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Bayer to Present Pulmonary Hypertension Data at American Thoracic Society (ATS) 2016 International Conference
Date:5/13/2016

WHIPPANY, N.J., May 13, 2016 /PRNewswire/ -- Bayer will present six abstracts investigating the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) with riociguat in scientific sessions at the 2016 American Thoracic Society (ATS) International Conference, to be held May 13-18th in San Francisco, California.

"We are pleased to share data from several recent and ongoing studies examining the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension with riociguat," said Dario Mirski, MD, Bayer's senior vice president and head of medical affairs for the Americas.  "Bayer is committed to continued exploration of this treatment option for patients with life-threatening diseases, and we look forward to the valuable scientific exchange at ATS this year."

The studies Bayer will present are:

  • Baseline Characteristics of Patients Enrolled in a Prospective Study of Riociguat for Pulmonary Hypertension Associated with Idiopathic Interstitial Pneumonia (RISE-IIP Study) *Note: this study has been discontinued.
    • Presentation:  Monday, May 16, 2016; 11:00 – 12:45 p.m.; Moscone Center; Area H, Hall D
  • Riociguat Treatment for Porto-Pulmonary Hypertension: A Subgroup Analysis from the PATENT-1 Study
    • Poster # 990
    • Presentation: Wednesday, May 18, 2016; 11:00 a.m. – 12:45 p.m.; Moscone Center; Area H, Hall D
  • Riociguat for the Treatment of Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension: Real-Life Data From the EXPERT Registry
    • Poster # 1028
    • Presentation: Wednesday, May 18, 2016; 11:00 a.m. – 12:45 p.m.; Moscone Center; Area H, Hall D
  • The RESPITE Study: Riociguat in Patients with PAH and an Inadequate Response to Phosphodiesterase 5 Inhibitors
    • Poster # 1012
    • Presentation: Tuesday, May 17, 2016; 2:15 p.m. – 3:00 p.m.; Moscone Center; Room 3024
  • Application of the Criteria for Satisfactory Clinical Response to Riociguat Treatment of Patients with Pulmonary Arterial Hypertension (PATENT-1 and PATENT-2)
    • Poster # 962
    • Presentation: Wednesday, May 18, 2016; 11:00 a.m. – 12:45 p.m.; Moscone Center; Area H, Hall D
  • Baseline Demographics of the Prospective, Multicenter, Single-Arm, Open-Label, Phase IV MOTION Study of Riociguat in Pulmonary Arterial Hypertension
    • Poster # 1024
    • Presentation: Wednesday, May 18, 2016; 11:00 a.m. – 12:45 p.m.; Moscone Center; Area H, Hall D

About Pulmonary Arterial Hypertension (PAH)
PAH (WHO Group 1), a form of PH, is characterized by elevated blood pressure in the pulmonary arteries. It is a chronic disease which 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 (WHO Group 4) is a progressive type of pulmonary hypertension, in which it is believed that thromboembolic occlusion (organized blood clots) of pulmonary vessels gradually lead to an increased blood pressure in the pulmonary arteries, resulting in an overload of the right heart. CTEPH may evolve after prior episodes of acute pulmonary embolism, but the pathogenesis is not yet completely understood. The standard and potentially curative treatment for CTEPH is pulmonary thromboendarterectomy (PTE), a surgical procedure in which the blood vessels of the lungs are cleared of clot and scar material. However, a considerable number of patients with CTEPH (20%-40%) are not operable and in up to 35 percent of patients, the disease persists or reoccurs after PTE.

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.

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.

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 is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their lives. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2015, the Group employed around 117,000 people and had sales of EUR 46.3 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.3 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.us.

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

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 April 20, 2016.

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