Gilead Sciences' remdesivir has courted high hopes as a potential treatment for COVID-19—so high, in fact, that the company previously had to shut down emergency access to the drug. Now, Gilead's revving up manufacturing of remdesivir to operate at light speed.
Gilead has stepped on the gas pedal to ramp up production of the coronavirus candidate, CEO Daniel O'Day said in an open letter Saturday, including making "process improvements" that have cut remdesivir's manufacturing timeline in half from one year to six months.
Thanks to that sped-up production schedule, Gilead plans to donate 1.5 million doses of remdesivir to ongoing clinical trials and through its expanded access and compassionate use programs, O'Day said.
Those 1.5 million doses––roughly equivalent to 140,000 treatment courses––are either ready for distribution or in the final stages of production, and Gilead hopes to have another 360,000 courses ready to go by October, O'Day said. By year-end, if the company meets its goal, it will have turned out 1 million treatment courses.
"Our efforts to increase supply continue with a strong sense of urgency," O'Day wrote. "There is a long way to go and a lot of work to be done but I’m pleased that, despite the challenges we have been able to get supply levels to where they are today in a very short space of time––through the resourcefulness of our teams, creative approaches and collaboration."
Manufacturing remdesivir at scale will help shore up the drug's supply with demand on the rise through Gilead's access programs and a suite of global clinical trials.
O'Day wrote that more than 1,700 patients have received remdesivir through the drugmaker's compassionate use program designed for children and pregnant women. The drugmaker is also adding U.S. and European sites to its new expanded access program, which allows hospitals or physicians to apply for emergency use of remdesivir for multiple severely ill patients at a time.
That expansion appears to be a quick turnaround after the company in March halted emergency access, citing overwhelming demand for the drug. At the time, Gilead said an "exponential increase" in remdesivir requests had flooded a patient-by-patient access program that was "never intended for use in response to a pandemic."
Remdesivir was originally designed to tackle Ebola by inhibiting an enzyme called RNA polymerase that’s used by many viruses to replicate, though it never succeeded in that indication. In a 2017 Science Translational Medicine study, scientist found the med could also kill SARS and MERS—two other coronaviruses that caused deadly outbreaks in the 21st century—in lab dishes.
Remdesivir has been tagged as one of a few potential COVID-19 therapies with the highest chances of success—but it's courted controversy along the way.
After applying for and receiving an FDA orphan tag for the drug—a designation that comes with seven-year market exclusivity—Gilead asked the FDA to rescind it late last month, hoping to fend off a wave of bad press over the government's decision.
In a separate open letter last week, O'Day said Gilead would “work to ensure affordability and access so that remdesivir is available to patients with the greatest need” if it’s eventually approved to treat COVID-19.
The first data readouts from remdesivir's clinical trials are expected to start reading out this week, according to SVB Leerink analyst Geoffrey Porges, and could cause a "huge sigh of relief" if it shows clinical efficacy.