Date: 2015-09-21
Type of information: Services contract
Compound: monoclonal antibody therapy for the treatment of Ebola virus infection
Company: Regeneron Pharmaceuticals (USA - NY) Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) (USA)
Therapeutic area: Infectious diseases
Type agreement: services contract production manufacturing
Action mechanism: monoclonal antibody
Disease: Ebola fever
Details: * On September 21, 2015, Regeneron Pharmaceuticals announced an agreement with the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) to develop, test and manufacture a monoclonal antibody therapy for the treatment of Ebola virus infection. Regeneron utilized its proprietary VelociGene® and VelocImmune® technologies, which enable the rapid identification and preclinical validation of fully human monoclonal antibodies, to develop a novel antibody therapy "cocktail" which includes a mixture of three antibodies. These technologies enabled the rapid identification and scale-up of the investigational antibody therapy. To date, Regeneron has conducted pre-clinical studies in animal models of Ebola virus infection. These antibodies have been discovered and developed pursuant to Regeneron's 2009 antibody discovery and development agreement with Sanofi and are subject to Sanofi's opt-in rights for development and commercialization.
Financial terms: ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide up to a total of $38 million over the next 23 months. The initial funding of approximately $17 million is designed to support an Investigational New Drug application with the FDA. Options in the agreement provide for an additional $21 million for a Phase 1 study in healthy volunteers, which is planned for January 2016, and further manufacturing and development studies.
Latest news:
