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Biopharma CEOs plot path to countering COVID-19 at White House meeting; Regeneron could make 200,000 doses/month by August

At a White House meeting Monday, biopharmaceutical executives presented a road map for a phased deployment of drugs and vaccines to combat COVID-19.

There was some misunderstanding around the table about the differences between vaccines and mAbs, and about the distinctions between starting a clinical trial, mass-producing a product, and receiving regulatory approval.

Despite the confusion, a clear path forward emerged.

The journey starts with repurposed antiviral therapies that could be ready by late spring, followed by mAbs to protect and treat COVID-19 patients that could be available as soon as this year, and ends with vaccines deployed in 18 to 36 months.

If ongoing trials demonstrate safety and efficacy, the first available treatment will be remdesivir from Gilead.

Daniel O’Day, chairman and CEO of Gilead Sciences Inc. (NASDAQ:GILD), reported that two 400-patient trials of remdesivir that are being conducted in China are “getting close to halfway enrolled.” Results should be available in April, he said.

In anticipation of success, Gilead is gearing up for large-scale manufacturing of remdesivir, including by repurposing manufacturing facilities, O’Day said.

Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases, suggested that if ongoing trials are successful, regulatory approval for remdesivir could come as soon as early summer. “If you know by June that it is effective, you just scale-up and manufacture.”

Paul Stoffels, vice chairman and CSO at Johnson & Johnson (NYSE:JNJ), reported that an industry consortium funded by the U.S. government and the EU is conducting screening of agents for activity against COVID-19. Any biopharmaceutical company can submit an agent to the consortium for testing, he said.

Dozens of companies, including big pharmas, have reported that they are scouring their shelves for antivirals that could be effective against the coronavirus that causes COVID-19.

Pfizer has “identified compounds that we think, due to their activity against related viruses, have high probability to be active against COVID-19,” Mikael Dolsten, the pharma’s CSO and president of worldwide research, development and medical, told President Donald Trump and other administration officials at the meeting.

Pfizer Inc. (NYSE:PFE) will work with labs that have access to live virus samples to conduct tests on repurposed compounds this month, Dolsten said. “That would allow us to work with FDA to identify the fastest path to bring things to patients -- if things go well this year.”

mAbs as a bridge to vaccines

Leonard Schleifer, president and CEO of Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) expressed optimism that his company will discover and develop mAbs that are effective in both protecting against and treating COVID-19 infection.

Schleifer highlighted Regeneron’s success in developing mAbs to treat emerging infectious diseases. “We know it worked for Ebola, we know that it worked for MERS in animals. We have a great degree of confidence that this would work” for COVID-19.

Regeneron will know “very quickly” if its mAbs are safe and effective, Schleifer said. The company could start mass producing antibody-based therapies in the late summer, he added.

“We have 1,000 antibodies that are already sitting in dishes; we’re screening them, we’re selecting them,” Schleifer said. “We anticipate, if all goes well, 200,000 doses per month can come out of our factory in New York, starting in August.”

Schleifer did not provide a timetable for clinical trials or regulatory approvals.

In addition to Regeneron, four other companies and academic groups are trying to discover and develop mAbs to treat and protect against COVID-19 (see “COVID-19 mAb Menagerie”).

mAbs could serve as a bridge between repurposed antiviral therapies and vaccines, Deborah Birx, a State Department official who is coordinating the Trump administration’s coronavirus response efforts, said at the White House meeting.

Vaccine developers reiterated timetables they have previously disclosed, including plans to start Phase I trials in the spring or early summer.

Fauci said that under the most favorable circumstances, a vaccine could be deployed in 12 to 18 months.

Stoffels said J&J’s goal is to have a COVID-19 vaccine ready for “the next season.”

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