Cardiome Pharma Corp. announced that it has signed an exclusive license agreement with an Allergan to commercialize XYDALBA™ (Dalbavancin) in France, the U.K., Germany, Belgium, Nordic nations, certain other European nations (not already partnered), various Middle Eastern nations and Canada.
XYDALBA™ was approved by the European Medicines Agency (EMA) in February 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) in May 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.
“Our license of XYDALBA™ is a transformational moment for Cardiome. XYDALBA™ will fit perfectly within our current commercial footprint alongside BRINAVESS, AGGRASTAT and ESMOCARD. Licensing a product of this profile is a strong signal of our progress and we look forward to working with Allergan to bring this compelling medicine to patients in need across our territories.” said William Hunter, M.D., President and CEO of Cardiome.
XYDALBA™ is not yet approved in other countries for which Cardiome has licensed rights in including Canada and Switzerland. Cardiome expects to initiate commercial sales of XYDALBA™ in its territories as early as 2016.
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