Sanofi’s vaccines global business unit Sanofi Pasteur has signed a deal with AstraZeneca’s biologics bramch MedImmune, to make and sell a monoclonal antibody-called MEDI8897-for the prevention of the most common reason for lower respiratory tract infections in newborns and infants, Respiratory Syncytial Virus (RSV).
As stated in Sanofi’s press release, MEDI8897 – which is currently in a Phase IIb study in preterm infants – is a highly potent monoclonal antibody (mAb) that neutralizes RSV by binding the RSV fusion (F) protein expressed on virions and infected cells. Furthermore, it has been made to last long so that only one dose would be needed for the entire RSV season. According to Sanofi, it is being developed for the passive immunization of the infant population. MEDI8897 is planned to move to a Phase III trial in healthy full-term infants. The drug got fast-track designation from the U.S. 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.
Bahija Jallal, Executive Vice President, MedImmune, said: “By combining our development expertise and leadership in RSV with Sanofi Pasteur’s significant global experience in commercialising paediatric vaccines we hope to provide an RSV disease prevention approach for all infants, both term and pre-term. This agreement supports our focus on our three main therapy areas, while delivering value from the innovative science in our pipeline through partnerships.”
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 said it will lead the commercialization activities for MEDI8897.
AstraZeneca said the revenue from the agreement, including the upfront payment and milestone payments, will be reported as Externalisation Revenue in the its financial statements. It also said the signing does not impact its financial guidance for 2017.