Actavis Receives Approval from the European Commission for Xydalba

Actavis has announced that the European Commission has granted Actavis' subsidiary Durata Therapeutics International, 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.

"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 CEO. "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 US as Dalvance (dalbavancin) for injection. Dalvance is indicated for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including MRSA.