Cardiome selects Quintiles to manage global regulatory affairs for Brinavess
Biopharmaceutical company Cardiome Pharma has selected Quintiles, a global provider of biopharmaceutical services, to provide comprehensive post-marketing lifecycle safety and global regulatory affairs services for Brinavess (vernakalant intravenous). Quintiles will begin providing these services effective immediately as Cardiome continues to prepare for the anticipated transfer of Brinavess from Merck to Cardiome.
"We are very pleased to begin our partnership with Quintiles during the pending return of global rights for the intravenous and oral formulations of vernakalant to Cardiome," said William Hunter, M.D., interim CEO of Cardiome. "Finding a highly capable service provider to deliver operational regulatory and pharmacovigilance support was a key priority to effectively and expeditiously transfer the registered marketing authorizations from Merck to Cardiome. We believe that Quintiles' global reach and extensive expertise in these areas will help facilitate a seamless worldwide transition."
In September 2012, Merck informed Cardiome that Merck (through two of its subsidiaries) would return the global marketing and development rights for both the intravenous and oral formulations of vernakalant to Cardiome. Vernakalant IV is marketed under the brand name Brinavess. Brinavess has received approval in the E.U. and certain other markets worldwide for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults: for non-surgery patients with AF of seven days or less and for post-cardiac surgery patients with AF of three days or less. Vernakalant IV is not approved for use in the U.S. or Canada.