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Amikacin Inhale Shows Promising Results in Phase II Study

Tuesday, May 20, 2008 General News J E 4
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TORONTO and BERLIN, May 19 Bayer HealthCaretogether with Nektar Therapeutics (Nasdaq: NKTR), today presented positivepreliminary Phase II data on their unique drug-device combination AmikacinInhale at the American Thoracic Society (ATS) annual meeting. AmikacinInhale, currently being studied for the adjunctive treatment of Gram-negativepneumonia in intubated and mechanically-ventilated patients, achieved over1000 times greater lung exposure to the antibiotic amikacin as compared tointravenous route of administration. This shows that targeting antibiotictherapy to the site of infection might offer superior bacterial eradicationand increased efficacy, which may result in a higher likelihood of thepatient's survival. Currently, Gram-negative pneumonia carries a mortalityrisk as high as 50 percent in mechanically-ventilated patients(1).

"Mechanically-ventilated patients in critical care units are atparticularly high risk of developing pneumonia. Most of them are alreadyseriously ill because of severe underlying diseases," said Professor MichaelNiederman, Chairman, Department of Medicine, Winthrop University Hospital, NewYork, and one of the lead investigators of the study. "Because of the highmorbidity and mortality of Gram-negative pneumonia, fast and efficienttreatment is essential. Intravenous therapies cannot always reach effectiveconcentrations in infected lungs at tolerable doses. The new study data showsthat the device successfully delivers the antibiotic directly to the site ofinfection, without reaching high systemic concentrations."

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

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

"A challenge in treating Gram-negative pneumonia in ICUs is that they havegrown increasingly resistant to currently available antibiotics," saidProfessor Donald Low, Head of the Department of Microbiology at the TorontoMedical Laboratories and Mount Sinai Hospital, Toronto, Canada. "A newtreatment option such as Amikacin Inhale, which fights pneumonia directly atthe site of infection, may be able to help decrease resistance -- especiallyif concomitant intravenous antibiotic therapy can also be reduced."

Amikacin Inhale will enter Phase III trials later this year to furtherassess its efficacy and safety in mechanically ventilated patients withGram-negative pneumonia. The enrolment for two pivotal Phase III studies willstart 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 IIstudy mechanically ventilated patients (MVP) received 400 mg doses of amikacinwith Amikacin Inhale every 24 hours (n=24) or every 12 hours (n=21) for 7-14days.

Serial serum, tracheal aspirate and urine samples were collected on Day 3.Clinical parameters, such as Clinical Pulmonary Infection Score (CPIS), dayson ventilator and intravenous antibiotic use were monitored. In another studyhealthy volunteers (n=14) inhaled a single dose of 400 mg of amikacin via theproprietary delivery system using the hand held adaptor. This was done tocom
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