Allergan Receives FDA Qualified Infectious Disease Product (QIDP) Designation And Fast Track Designation For ATM-AVI (Aztreonam And Avibactam) For Antibiotic-Resistant Gram-Negative Infections

-- FDA QIDP and Fast Track Designations Signify Significant Milestones in Allergan Commitment to Addressing Unmet Medical Needs in the Treatment of Antibiotic Resistant Infections --

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Allergan plc

Nov 11, 2019, 07:30 ET

DUBLIN, Nov. 11, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation for ATM-AVI (aztreonam and avibactam), for the treatment of complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI), and hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP). ATM-AVI is an investigational, fixed-dose, intravenous combination antibiotic under development globally.

"The rate of antibiotic resistance is increasing worldwide and there are limited options available to patients with these challenging and life-threatening infections, underscoring the need for the pharmaceutical industry and government to work together to bring forward new potential treatment options," said David Nicholson, EVP and Chief R&D Officer, Allergan. "The QIDP Designation shows the importance of ATM-AVI for treating serious or life-threatening infections, and the Fast Track Designation allows us to work even closer with the FDA to bring patients a new treatment faster."

The QIDP designation provides certain incentives for the development of new antibiotics, including priority review and eligibility for the FDA's Fast Track Designation, and a five-year regulatory exclusivity extension. The Fast Track Designation is designed to facilitate the development, and accelerate the review of drugs to treat serious conditions that do not have sufficient treatment options.

ATM-AVI has activity against metallo β-lactamase (MBL)-producing Gram-negative pathogens, for which there are currently very limited treatmentoptions. Although aztreonam is not inactivated by metallo beta-lactamases (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. When combined with avibactam's ability to inhibit many serine-β-lactamases , aztreonam's activity is restored against pathogens that co-produce MBLs and serine enzymes, thus presenting a new treatment for patients with these infections. ATM-AVI is currently in Phase III trials.

ATM-AVI is being jointly developed with Pfizer. Allergan holds the rights to commercialize ATM-AVI in North America, while Pfizer holds the rights to commercialize this investigational therapy in the rest of the world.

ATM-AVI is a drug candidate under development and supported by public-private partnerships between Pfizer and the Biomedical Advanced Research and Development Authority (BARDA)*, and between Pfizer and the European Union's Innovative Medicines Initiative (IMI) – a partnership between the European Union and the European pharmaceutical industry, under a project called COMBACTE-CARE (Combating Bacterial Resistance in Europe – Carbapenem Resistance)**. Allergan's anti-infective portfolio also includes AVYCAZ ® (ceftazidime and avibactam), TEFLARO ® (ceftaroline fosamil), DALVANCE ® (dalbavancin) and MONUROL ® (fosfomycin tromethamine).

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.

With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan's website at www.Allergan.com.

Forward-Looking Statement

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 on existing trends and information as of the date of this release. 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 difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS^®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; 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, 2018 and Allergan's Quarterly Report on Form 10-Q for the period ended September 30, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

*This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under OTA number HHSO100201500029C.

**This research project receives support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no 115620 resources of which are composed of financial contribution form the European Union Seventh Framework Programme (FP7/2007-2013) and EFPIA companies in kind contribution.