Bayer's inhaler drug gets thumbs up in test
[Data from Phase II studies of NKTR's inhaled aminoglycoside, which was partnered with Bayer last Aug, show high lung exposure with/without mechanical ventilation. Two phase III will being in Q4:08.]
reuters.com
Tue May 20, 2008 9:44am EDT
FRANKFURT, May 20 (Reuters) - Bayer's (BAYG.DE: Quote, Profile, Research) experimental inhaler drug looked set to become a hit after a study of the device that patients use to inhale the antibiotic showed promising results, analysts said on Tuesday.
Deutsche Bank analysts said that the test results of drug-device combo Amikacin Inhale came as a surprise and that they expected the innovation could earn more than 200 million euros ($311 million).
Bayer and its partner, Nektar Therapeutics (NKTR.O: Quote, Profile, Research), are investigating the drug device for the treatment of Gram-negative pneumonia in intubated and mechanically-ventilated patients.
Gram-negative pneumonia, which is caused by a group of pathogens, accounts for a substantial proportion of pneumonia in intensive care units.
According to the Phase II study, Amikacin Inhale achieved over 1,000 times greater lung exposure to the antibiotic amikacin compared to injections.
"This shows that targeting antibiotic therapy to the site of infection might offer superior bacterial eradication ... which may result in a higher likelihood of the patient's survival," the companies said late on Monday.
Currently, Gram-negative pneumonia kills one in two mechanically-ventilated patients.
Michael Niederman, chairman of the Department of Medicine at the Winthrop University Hospital in New York and one of the lead investigators of the study, said mechanically-ventilated patients in critical care were at high risk of pneumonia.
"Intravenous therapies cannot always reach effective concentrations in infected lungs at tolerable doses," he said.
"The new study data shows that the device successfully delivers the antibiotic directly to the site of infection, without reaching high systemic concentrations."
Amikacin Inhale combines a liquid formulation of the aminoglycoside antibiotic amikacin with Nektar's proprietary Liquid Pulmonary Technology, designed to deliver amikacin deep into the infected lungs.
The companies said enrolment for two late stage studies to further assess its effectiveness and safety will start in the fourth quarter of 2008. |
