromboembolic pulmonary hypertension. Am J Respir Crit Care Med 2008;177:1122-7

4 Freed, DH et al. Survival after pulmonary thromboendarterectomy: effect of residual pulmonary hypertension. J Thorac Cardiovasc Surg 2011;141:383-7

5 Humbert, M. Pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension: pathophysiology. Eur Respir Rev 2010;19:59–63

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