Allergan plc (NYSE: AGN) today announced that it has entered into a global agreement with AstraZeneca to develop and commercialize ATM-AVI, an investigational, fixed-dose antibiotic combining aztreonam and avibactam. Together, the two companies will evaluate the combination to treat serious infections caused by metallo βlactamase MBL-producing Gram-negative pathogens, a difficult-to-treat sub-type of carbapenem-resistant Enterobacteriaceae (CRE), for which there are currently very limited treatments, thus presenting a new treatment option for patients with MBL-producing pathogens. Under the terms of the agreement, Allergan will maintain commercialization rights in the U.S. and Canada and AstraZeneca will maintain commercialization rights in all other countries.
ATM-AVI is the first drug candidate to be developed under a public-private partnership agreement between AstraZeneca and the Biomedical Advanced Research and Development Authority (BARDA), a part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR). Announced in September 2015, the goal of this strategic alliance is to develop a portfolio of drug candidates over the next five years with dual uses in treating illnesses caused by bioterrorism agents and antibiotic-resistant infections.
"The rate of antibiotic resistance continues to increase worldwide, representing a truly global threat that requires collaboration and sustained commitment from industry and government to develop solutions," said David Nicholson, Executive Vice President, Global Brands Research and Development, Allergan. "As a leader in anti-infectives, we are dedicated to the ongoing research and development of innovative products, like ATM-AVI, for patients with difficult-to-treat infections who, today, have very few or no effective options."
Aztreonam is not inactivated by MBLs, as a single agent it has limited utility because the vast majority of MBL-producing pathogens also express serine-β-lactamases that can inactivate it. With avibactam's ability to inhibit many serine-β-lactamase enzymes, aztreonam's activity is restored against pathogens that co-produce MBLs and serine enzymes, thus presenting a new treatment option for patients.
"This collaboration represents an important milestone in the development of ATM-AVI. Antimicrobial resistance is a huge global health challenge, which is increasingly at the forefront of the public health agenda. We look forward to working with health authorities to help bring this much-needed new treatment option to patients," said Hans Sijbesma, Managing Director, Antibiotics Business Unit, AstraZeneca.
The European Union's Innovative Medicines Initiative (IMI), a partnership between the European Union and the European pharmaceutical industry, is currently supporting the Phase 2 clinical study of ATM-AVI in Europe under a project called COMBACTE-CARE and is joining. BARDA and AstraZeneca in supporting global phase 3 clinical development needed to apply for regulatory approval of ATM-AVI.