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January 31, 2016

Allergan and AstraZeneca to develop ATM-AVI for antibiotic-resistant gram-negative infections

Irish drug-maker Allergan has entered into a global agreement with UK's AstraZeneca to develop and commercialise ATM-AVI, an investigational, fixed-dose antibiotic combining aztreonam and avibactam.

Irish drug-maker Allergan has entered into a global agreement with UK’s AstraZeneca to develop and commercialise ATM-AVI, an investigational, fixed-dose antibiotic combining aztreonam and avibactam.

The firms will jointly 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.

ATM-AVI is the first drug candidate to be developed under a public-private partnership (PPP) agreement signed between AstraZeneca and the Biomedical Advanced Research and Development Authority (BARDA) in September last year.

BARDA is part of the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).

"The rate of antibiotic resistance continues to increase worldwide, representing a truly global threat that requires collaboration and sustained commitment."

As part of the new deal, Allergan will be responsible for maintaining commercialisation rights in the US and Canada, while AstraZeneca will maintain commercialisation rights in all other countries.

Allergan Global Brands Research and Development executive vice-president David Nicholson said: "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.

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"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."

According to Astrazeneca, 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-ß-lactamases that can inactivate it.

Avibactam has the ability to inhibit many serine-ß-lactamase enzymes and by using this, aztreonam’s activity is restored against pathogens that co-produce MBLs and serine enzymes.

Currently, the European Union’s Innovative Medicines Initiative (IMI) is supporting and joining the Phase II clinical trial of ATM-AVI in Europe under a project called COMBACTE-CARE.

IMI is a partnership between the European Union and the European pharmaceutical industry.

In order to support global Phase III clinical development, BARDA and AstraZeneca will have to apply for regulatory approval of ATM-AVI.

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