2015年3月4日讯 /生物谷BIOON/ --仿制药巨头阿特维斯（Actavis）近日宣布，欧盟委员会（EC）已批准旗下Durata公司开发的抗生素产品Xydalba（dalbavancin，达巴万星）注射液，用于治疗由革兰氏阳性菌（包括耐甲氧西林金黄色葡萄球菌，MRSA）导致的急性细菌性皮肤和皮肤结构感染（ABSSSI）。
Xydalba是首个也是唯一一个获批用于ABSSSI治疗的每周一次双剂量治疗方案静脉注射（IV）抗生素，首次给药1000mg，一周后给药500mg，每次给时间大于30分钟。在临床试验中，dalbavancin治疗ABSSSI时，疗效不劣于万古霉素-利奈唑胺对照方案。在美国，dalbavancin于2014年5月获FDA批准用于ABSSSI适应症，并以品牌名Dalvance（dalbavancin注射液）销售。
dalbavancin（达巴万星）是第二代、半合成脂糖肽类抗生素，对多种革兰氏阳性菌（包括MRSA和化脓性链球菌）及某些链球菌均表现很强的抗菌活性，该药半衰期长，每周给药一次即可。
dalbavancin——辉瑞的笑柄
有意思的是，dalbavancin被业界视为美国制药巨头辉瑞的一个笑柄。dalbavancin最初由美国Vicuron公司发现和开发，之后于2005年被辉瑞以19亿美元收购，当时该药是抗生素领域的明星药物之一，但被辉瑞接手后接下来数年研发经历诸多困难，最初成为一个让人失望的产品而被迫出售。
2009年才成立的Durata公司仅支付1000万美元前期费用超低价接盘dalbavancin并继续研发，最终成为该公司的重量级产品，并于去年5月获FDA批准。有分析师预计，到2019年，dalbavancin的销售额将达到4.5亿美元。去年12月，因看中dalbavancin的市场潜力，仿制药巨头阿特维斯（Actavis）斥资6.75亿美元将Durata收购。
英文原文：Actavis Receives Approval from the European Commission for XYDALBA™ (dalbavancin)
- Treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in Adults - - New Treatment's Unique Dosage Regimen Offers a New Approach to the Treatment of ABSSSI
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.
"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.