Anti-Infective Advisory Committee Recommends Approval Of Actavis' Ceftazidime-Avibactam

- Potential Treatment for Hospitalized Patients with Complicated Intra-Abdominal and Complicated Urinary Tract Infections -

- Potential Approval to address serious or Life-threatening Infections where an Unmet Need exists in Patients for whom limited or no Treatment Options are Available -

Dec 05, 2014, 16:46 ET from Actavis plc

DUBLIN, Dec. 5, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that the Anti-Infective Drugs Advisory Committee convened by the U.S. Food and Drug Administration (FDA) has voted to recommend approval of Actavis' New Drug Application (NDA) for ceftazidime-avibactam, an investigational antibiotic being developed to treat hospitalized patients when limited or no treatment options are available for complicated intra-abdominal infections (cIAI) (in combination with metronidazole) and complicated urinary tract infections (cUTI) (including acute pyelonephritis) caused by Gram-negative pathogens.

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The committee found the scientific and clinical evidence submitted by Cerexa, Inc., a wholly owned subsidiary of Actavis, adequately demonstrated the safety and efficacy of ceftazidime-avibactam in the treatment of the proposed cIAI and cUTI indications. The committee voted not to recommend approval of the combination for hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP) and bacteremia.

"We are pleased with the committee's positive recommendation for ceftazidime-avibactam. It reinforces our belief in the safety and efficacy of the compound and its potential to address significant unmet needs as a new treatment option for patients with serious and life-threatening infections," said David Nicholson, Senior Vice President, Global Brands Research and Development, Actavis. "As public health officials continue to sound the alarm on antibiotic-resistant infections, Actavis remains committed to advancing the ceftazidime-avibactam clinical development program, including for the combination of hospital acquired bacterial pneumonia (HABP)/ ventilator-associated bacterial pneumonia (VABP) and bacteremia, and working closely with the FDA as it completes its review of our New Drug Application."

Ceftazidime-avibactam inhibits a broad range of β- lactamases, including Class A (Extended-Spectrum β-Lactamases and Klebsiella pneumoniae carbapenemase), Class C (AmpC) and some class D enzymes produced by Gram-negative pathogens that are encountered in the hospital setting and involved in some of the most serious infections like cIAI and cUTI.

The Advisory Committee recommendation is not binding on the FDA, which makes the final decision regarding approval. Actavis expects FDA action on its NDA for ceftazidime-avibactam during the first quarter of 2015.

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 a well-established 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 addresses important needs in the treatment of Gram-negative infections, including those caused by extended spectrum β-lactamase-producing Gram-negative pathogens, carbapenem-resistant Enterobacteriaceae (CRE) and multidrug-resistant (MDR) Pseudomonas aeruginosa.

Ceftazidime-avibactam is being jointly developed with Astra Zeneca. Actavis 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. The Centers for Disease Control and Prevention (CDC) has identified antibiotic resistance as a threat in the U.S. and has categorized the level of concern for carbapenem-resistant Enterobacteriaceae (CRE) as "urgent" and for both Extended spectrum β-lactamase producing Enterobacteriaceae (ESBLs) and MDR P. aeruginosa as "serious." 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, affecting approximately 1.1 million 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), affecting 2.9 million patients each year, 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.

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 Actavis' current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' 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 Actavis' products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2014. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

CONTACTS:
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David Belian
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SOURCE Actavis plc



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