FDA Grants QIDP Designation to Bayer's Amikacin Inhale and Ciprofloxacin Dry Powder for Inhalation

WHIPPANY, N.J., Nov. 24, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has granted qualified infectious disease product (QIDP) designation to two Bayer investigational agents, Amikacin Inhale and Ciprofloxacin Dry Powder for Inhalation (DPI).  The QIDP designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, passed by the US Congress in July 2012 to encourage pharmaceutical companies to develop new antimicrobial drugs.  Antimicrobial drugs designed to treat serious and life-threatening infections, designated as QIDP, are eligible for fast-track designation, priority review by FDA and a five-year extension of market exclusivity.  Amikacin Inhale is being developed by Bayer HealthCare in collaboration with Nektar Therapeutics (NASDAQ: NKTR).

Amikacin Inhale (BAY 41-6551) is being investigated to evaluate the efficacy and safety of adjunctive aerosolized amikacin inhalation solution versus aerosolized placebo in the treatment of intubated and mechanically ventilated adult patients with Gram-negative pneumonia receiving standard of care intravenous antibiotics. Ciprofloxacin DPI is being investigated to evaluate if the time to first pulmonary exacerbation of bronchiectasis can be prolonged, or its frequency reduced, by inhalation of ciprofloxacin for 28 days every other 28 days, or for 14 days every other 14 days over 48 weeks, in patients suffering from non-cystic fibrosis bronchiectasis[i]. 

"We welcome the QIDP designation for Ciprofloxacin DPI and Amikacin Inhale, as we continue investigating the safety and efficacy of their use in delivering anti-infective therapy directly to the lungs of patients suffering from non-cystic fibrosis bronchiectasis and intubated and mechanically ventilated patients suffering from Gram-negative pneumonia respectively," said Dario Mirski, MD, Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.  "Bayer is committed to researching ways to deliver appropriate therapies to patients suffering from these very serious diseases."

About Amikacin Inhale

Amikacin Inhale (BAY 41-6551), is the development name for an integrated drug-device combination, developed by Bayer HealthCare in collaboration with Nektar Therapeutics as an adjunctive therapy for intubated and mechanically ventilated patients with Gram-negative pneumonias. It comprises Amikacin Inhalation Solution delivered by a Pulmonary Drug Delivery System (PDDS). Amikacin Inhale is being investigated in two configurations, an on-vent drug-device that works within the ventilator setting, and an off-vent drug-device for extubated patients.  

About Ciprofloxacin DPI

Ciprofloxacin dry powder for inhalation (DPI) is the development name of a drug-device combination currently being investigated in non-cystic fibrosis bronchiectasis (NCFB) by Bayer HealthCare. It combines Ciprofloxacin DPI 32.5 mg (formulated using Novartis' PulmoSphere™ technology) with the Novartis T-326 inhaler, a small, portable manually breath-activated device.

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 Pharmaceuticals Inc. 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.

[i] Clinicaltrials.gov

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