Roche and Polyphor, a privately-held Swiss pharmaceutical company, have entered into an exclusive worldwide license agreement to develop and commercialize Polyphor’s investigational macrocycle antibiotic, POL7080, for patients suffering from bacterial infections caused by Pseudomonas aeruginosa.

Roche will make an upfront payment of $39 million to Polyphor and development, regulatory and commercial milestones, potentially up to $519.5 million. In addition, Polyphor is entitled to receive tiered, double-digit royalties on product sales. Polyphor will retain the option to co-promote an inhaled formulation of POL7080 in Europe. The transaction is subject to customary regulatory clearances including termination of the applicable Hart-Scott-Rodino waiting period.

Antimicrobial resistance represents a major threat to public health worldwide, leading to 25,000 deaths and related costs of over $2 billion in healthcare expenses and productivity losses in the European Union alone each year. Pseudomonas aeruginosa accounts for one in every 10 hospital-acquired infections in the U.S. and is listed as one of the six most dangerous drug-resistant microbes. Over 15% of Pseudomonas aeruginosa isolates were resistant to at least three classes of antibiotics and close to 5% were resistant to all five classes under surveillance.

POL7080 belongs to a new class of antibiotics that kills Pseudomonas aeruginosa by a novel mode of action. It has demonstrated clinical safety and tolerability in a phase I clinical trial and holds promise for the treatment of serious and often life-threatening bacterial infections caused by multi-drug-resistant (MDR) Pseudomonas species.

“As part of our Infectious Diseases research strategy we focus on areas of high unmet medical need, where we feel we can make the most difference for patients. We are excited to partner with Polyphor as we build a portfolio of novel antibiotics,” said Janet Hammond, head of infectious diseases discovery and translational area in Roche pRED. “As the incidence of drug-resistant infections is creating an urgent demand for new therapeutic options, we look forward to adding this potentially important, targeted agent with a novel mechanism of action to our portfolio of innovative medicines.”