Drugmaker Gilead Sciences aims to produce more than 1 million courses of treatment of a drug it is investigating in Covid-19 by the end of the year, its CEO wrote in a letter over the weekend.
In the letter, released on Saturday, Daniel O’Day wrote that the Foster City, California-based company already had 1.5 million individual doses of the drug remdesivir on hand that it would make available at “no cost” for compassionate use, expanded access and clinical trial programs. The number of doses “could equate to well over 140,000 treatment courses for patients,” O’Day wrote.
The letter comes two weeks after Gilead requested that the Food and Drug Administration rescind the orphan drug designation it had granted to remdesivir following a public backlash against the decision.
As of Monday, there were nearly 1.3 million confirmed cases of Covid-19 and 70,590 deaths around the world, including nearly 338,000 in the U.S., which now has the largest number of cases by far of any country. In the U.S., 9,654 people had died, including more than 3,000 in New York City alone.
Remdesivir, a drug that Gilead originally developed for Ebola virus, is one of several drugs in development as potential therapies for Covid-19. Its development in Covid-19 was prompted by preclinical data showing that it may have activity against coronaviruses, as well as anecdotal accounts of efficacy in patients infected with the Covid-19 coronavirus, SARS-CoV-2. Others include Regeneron Pharmaceuticals and Sanofi’s Kevzara (sarilumab) and Incyte and Novartis’ Jakafi (ruxolitinib), the latter of which is planned to enter a Phase III study for Covid-19-related cytokine storm.
O’Day wrote that the company has laid out an “ambitious” goal to produce more than 500,000 courses of treatment of remdesivir by October. It has ramped up production of the drug using active pharmaceutical ingredients that it has on hand and plans to expand its supplies further by expanding its global capacity for raw materials and production while working with pharmaceutical and chemical manufacturers around the world, O’Day wrote.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Gilead is sponsoring two randomized, Phase III, open-label studies of remdesivir, whose development name is GS-5734. One is in 400 patients with severe disease at 91 sites in the U.S., Europe and Asia and is testing five- and 10-day regimens of the drug against standard-of-care treatment to determine how well it normalizes temperature and oxygen saturation after 14 days. The other is enrolling 600 patients at 96 U.S. and overseas sites with moderate disease and is comparing the same regimens against standard of care to test the drug’s effect on time to discharge.
Both trials are expected to reach completion in May, but are still in the process of recruiting patients, with two sites listed as not yet open for recruitment.
In addition, Gilead is sponsoring expanded-access programs for patients unable to partake in the clinical trials. The company had previously been allowing patients to use remdesivir under compassionate use protocols, but had to take that program offline and replace it with the current expanded access program after its computer system became overwhelmed with requests.
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