Date: 2016-01-29
Type of information: Development agreement
Compound: ATM-AVI (aztreonam and avibactam)
Company: Allergan (Ireland), now Pfizer (USA - NY) AstraZeneca (UK)
Therapeutic area: Infectious diseases
Type agreement: development commercialisation
Action mechanism: antibiotic/beta-lactamase inhibitor. Aztreonam is a monobactam originally isolated from Chromobacterium violaceum. The monobactams are structurally different from other beta-lactam antibiotics (e.g., penicillins, cephalosporins, cephamycins). Avibactam is a next generation non-beta lactam beta-lactamase inhibitor.
Disease: infections caused by metallo ßlactamase MBL-producing Gram-negative pathogens
Details: * On January 29, 2016, Allergan 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 ßlactamase 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).
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.
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