Amikacin Inhale Shows Promising Results in Phas...(ection without reaching highsystemic con...),Health

Amikacin Inhale is a unique drug-device combination, being developed by Bayer HealthCare in cooperation with Nektar Therapeutics, combining a special liquid formulation of the aminoglycoside antibiotic amikacin with Nektar Therapeutics' proprietary Liquid Pulmonary Technology (LPT(TM)), designed to deliver amikacin deep into the infected lungs.

The device can be integrated into mechanical ventilation systems and can also be used as a handheld 'off-vent' device for patients no longer requiring breathing assistance. This allows for a unique full course of drug therapy in critically ill patients with Gram-negative pneumonia. 'Gram-negative pneumonia' refers to pneumonia caused by a laboratory-defined group of pathogens, the Gram-negative bacteria. These account for a substantial proportion, if not the majority of pneumonias in intensive care units (ICUs).

"A challenge in treating Gram-negative pneumonia in ICUs is that they have grown increasingly resistant to currently available antibiotics," said Professor Donald Low, Head of the Department of Microbiology at the Toronto Medical Laboratories and Mount Sinai Hospital, Toronto, Canada. "A new treatment option such as Amikacin Inhale, which fights pneumonia directly at the site of infection, may be able to help decrease resistance -- especially if concomitant intravenous antibiotic therapy can also be reduced."

Amikacin Inhale will enter Phase III trials later this year to further assess its efficacy and safety in mechanically ventilated patients with Gram-negative pneumonia. The enrolment for two pivotal Phase III studies will start in the fourth quarter of 2008.

About Phase II Studies

High Amikacin Lung Deposition in MVP(2)

In the multi-center, randomized, double-blind, placebo-controlled Phase II study mechanically ventilated patients (MVP) received 400 mg doses of amikacin with Amikacin Inhale every 24 hours (n=2
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