Navigation Links
Bayer Initiates Phase III Trial of Investigational Inhaled Amikacin Solution (BAY41-6551T) in Mechanically Ventilated Patients with Gram-negative Pneumonia
Date:4/16/2013

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 www.clinicaltrials.gov

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 www.nektar.com.

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 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.
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:
*Name:
*Comment:
*Email:
(Date:4/27/2016)... , April 27, 2016 ... titled, "Skincare Devices Market - Global Industry Analysis, Size, ... to the report, the global skincare devices market was ... anticipated to expand at a CAGR of 10.1% from ... 2023. Browse the full Skincare Devices Market (Treatment ...
(Date:4/27/2016)... April 27, 2016  Bayer Animal Health today ... from the University of Florida College of Veterinary ... Excellence in Communication Award (BECA). Brittany was selected ... awarded a total of $70,000 in scholarship funds ... years, Bayer has provided a total of $232,500 ...
(Date:4/27/2016)... , April 27, 2016 ... ), a developer of a new generation of ... positive overall survival results for Paclical/Apealea in the ... 789 patients with epithelial ovarian cancer. These preliminary ... Paclical/Apealea in combination with carboplatin versus Taxol in ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... , ... Our bodies are bombarded daily by environmental and lifestyle factors that ... is to adopt a more healthful diet, but too many people think that food ... Nutritionist and the creator of the Newport Beach Cleanse and 14-Day Eating Plan, disagrees ...
(Date:4/29/2016)... ... April 29, 2016 , ... Conditions were ideal for Global Lyme Alliance’s ... Sunday, with sunny skies, a light breeze and temperatures in the 60s. Over 400 ... 5k Run and Walk and 1-mile walk were held to increase awareness about ...
(Date:4/29/2016)... Kansas City, Missouri (PRWEB) , ... April 29, 2016 , ... ... Unlike traditional crutches which put pressure on the armpits, the M+D Crutch evenly distributes ... less strain on their wrists and hands when using the crutches than with other ...
(Date:4/29/2016)... , ... April 29, 2016 , ... New York City based oral and maxillofacial surgeon ... is a very effective way to treat obstructive sleep apnea. Dr. Jamali is proud to ... is a procedure that involves one or both jaw bones. This surgery is performed to ...
(Date:4/29/2016)... ... April 29, 2016 , ... Regenerative Medicine Solutions (RMS) scored ... satisfaction survey, earning them second place for Tampa’s Best Places to Work. They were ... “This is a great accomplishment for our team,” says RMS Human Resources Manager Irene ...
Breaking Medicine News(10 mins):