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Roche enters into antibiotic license deal with Meiji and Fedora

Roche has entered into a license agreement with Meiji Seika Pharma (Meiji) and Fedora to develop and commercialize OP0595, a beta-lactamase inhibitor currently in Phase I clinical development.

Roche Basel site

Beta-lactamase inhibitors are designed to restore or potentiate the activity of beta-lactam antibiotics.

As part of the deal, Roche secured worldwide rights from both companies to develop and commercialize with the exception of Japan, where Meiji will retain sole commercialization rights.

The company said that the combination of OP0595 with a beta-lactam antibiotic targets severe infections caused by Enterobacteriaceae, including multi-drug-resistant strains.

Roche head of Infectious Diseases for Pharma Research and Early Development (pRED) Janet Hammond said: "There is an urgent need for new antibiotics able to combat the increasing resistance to antibiotics that is being seen worldwide.

"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."

The deal will see Meiji and Fedora receive upfront plus development, regulatory and sales event milestone payments totalling potentially about $750m as well as they are entitled to receive tiered royalties on sales of products originating from this partnership.

Meiji managing executive officer Pharmaceutical Development Division Hitoshi Yamaguchi said: "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 founder and CEO Christopher Micetich said: "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."


Image: Roche site in Basel, Switzerland. Photo: courtesy of F. Hoffmann-La Roche Ltd.