Roche has formed a licensing agreement with Meiji Seika Pharma and Fedora announced for the development and commercialization of OP0595, a beta-lactamase inhibitor in Phase I clinical development. Under the agreement, Roche obtains worldwide rights from both companies for development and commercialization with the exception of Japan, where Meiji will retain sole commercialization rights. Beta-lactamase inhibitors restore or potentiate the activity of beta-lactam antibiotics. The combination of OP0595 with a beta-lactam antibiotic targets severe infections caused by Enterobacteriaceae, including multi-drug-resistant strains.

Under the terms of the agreement, Meiji and Fedora will receive upfront plus development, regulatory and sales event milestone payments totaling potentially up to $750 million. In addition, Meiji and Fedora are entitled to receive tiered royalties on sales of products originating from this collaboration.

“There is an urgent need for new antibiotics able to combat the increasing resistance to antibiotics that is being seen worldwide,” said Janet Hammond, Head of Infectious Diseases for Roche Pharma Research and Early Development (pRED), in a company release. “Roche has a strong legacy in antibiotics and this collaboration demonstrates we are continuing to execute on our commitment. This beta-lactamase inhibitor has the potential for an expanded spectrum against multi-drug resistant bacteria and could be a much needed option for patients suffering from difficult-to-treat infections.”

Meiji Seika Pharma is a producer of antibacterial drugs based in Tokyo, Japan. Fedora Pharmaceuticals has developed a family of beta-lactamase inhibitors designed to have activity against pathogens containing all four classes of beta-lactamases. The beta-lactamase inhibitors under development at Fedora will be used in combination with various beta-lactam antibiotics to treat those antibiotic infections currently resistant to therapy. Fedora was founded in 2012 and is headquartered in Edmonton, Alberta, Canada.

Source: Roche