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news.Cardiome Pharma's affiliate has signed an exclusive license agreement with an affiliate of Allergan plc that will result in the Cardiome Group commercializing XYDALBA (Dalbavancin) in France, the U.K., Germany, Belgium, Nordic nations, certain other European nations (not already partnered), various Middle Eastern nations and Canada.
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Cardiome will provide Allergan with a staggered upfront payment totalling US$13 million and will provide Allergan additional milestone payments and royalties based upon commercial achievements and sales of XYDALBA.
Additional terms of the agreement were not disclosed.
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," said William Hunter, M.D., President and CEO of Cardiome.
"Over the past three years we have restructured and redirected Cardiome to become a differentiated specialty pharmaceutical company focused on commercializing proprietary growth pharmaceuticals in Europe and Canada. 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."
XYDALBA is approved for sale in the following territories licensed by Cardiome: the U.K., Germany, France, Denmark, Iceland, Finland, Malta, Norway, Sweden, Belgium, Netherlands, Luxemburg, and Ireland.
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.