Navigation Links
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 /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 treating diseases.

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

BAYER® and the Bayer Cross® are registered trademarks of 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 website at 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.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Bayer Employees Named Rising Stars by Healthcare Businesswomens Association
2. Regeneron and Bayer Announce Co-Promotion Agreement With Santen For EYLEA® (aflibercept) Injection in Japan
3. Bayer Partnership Delivers Industry-First Dose Management Offering
4. Zacks Bull and Bear of the Day Highlights: Discover Financial Services, POSCO, AstraZeneca, Bayer and Takeda Pharmaceutical
5. U.S. FDA Grants Priority Review to the New Drug Application for Bayers Regorafenib to Treat Patients with Metastatic Colorectal Cancer
6. Bayer Submits New Drug Application for Regorafenib for the Treatment of Gastrointestinal Stromal Tumors (GIST)
7. Hagens Berman Sobol Shapiro LLP and Douglas & London P.C. Announce Proposed Class Action Settlement in Bayer Combination Aspirin Products Litigation
8. MediSapiens sapprête à fournir à Bayer HealthCare Pharmaceuticals une nouvelle application informatique en nuage pour analyser et visualiser les données génomiques multidimensionnelles
9. MediSapiens liefert neue Cloud-Computing-App zur Analyse und Visualisierung multidimensionaler Genomdaten an Bayer HealthCare Pharmaceuticals
10. MediSapiens to Provide Bayer HealthCare Pharmaceuticals With a New Cloud Computing Application to Analyze and Visualize Multi-Dimensional Genomics Data
11. Bayers Second Annual Virtual Walk for Hemophilia Raises Funds, Generates Excitement in the Hemophilia Community
Post Your Comments:
(Date:6/23/2016)... Ill. and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment ... Astellas Farma Brasil as the company,s second affiliate in Latin America . ... ... General Manager of Astellas Farma Colombia ... ...
(Date:6/23/2016)... PRINCETON, N.J. , June 23, 2016  Guerbet ... of Premier Inc.,s Supplier Horizon Award . ... this year, Guerbet was recognized for its support of ... value creation through clinical excellence, and commitment to lower ... delighted to receive this recognition of our outstanding customer ...
(Date:6/23/2016)... June 23, 2016 Research and ... Procedure Volumes: Global Analysis (United States, China, Japan, Brazil, ... report to their offering. ... for healthcare business planners, provides surgical procedure volume data ... trends with an in-depth analysis of growth drivers and ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... ... People across the U.S. are sharpening their pencils and honing their writing ... which patients and their families pay tribute to a genetic counselor by nominating him ... Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In April, Genome ...
(Date:6/24/2016)... New York, NY (PRWEB) , ... June 24, ... ... lifestyle publication Haute Living, is proud to recognize Dr. Barry M. Weintraub as ... believes that “the most beautiful women in the world, and the most handsome ...
(Date:6/24/2016)... ... June 24, 2016 , ... Strategic Capital Partners, LLC ... by obtaining investment capital for emerging technology companies. SCP has delivered investment ... resulted in more than a million dollars of capital investment for five companies. ...
(Date:6/24/2016)... ... ... Venture Construction Group (VCG) sponsors Luke’s Wings 5th ... Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, 20852. The event raised ... have been wounded in battle and their families. Venture Construction Group is a 2016 ...
(Date:6/24/2016)... Gilbert, Arizona (PRWEB) , ... June 24, 2016 ... ... Gilbert-based practice, is supporting the upcoming 2016 Miss Arizona pageant as its official ... primarily serves Scottsdale, Tempe, Mesa, and Chandler, Arizona. , Dr. Olson says ...
Breaking Medicine News(10 mins):