Marketing and Promotion of Xydalba Has Now Commenced in Six European Countries
VANCOUVER, Oct. 30, 2017 /CNW/ - Cardiome Pharma Corp. (NASDAQ:CRME /TSX:COM) today announced that it has initiated the commercial launch of Xydalba™ (dalbavancin hydrochloride) in Sweden, Finland and the Republic of Ireland. Xydalba is approved by the European Medicines Agency (EMA) for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) in adults.
"We're making steady progress in advancing the commercial availability of Xydalba throughout our licensed territories and have now launched this important antibiotic in a total of six European countries," said Hugues Sachot, Cardiome's Chief Commercial Officer. "Our established commercial infrastructure throughout Europe continues to support these launches and ensures that patients suffering from infectious disease have access to this acute care treatment."
"Xydalba offers medical professionals a flexible dosing option that will allow them to best manage therapy of this serious infection based on individual patient need," said Dr. William Hunter, Cardiome's President and CEO. "Our geographic footprint continues to expand, allowing us to make our portfolio of differentiated hospital products available to patients through our ex-U.S. global distribution capabilities and as we build a world-class acute care pharmaceutical company.
Xydalba was approved by the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including MRSA. Dalbavancin is commercialized under the trade name Dalvance® in the U.S. and Xydalba in certain countries outside the U.S. Cardiome has rights to commercialize Xydalba under an agreement with Allergan plc in France, the United Kingdom, Germany, Belgium, Nordic countries, certain other Western European countries, various Middle Eastern countries, and Canada.
Xydalba™ for infusion 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 30-minute, one-dose treatment option for acute bacterial skin and skin structure infections (ABSSSI) that delivers a full course of IV therapy. Xydalba can be administered as either one 1500 mg dose or as 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.
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 Cardiome Pharma Corp.
Cardiome Pharma Corp. is a revenue-generating, specialty pharmaceutical company focused on providing innovative, high-quality brands that meet the needs of acute care physicians and patients. With a commercial presence and distribution network covering over 60 countries worldwide, Cardiome develops, acquires and commercializes brands for the in-hospital, acute care market segment. The Company's portfolio of approved and marketed brands includes: Xydalba™ (dalbavancin hydrochloride), for the treatment of acute bacterial skin and skin structure infections (ABSSSI); Zevtera®/Mabelio® (ceftobiprole medocaril sodium), a cephalosporin antibiotic for the treatment of community- and hospital-acquired pneumonia (CAP, HAP); Brinavess® (vernakalant IV) for the rapid conversion of recent onset atrial fibrillation to sinus rhythm; Aggrastat® (tirofiban hydrochloride) for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome, and Esmocard® and Esmocard Lyo® (esmolol hydrochloride), a short-acting betablocker used to control rapid heart rate in a number of cardiovascular indications. Cardiome's pipeline of product candidates includes Trevyent®, a drug device combination that is designed to deliver Remodulin® (treprostinil) the world's leading treatment for pulmonary arterial hypertension.
Cardiome is traded on the NASDAQ Capital Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.
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SOURCE Cardiome Pharma Corp.
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