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March 3, 2017

Sanofi Pasteur, MedImmune 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.

    “RSV is considered to be the most important missing indication in the vaccination schedule of newborns," stated David Loew, Sanofi evp and head of Sanofi Pasteur. "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. We look forward to working with MedImmune to offer a solution to this common lower-respiratory disease when infants are most vulnerable."

    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.

    The deal between MedImmune and the Sanofi vaccines operation comes just a couple of days after MedImmune reported a 3-year research partnership with Michigan Medicine to develop new approaches to preventing and treating diabetes, obesity, and related metabolic disorders.

    Last week, Arsanis secured global rights to a series of RSV-targeting antibodies from Adimab, and won $9.3 million in funding from the Bill & Melinda Gates Foundation to support preclinical development of a lead candidate.

    Also last month, Aviragen reported the failure of its fusion protein inhibitor BTA585 to meet its primary viral load endpoint of in a Phase IIa RSV trial in adult volunteers.

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