Roche, Regeneron to Boost Supply of COVID-19 Antibody Combo

Roche and Regeneron recently announced a partnership to develop, manufacture, and distribute Regeneron’s investigational COVID-19 antibody combination.

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The antibody, REGN-COV2, has the potential to treat individuals infected with the virus and those who have been exposed, spreading the slow of the pandemic.

Roche and Regeneron will increase the supply of REGN-COV2 to at least three and a half times the current capacity, Roche said. There is also potential for even further expansion.

"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 defense against the COVID-19 pandemic,” Bill Anderson, chief executive officer of Roche Pharmaceuticals, said in the announcement.

“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.”

Currently, REGN-COV2 is being studied in two Phase 2/3 clinical trials for COVID-19 treatment and in a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals.

Roche noted that if the antibody proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the US. Roche will distribute outside the US.

“Regeneron has progressed the REGN-COV2 research and development program at record speed and worked tirelessly to maximize our in-house manufacturing capacity,” said Leonard S. Schleifer, MD, PhD, 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.”

Under the agreement, the companies will dedicate a specific manufacturing capacity to REGN-COV2 each year, with the technology transfer process already underway, Roche said.

Roche and Regeneron will also jointly fund the ongoing Phase 3 prevention and Phase 1 healthy volunteer safety studies, as well as additional global studies to evaluate the antibody as a COVID-19 treatment.

Roche has been a company on the frontlines of the pandemic since the beginning.

The company’s efforts have included launching COVID-19 diagnostic tests for active infection and the detection of antibodies in patients who have been exposed to the virus and investigating treatments from its existing portfolio.

Roche has also worked to increase manufacturing and supply chain capacity to meet COVID-19 demand and ensurethe supply of existing medicines and diagnostics to patients globally.

At the end of April, Roche announced the development of a serology test to detect antibodies in individuals who have been exposed to the coronavirus.

The Anti-SARS-CoV-2 serology test, Elecsys, was designed to identify individuals who have been infected by the virus, especially those who do not display any symptoms. The test can also screen high-risk groups including healthcare workers and food supply workers who may have developed immunity and can safely return to work. 

Once experts understand more about the immunity of COVID-19, potential drug and vaccine options will advance and help society return to normality faster. 

The test may also be used in epidemiological research to uncover the spread of the disease and may also be used simultaneously with molecular tests to help the diagnosis of potential COVID-19 patients.

Hospitals and other laboratories can leverage the test on Roche’s cobas e analyzers.

“Timely availability and fast access to reliable, high quality tests are essential for healthcare systems. The antibody test is an important next step in the fight against COVID-19. Roche’s antibody test can be quickly scaled and made broadly available around the world as our instrument infrastructure is already in place.” Thomas Schinecker, CEO Roche Diagnostics, said in the announcement.