US drugmaker advances virus vaccine, treatment candidates
Merck & Co. moved to bolster the global fight against the coronavirus, unveiling development plans for a pill to the treat the infection and two vaccines to prevent it.
The U.S. drugmaker bought rights to develop a promising antiviral discovered at Emory University and will work with partners to advance candidate vaccines based on the technology behind Ebola and measles immunizations, according to statements on Tuesday.
CEO Kenneth Frazier said the pandemic and Merck’s efforts to counter it have delayed planned leadership changes, but galvanized the Kenilworth, New Jersey-based company’s commitment to global solidarity. Even as a rush to restart economies has prompted some nations to compete for vital pharmaceuticals, Merck won’t be pressured to supply any one country, and will prioritize access for health-care workers and others at highest risk, he said.
“This is a global pandemic. No one country can solve it, and we can’t put borders around any one country,” Frazier, 65, said in a phone interview. “If we’re successful, we want to ensure broad, supportable access for whoever needs it, wherever they are.”
Merck shares rose 2.5% in premarket trading. They’ve fallen 16% so far this year.
The company, which over the past century has pioneered inoculations to stop diseases from diphtheria to Ebola, started researching ways to thwart Covid-19 after the pandemic-causing virus was discovered, and has evaluated hundreds of potential vaccines, Frazier said.
Merck’s immunization against Ebola – the only one approved by the Food and Drug Administration – provided a reference point for a candidate Covid vaccine since it confers protection with a single shot and uses technology that’s shown to be safe and effective, Frazier said.
A collaboration with International AIDS Vaccine Initiative Inc., a nonprofit scientific research organization, aims to develop a Covid vaccine by adapting the so-called recombinant vesicular stomatitis virus technology behind Merck’s Ebola shot.
IAVI scientists in Brooklyn are researching the experimental shot, which is receiving funding from the Biomedical Advanced Research and Development Authority, or BARDA, and may enter human studies later this year.
“We start with a platform we understand,” Frazier said. “We understand how it behaves, how to make it, how to scale it up, because we have experiencing with that platform.”
Merck will buy Themis, a privately held biotechnology company, for an undisclosed sum, gaining a Covid-19 vaccine candidate that uses the existing measles virus vector platform. Development of the shot has received support from the Coalition for Epidemic Preparedness Innovations. It’s slated to start phase 1 clinical studies within weeks, Frazier said.
He said he’s unable to say how much any successful immunization would cost, but that Merck is committed to supplying “affordable access.” Also the company would need to find partners to manufacture them en masse to meet global demand. “We’re prepared to do that,” he said.
Merck is also pressing ahead with potential treatments for Covid-19. It agreed to buy rights to EIDD-2801, an antiviral compound discovered at Emory University, from Ridgeback Biotherapeutics LP, a closely held biotechnology company.
An early stage clinical trial showed it was well-tolerated, while preclinical studies by scientists at Emory and the University of North Carolina at Chapel Hill found it induced mutations in a broad range of coronaviruses, causing them to make catastrophic errors when they replicate. Remdesivir, the antiviral infusion developed by Gilead Sciences Inc. works in a similar way and has been shown to improve outcomes in some patients, Frazier said.
“But importantly, this compound can be given in pill form, which would make it easier to use,” he said.
EIDD-2801 may potentially arrest infections at an earlier stage, he said, adding that it also appears easier to synthesize and manufacture on a large scale.
Merck announced in April a research collaboration with the Institute for Systems Biology to investigate and define the molecular mechanisms of the virus and Covid-19, the disease it causes, and identify targets for medicines and vaccines.
That same month, Merck joined the U.S. National Institutes of Health in an effort known as Activ, or Accelerating Covid-19 Therapeutic Interventions and Vaccines. The public-private partnership brought together government health agencies and 16 biopharmaceutical companies with the goal of expediting development and production.
Merck scientists spent time determining optimal research strategies, Frazier said. “They’re asking, what kind of vaccine and therapeutic does the world need to deal not just with the pandemic, but the endemic phase.”
He said the pandemic and the company’s research and development efforts to fight it have disrupted plans to appoint his successor and a replacement for R&D leader Roger Perlmutter, a former president of the American Association of Immunologists who first joined Merck in 1997.
“We’ll get back to normal at some point,” Frazier said. “I’m totally confident in the high quality people who we have behind me and behind Roger Perlmutter.”