Cardiome Accepts the Transfer of Sponsorship of U.S. and Canadian Vernakalant IV and Oral Regulatory Filings from Merck
NASDAQ: CRME TSX: COM
VANCOUVER, May 2, 2013 /CNW/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced completion of the transfer of sponsorship of the U.S. Investigational New Drug Applications for vernakalant intravenous (IV) and oral, and the transfer of the U.S. New Drug Application for vernakalant IV from Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck). In addition to the transfer of the U.S. regulatory filings, Merck Canada Inc., a subsidiary of Merck, transferred its sponsorship of all vernakalant Canadian Clinical Trial Applications to Cardiome.
"The complete transfer of U.S. and Canadian regulatory responsibilities from Merck is important to Cardiome from a strategic, commercial, and value standpoint," said William Hunter, M.D., CEO of Cardiome. "Having full control of vernakalant IV and oral in North America enables Cardiome to freely engage U.S. and Canadian regulatory agencies to potentially determine the pathways forward for these key programs. Cardiome is excited about the opportunity to continue the clinical development of both programs, which could provide atrial fibrillation patients and physicians new options in the management of this condition."
In September 2012, Merck informed Cardiome that Merck (through two of its subsidiaries) would return the global marketing and development rights for both the IV and oral formulations of vernakalant to Cardiome.
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, BRINAVESSTM (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.
SOURCE: Cardiome Pharma Corp.
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Posted: May 2013