France-based Sanofi Pasteur has signed an agreement with AstraZeneca’s global biologics research and development arm MedImmune to develop and commercialise a monoclonal antibody known as MEDI8897.
MEDI8897 prevents respiratory syncytial virus (RSV) associated illness in newborns and infants.
Under the agreement, Sanofi Pasteur will make an upfront payment of €120m and up to €495m upon achievement of certain development and sales-related milestones.
Sanofi Pasteur head David Loew said: "As a global leader in the pediatric vaccine industry, this deal with MedImmune therefore makes perfect sense for Sanofi Pasteur.
“RSV causes major, seasonal worldwide outbreaks and the severity is predominant among young infants."
The monoclonal antibody (mAb) MEDI8897 neutralises RSV by binding the RSV fusion (F) protein expressed on virions and infected cells and is being developed for the passive immunisation of the infant population.
It has been engineered to have a long half-life to enable the requirement of only one dose for the entire RSV season.
At present, MEDI8897 is being investigated in a Phase IIb study in pre-term infants, with further plans for a Phase III trial in healthy full-term infants.
The US FDA granted fast-track designation to MEDI8897 in 2015.
All development activity up to the first approval will be led by MedImmune, while AstraZeneca will retain MEDI8897 manufacturing activities.
Sanofi-Pasteur will lead the commercialisation activities for the antibody.
Image: This electron micrograph depicts the Respiratory Syncytial Virus (RSV) pathogen. Photo: courtesy of CDC / Dr Erskine Palmer.