BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3 for National Preparedness

Shots:

  • Regeneron will be responsible to deliver treatment doses for six years post-approval of product from the FDA, will receive compensation of ~$10M & average of $67M/year in 2021 and each for the next five years (2022-2026) respectively
  • In 2019, the PALM trial evaluated REGN-EB3 vs ZMapp conducted in the Democratic Republic of the Congo, was stopped as the REGN-EB3 crossed the pre-specified superiority threshold for preventing death in Ebola patients
  • Regeneron’s REGN-EB3 is a novel anti-viral Ab cocktail developed using its VelociSuite platform in collaboration and funding provided by BARDA. The product is under priority review by the US FDA with PDUFA date Oct 25, 2020

Click here to read full press release/ article | Ref: BusinessWire | Image: Behnace




Moderna snags another $472M from BARDA, launches Phase III Covid-19 vaccine trial

The company had received $483 million from BARDA in April to fund the development of the vaccine, mRNA-1273, through Phase III, but that amount was based on a smaller anticipated number of participants than the 30,000 it now plans to enroll into the trial, named COVE.

BARDA, DoD give Regeneron $450M contract for Covid-19 antiviral drug

The contract covers manufacture and supply of the two-antibody drug cocktail REGN-COV2. The company had announced Monday that it entered the drug into three late-stage clinical studies, both as a treatment for existing SARS-CoV-2 infections and a preventive treatment for healthy exposed people.