Bayer to Present Data Investigating Recently Approved Adempas® (riociguat) Tablets

  Bayer to Present Data Investigating Recently Approved Adempas® (riociguat)
                                   Tablets

PR Newswire

WHIPPANY, N.J., Oct. 28, 2013

WHIPPANY, N.J., Oct. 28, 2013 /PRNewswire/ --Bayer HealthCare today announced
preliminary results from two ongoing, open-label, long-term extension studies
investigating its recently approved Adempas^®(riociguat) tablets will be
presented in scientific forum at CHEST 2013, the annual meeting of the
American College of Chest Physicians,October 26– 31, inChicago, IL.

Adempas was approved by the United States Food and Drug Administration on
October 8, 2013 for: (i) 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; and (ii) the treatment of adults with pulmonary arterial
hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO
functional class and delay clinical worsening.

In PAH, efficacy was shown in patients on Adempas monotherapy or in
combination with endothelin receptor antagonists (ERAs) or prostanoids
(inhaled, oral or subcutaneous). Studies establishing effectiveness 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%).

"Bayer is excited to discuss results from our ongoing, open-label, long-term
extension studies investigating Adempas," saidPamela A. Cyrus, M.D., Vice
President and Head of U.S. Medical Affairs, Bayer HealthCare
Pharmaceuticals."We are pleased that new data sets from our clinical program
for Adempas were accepted for presentation at CHEST 2013 and look forward to
sharing them with the scientific community."

The studies to be presented are:

  oRiociguat for the Treatment of Pulmonary Arterial Hypertension (PAH):
    1-Year Results from the PATENT-2 Long-term Extension Study

       oOctober 29, 2013, 4:30 p.m. to 5:30 p.m., Room W184d, McCormick Place
         Chicago

  oRiociguat for the Treatment of Chronic Thromboembolic Pulmonary
    Hypertension (CTEPH): 1-Year Results from the CHEST-2 Long-term Extension
    Study

       oOctober 29, 2013, 4:30 p.m. to 5:30 p.m., Room W184d, McCormick Place
         Chicago

ADEMPAS® (riociguat) tablets 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:

  oPregnancy. 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
  oCo-administration with nitrates or nitric oxide donors (such as amyl
    nitrite) in any form.
  oConcomitant administration with phosphodiesterase (PDE) inhibitors,
    including specific 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:

  oPrescribers must be certified with the program by enrolling and completing
    training.
  oAll 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.
  oFemale patients of reproductive potential must comply with the pregnancy
    testing and contraception requirements.
  oPharmacies 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
atwww.AdempasREMS.comor 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 program, 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® and Adempas® are registered trademarks of Bayer.

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.

* World Health Organization

Intended for U.S. media only

SOURCE Bayer HealthCare Pharmaceuticals

Website: http://www.berlex.com
Contact: Media, Marcy Funk, +1 862-404-5385, marcy.funk@bayer.com
 
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