BioPharma

Regeneron, Roche team up in global deal on Covid-19 antibody cocktail

The deal brings Roche's considerable manufacturing heft to Regeneron's efforts to develop the two-antibody cocktail, REGN-COV2. Regeneron will distribute the drug in the U.S., while Roche will distribute it ex-U.S.

A major European pharmaceutical company has signed on to distribute an antibody drug under development for Covid-19 outside the U.S.

Tarrytown, New York-based Regeneron Pharmaceuticals said Wednesday that it had made an agreement with Swiss drugmaker Roche to partner and the development and manufacture of REGN-COV2, Regeneron’s monoclonal antibody treatment for SARS-CoV-2 infection. Under the deal, Regeneron will distribute the drug in the U.S., while Roche will be responsible for ex-U.S. distribution.

Shares of Regeneron were up about 2% on the Nasdaq when markets opened Wednesday. Shares of Roche were up by around the same amount on the Swiss Exchange.

REGN-COV2 consists of a cocktail of two antibodies that work by binding noncompetitively to the critical receptor binding domain of the SARS-CoV-2 virus’ spike protein, thereby diminishing the ability of the virus to escape via resistance mutations. Regeneron started late-stage clinical trials of the drug last month and also secured a $450 million manufacture and supply contract from the Department of Defense and the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.

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

Regeneron and Roche will both fund the Phase III prevention and Phase I healthy volunteer safety studies, along with any additional global trials, and bear distribution expenses for their respective territories. Roche will secure regulatory approval outside the U.S. after initial approval by the European Medicines Agency.

Regeneron is currently running two large studies under an unusual Phase I/II/III design. One is enrolling 2,970 patients hospitalized with Covid-19, while the other is enrolling 2,104 ambulatory patients. There is also the Phase III prevention study, which is enrolling 2,000 participants.

In a note to investors, RBC Capital Markets analyst Kennen MacKay wrote that the deal adds validation both to REGN-COV2’s potential as a therapeutic and to Regeneron’s antibody development program. It also commits Roche’s “vast” antibody-manufacturing capability toward the drug’s production, increasing the capacity from from tens of thousands of doses per month to hundreds of thousands.

Photo: mediaphotos, Getty Images

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