Bayer Initiates Phase III Trial of Investigational Inhaled Amikacin Solution
(BAY41-6551T) in Mechanically Ventilated Patients with Gram-negative Pneumonia
WAYNE, N.J., April 16, 2013
WAYNE, N.J., April 16, 2013 /PRNewswire/ --Bayer HealthCare Pharmaceuticals
Inc. announced today that patient enrollment is underway in its global Phase
III trial program to evaluate the efficacy and safety of adjunctive
aerosolized BAY41-6551 versus aerosolized placebo in the treatment of
intubated and mechanically ventilated patients with Gram-negative pneumonia
receiving standard of care intravenous antibiotics. BAY41-6551 consists of
amikacin inhalation solution delivered by a Pulmonary Drug Delivery System
(PDDS) developed by Nektar Therapeutics (NASDAQ: NKTR).
"Bayer continues to invest in research for potential treatment options for
many difficult to treat diseases," said Pamela A. Cyrus, MD, Vice President
and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "This
study is designed to evaluate the effectiveness of a solution of amikacin
formulated for inhalation, delivered through a proprietary drug delivery
system, as an adjunctive therapy for Gram-negative pneumonia in intubated and
mechanically ventilated patients."
About the Phase III INHALE Study Program
The global INHALE study program is comprised of two prospective, randomized,
double-blind, placebo-controlled, multicenter studies to evaluate the safety
and efficacy of BAY41-6551 as adjunctive therapy in intubated and
mechanically-ventilated patients with Gram-negative pneumonia receiving
standard of care intravenous antibiotics. The study will enroll patients age
18 or above that have microbiologically-confirmed pneumonia caused by
Gram-negative organisms. INHALE will be a large multi-center global program
involving centers in North America, South America, Europe, Japan, Australia
and Asia. For more information about the trial, please visit
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, Diabetes Care, and Pharmaceuticals divisions. As a specialty
pharmaceutical company, Bayer HealthCare Pharmaceuticals provides products for
Diagnostic Imaging, 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
About Nektar Therapeutics
BAY41-6551 is being developed through a collaboration with Nektar Therapeutics
(NASDAQ:NKTR). Nektar Therapeutics is a biopharmaceutical company developing
therapeutics based on its proprietary technology platforms. Nektar has a
robust R&D pipeline of therapeutic candidate in pain, oncology and other
therapeutic areas. Nektar is headquartered in San Francisco, California, with
additional operations in Huntsville, Alabama and Hyderabad, India. Further
information about the company and its drug development programs and
capabilities may be found online at www.nektar.com.
BAYER^® and the Bayer Cross^® are registered trademarks of Bayer.
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 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.
SOURCE Bayer HealthCare Pharmaceuticals Inc.
Contact: Marcy Funk, +1-973-305-5385, firstname.lastname@example.org
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