Actavis Receives Approval from the European Commission for XYDALBA™ (dalbavancin)

DUBLIN, March 2, 2015 /PRNewswire/-- Actavis plc (NYSE: ACT) today announced that the European Commission has granted Actavis' subsidiary Durata Therapeutics International B.V., marketing authorization for XYDALBA™ (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. XYDALBA is the first and only once-weekly IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes.

Logo - http://photos.prnewswire.com/prnh/20130124/NY47381LOGO

"We are excited that XYDALBA has received regulatory approval throughout Europe," said David Nicholson, Executive Vice President, Global Brands Research and Development, Actavis. "The unique dosage regimen of XYDALBA provides a new treatment approach that gives patients, healthcare professionals and hospitals greater flexibility in managing serious skin infections in both inpatient and outpatient sites of care. At Actavis, we are dedicated to helping bridge the gap in existing treatment options and are pleased to bring XYDALBA to patients."

Through a license and supply agreement with Angelini, an international group leader in the pharmaceutical and mass-market sectors, XYDALBA will be commercialized in 36 countries, which include Italy, Spain, Poland, Portugal, many Eastern European countries, Russia, Turkey, and Commonwealth of Independent States.

"Angelini is proud of partnering with Actavis on XYDALBA for treating patients affected by serious skin infections. The new approach will allow patients, healthcare professionals and hospitals to overcome the standard daily or twice-daily IV antibiotic infusions," said Gianluigi Frozzi, Angelini Pharmaceutical Division's Chief Executive Officer. "The agreement is part of the Angelini effort in the field of treatment of infectious diseases. Now approved in the EU, our experienced sales force and extensive network will bring XYDALBA to over 30 countries."

The European Commission decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 18 December 2014 and is applicable to all 28 Member States and the three European Economic Area countries not Member States of the European Union.

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 XYDALBA
XYDALBA is a second generation, semi-synthetic lipoglycopeptide, which consists of a lipophilic side-chain added to an enhanced glycopeptide backbone. XYDALBA is the first and only IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes. XYDALBA demonstrates bactericidal activity in vitro against a range of Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant, also known as MRSA, strains) and Streptococcus pyogenes, as well as certain other streptococcal species.

ABOUT ABSSSI
There were more than 4.8 million hospital admissions of adults with ABSSSI from 2005 through 2011, which included patients with cellulitis, erysipelas, wound infection and major cutaneous abscess. In fact, hospital admissions for ABSSSI significantly increased by 17.3 percent during this timeframe. The majority of all skin and soft tissue infections in hospitalized patients are caused by streptococci and Staphylococcus aureus, and approximately 59 percent of these S. aureus infections in the U.S. are estimated to be caused by MRSA. Early and effective treatment of ABSSSI is critical to optimize patient recovery and for certain patients may also help to avoid potentially lengthy and costly hospital stays.

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; risks associated with acquisitions, mergers and joint ventures; 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' Annual Report on Form 10-K for the year ended December 31, 2014. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

CONTACTS:                    Investors:
                                       Lisa DeFranceso                   
                                       (862) 261-7152

                                       Media:
                                       Charlie Mayr
                                       (862) 261-8030

                                       David Belian
                                       (862) 261-8141

SOURCE Actavis plc

Related Links

http://www.actavis.com

WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?

440k+
Newsrooms &
Influencers

9k+
Digital Media
Outlets

270k+
Journalists
Opted In

GET STARTED