FDAnews
www.fdanews.com/articles/198643-roche-pitches-in-on-regenerons-covid-19-antibody-combination

Roche Pitches in on Regeneron’s COVID-19 Antibody Combination

August 20, 2020

Swiss pharma giant Roche is partnering with Regeneron Pharmaceuticals to ramp up production of the New York-based biotech’s COVID-19 antibody cocktail candidate, REGN-COV2.

The two companies will dedicate manufacturing capacity for the double-antibody combination, and they expect to produce “at least three-and-a-half times the current capacity,” Roche said.

The antibody cocktail is designed to block the spike protein that the SARS-CoV-2 coronavirus uses as a key to enter human cells.

Under the agreement, Roche will handle worldwide distribution beyond the U.S. if the two-antibody combination gets regulatory approval. Regeneron’s CEO Leonard Schleifer said the collaboration “provides important scale and global expertise” to bring the treatment to more patients.

In addition to bolstering manufacturing, Roche will help Regeneron with clinical trials, including an ongoing phase 3 prevention study and other international studies for treatment or prevention.

The late-stage prevention study kicked off in the U.S. in July. REGN-COV2 is also being evaluated in two phase 2/3 trials as a coronavirus treatment. Preliminary results of those two studies are expected within weeks (DID, July 7). — James Miessler