Roche, the world’s largest biotech company and frontrunner in providing medicines in oncology, immunology, and infectious diseases has joined forces with Meiji Seika Pharma Co., Ltd. and Fedora Pharmaceuticals to fight increasing bacterial resistance to antibiotics. Under the agreement, Roche has obtained worldwide rights (except Japan) from both companies for development and commercialization of OP0595, a beta-lactamase inhibitor in phase I clinical development.
Roche aims to develop OP0595 as part of a combination therapy with a beta-lactam antibiotic that will target severe infections caused by Enterobacteriaceae, including multidrug-resistant strains.
In the press release announcing the agreement, Janet Hammond, Head of Infectious Diseases for Roche Pharma Research and Early Development (pRED) said, “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.”
Difficult-to-treat bacterial infections are a global problem. In 2013, the Centers for Disease Control and Prevention (CDC), reported that superbugs or bacteria that are increasingly resistant to common antibiotics are responsible for about 2 million infections and more than 23,000 deaths each year, with many more fatalities from conditions that are complicated by antibiotic-resistant infections.
Bacteria can develop drug resistance when antibiotics are used too often or without a purpose (such as to treat a viral infection), an antibiotic is stopped too early or if the patient does not follow the dose or schedule instructions for an antibiotic. While taking the medication can destroy harmful bacteria, improper use of antibiotics can leave some of the resistant bacteria to stay in the body and grow. This can lead to further infection in the same person and cause it to spread to others, spawning strains of bacteria that are more difficult to treat.
Meiji Seika Pharma (Meiji) is a leading maker of antibacterial drugs. Hitoshi Yamaguchi, Managing Executive Officer, Pharmaceutical Development Division of Meiji, said that the development of OP0595 is the outcome of Meiji’s proud legacy in anti-infective medicines.
Fedora Pharmaceuticals is dedicated to the discovery and development of novel antibiotics targeting life-threatening microbial drug resistance, and have developed a family of beta-lactamase inhibitors designed to confront pathogens containing all four classes of beta-lactamases.
Under the terms of the agreement with Roche, Meiji and Fedora will receive upfront plus development, regulatory and sales event milestone payments totaling potentially up to $750 million and will also receive tiered royalties on sales of products arising from the partnership.