NKTR-061 (BAY41-6551)

Market information
NKTR-061, also known as BAY41-6551, is under development by Nektar’s partner, Bayer, to treat Gram-negative pneumonias, including Hospital-Acquired (HAP), Healthcare-Associated (HCAP) and Ventilator-Associated pneumonias (VAP). Gram-negative pneumonias are often the result of complications of other patient conditions or surgeries. Gram-negative pneumonia carries a mortality risk of over 50 percent in mechanically-ventilated patients and accounts for a substantial proportion of the pneumonias in intensive care units (ICUs) today.

NKTR-061 Clinical Data and Product Profile
NKTR-061, the Amikacin Inhale drug-device combination product, is being developed in partnership with Bayer HealthCare. Amikacin Inhale will be adjunctive therapy to the current antibiotic therapies administered intravenously as standard of care. The targeted aerosol delivery platform in NKTR-061 delivers antimicrobial agent directly to the site of infection in the lungs. The product can be integrated with conventional mechanical ventilators or used as a hand-held 'off-vent' device for patients no longer requiring breathing assistance.

Phase 2 clinical data for Amikacin Inhale shows that patients achieved over 1,000 times greater lung exposure to the antibiotic amikacin with NKTR-061 than the IV route of administration. Targeting the antibiotic therapy to the site of infection could offer superior bacterial eradication and increased efficacy, which may result in a higher likelihood of survival.

May 15-20, 2009 American Thoracic Society (ATS) 2009 International Conference San Diego, CA

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