Regeneron recruits Roche to make COVID-19 antibody drug REGN-COV2

Roche has agreed to help Regeneron manufacture its COVID-19 antibody cocktail REGN-COV2, which started late-stage clinical testing a few weeks ago, in a deal that could more than triple supplies of the drug if it gets approved.

Regeneron is already working on ramping up manufacturing capacity for REGN-COV2, with the help of $450 million in funding from the US government, but has admitted that it won’t be able to meet the expected demand for the drug on its own.

The agreement with Roche will “substantially” increase the number of doses available if the drug works in clinical trials.

REGN-COV2 was the first therapeutic to be backed under the Trump administration’s Operation Warp Speed, which previously had focused only on coronavirus vaccines.

It is being tested in phase 2/3 trials both as a treatment for coronavirus infections as well as prophylaxis against infection in people exposed to SARS-CoV-2, with initial results expected before the end of September.

The US deal envisaged 70,000 to 300,000 therapeutic doses of the drug being made available by September, equivalent to 420,000 to 1.3 million prevention doses.

Under the terms of the agreement, each company has committed to dedicate a portion of its production capacity to REGN-COV2 each year.

The two partners think that by working together they could increase capacity to provide up to 2 million therapeutic or 8 million prophylactic courses a year.

Meanwhile, in addition to chipping in for its production, Roche also gets distribution rights to the antibody cocktail outside the US, in return for jointly funding and carrying out the phase 3 stage of the prevention trial as well as phase 1 healthy volunteer safety studies outside the US.

The Swiss drugmaker will also take responsibility for filing REGN-COV2 outside the US and carrying out any trials needed in those countries. Profits from the drug will be split, with Regeneron’s share expected to be in the 50% to 60% range.

REGN-COV2 was developed by Regeneron based on tests in mice genetically modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19.

The cocktail targets two components in the spike protein on SARS-CoV-2, the virus that causes COVID-19, with the aim of preventing attachment of the virus to host cells and interrupting infection.

The same approach has been used in the development of Regeneron’s Ebola candidate REGN-EB3, which is under review at the FDA with a verdict due in October.