Cardiome Pharma Corp. has completed the transfer of sponsorship of the US Investigational New Drug Applications for vernakalant intravenous (IV) and oral, and the transfer of the US New Drug Application for vernakalant IV from Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck). In addition to this transfer of the US 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 US and Canadian regulatory responsibilities from Merck is important to Cardiome from a strategic, commercial, and value standpoint,” said William Hunter, MD, CEO of Cardiome. “Having full control of vernakalant IV and oral in North America enables Cardiome to freely engage US 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 programmes, 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.

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.