vaccine parenteral vialSanofi and its vaccines global business unit Sanofi Pasteur have announced an agreement with MedImmune, the global biologics research and development arm of AstraZeneca, to develop and commercialise a monoclonal antibody — called MEDI8897 — for the prevention of Respiratory Syncytial Virus (RSV) associated illness in newborns and infants.

According to the Centers for Disease Control and Prevention, RSV is the most common cause of lower respiratory tract infections in children younger than 1 year of age in the United States and worldwide.

MEDI8897 is a highly potent monoclonal antibody (mAb) that 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 only one dose would be needed for the entire RSV season.

It is being developed for the passive immunization of the infant population. MEDI8897 is currently being investigated in a Phase IIb study in preterm infants with plans for a Phase III trial in healthy full-term infants. MEDI8897 received fast-track designation from the US FDA in 2015.

 “RSV is considered to be the most important missing indication in the vaccination schedule of newborns,” said David Loew, Sanofi Executive Vice President and head of Sanofi Pasteur. 

“As a global leader in the paediatric 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,” he continued. “We look forward to working with MedImmune to offer a solution to this common lower-respiratory disease when infants are most vulnerable.”

Under the terms of the agreement, Sanofi Pasteur will make an upfront payment of €120 million and pay up to €495 million upon achievement of certain development and sales-related milestones.

The two companies will share all costs and profits equally. MedImmune will continue to lead all development activity up to the first approval, and AstraZeneca will retain MEDI8897 manufacturing activities. Sanofi-Pasteur will lead the commercialization activities for MEDI8897.