Merck & Co. obtained exclusive rights to market and distribute CSL Biotherapies’ seasonal influenza vaccine, Afluria, in the U.S. for the 2010/2011–2015/2016 flu seasons. CSL will supply Afluria to Merck and retain marketing responsibility outside the U.S.
Merck will assume responsibility for all aspects of commercialization in the U.S. Afluria was approved by the FDA in September 2007. It is indicated for the active immunization of persons age 18 years and older against influenza disease caused by influenza virus subtypes A and type B. This indication is based on immune response elicited by Afluria, and there have been no controlled trials demonstrating a decrease in influenza disease after vaccination with Afluria.
CSL recently reported that the FDA licensed a new vaccine filling and packaging facility in Kankakee, IL. The site includes a high-speed, single-dose vaccine syringe filling line and will primarily provide filling and packaging services for influenza vaccine supply to the U.S. market.