Actavis Announces FDA Acceptance of the NDA Filing for Ceftazidime-Avibactam, a Qualified Infectious Disease Product

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• USA - English

DUBLIN, Sept. 5, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' application for ceftazidime-avibactam, its investigational antibiotic for the treatment of patients with Complicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI), including those caused by multi-drug resistant Gram-negative bacterial pathogens.

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As agreed with FDA, ceftazidime-avibactam was submitted as a 505(b)(2) NDA for the treatment of patients with cIAI and cUTI based on the efficacy and safety of ceftazidime, data from Phase II ceftazidime-avibactam studies, robust microbiology and PK/PD analyses. The FDA action date for ceftazidime-avibactam under the Prescription Drug User Fee Act (PDUFA) is expected during Q1 2015.

On August 19, 2014, Actavis announced positive topline results from the single pooled dataset of RECLAIM-1 and -2, pivotal Phase III studies evaluating the potential for ceftazidime-avibactam as a treatment for adult patients with cIAI. The company intends to submit the results of the Phase III studies to the FDA as a supplemental New Drug Application (sNDA).

"Today, there exists a serious and unmet need for new options to treat patients suffering from infections due to resistant Gram-negative pathogens, including Carbapenem Resistant Enterobacteriaceae (CRE)," said David Nicholson, Senior Vice President, Actavis Global Brands R&D.  "The acceptance of our filing for approval of ceftazidime-avibactam is a continuation of Actavis' commitment to advancing anti-infective research and development, with a focus on enhancing patient care and outcomes for areas of greatest unmet medical need."

The FDA granted ceftazidime-avibactam Qualified Infectious Disease Product (QIDP) status for its indications of cIAI, cUTI and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) on March 11, 2013.  The QIDP designation provides certain incentives for the development of new antibiotics, including priority review, eligibility for the FDA's fast track program, and a five-year extension of exclusivity under the Hatch-Waxman Act.

About CEFTAZIDIME-AVIBACTAM
Ceftazidime-avibactam is an investigational antibiotic being developed to treat serious Gram-negative bacterial infections. It consists of ceftazidime, a third-generation, antipseudomonal cephalosporin, that is an established and respected treatment for serious Gram-negative bacterial infections, and avibactam, a next generation, non-β lactam β-lactamase inhibitor.

The addition of avibactam to ceftazidime protects ceftazidime from breakdown by β-lactamases. ceftazidime-avibactam offers a differentiated profile versus existing treatment options in serious Gram-negative infections through its coverage of a broad range of species of carbapenem-resistant Enterobacteriaceae (CRE) together with difficult to treat Pseudomonas aeruginosa combined with robust coverage of extended spectrum β-lactamase (ESBL)-expressing pathogens.

Ceftazidime-avibactam is being jointly developed with Astra Zeneca.  Forest Laboratories LLC., a subsidiary of Actavis plc, holds the rights to commercialize ceftazidime-avibactam in North America, while AstraZeneca holds the rights to commercialize ceftazidime-avibactam in the rest of the world.

About Gram-Negative Infections
Gram-negative bacteria are highly adaptive pathogens that can develop resistance through several mechanisms and can pass along genetic materials that allow other bacteria to become drug-resistant as well. Highly resistant Gram-negative bacteria of greatest concern include Enterobacteriaceae that are resistant to ESBLs, including CRE, as well as multidrug-resistant Pseudomonas, two serious health threats that have been identified by the CDC as requiring urgent action. Many of these Gram-negative pathogens are particularly worrisome because they are becoming resistant to nearly all drugs, including the carbapenems, often considered the last line of defense in these challenging infections.

Gram-negative bacteria are common causes of intra-abdominal infections, urinary tract infections, and healthcare-associated (nosocomial) pneumonia and bloodstream infections.

Complicated intra-abdominal infections are a considerable problem, with appendicitis alone affecting approximately 300,000 patients each year. Intra-abdominal infections are the second most common cause of infectious mortality in the intensive care unit.

Complicated urinary tract infections are also often caused by Gram-negative pathogens. Escherichia coli (E. coli) is one of the common organisms causing urinary tract infections (UTIs), and is becoming increasingly resistant to available antibiotics.

About Actavis
Actavis plc (NYSE:ACT), headquartered in Dublin, Ireland, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world.

Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women's health, urology, cardiovascular, respiratory and anti-infective therapeutic categories. The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications. Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world.

For more information, visit Actavis' website at www.actavis.com.

Actavis Cautionary Statement Regarding Forward-Looking Statements
Statements contained in this communication that refer to Actavis' estimated or anticipated future results, including estimated synergies, or other non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing trends and information as of the date of this communication. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' business. These factors include, among others, the timing and success of product launches; the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions, if any; market acceptance of and continued demand for Actavis' products; difficulties or delays in manufacturing; and such other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis plc's Annual Report on Form 10-K for the year ended December 31, 2013, Quarterly Report on Form 10-Q for the quarter ended June 30, 2014 and from time to time in Actavis' other investor communications. Except as expressly required by law, Actavis disclaims any intent or obligation to update or revise these forward-looking statements.

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SOURCE Actavis plc