Regeneron CEO: Manufacturing not up to snuff for COVID-19 vaccines, therapies

Len Schleifer
During an earnings call with analysts last week, CEO Len Schleifer said Regeneron was already working to scale up production of a possible antibody cocktail treatment for COVID-19. (WSJ)

Regeneron has been at the forefront of the COVID-19 fight for months with partnered med Kevzara in clinical trials and an antibody cocktail in development. But success in the clinic means nothing if drugmakers can't produce a therapy or vaccine fast enough––and the company's helmsman is sounding the alarm.

While U.S. distribution channels for possible COVID-19 vaccines and therapies are adequate to meet patients' needs, manufacturing capacity to fulfill those orders is "limited," Regeneron CEO Len Schleifer told CNN's "State of the Union" Sunday. 

Drugmakers across the board are working to boost their production capacity as they move through the clinical testing process, but Schleifer said those efforts haven't scaled up enough to fill global demand. 

"If there's something we have to learn from this pandemic so that when COVID-21 or -25 or -32 comes along, we need a little bit more capacity already in place so that we can get it to everybody,” he told CNN's Jake Tapper. 

Schleifer's comments are a troubling assessment of the pharmaceutical industry's capabilities to take on COVID-19 with a therapy or vaccine, particularly from a company like Regeneron that is on the front lines of the battle against the virus.

RELATED: Regeneron scales up manufacturing, eyes human tests of COVID-19 antibody cocktail in June

During an earnings call with analysts last week, Schleifer said Regeneron was already working to scale up production of a possible antibody cocktail treatment for COVID-19.

Regeneron has designed two potential cocktail therapies by selecting from hundreds of neutralizing antibodies against SARS-CoV-2 from a mouse model and from humans who have recovered.

“We have already begun large-scale manufacturing and anticipate initiating clinical trials with the lead cocktail in June,” Schleifer said on the call.

The therapies were designed based on the same antibody platform behind Regeneron’s Ebola candidate REGN-EB3, which was recently accepted by the FDA for priority review after outperforming Mapp Biopharmaceutical’s ZMapp. Regeneron hopes to have a "couple of hundred thousand doses" of the potential treatment developed by the end of the summer, Schleifer said.

RELATED: After disappointing early numbers, Sanofi and Regeneron scale back Kevzara's COVID-19 test

Regeneron has also worked on a second front to repurpose its IL-6 inhbitor Kevzara, co-developed with Sanofi, as a possible therapy for COVID-19 but so far has seen limited success.

Recently, the partners found the drug offered no additional benefits over standard of care in patients with severe disease but noticed some potential in critically ill patients who rely on ventilators to breathe. After those disappointing early data, the companies chose to advance only the “critical” cohort into a phase 3 study.

Meanwhile, on the vaccine front where Regeneron isn't part of the race, drugmakers are working to boost production to meet possible billion-dose goals as soon as next year.

RELATED: Pfizer plans to farm out manufacturing for some of its drugs to make way for COVID-19 vaccine

Pfizer, which is developing a candidate with partner BioNTech, said Monday that it was evaluating the need for outsourcing production of some its drug portfolio to make way for a massive COVID-19 vaccine effort in the coming months.

The drugmaker will lean on its 200-strong network of contractors as part of a plan to "build a robust U.S.-based supply chain as well as one based in Europe," a Pfizer spokesperson said.

Earlier this month, Moderna and Lonza struck a deal to flesh out manufacturing suites at two Lonza facilities to boost production of Moderna's mRNA vaccine candidate, dubbed mRNA-1273, which just won FDA approval to enter phase 2 human trials. Moderna said the Lonza tie-up could help it produce 1 billion shots a year if its candidate is approved.

Johnson & Johnson, meanwhile, struck multiple manufacturing deals to hit its own billion-dose goal, including with Emergent BioSolutions and Catalent. AstraZeneca, in parallel, has signed on to produce and distribute vaccines for the University of Oxford's promising program, which is speeding ahead.

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