Cardeas Pharma Announces that FDA Grants QIDP Designation and Fast Track Review for the Company’s Antibiotic Combination ProductCompany initiates phase 2 study
SEATTLE, WA – January 8, 2014 – Cardeas Pharma Corporation, a biopharmaceutical company focused on the development of innovative therapies for the treatment of multi-drug resistant (MDR) bacterial infections, announced today that the U.S. Food and Drug Administration (FDA) has designated their investigational antibiotic combination product, Amikacin Fosfomycin Inhalation System, as a Qualified Infectious Disease Product (QIDP) for the adjunctive treatment of mechanically ventilated patients with bacterial pneumonia. FDA additionally granted fast track review of the combination product development program under section 506(a)(2) of the Federal Food, Drug and Cosmetic Act.
QIDP designation provides certain incentives under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act as part of the FDA Safety and Innovation Act. These incentives include priority review and an additional five year extension of market exclusivity following product approval.
Enrollment has begun in Cardeas’ Phase 2 IASIS study of Amikacin Fosfomycin Inhalation System, a drug-device combination of antibiotic solutions and a proprietary delivery system, as a potential treatment for MDR bacterial infections. IASIS is a global randomized, double-blind, superiority trial designed to evaluate the safety and efficacy of twice-daily investigational product versus placebo in the adjunctive treatment of healthcare associated pneumonia (HCAP) in mechanically ventilated patients. Additional information concerning the Phase 2 study is available at www.clinicaltrials.gov. Cardeas completed its Phase 1b study in patients last year, with positive safety and tolerability findings at all doses tested in the study.
“The GAIN Act is intended to encourage development of products to treat the threat posed by highly resistant ‘superbugs.’ Cardeas is pleased that the FDA has recognized that our lead product, Amikacin Fosfomycin Inhalation System has value as a potential response to this urgent unmet public health need,” said Dr. Bruce Montgomery, CEO of Cardeas.
About Amikacin Fosfomycin Inhalation System
Cardeas has developed a novel antibiotic formulation of two drugs, Amikacin and Fosfomycin, with synergistic in vitro activity against highly resistant Gram-negative bacteria. The Amikacin Fosfomycin Inhalation System is intended as adjunctive therapy to IV antibiotics in mechanically-ventilated patients with Gram-negative bacterial pneumonia, including patients infected with MDR Gram-negative bacteria or those co-infected with Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA). The combination product consists of two investigational drug product components, Amikacin Inhalation Solution and Fosfomycin Inhalation Solution, and PARI’s Investigational eFlow® Inline Nebulizer System, a single-patient use nebulizer that creates small, uniform aerosol to deliver drug to the lungs.
About eFlow® Technology and PARI Pharma GmbH
Cardeas Pharma’s proprietary combination of amikacin/fosfomycin is delivered by an investigational eFlow Inline Nebulizer System developed by PARI Pharma and optimized for the amikacin fosfomycin combination product. The device incorporates eFlow Technology to enable efficient aerosol delivery of medication to intubated patients on a mechanical ventilator. eFlow Technology uses a vibrating, perforated membrane that includes thousands of laser-drilled holes. The eFlow nebulizer produces an aerosol with a small, precisely defined droplet size, reducing aerosol losses and improving delivery of nebulized drugs via the circuit of a ventilator. Designed as a single-patient, multi-treatment delivery system, the eFlow Inline nebulizer may be an important tool for caregivers treating patients on invasive and non-invasive ventilation. PARI Pharma focuses on the development of aerosol delivery devices and inhalation drug development to advance aerosol therapies. More information may be found online at www.paripharma.com.
About Cardeas Pharma Corporation
Cardeas Pharma is a privately held biopharmaceutical company dedicated to the development and commercialization of inhaled antibiotics to treat serious, hospital-acquired respiratory infections with highly antibiotic-resistant organisms. By combining novel formulations of proven antibiotics with cutting edge drug delivery technology, Cardeas seeks to address significant unmet medical needs in the critical-care setting. More information can be found at www.cardeaspharma.com.