Bayer to Present Data in Pulmonary Arterial Hypertension and Non-Cystic Fibrosis Bronchiectasis at the 2016 Annual Meeting of the American College of Chest Physicians

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Oct 18, 2016, 08:00 ET

WHIPPANY, N.J., Oct. 18, 2016 /PRNewswire/ -- Bayer announced today that data from its pulmonary disease franchise will be presented in a scientific session at the 2016 annual meeting of the American College of Chest Physicians (CHEST 2016), October 22-26 in Los Angeles. Data presentations consist of three oral scientific sessions, including two late-breaking abstracts.

"Our data reflects Bayer's commitment to advancing the scientific research in diseases of high unmet need, particularly pulmonary arterial hypertension and non-cystic fibrosis bronchiectasis," said Aleksandra Vlajnic, Vice President of Medical Affairs at Bayer. "We will continue working with physician and patient communities to increase understanding of these diseases and help accelerate time from diagnosis to treatment for these commonly under-detected, and therefore under-treated, pulmonary conditions."

The studies Bayer will present are:

Effects of Riociguat in Treatment-Naïve vs. Pretreated Patients with Pulmonary Arterial Hypertension: 2-year Efficacy Results from the PATENT-2 Study
Session: Pulmonary Hypertension [4080]
Date/Time: October 24, 2016, 5:15pm
Location: 409A (LA Convention Center)
Presenter: Dr. McConnell, Oral presentation

The Relationship between NO Pathway Biomarkers and Response to Riociguat in the RESPITE Study of Patients with PAH Not Reaching Treatment Goals with Phosphodiesterase 5 Inhibitors
Session: Late-Breaking Abstracts [4175]
Date/Time: October 25, 2016, 9:03-9:22am
Location: Room 411 (LA Convention Center)
Presenter: Dr. Klinger, Oral Presentation

Efficacy and Tolerability of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in Bronchiectasis (Non-CF Etiology): Results from the Phase III RESPIRE 1 Study
Session: Late-Breaking Abstracts [4175]
Date/Time: October 25, 2016, 9:22-9:40am
Location: Room 411 (LA Convention Center)
Presenter: Dr. Kevin Winthrop, Oral Presentation

About Non-Cystic Fibrosis Bronchiectasis (NCFB)
In patients with NCFB, sputum pools in the small airways and becomes a place for bacterial growth, often leading to chronic airway infections with bacteria such as Haemophilus influenzae or Pseudomonas aeruginosa.[i] Reduced sputum clearance leads to repeated infections, airway damage, and in a cyclic manner, increasingly severe disease with worsening airway damage.

NCFB symptoms include cough (often with thick, discolored sputum), breathlessness, increased tiredness, and hemoptysis (coughing up blood). Patients tend to have regular sudden worsening in symptoms, called exacerbations or disease flare-ups, which can last for weeks.[ii] Exacerbations are more common in patients with a high number of bacteria in their airways.[iii]

About Ciprofloxacin DPI
Ciprofloxacin DPI is an investigational agent in development by Bayer as long-term intermittent therapy to reduce exacerbations in NCFB patients with bacterial respiratory pathogens. It comprises ciprofloxacin, a fluoroquinolone antibiotic, formulated into a dry powder for inhalation using PulmoSphere™ technology, and administered with the T-326 dry powder inhaler.

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

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

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.

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.

Bayer: Science For A Better Life
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 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 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.

[i] McShane PJ et al. Non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2013;188(6):647-656.

[ii] Brill SE et al. Lung function, symptoms and inflammation during exacerbations of non-cystic fibrosis bronchiectasis: a prospective observational cohort study. Respir Res. 2015;16:16.

[iii] Chalmers JD et al. Short- and long-term antibiotic treatment reduces airway and systematic inflammation in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2012;186(7):657-665.

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