Dive Brief:

  • The federal government will pay Regeneron $450 million to scale up manufacturing of the New York biotech’s experimental COVID-19 antibody-based drug, announcing Tuesday a deal that claims up to 300,000 doses for the U.S. by this fall.
  • Regeneron is advancing the combination treatment, dubbed REGN-COV2, into a U.S.-based Phase 3 trial in people who have been exposed to a COVID-19 patient, with results possibly forthcoming by later this summer. A Phase 1 safety trial showed the drug to be safe, Regeneron said Monday.
  • The deal is another example of the U.S. government’s aggressive approach to securing supply of COVID-19 treatments. An agreement with Gilead for the biotech’s antiviral drug remdesivir procured for the U.S. all of the company’s production in July, and 90% in August and September.

Dive Insight:

Regeneron’s agreement with the Defense Department and the Biological Advanced Research and Development Authority, or BARDA, supports the manufacturing of an estimated 70,000 to 300,000 doses of REGN-COV2. The first doses could be available as early as late summer, and the production run complete by the fall.

If REGN-COV2 is used preventively, rather than as a treatment for diagnosed patients, the supply could yield as many as 1.3 million individual doses, Regeneron said.

In exchange for funding, the government claims ownership of all of the doses — a similar provision to an agreement reached Tuesday by the U.S. and Novavax for the biotech’s experimental coronavirus vaccine. Should positive data justify an emergency use authorization or formal approval from the Food and Drug Administration, the government will be in charge of distributing the doses it owns.

In both cases, the agreements are designed to ready doses for immediate shipping upon regulatory clearance, and the U.S. government would provide both the vaccine and the drug to Americans for free. Healthcare professionals and institutions could still bill insurers for the cost of administering REGN-COV2 or Novavax’s vaccine, a statement from the Health and Human Services Department said.

Regeneron’s antibody-drug combination targets two separate pieces of the SARS-CoV-2’s characteristic “spike” protein, aiming to block its entry into cells and prevent replication. While antibodies aren’t used routinely to prevent viral infections, some see them as a potential treatment “bridge” that could yield FDA-ready data quickly while much-larger vaccine trials are underway.

Regeneron similarly worked in cooperation with the U.S. government to develop an antibody cocktail for Ebola infections, called REGN-EB3.

On Monday, Regeneron announced it was advancing REGN-COV2 into a Phase 3 trial to prevent infections in patients who have had close exposure to a COVID-19 patient, which will be in the U.S. only and enroll around 2,000 patients. It will also initiate two Phase 2/3 trials, one in hospitalized patients and the other in non-hospitalized patients, which will enroll 1,850 and 1,050 patients respectively, in the U.S., Brazil, Mexico and Chile.

If REGN-COV2 gains authorization or approval, U.S. residents will have exclusive access to it until Regeneron can run a subsequent batch for commercial sale worldwide.

Scarcity outside the U.S. has also been an issue with Gilead’s remdesivir, although that company has licensed that antiviral to generic manufacturers covering developing nations, and at least one other manufacturer says it has launched a copycat under a World Trade Organization patent waiver.

That may not be as easily done with REGN-COV2. As a biological product, copying and manufacturing it will be much more complicated, and only specialized manufacturers may be able to produce a similarly acting drug.

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