OREANDA-NEWS. Roche (SIX: RO, ROG; OTCQX: RHHBY), Meiji Seika Pharma (Meiji) and Fedora announced today that they have entered into a license agreement for the development and commercialization of OP0595, a beta-lactamase inhibitor in phase I clinical development. Under the agreement, 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.”

Under the terms of the agreement, 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.

Hitoshi Yamaguchi, Managing Executive Officer, Pharmaceutical Development Division of Meiji, commented: “We are delighted to be collaborating with the team at Roche to develop this novel therapy to address potentially life-threatening bacterial infections. 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.”

“We have seen truly impressive bacterial eradication in highly resistant strains generated by combination of this beta-lactamase inhibitor with existing beta-lactam antibiotics,” commented 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.”

About beta-lactamase inhibitors and beta-lactam antibiotics

The era of antibiotics began in the 1940s with the introduction of penicillin. The beta-lactam class which includes penicillins, cephalosporins, monobactams and carbapenems, contributes an estimated 65% of global antibiotic sales. The efficacy of these life-saving antibiotics is threatened by rising bacterial resistance caused by beta-lactamase enzymes which render the antibiotics increasingly ineffective. Beta-lactamase inhibitors are administered in combination with beta-lactam antibiotics to restore or extend their ability to treat bacterial infections caused by beta-lactamase producing, antibiotic-resistant bacteria.

About Antimicrobial resistance

The availability of penicillin in the 1940s led to a dramatic reduction in illness and death, and it became known as a ‘wonder drug’ which cured many different types of infections. However, overuse and inappropriate use of antibiotics has enabled infectious organisms to adapt to antimicrobial drugs. Some microorganisms develop resistance to single drugs while others develop resistance to several antimicrobial agents or even classes of drugs. These organisms are often referred to as multi-drug-resistant strains, and are threatening to undermine the tremendous life-saving power of antibiotics.

There are high proportions of antibiotic resistance in bacteria that cause common infections (e. g. urinary tract infections, pneumonia, bloodstream infections) and bacterial resistance to antibiotics occurs to varying degrees throughout the world. People infected with drug-resistant bacteria are at increased risk of worse clinical outcomes, are more likely to have longer and more expensive hospital stays, and may have a higher risk of death as a result of their infections.

In the USA, 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.

Antimicrobial resistance is a global problem driven by many interconnected factors. The need for coordinated action has been recognized by the US, the EU and their partner countries. The Transatlantic Taskforce for Antimicrobial Resistance (TATFAR) issued their progress report in May 2014. One of the report’s recommendations is incentives to stimulate the development of new antibacterial drugs for use in human medicine.

About Meiji Seika Pharma Co., Ltd. – Ethical Pharmaceuticals Business

Since beginning penicillin production in 1946, Meiji Seika Pharma (Meiji) has become a leading maker of antibacterial drugs. Through the years, Meiji has been accumulating a wealth of proprietary technologies on R&D, and manufacturing and providing pharmaceutical products of excellent quality to customers in Japan and overseas. Drawing on accumulated know-how in the specialty drug business, Meiji has recently begun supplying generic drugs that are comparable to specialty drugs in terms of quality, thereby serving as a "Specialty and Generic Pharmaceuticals Company" to accommodate customer’s diverse medical requirements.

About Fedora Pharmaceuticals

Fedora Pharmaceuticals, internationally recognized experts in this area, have developed a family of beta-lactamase inhibitors designed to have activity against pathogens containing all four classes of beta-lactamases. The beta-lactamase inhibitors under development at Fedora will be used in combination with various beta-lactam antibiotics to treat those antibiotic infections currently resistant to therapy. Fedora was founded in 2012 and is headquartered in Edmonton, Alberta, Canada. For more information on the company, please visit www.fedorapharma.com.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.