VANCOUVER, June 21, 2017 /CNW/ - Cardiome Pharma Corp. (NASDAQ:CRME /TSX:COM) today announced that its affiliate has signed an exclusive license and distribution agreement with Tzamal Medical Ltd. ("Tzamal") that will advance XYDALBA™ toward commercialization in Israel. As part of the agreement, Tzamal will be responsible for obtaining regulatory and pricing approvals for XYDALBA™ from Israel's Ministry of Health. Cardiome will receive an upfront payment, as well as additional payments, based upon commercial achievements and sales of XYDALBA™. Additional terms were not disclosed.
"Tzamal is a proven leader at providing Israel's hospitals with high-quality medications across a number of therapeutic areas including anti-infectives," said Hugues Sachot, Cardiome's Chief Commercial Officer. "Cardiome recently announced its launch of XYDALBA™ in the major markets of the U.K., France and Germany, and extending the availability of XYDALBA™ to Israel is a logical step in commercializing this important medicine across the territories we cover."
"Based on the high-quality registration file of XYDALBA™, we expect to complete a timely registration and launch within the next 12 to 18 months, and we are confident that the product's unique benefits will position it as a first-choice treatment for its approved indications and the important underserved market segment it targets," said Edi Steinberg, General Manager of Tzamal Bio Pharma Ltd.
XYDALBA™ was approved by the European Medicines Agency (EMA) on February 19, 2015 as a treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) in adults and by the U.S. Food and Drug Administration (FDA) on May 23, 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.
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.
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, Canada, 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 Amomed 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: Justin Renz, Cardiome Investor Relations, (604) 677-6905 ext. 128 or Toll Free: 1-800-330-9928, Email: [email protected]