NASDAQ: CRME TSX: COM
VANCOUVER, Dec. 20, 2016 /PRNewswire/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) announced that it has initiated the commercial launch of XYDALBA™ (dalbavancin hydrochloride) in Germany ahead of the expected 2017 launch, and that it has made its first sales of the drug to German hospitals. XYDALBA is approved by the European Medicines Agency for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. It is administered as either a single, 30-minute intravenous infusion of 1500 mg, or as two infusions, 1000 mg followed one week later by 500 mg.
"We are pleased to continue the roll-out, especially in the German market, of XYDALBA beyond the previously announced launch in the UK," said Hugues Sachot, Cardiome's Senior VP Commercial commenting on the XYDALBA launch in Germany. "In support of a strong launch in Germany, we've expanded our regional team with key account managers (KAMs) and a medical science liaison focused exclusively on XYDALBA. Germany has traditionally been a strong market for antibiotics and we are committed to making XYDALBA available to all of our customers here. We expect to follow up the commercialization of XYDALBA in the UK and German markets with launches in additional European countries during the first half of 2017."
"We are excited that XYDALBA is now available to our German customers who will have the flexibility to choose how XYDALBA is dosed in treating ABSSSI patients," said Dr. Kiran Bhirangi, Cardiome's Head of Medical Affairs. "We will work closely with our customers to ensure that they and their patients fully recognize the benefits offered by XYDALBA as shown in the DISCOVER1 trials."
According to Datamonitor, the diagnosed incidence of ABSSSI was ~216,000 patients in 2012 and is expected to grow to over 300,000 by 2030.2 The German ABSSSI hospital market is valued at ~$123M.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.
- 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 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.