Fedora Pharmaceuticals Inc.

January 13, 2015 By Mark Terry , BioSpace.com Breaking News Staff Swiss-based Roche announced today it had inked a $750 million deal with Japan’s Meiji Seika Pharma and Canada’s Fedora Pharmaceuticals for a beta-lactamase inhibitor OP0595 for antibiotic resistant bacteria. Roche will develop and commercialize the compound worldwide, except Japan. Meiji will maintain Japanese rights to the drug. “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 in a statement. “ 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.” Beta-lactamase inhibitors act to potentiate, or in some cases, restore the activity of beta-lactam antibiotics. OP0595, in combination with beta-lactam antibiotics, improves response to multi-drug-resistant strains of Enterobacteriaceae. Beta-lactam antibiotics include penicillins, cephalosporins, monobactams and carbapenems. They account for approximately 65 percent of antibiotic sales worldwide. As part of the deal, Meiji and Fedora will receive upfront payments as well as development, regulatory and sales milestone payments. Both Meiji and Fedora may receive tiered royalties. Meiji is a leading maker of antibacterial drugs. It also is a major supplier of generic drugs comparable to specialty drugs. “We are delighted to be collaborating with the team at Roche to develop this novel therapy to address potentially life-threatening bacterial infections,” said Hitoshi Yamaguchi , managing executive officer of the Pharmaceutical Development Division of Meiji in a statement. “The therapy is the outcome of our proud legacy in anti-infective medicines. Combined with Roche ’s extensive global development, manufacturing and commercial expertise, we look forward to a successful clinical development culminating in making this novel medicine available.” Fedora Pharmaceuticals , headquartered in Edmonton, Alberta, Canada, has developed a family of beta-lactamase inhibitors that shows activity against bacterial pathogens that contain all four classes of beta-lactamases. The company was founded in 2012. “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 Micetich , founder and chief executive of Fedora in a statement. “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.”