Roche has partnered with Regeneron Pharmaceuticals to develop, manufacture and distribute the latter’s antiviral antibody combination, REGN-COV2, as a potential treatment of Covid-19.
REGN-COV2 could help treat patients with symptoms and also prevent the disease in individuals exposed to the virus.
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The partners expect to boost the supply of the therapeutic by at least three and a half times the existing capacity and may expand even further.
Currently, the drug candidate is undergoing two Phase II / III clinical trials as a Covid-19 treatment and a Phase III trial to prevent the disease in household contacts of infected patients.
If clinical trials are successful and regulatory approvals obtained, Regeneron will distribute REGN-COV2 in the US, while Roche will distribute everywhere else.
Roche Pharmaceuticals CEO Bill Anderson said: “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.
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By GlobalData“We’re committing our manufacturing expertise and capacity, and our global distribution network to bring Regeneron’s potential antibody combination to as many people around the world as we possibly can.”
Both companies dedicated certain manufacturing capacity to REGN-COV2 per year and already started the technology transfer process. Each party will be responsible for its own distribution costs in their designated territories.
The partners will together fund and execute the ongoing Phase III prevention and Phase I healthy volunteers safety studies, along with other global studies of the therapeutic in Covid-19 indication.
Regeneron Pharmaceuticals president and CEO Leonard Schleifer said: “Regeneron has progressed the REGN-COV2 research and development programme at record speed and worked tirelessly to maximise our in-house manufacturing capacity.
“This major collaboration with Roche provides important scale and global expertise to bring REGN-COV2 to many more patients in the US and around the globe.”
Roche will principally carry out activities related to regulatory approvals outside the US, after the initial European Medicines Agency (EMA) authorisation.
Last month, Regeneron received a $450m contract from the US for the manufacture and supply of REGN-COV2 against Covid-19.
