Covid-19 roundup: Fauci, Collins intervene to stop FDA plasma authorization, citing weak data; Roche, Regeneron try to take antibodies global
The FDA has placed on hold an emergency authorization for the use of plasma as a Covid-19 treatment following the intervention of top federal health officials who claimed the available data were too weak, according to a report in the New York Times.
NIAID clinical director H. Clifford Lane confirmed the hold to the Times, adding plasma may still be authorized sometime in the future.
Much has been made about the prospect of utilizing donated plasma from recovered Covid-19 patients to treat those currently infected with the disease. The theory goes that antibodies in the plasma can help reduce the time patients spend in hospitals as well as mortality rates if the treatment is administered quickly.
The use of plasma to treat disease has been around since the early 20th century and doctors used similar therapies during the influenza pandemic of 1918. One of the biggest studies into adapting the technique for Covid-19 came from the Mayo Clinic last week, which showed statistically significant improvements in mortality rates among the most severe cases. Individuals receiving plasma treatment within three days of diagnosis had a seven-day death rate of 8.7% while those who got plasma four days or later had an 11.9% rate.
However, that study was limited by the lack of a placebo group, a drawback the Mayo Clinic itself addressed at the time. Several top health officials, such as Lane, Anthony Fauci and Francis Collins, urged the FDA to hold off on plasma authorization based on the data from that study, the Times wrote.
Wednesday’s hold follows a cadre of former FDA commissioners acknowledging the potential benefits of plasma treatments in an op-ed to the Washington Post two weeks ago. They cautioned, though, that more research into the therapy’s safety and efficacy is needed. — Max Gelman
UPDATED: Roche partners with Regeneron on a Covid-19 antibody cocktail, adding global manufacturing/marketing muscle
It’s one of those unlikely alliances you’d only see in a pandemic: Roche is signing on to be a manufacturing and distribution partner for Regeneron’s tailor-made Covid-19 antibody cocktail.
There’s no upfront or milestones, but the companies say they’ve already begun the tech transfer process for Roche, with an agreement in place since late July. The Swiss pharma giant will be tasked with distribution — plus all the clinical and regulatory work needed — outside of the US, while the Tarrytown, NY-based biotech focused on the home turf.
By teaming up with Roche, Regeneron expects to increase supply of REGN-COV2 by at least three and a half times. Roche will hold the rights for at least seven years after the first commercial sales in the European Union, assuming all goes smoothly.
In Geoffrey Porges’ view, the collaboration adds credibility to a program that still doesn’t have clinical validation and could have been restricted by manufacturing capacity, crowded out by US orders.
“While the Roche collaboration will reduce REGN’s profits from REGN-COV2, it should substantially reduce the development cost, which would have burdened Regeneron for the next few years (est. half-billion dollar cost for REGN-COV2 in 2020E based on Regeneron’s Q2 guidance revision),” he wrote.
While Regeneron CEO Len Schleifer has previously predicted it could have emergency doses ready by the end of summer, clinical trials appear to be taking longer than expected as investigators struggle to enroll patients in overwhelmed hospitals. In the most recent analyst call, Schleifer said they’re now hoping to generate initial data by early September.
Porges estimates the benchmark for efficacy in the treatment setting to be 50% to 60% reduction in disease mortality, and that for prophylaxis to be 60% or greater reduction in clinically signicant, symptomatic Covid-19 disease — both likely achievable judging from primate data.
A spokesperson told Endpoints News that the initial data in September will include virology and biomarkers.
In addition to having Roche jointly fund the ongoing Phase III prevention study, a Phase I multi-dose safety trial and any new global studies, Regeneron is also keeping its hand on a significant portion of the profits.
From the 8-K:
Any worldwide gross profits from the Antibody Product will be aggregated and shared based on a pre-specified formula, which is estimated to result in Regeneron receiving approximately 50% – 60% of the worldwide gross profits, depending on the amount of manufactured Antibody Product delivered by each party.
Bill Anderson, the CEO of Roche Pharma, highlighted the potential for REGN-COV2 both as a treatment and protection for people exposed to the coronavirus, making it a “critical line of defense.” Designed specifically to combat SARS-CoV-2, the therapy comprises two different virus-neutralizing antibodies that bind to the receptor binding domain of the virus’ spike protein.
“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,” he said.
That translates to at least 100,000 liters of “annualized bioreactor capacity on a full-time campaign basis” to manufacture the product, according to an SEC filing from Regeneron. On its part, Regeneron will dedicate 40,000 liters of its in-house capacity to the Covid-19 program.
Historic rivals in eye diseases and inflammatory conditions, Roche and Regeneron (partnered with Sanofi) took their respective IL-6 antibodies to trials in hopes of dampening the damaging immune response that plague patients with severe Covid-19 — only to be slapped by failures. That left Roche with little to offer in the therapeutic fight against the coronavirus, even as its diagnostics unit continues to sell much-needed antigen and antibody tests.
Schleifer sees the deal as validation for his team’s record speed and tireless work as the pharma partner provides “important scale” to the endeavor.
He has struck a $450 million deal with Operation Warp Speed to supply up to 1.6 million doses in the US, both for therapeutic and prophylactic use. Back in March he noted the company could begin making 200,000 clinical doses a month beginning in August, and it’s been looking to maximize capacity on commercial scale material. — Amber Tong
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