Bayer to Present Pulmonary Hypertension Data at the American Thoracic Society 2018 International Conference

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May 15, 2018, 09:00 ET

WHIPPANY, N.J., May 15, 2018 /PRNewswire/ -- Bayer announced today that clinical data from its pulmonary disease franchise will be presented in scientific sessions at the 2018 American Thoracic Society (ATS) International Conference, May 18-23^rd in San Diego, CA. Bayer will share results from several studies of riociguat as a treatment for pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), including an update from the EXPERT registry, an ongoing long-term safety study, and evaluations of risk assessment tools in patients receiving treatment, which is part of a collaboration between Bayer and MSD (known as Merck in the U.S. and Canada).

"Risk prediction and assessment are critical in the development of effective management strategies for PAH and CTEPH," said Aleksandra Vlajnic, M.D., Vice President of Medical Affairs at Bayer. "Our continued research underscores our commitment to uncovering new clinical knowledge that contributes to improving outcomes for patients living with these often underdiagnosed and undertreated pulmonary diseases."

The presentations being made are:

Riociguat in Pulmonary Arterial Hypertension (PAH): Evaluation of Abbreviated Versions of the ERS/ESC Risk Assessment Tool in PATENT-2

Sunday, May 20, 2018; 11:15 a.m. – 1:00 p.m.
San Diego Convention Center; Area B (Hall A-B2, Ground Level)
Presenter: Dr. Marc Humbert, Assistance-Publique–Hôpitaux de Paris

The MOTION Study to Assess the Effect of Riociguat on Patient-Reported Outcomes in PAH: Correlations Between The Living With Pulmonary Hypertension Questionnaire and Secondary Endpoints

Sunday, May 20, 2018; 11:15 a.m. – 1:00 p.m.
San Diego Convention Center; Area B (Hall A-B2, Ground Level)
Presenter: Dr. Franck Rahaghi, Cleveland Clinic Florida

Riociguat in Chronic Thromboembolic Pulmonary Hypertension (CHEST): Evaluation of Abbreviated Version of the ERS/ESC Risk Assessment Tool in CHEST-2

Monday, May 21, 2018; 11:15 a.m. – 1:00 p.m.
San Diego Convention Center; Area J (Hall A-B2, Ground Level)
Presenter: Dr. Harrison Farber, Boston University School of Medicine

Riociguat for the Treatment of Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension: Safety Update from the EXPERT Registry

Tuesday, May 22, 2018; 11:15 a.m. – 1:00 p.m.
San Diego Convention Center; Area C (Hall A-B2, Ground Level)
Presenter: Dr. Hans Klose, University Medical Center Hamburg-Eppendorf

The presentations include data about riociguat, which is marketed as Adempas^® in the U.S. Since October 2014, the worldwide strategic collaboration between Bayer and MSD in the field of sGC modulators, brings together the two leading companies in this field, who both have the stated intent to fully evaluate this therapeutic class in areas of unmet medical need. ADEMPAS^®, the first sGC stimulator of this collaboration, is developed by Bayer and MSD, and it has received marketing authorization in the U.S., Canada, EU, Japan and other countries around the world.

About Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension (PAH) is defined by elevated pressure in the arteries going from the right side of the heart to the lungs.[1] Typical symptoms of PAH include shortness of breath on exertion, fatigue, weakness, chest pain and syncope.[2] PAH is caused by abnormalities in the walls of the pulmonary arteries.1^,[3]

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 Adempas^® (riociguat)
Riociguat, licensed in the U.S. as Adempas, 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).

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 one month after stopping treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment.

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

INDICATIONS

Adempas (riociguat) tablets 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 indicated for the treatment of adults with pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve 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

Contraindications

Adempas is contraindicated in:

Pregnancy. Based on data from animal reproduction studies, Adempas may cause fetal harm when administered to a pregnant woman and is contraindicated in females who are pregnant. 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 (PDE)-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE inhibitors (such as dipyridamole or theophylline) is contraindicated. Do not administer within 24 hours of sildenafil. Do not administer 24 hours before or within 48 hours after tadalafil.
Patients with Pulmonary Hypertension associated with Idiopathic Interstitial Pneumonias (PH-IIP).

Warnings and Precautions

Embryo-Fetal Toxicity. Based on data from animal reproduction studies, Adempas may cause embryo-fetal toxicity when administered to a pregnant female and is contraindicated in females who are pregnant. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment, monthly during treatment, and for one month after stopping treatment. Advise females of reproductive potential to use effective contraception during treatment with Adempas and for at least one month after the last dose.

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.

About Bayer
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 quality of life. 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 2017, the Group employed around 99,800 people and had sales of EUR 35.0 billion. Capital expenditures amounted to EUR 2.4 billion, R&D expenses to EUR 4.5 billion. For more information, go to www.bayer.us.

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Media Contacts:
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Bayer, Product Communications
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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] Rosenkranz S. Pulmonary hypertension: current diagnosis and treatment. Clin Res Cardiol. 2007;96(8):527-541.

[2] McKenna SP et al. 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.

[3] Galiè, N et al. A meta-analysis of randomized controlled trials in pulmonary arterial hypertension. Eur Heart J 2009;30:394-403.

SOURCE Bayer