Roche has obtained rights from Meiji Seika Pharma (Meiji) and Fedora Pharmaceuticals to develop and commercialize the Phase I beta-lactamase inhibitor OP0595 worldwide except Japan, as part of a treatment designed to fight bacterial resistance to antibiotics. The deal—which reflects growing interest by Roche in developing infectious-disease drugs—could generate up to $750 million for the two licensors.
OP0595 is an injection drug that targets beta-lactamase enzymes in combination with new or existing beta-lactam antibiotics, with the goal of enhancing their effectiveness in difficult-to-treat bacterial infections. Roche envisions developing OP0595 as part of a combination therapy with a beta-lactam antibiotic that will target severe infections caused by Enterobacteriaceae, including multidrug-resistant strains.
Under their licensing agreement with Roche, Meiji, and Fedora will receive upfront plus payments tied to development, regulatory and sales event milestones that could total up to $750 million. Meiji and Fedora are also entitled to tiered royalties on sales of products originating from the partnership.
Meiji retains sole commercialization rights in Japan.
“Roche has a strong legacy in antibiotics and this collaboration demonstrates we are continuing to execute on our commitment,” Janet Hammond, head of infectious diseases for Roche Pharma Research and Early Development (pRED), said in a statement. “This beta-lactamase inhibitor has the potential for an expanded spectrum against multidrug resistant bacteria and could be a much needed option for patients suffering from difficult-to-treat infections.”
OP0595 is Roche’s latest move toward rebuilding its infectious diseases antibiotics specialty—a therapeutic area the pharma giant left more than a decade ago. Roche returned to the space in 2013 by partnering with Polyphor to develop and commercialize its Phase II-initiated investigational macrocycle antibiotic POL7080 for bacterial infections caused by Pseudomonas aeruginosa. That collaboration could net Polyphor up to CHF 500 million ($490.4 million).
Roche followed up that deal early last year, by launching with an up-to-$191 million-plus collaboration with Discuva aimed at discovering and developing new antibiotics for infections caused by multidrug resistant Gram-negative bacteria.
According to Roche, an estimated 65% of global antibiotic sales is generated by beta-lactam class antibiotics—which include penicillins, cephalosporins, monobactams, and carbapenems. Yet their efficacy has been threatened by growing bacterial resistance caused by beta-lactamase enzymes which render the antibiotics increasingly ineffective. Roche reasons that efficacy can be restored through a combination treatment that includes a beta-lactamase inhibitor.
As of December 11, OP0595 completed a Phase I trial assessing its safety, tolerability, and pharmacokinetic profile in healthy male, Caucasian, adult subjects at single escalating doses after seven days following intravenous administration.
OP0595 is one of three infectious disease compounds in Meiji’s R&D pipeline. The other two are ME1100 (arbekacin), another Phase I compound indicated to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia; and ME1111, an Antionychomycosis treatment in Phase II development.
Developing beta-Lactamase inhibitors is the specialty of Fedora, which is working to build a portfolio of the compounds. Fedora’s lead product, FPI-1459, is a Phase I candidate, while another compound, FPI-1465, showed activity in several in vitro and preclinical animal models of infection against pathogens containing all four β-lactamase classes, including the metallo-family of β-lactamase enzymes.
Fedora has acquired rights to a family of β-lactamase inhibitors discovered by scientists at Naeja Pharmaceuticals.