Roche and Regeneron have partnered to bolster manufacturing and global development capabilities for the latter’s investigational double antibody cocktail for COVID-19.
In July, Regeneron advanced the antibody cocktail, REGN-COV2, into a phase 3 trial being jointly run by the US National Institute of Allergy and Infectious Diseases (NIAID). The company is hoping the drug can demonstrate efficacy as a preventative treatment among uninfected people who have had close exposure to a COVID-19 patient.
The drug is also currently being studied in two phase 2/3 clinical trials for the treatment of individuals infected with COVID-19. If REGN-COV2 proves safe and effective in these trials, under the terms of the new deal Regeneron will distribute and record sales in the US while Roche will be responsible for distribution outside the US.
According to Roche, the collaboration with Regeneron is expected to increase the supply of the antibody cocktail by at least three and a half times its current capacity, with potential to expand this further.
Roche and Regeneron will jointly fund and execute the ongoing phase 3 prevention trial, as well as further phase 1 safety studies in healthy volunteers.
“Regeneron has progressed the REGN-COV2 research and development programme at record speed and worked tirelessly to maximise our in-house manufacturing capacity,” said Leonard Schleifer, president and chief executive officer of Regeneron.
“This major collaboration with Roche provides important scale and global expertise to bring REGN-COV2 to many more patients in the United States and around the globe,” he added.
Roche had been attempting to repurpose its existing arthritis med Actemra (tocilizumab) as a treatment for COVID-19 associated pneumonia, although the drug did not meet its primary endpoint of improved clinical status in phase 3.
The Swiss pharma company also received an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) early on in the pandemic for its COVID-19 molecular test. Following that, Roche also secured an EUA from the FDA for its COVID-19 antibody test in May.
“We are excited about the potential for one medicine to serve both as a treatment for those infected as well as protection for people exposed to the virus. REGN-COV2 could be a critical line of defence against the COVID-19 pandemic,” said Bill Anderson, chief executive officer of Roche.