Sanofi, AstraZeneca in $650-Million mAb Deal
Sanofi and its vaccines global business unit, Sanofi Pasteur, have entered into an agreement with MedImmune, the global biologics research and development arm of AstraZeneca, to develop and commercialize a monoclonal antibody (mAb) for preventing respiratory syncytial virus (RSV)-associated illness in newborns and infants in a deal worth up to $651 million.
Under the agreement, Sanofi Pasteur will make an upfront payment of EUR 120 million ($127 million) and pay up to EUR 495 million ($526 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 initial approvals; AstraZeneca will retain manufacturing activities for the mAb, and Sanofi-Pasteur will lead the commercialization activities.
The mAb, MEDI8897, binds the RSV fusion protein expressed on virions and infected cells, according to Sanofi. MEDI8897 is being developed for the passive immunization of the infant population. It 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 Food and Drug Administration in 2015.