Regeneron (REGN), BARDA Enter MERS Virus Antibodies Manufacturing Agreement

August 22, 2016 8:31 AM EDT

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Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced an agreement with the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) to manufacture and study two antibody therapies for the potential prevention and treatment of Middle East Respiratory Syndrome (MERS). Regeneron has previously published details on how its proprietary VelociGene® and VelocImmune® technologies enabled the rapid identification and preclinical validation of these antibody candidates.

HHS will provide funding to Regeneron of up to $8.9 million to support packaging and labeling of the antibodies for human use (known as "fill and finish"), the preparation and submission of an Investigational New Drug application with the U.S. Food and Drug Administration (FDA), and a National Institutes of Health-conducted clinical trial in healthy volunteers. Currently there are no approved medicines or vaccines to treat or prevent MERS, which causes severe respiratory tract infections and is associated with high death rates. Cases of MERS have been reported in the Middle East, South Korea, Europe, the United States, Africa and other countries in Asia.

"Regeneron has built a unique rapid response platform to address emerging infectious disease threats. In addition to the programs in MERS and Ebola that we are advancing with BARDA, we are also quickly progressing a preclinical program targeting the Zika virus," said Neil Stahl, Ph.D., Executive Vice President of Research and Development at Regeneron. "We are committed to partnering with the government and other organizations to swiftly address these emerging public health emergencies."

Regeneron and BARDA have an existing agreement to advance a potential therapy for Ebola that was discovered and developed at Regeneron. The investigational Ebola therapeutic has recently entered a Phase 1 human clinical study and received Orphan Drug Designation from the FDA.

The MERS antibodies have been discovered and developed pursuant to Regeneron's antibody discovery and preclinical development agreement with Sanofi and are subject to Sanofi's opt-in rights for development and commercialization.



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