Sanofi and AZ ink €600m deal for RSV jab

Annual severe infections with RSV, the most common cause of lung inflammation in infants, sum up to 125,000 cases in the US alone. MedImmune’s monoclonal antibody MEDI8897got fast track designation from the FDA in April 2015 and is being tested on 1,500 preterm infants in a Phase IIb proof-of-concept study running until 2018. According to David Loew, Sanofi Executive Vice President and head of Sanofi Pasteur, RSV is considered to be the most important missing indication in the vaccination schedule of newborns. 

Under the terms of the agreement, Sanofi Pasteur will make an upfront payment of €120m and pay up to €495m in development and sales-related milestones. The companies will share all costs and profits equally. MedImmune will continue to lead all development activity up to market approval, and AstraZeneca will retain MEDI8897 manufacturing activities. Sanofi Pasteur will lead the commercialisation activities for MEDI8897. 

MEDI8897 neutralises RSV by binding the RSV fusion (F) protein expressed on virions and infected cells; it has been engineered to have a long half-life so that one dose of the passive immunisation is expected to be sufficient for the entire RSV season.