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.
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model—Growth Pharma. Allergan is focused on developing, manufacturing, and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines, and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, health care providers, and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
For more information, visit Allergan's website at www.allergan.com.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. It is important to note that Allergan's goals and expectations are not predictions of actual performance. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the inherent uncertainty associated with financial projections; the difficulty of predicting the timing or outcome of FDA or other regulatory approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; costs and efforts to defend or enforce intellectual property rights; the availability and pricing of third party sourced products and materials; successful compliance with governmental regulations applicable to Allergan's facilities, products and/or businesses; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2014, Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015, Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, and from time to time in Allergan's other investor communications. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
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