In the race to find a treatment for patients with COVID-19 infections, Foster City-based Gilead Sciences is going all in on its experimental drug, remdesivir.
It took only eight days in early February for the biopharmaceutical company to fill its first vials of remdesivir, an experimental antiviral drug, to proceed with clinical trials and emergency use as a treatment for the novel coronavirus.
“From that moment on, it was all hands on deck,” Charlie Langdon, senior director of manufacturing of the Gilead’s La Verne facility, announced on the company’s website. “This wasn’t just one department—this was literally our entire site coming together and strategizing about what we needed to be done to make this happen as quickly as possible.
On the first day of this month, the FDA finally authorized remdesivir for emergency use, making it easier t administer to hospitalized patients during the COVID-19 pandemic. The federal government will now lead an effort to distribute the treatment.
A recent report published in the New England Journal of Medicine tracked 53 people who were given a 10-day course of remdesivir. The patients were hospitalized with COVID-19, needed respiratory support and received the treatment on a compassionate-use basis, which allows people to take unapproved medicines when no other approved treatment options are available.
Over a median follow-up of 18 days, 36 of the 53 patients showed oxygen improvement, while 15 percent of the patients worsened. Of the 30 patients who received invasive mechanical ventilation, the study found that 17 were able to get off their breathing device.
All told, 47 percent of the patients were reportedly discharged, while 13 percent died.
Due to a lack of a control group in the study, however, some in the biomedical industry have expressed skepticism with the results.
“The data from this paper are almost uninterpretable,” Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said in a Bloomberg.com article. “There is some evidence suggesting efficacy, but we simply do not know what would have happened to these patients had they not been given the drug.”
Gilead Sciences turned down a phone interview request from San Jose Inside, replying with an email, saying: “We are not able to make an interview work at this time.”
Remdesivir has become a promising therapeutic treatment for COVID-19 due to its broad antiviral spectrum activity against members of several virus families, including filoviruses like Ebola and various coronaviruses.
However, researchers and scientists won’t get a clearer picture on whether remdesivir can be the eventual treatment for COVID-19 until the results of larger clinical trials are released in the coming weeks and months.
While Gilead promised to donate its initial supply of 1.5 million doses of the drug, the company told shareholders this week that it will need to start charging to make production economically feasible going forward.
“Going forward, we will develop an approach that is guided by the principles of affordability and access,” Gilead CEO Daniel O’Day told investors Wednesday on a call during the firm’s yearly meeting.
In a quarterly financial filing made earlier on the same day as the investor meeting, Gilead declared that its investment in remdesivir for 2020 “could be up to $1 billion or more,” with the bulk of it scaling up manufacturing capacity.