Despite hundreds of potential therapies for COVID-19 seeking to make their case, very few have crossed the finish line. One graduate candidate, Regeneron’s two-antibody cocktail, has earned early plaudits – and now a pharmaceutical giant is jumping on board to boost production in a big way.
Regeneron will partner with Swiss drug maker Roche to more than triple production of COVID-19 antibody therapy at New York biotech, REGN-COV2, for a planned global development, the partners said Wednesday.
Under a seven-year licensing agreement, Regeneron and Roche will reserve each production capacity for the therapy in preparation for future regulatory approvals, with Regeneron handling the U.S. development and Roche taking over elsewhere.
Roche will recharge a maximum of 10,000 liters of bioreactor capacity to meet at the end of the agreement with Regeneron which rolls out 4,000 liters, according to a submission of securities. Through the deal, more space can be allocated in case of future emergency.
The partners expect that every year 650,000 to 2 million treated doses, or 4 million to 8 million preventive doses, of the cocktail will be reversed, Regeneron said. Final dosages are still being worked out in clinical trials and could change these figures.
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Regeneron has begun making doses of the cocktail prior to FDA approval, a spokeswoman said. The partners expect that joint production in the first half of 2021 will begin with the technology transfer that is already underway.
“Regeneron has advanced the REGN-COV2 research and development program at record speed and worked unsafely to maximize our own production capacity,” said Regeneron CEO Len Schleifer in a statement. “This great partnership with Roche provides significant scale and global expertise to bring REGN-COV2 to many more patients in the United States and around the world.”
While Regeneron has yet to release a proposed list price for REGN-COV2, the company expects to share profits with Roche based on the amount of therapy each partner produces, a spokeswoman said. The profit sharing will come in when Roche secures a European approval for the therapy, and Regeneron expects to hit between 50% and 60% of the hall.
Roche will also be on hand to fund current and future clinical trials for REGN-COV2, including an ongoing Phase 3 trial to treat severe COVID-19 patients and a Phase 1 preventive study.
Regeneron’s promise of antibody therapy could gain even more interest in the coming weeks as new data wins out over a wide range of potential therapies. Another possible path to therapy, convalescent plasma of recovered patients, now seems less likely to succeed; top US health officials intervened this week to stop an FDA approval for emergency use based on weak emerging data, The New York Times reported.
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Roche’s assistance represents a major step up for Regeneron’s antibody hopefully after the US took a flyer on therapy last month.
In early July, Regeneron and the Trump administration signed a $ 450 million pact for US cocktail offerings. As part of the deal, Regeneron agreed to increase production to 1.6 million doses of the therapy as early as the end of the summer.
The drugmaker said the order ranged anywhere from 70,000 to 300,000 treated doses and 420,000 to 1.3 million preventive doses. Regeneron agreed to bulk and unfinished lots of the cocktail, as well as completed doses until 2020.
If the FDA eventually loses an emergency authorization for both uses, the government would make doses available at no cost and treat distribution.
RELATED: Sanofi, Regeneron Close Kevzara Trial in COVID-19 After Failing to Benefit Ventilated Patients
Regeneron originally took a bilingual strategy in its COVID-19 response, and followed up with a new antibody cocktail, as well as reimbursed IL-6 inhibitor Kevzara for bad patients – but that second path did not work as planned.
Last month, partners Sanofi and Regeneron stopped their US study on Kevzara in mechanically ventilated COVID-19 patients after the drug failed to prevent deaths or get patients out of ventilation, among other important endpoints.
Kevzara, added to standard-of-care therapy, not only succeeded in improving the condition of patients after 22 days, but the “small positive trends” of the drug in ventilated patients were also compensated by poor results in a partially enrolled subgroup that had not been the start of treatment, the companies said.
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