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:1/19/2017)... Incretin Mimetics/GLP-1 Agonists, SNDRIs, Lipase Inhibitors, Serotonin Receptor Agonists, Sympathomimetic-GABA ... drugs market is expected to grow at a CAGR of ... of 38.7% in the second half of the forecast period. The ... 2016 to 2027. The market is estimated at $1,058 million in ... ...
(Date:1/19/2017)... -- James Gilbart , ... 2):3-8; http://www.touchoncology.com/articles/optimising-clinical-outcomes-gastrointestinal-cancers-through-inhibiting-angiogenesis-and ...      ... in a supplement to European Oncology & Haematology ... by James Gilbart and Axel ...
(Date:1/19/2017)... , Jan. 19, 2017   Science Exchange , ... to announce that the first five replication studies ... have been published in eLife today. Despite intense ... the first practical evaluation of reproducibility rates that ... studies. Unlike other assessments of reproducibility, the results ...
Breaking Medicine Technology:
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... ... wellness products to enhance people’s everyday lives, recently attended the January ECRM Trade ... , ATP Science is known for its large range of supplements that keep ...
(Date:1/20/2017)... ... ... Michael and Betsy Brauser celebrated 5 years of Betsy’s participation in a ... has been life-saving as she has been on the trial for more than six ... ovarian cancer in 2009. She underwent standard chemotherapy but a year later went to ...
(Date:1/20/2017)... ... 20, 2017 , ... Vitamin Well has launched two new ... have been produced in collaboration with Zlatan Ibrahimovic and have been developed to ... a successful launch in Sweden last year, the next generation sports drinks VW+001 ...
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... “The Angel”: ... the Lord has set out for each of his children. “The Angel” is the ... School of Music in New York City, and impassioned writer. , When asked of ...
(Date:1/20/2017)... ... ... fine examination of how God handles sin, including how to let go of lingering guilt ... over ten long years has been waiting to release this powerful insight about forgiveness that ... serving the Lord for over twenty years, and he has been preaching and teaching the ...
Breaking Medicine News(10 mins):