XYDALBA™ (dalbavancin) Receives CHMP Positive Opinion for the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in Adults

Dec 19, 2014, 16:15 ET from Actavis plc

DUBLIN, Dec. 19, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted Actavis' subsidiary Durata Therapeutics International, B.V., a positive opinion for XYDALBA (dalbavancin), for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

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XYDALBA is a bactericidal lipoglycopeptide. Its mechanism of action in susceptible Gram-positive bacteria involves interruption of cell wall resulting in bacterial cell death.

XYDALBA is active against important groups of Gram-positive bacteria, including strains of methicillin resistant Staphylococcus aureus (MRSA) and some S. aureus with reduced susceptibility to glycopeptides (GISA), as well as pathogenic streptococci.  In addition, it possesses a pharmacokinetic (PK) profile, which allows once-weekly intravenous (IV) dosing. The most common side effects are nausea, diarrhoea and headache.

"The CHMP positive opinion is a significant step forward to bringing XYDALBA, a novel antibiotic treatment option, to patients," said David Nicholson, Actavis Senior Vice President, Global Brands R&D. "There is an unmet need that exists for patients suffering from serious skin infections caused by resistant organisms and we are committed to developing innovative antibiotic treatment options for patients worldwide."

The CHMP opinion will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization.

XYDALBA is marketed in the United States as DALVANCE® (dalbavancin) for injection. DALVANCE® is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by Susceptible Gram-positive bacteria, including MRSA.

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 EMA 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.


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SOURCE Actavis plc