Bayer's $175 million pneumonia drug fails at phase 3

Bayer has been hit by the news that its latest effort in the pneumonia space failed at the Phase 3 stage. The company revealed that Amikacin Inhale was unsuccessful in demonstrating superiority against placebo when used alongside standard of care in the treatment of intubated and mechanically ventilated patients with Gram-negative pneumonia.

Amikacin Inhale is a product of a potentially $175 million partnership in 2007 between Bayer and Nektar Therapeutics to co-develop and co-market the drug. The product itself is a combination of a specially formulated aminoglycoside antibiotic solution with Nektar’s Synchronized Inhalation System with a vibrating mesh nebuliser, designed to enable use in patients using mechanical ventilation units.

"The results of the INHALE study are disappointing, considering that morbidity and mortality remain significant in these patients," commented Bayer’s Head of Development Joerg Moeller. "However, the study provides important clinical data for this difficult-to-treat disease."

Amikacin Inhale had produced promising results during Phase 2 trials, achieving over 1,000 times greater lung exposure than standard intravenous administration.

The two companies also worked together on Cipro Inhale, another drug-device combination that was knocked back by the FDA last week as a treatment to reduce exacerbations in adults with non-cystic fibrosis bronchiectasis and bacterial respiratory pathogens, spelling yet another disappointment for the pair.