NASDAQ: CRME TSX: COM
VANCOUVER, June 27, 2013 /PRNewswire/ - Cardiome Pharma Corp. CRME COM today announced adoption of the decision by the European Commission of the transfer of the centrally-approved marketing authorisation (MA) for BRINAVESS™ (vernakalant intravenous) from Merck Sharp & Dohme Limited to Cardiome. The decision marks Cardiome's assumption of responsibilities as the new marketing authorization holder (MAH) for BRINAVESS™ in the member states of the European Union. Cardiome and Merck will continue to work together until September 15, 2013 to finalize the organizational arrangement for transfer of all responsibilities, including batch release, and operational management of SPECTRUM, the post-approval safety study.
"The transfer of the European marketing authorization to Cardiome marks an important milestone in the company's history," said William Hunter, M.D., Cardiome's president and CEO. "Cardiome now assumes full control of all key commercialization activities for BRINAVESS™ in the European Union and as of July 1st, will begin realizing the benefit from worldwide product revenues."
A transfer of marketing authorization is the procedure by which the MA is transferred from the currently approved marketing authorization holder to a new MAH which is a different person/legal entity.1 The MAH is allowed to market medicines and make it available to patients and healthcare professionals throughout the European Union when the product is registered via the centralized procedure.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a biopharmaceutical company dedicated to the
discovery, development and commercialization of new therapies that will
improve the health of patients around the world. Cardiome has one
marketed product, BRINAVESS™ (vernakalant IV), approved in Europe and
other territories for the rapid conversion of recent onset atrial
fibrillation to sinus rhythm in adults.
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.
References:
- http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000045.jsp&mid=WC0b01ac0580023e80, accessed June 26, 2013
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SOURCE Cardiome Pharma Corp.
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