NASDAQ: CRME TSX: COM
VANCOUVER, Dec. 8, 2016 /CNW/ - Cardiome Pharma Corp. (NASDAQ: CRME /TSX: COM) announced that it has launched XYDALBA in the UK earlier than expected. The European Medicines Agency (EMA) approved XYDALBA for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. 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 intravenously over 30 minutes.
Commenting on the XYDALBA launch in the UK, Hugues Sachot, Cardiome's Senior VP Commercial said, "This is an exciting moment for Cardiome as we begin the commercial roll-out for XYDALBA across our European territories. XYDALBA is a key product for Cardiome and we've supported its launch by strengthening our regional European teams with the addition of strong medical and commercial teams who all have strong anti-infective expertise. The feedback we've received about XYDALBA from our physician advisory boards has been very positive and the flexible dosing options may hasten early discharge, thereby increasing bed availability. We are excited to have launched XYDALBA ahead of schedule."
"We are pleased that XYDALBA is now available to our medical professionals in the UK," said Dr. Kiran Bhirangi, Cardiome's Head of Medical Affairs. "The single dose option provides the opportunity that the patient will get a full course of antibiotic therapy without the need to return to the hospital multiple times for follow-up dosing. We believe that XYDALBA's efficacy as demonstrated in the DISCOVER trials1 and its flexible dosing options will resonate with our medical professionals by allowing them to choose how to manage therapy based on their patients' needs and availability of resources."
According to Datamonitor, the diagnosed incidence of ABSSSI was ~280,000 patients in 2012 and is expected to grow to over 400,000 by 2030.2 The UK ABSSSI hospital market is valued at ~$74M.3
- Boucher HW, Wilcox M, Talbot GH, Puttagunta S, Das AF, Dunne MW. Once-weekly dalbavancin versus daily conventional therapy for skin infection. N Engl J Med. 2014;370(23):2169-2179 and Dunne MW, Puttagunta S, Giordano P, Krievins D, Zelasky M, Baldassarre J. A randomized clinical trial of single dose vs weekly dalbavancin for treatment of acute bacterial skin and skin structure infection. Clin Infect Dis. 2016;62(5):545-551.
- Datamonitor Healthcare. Skin and Skin Structure Infections: Epidemiology. November 2013.
- IMS Midas, 2015.
XYDALBA (dalbavancin) for injection 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.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a specialty pharmaceutical company dedicated to the development and commercialization of innovative therapies that will improve the quality of life and health of patients suffering from disease. Cardiome has two marketed, in-hospital, cardiology products, BRINAVESS® (vernakalant IV), approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults, and AGGRASTAT® (tirofiban HCl) a reversible GP IIb/IIIa inhibitor indicated for use in patients with acute coronary syndrome. Cardiome also commercializes ESMOCARD® and ESMOCARD LYO® (esmolol hydrochloride), a short-acting beta-blocker used to control rapid heart rate in a number of cardiovascular indications, on behalf of their partner AOP Orphan Pharma in select European markets. Cardiome has also licensed: XYDALBA™ (dalbavancin hydrochloride), a second generation, semi-synthetic lipoglycopeptide approved in the EU for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults for select European and Middle Eastern nations and Canada from Allergan; and TREVYENT®, a development stage drug device combination that is under development for Pulmonary Arterial Hypertension for Europe, the Middle East and for Canadian markets from SteadyMed Therapeutics.
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.
For further information: David Dean, Cardiome Business Development and Investor Relations, (604) 677-6905 ext 311 or Toll Free: 1-800-330-9928, Email: [email protected]