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Merck to pay $425M for biotech to get Covid-19 drug, but says manufacturing will be a challenge
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November 23, 2020
https://www.statnews.com/2020/11/23/merck-to-pay-425m-for-biotech-to-get-covid-19-drug-but-says-manufacturing-will-be-a-challenge/
The drug giant Merck said Monday it would purchase Rockville, Md.-based OncoImmune for $425 million in cash to obtain the company's treatment for patients hospitalized with severe and critical Covid-19.
In an interview with STAT, Merck's head of research and development, Roger Perlmutter, said that clinical trials for the treatment, CD24Fc, were encouraging but that manufacturing could prove a challenge. Still, he said, he hopes that, if proven safe and effective, it will be possible to make the medicine in useful quantities in the first half of 2021.
"I think that the critical issue for any kind of regulatory action, whether it's emergency use authorization or actual approval, is that there's no point in having an emergency use authorization if you don't have any of the materials to distribute," Perlmutter said.
On Sept. 24, OncoImmune released an interim look from an ongoing trial of CD24Fc in patients who were hospitalized with Covid-19 and required supplemental oxygen but were not mechanically ventilated. In the analysis of 203 patients, those treated with CD24Fc showed a 60% higher probability of improvement in clinical status. The combined risk of the patient having respiratory failure was reduced by more than 50%.
Those data have not been shared in detail so that outside experts can analyze them. Merck said detailed results will be submitted for publication in a peer-reviewed medical journal.
The medicine, which was previously being tested for graft-versus-host disease, an immune condition in transplant patients, is thought to work by tamping down the immune system, which can overreact in patients infected with the novel coronavirus. Results of immune-system-modulating drugs in Covid have been mixed. Dexamethasone, a steroid, has been shown to reduce mortality in similar patients, but more modern biotech drugs have failed.
Given the availability of Covid-19 vaccines sometime next year, how much need will there be for such a medicine?
"Our hope is that a drug for Covid-19 proves to be ultimately not needed," Perlmutter said. "Everyone would want that. My fear is that the logistics associated with vaccine distribution, the challenges associated with getting appreciable numbers of people vaccinated because of what we delicately term vaccine hesitancy, and the fact that this is a global pandemic that potentially affects 7 billion people means there will be an awful lot of people around the world who will be severely or critically ill with Covid-19 for a fairly long period of time."
Merck also is developing an antiviral medicine, licensed from Ridgeback Biopharmaceuticals, aimed at Covid-19, as well as two potential vaccines for Covid-19, which are trailing those of several other drug makers, including the team of Pfizer and BioNTech, Moderna, AstraZeneca, and Johnson & Johnson.
Perlmutter said he is "over the moon" about the results from Pfizer/BioNTech and Moderna. Both vaccines have shown more than 95% efficacy at preventing symptomatic Covid-19 infections. But he said Merck's vaccines, which will be easy to manufacture and which he hopes might be given in one dose, might still play a role.
"If our vaccines are needed, I don't want to be in a situation where we don't have them. So we'll continue doing the registration enabling study on that timeline."
He said that because the new vaccines would not be available everywhere in the world before Merck begins its own studies, he did not think conducting studies would present a problem.
Perlmutter is set to retire at the end of the year. "What I've told everyone is until midnight, December 31st, I'm going hammer and tongs and then I'll turn into a pumpkin and do something else for a while." However, he said that he would not have made a decision on a big acquisition without the approval and agreement of his successor, Dean Li.
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