Sanofi Pasteur, MedImmune (global biologics R&D arm of AstraZeneca) to Partner on Phase II-Stage mAb against RSV in Infants

Sanofi Pasteur and MedImmune, the global biologics R&D arm of AstraZeneca, agreed to a potentially €615 million (approximately $649 million) collaboration to develop the latter’s Phase II-stage monoclonal antibody (mAb) MEDI8897 for the passive immunization of newborns and infants against respiratory syncytial virus (RSV).

Under terms of the deal, Sanofi Pasteur will pay the AstraZeneca biologics unit €120 million (roughly $127 million) up front and potentially another €495 million (approximately $523 million) in development and sales-related milestones. Costs and profits will be shared equally by the two firms, and MedImmune will continue to head development activities up to first approval. Sanofi Pasteur will head commercialization of MEDI8897; manufacturing responsibilities will lie with AstraZeneca.

MEDI8897 is designed to neutralize RSV by binding to the RSV fusion (F) protein. The mAb is undergoing a Phase IIb study in preterm infants, and a Phase III study in health full-term infants is being planned. MEDI8897 was awarded fast-track designation by the FDA in 2015.