Allergan Announces Collaboration with AstraZeneca to Develop and Commercialize ATM-AVI for Antibiotic-Resistant Gram-Negative Infections

PRESS RELEASE

DUBLIN

,

Jan. 29, 2016

/PRNewswire/ --

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.