Roche, Meiji Seika Pharma and Fedora have entered into a license agreement for the development and commercialization of OP0595, a beta-lactamase inhibitor in phase I clinical development. Meiji Seika Pharma is a Japan-based maker of antibacterial drugs. Fedora Pharmaceuticals is headquartered in Edmonton, Alberta, Canada.

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.

"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). "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 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.

"We have seen truly impressive bacterial eradication in highly resistant strains generated by combination of this beta-lactamase inhibitor with existing beta-lactam antibiotics," said Christopher G. Micetich, founder and CEO of Fedora Pharmaceuticals. "The properties of OP0595 and its ability to be combined with new or existing beta-lactam antibiotics promise a significant advance in the battle against increasing multi-drug-resistant bacteria."

In the U.S., the Centers for Disease Control (CDC) estimates that more than two million patients are affected by drug-resistant infections each year, with direct healthcare costs as high as $20 billion and with additional costs to society for lost productivity potentially doubling these figures.