Bayer's Investigational Drug Riociguat Granted FDA Orphan Drug Designation for Treatment of Pulmonary Arterial Hypertension and

Bayer's Investigational Drug Riociguat Granted FDA Orphan Drug Designation for
   Treatment of Pulmonary Arterial Hypertension and Chronic Thromboembolic
                            Pulmonary Hypertension

PR Newswire

WHIPPANY, N.J., Sept. 25, 2013

WHIPPANY, N.J., Sept. 25, 2013 /PRNewswire/ --Bayer HealthCare today
announced that the U.S. Food and Drug Administration's (FDA) Office of Orphan
Products Development has granted two separate orphan drug designations for its
investigational, oral medication riociguat, proposed trade name Adempas^®, for
the treatment of pulmonary arterial hypertension (PAH) and chronic
thromboembolic pulmonary hypertension (CTEPH). The Orphan Drug Designation
program provides orphan status to drugs and biologics that are defined as
those intended for the safe and effective treatment, diagnosis or prevention
of rare diseases and disorders that affect fewer than 200,000 people in the
U.S., or that affect more than 200,000 persons but are not expected to recover
the costs of developing and marketing a treatment drug.

Bayer submitted a New Drug Application (NDA) for riociguat in February 2013
for two indications: (i) the treatment of PAH (WHO Group 1) to improve
exercise capacity, improve WHO functional class and delay clinical worsening;
and (ii) the treatment of persistent/recurrent CTEPH (WHO Group 4) after
surgical treatment or inoperable CTEPH to improve exercise capacity and WHO
functional class.

PAH and CTEPH are both life-threatening forms of pulmonary hypertension that
cause significantly increased pressure in the pulmonary arteries. Riociguat is
an investigational, oral medication for the treatment of adult patients with
PAH or persistent/recurrent CTEPH after surgical treatment or inoperable
CTEPH. If approved by the FDA, it would create a new class of drugs available
in the U.S. Pulmonary hypertension is associated with endothelial
dysfunction, impaired synthesis of nitric oxide (NO) and insufficient
stimulation of soluble guanylate cyclase (sGC). Riociguat stimulates sGC
independent of NO and increases the sensitivity of sGC to NO.

About Pulmonary Arterial Hypertension (PAH)

In PAH, a rare and life-threatening disease, the blood pressure in the
pulmonary arteries (the arteries that take de-oxygenated blood to the lungs
from the heart) is significantly increased. PAH is characterized by
morphological changes to the endothelium of the arteries of the lungs causing
remodeling of the tissue, vasoconstriction and thrombosis-in-situ. As a result
of these changes, the blood vessels in the lungs are narrowed, making it
difficult for the heart to pump blood through to the lungs. In most cases, PAH
has no known cause and, in some cases, it can be inherited.

About Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

CTEPH is also a rare and life-threatening disease in which it is believed that
thromboembolic occlusion (organized blood clots) of pulmonary vessels
gradually lead to an increased 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 treatment for CTEPH is pulmonary endarterectomy
(PEA), a surgical procedure in which the blood vessels of the lungs are
cleared of clot and scar material. However, CTEPH is inoperable in an
estimated 20 to 40 percent of patients, and, in some cases, the disease
persists or reoccurs after surgery.

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®, 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.

Intended for U.S. media only

SOURCE Bayer HealthCare Pharmaceuticals

Contact: Marcy Funk, Communications, Bayer HealthCare, Telephone: (862)
404-5385, E-Mail: marcy.funk@bayer.com
 
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