Bayer Submits New Drug Application for Riociguat for the Treatment of Pulmonary Arterial Hypertension and Persistent/Recurrent

    Bayer Submits New Drug Application for Riociguat for the Treatment of
       Pulmonary Arterial Hypertension and Persistent/Recurrent Chronic
                    Thromboembolic Pulmonary Hypertension

PR Newswire

WAYNE, N.J., Feb. 11, 2013

WAYNE, N.J., Feb. 11, 2013 /PRNewswire/ -- Bayer HealthCare today announced
that the company has submitted a New Drug Application (NDA) to the U.S. Food
and Drug Administration (FDA) seeking approval for riociguat, an
investigational compound for the treatment of pulmonary arterial hypertension
(PAH) and persistent/recurrent chronic thromboembolic pulmonary hypertension
(CTEPH) after surgical treatment or inoperable CTEPH.

"Bayer is submitting an NDA for riociguat for the treatment of two distinct
forms of pulmonary hypertension. If approved, riociguat would be the first
pharmacological treatment for CTEPH, and it would have the potential to add an
important new treatment option to the armamentarium for PAH," said Pamela A.
Cyrus, MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare
Pharmaceuticals. "The submission of riociguat is an important milestone in
our cardio-pulmonary pipeline and is an example of Bayer's commitment to
advancing treatment for hard to treat diseases."

The submission is supported by data from two global Phase III studies of
riociguat CHEST-1 and PATENT-1. Data from these two studies were presented in
October 2012 at CHEST 2012, the annual meeting of the American College of
Chest Physicians (ACCP). Both Phase III studies on riociguat met their
primary endpoint.

About CHEST
CHEST (Chronic Thromboembolic Pulmonary Hypertension sGC-Stimulator Trial) is
a
Phase III trial to assess the efficacy and safety of oral riociguat in the
treatment of patients with either inoperable CTEPH or CTEPH which has
persisted or reoccurred after pulmonary endarterectomy (PEA). CHEST is a
multi-center, multi-national program with active centers in 26 countries. The
program includes a randomized, double-blinded, placebo-controlled trial phase
(CHEST-1) and an open label extension trial phase (CHEST-2).

In the CHEST-1 study, 261 patients with inoperable CTEPH or with persistent or
recurrent CTEPH after PEA were randomized and treated with either riociguat or
placebo orally for 16 weeks. The primary endpoint of the trial was improvement
in 6-minute walking distance. Riociguat was titrated, over a period of eight
weeks in doses of 0.5 mg increments, from 1.0 mg up to 2.5 mg, three times a
day. After the titration phase, patients were followed up for another eight
weeks on their last dose to complete CHEST-1. Patients from both arms then had
the option of participating in the open label extension study (CHEST-2) after
completing an eight-week blinded sham titration. CHEST-2 is continuing to
investigate riociguat in CTEPH patients. Results of CHEST-2 will be presented
at an upcoming scientific congress in 2013.

About PATENT
PATENT (Pulmonary Arterial Hypertension sGC-Stimulator Trial) is a Phase III
trial to assess oral riociguat in the treatment of treatment naïve patient and
pre-treated patients with symptomatic PAH. PATENT is a multi-center,
multi-national program with active centers in 32 countries. The program
includes a randomized, double-blind, placebo-controlled trial phase (PATENT-1)
and an open label extension trial phase (PATENT-2).

In the PATENT-1 study, 445 patients with symptomatic PAH were randomized to
receive either placebo or two different doses of riociguat orally over a
period of 12 weeks. . The primary endpoint of the trial was improvement in
6-minute walking distance. The riociguat dose was titrated, over a period of
eight weeks in doses of 0.5 mg increments from 1.0 mg up to 2.5 mg three times
daily. Patients were then followed for an additional four weeks to complete
the study. Patients then had the option of participating in the open label
extension study, after completing an eight-week blinded sham titration.

About Riociguat
Riociguat (BAY 63-2521), discovered and developed at the Bayer research
laboratories, is an investigational oral soluble guanylate cyclase (sGC)
stimulator that is being studied in CTEPH and PAH, as well as other forms of
pulmonary hypertension. Riociguat is an investigational agent and is not
approved by the FDA, EMA or other health authorities.

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^® 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

Website: http://www.bayer.com
Contact: Marcy Funk, Communications, Bayer HealthCare, +1-973-305-5385,
marcy.funk@bayer.com
 
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