Roche has signed a licensing agreement with Polyphor to develop and commercialise Polyphor’s investigational macrocycle antibiotic, POL7080, for the treatment of patients suffering from bacterial infections caused by Pseudomonas aeruginosa.
Under the deal, Roche will pay around CHF500m ($548m) to Polyphor, which includes an upfront payment of CHF35m ($38m) and milestone payments upon reaching certain development, regulatory and commercial milestones, potentially up to CHF465m ($509m).
In addition, Polyphor is eligible to receive tiered double-digit royalties on product sales and will retain the option to co-promote an inhaled formulation of POL7080 in Europe.
Roche head of infectious diseases discovery and translational area Janet Hammond said the deal is part of the company’s strategy to focus on areas of high unmet medical need and build a portfolio of novel antibiotics.
"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," Hammond said.
POL7080 kills Pseudomonas aeruginosa, a so-called ‘superbug’ bacterium found in hospitals and resistant to many antibiotic treatments, by a novel mode of action.
Polyphor CEO and co-founder Jean-Pierre Obrecht said: "This agreement is also an important milestone for Polyphor as it is a further validation of our macrocycle technologies and rewards more than ten years of research and development efforts."
According to Roche, POL7080 demonstrated clinical safety and tolerability in a Phase I clinical trial and could be developed for combating life-threatening infections with Pseudomonas aeruginosa, which frequently occur in the hospital setting and chronic lung infections.
In preclinical studies, POL7080 was highly active on a broad panel of clinical isolates, including multi-drug resistant Pseudomonas bacteria with outstanding in vivo efficacy in septicaemia, lung and thigh infection models.
POL7080 belongs to a proprietary new class of antibiotics; it selectively kills the dangerous bacteria Pseudomonas aeruginosa and opens up new treatment options for serious and often life-threatening infections.
Antimicrobial resistance is a growing healthcare concern worldwide, as antibiotics lose effectiveness over time and bacteria evolve and mutate, becoming resistant.
Pseudomonas aeruginosa causes one in every ten hospital-acquired infections in the US and is listed as one of the six most dangerous drug-resistant microbes, according to Roche.
Image: Phagocytosis of bacteria Pseudomonas aeruginosa by neutrophil in patient with bloodstream infection. Photo: courtesy of Paulo Henrique Orlandi Mourao.