BASEL, Switzerland—Roche and privately held Polyphor Ltd., a pharmaceutical company specializing in the development of macrocycle drugs to address high unmet medical needs, have announced the establishment of an exclusive worldwide license agreement for the development and commercialization of POL7080, Polyphor’s investigational antibiotic indication for patients with bacterial infections caused by Pseudomonas aeruginosa.
Per the terms of the agreement, Roche will pay Polyphor 35 million Swiss francs (approximately $38.4 million) up front, for which it will receive a license to POL7080. Polyphor also stands to earn up to 465 million Swiss francs (approximately $509.9 million) in additional payments if certain development, regulatory and commercial milestones are met, and is also entitled to tiered double-digit royalties on product sales. Polyphor will have an option to co-promote an inhaled formulation of the compound in Europe. The transaction is subject to customary regulatory clearances.
“We are delighted about this license agreement,” Jean-Pierre Obrecht, CEO and co-founder of Polyphor, commented in a statement. “Roche is an ideal partner for POL7080, due to its long history of antibiotic development coupled with its strong scientific, clinical and commercial capabilities. This agreement is also an important milestone for Polyphor as it is a further validation of our macrocycle technologies and rewards more than 10 years of research and development efforts. We are proud that Roche is building on our discovery and clinical results to bring this urgently needed product to the patients as rapidly as possible.”
Pseudomonas aeruginosa is a Gram-negative bacterium that accounts for one in every 10 hospital-acquired infections in the United States, according to the U.S. Centers for Disease Control and Prevention (CDC), and the Infectious Diseases Society of America currently lists it as of one of the six most dangerous drug-resistant microbes. Infections most often strike people in hospitals—leading to infections of the blood, pneumonia or post-surgical infections—though healthy people can also be affected, according to the CDC. The European Centre for Disease Prevention and Control (ECDC) notes that more than 15 percent of Pseudomonas aeruginosa isolates proved resistant to at least three classes of antibiotics, with nearly 5 percent proving resistant to all fives classes under surveillance. Antimicrobial resistance currently accounts for 25,000 deaths and related healthcare and lost productivity costs of more than 1.5 billion euros (approximately $2 billion) annually, according to a joint 2009 report from the ECDC and the EMEA.
POL7080 has demonstrated clinical safety and tolerability in a Phase I trial in healthy volunteers in Europe, with all primary study objectives met. In preclinical studies, the compound proved to be highly active against a panel of clinical isolates, including multi-drug resistant Pseudomonas bacteria, with significant efficacy in vivo against septicemia, lung and thigh infection models, Polyphor notes on its website.
“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,” Janet Hammond, head of Infectious Diseases Discovery & Translational Area in Roche pRED, said in a press release. “We are excited to partner with Polyphor as we 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.”