Will Gilead Sciences make a fortune out of remdesivir if the antiviral proves effective against the novel coronavirus? Maybe—or maybe not.
The Big Biotech will “work to ensure affordability and access so that remdesivir is available to patients with the greatest need” if it’s approved, CEO Daniel O’Day wrote in an open letter Saturday. But with a large pool of potential patients, that still leaves plenty of room for revenue.
The pledge comes shortly after Gilead rescinded its request for an FDA orphan drug designation, which comes with the perk of seven-year market exclusivity. Critics lamented that it would allow Gilead to charge high prices for remdesivir for years.
President Donald Trump has highlighted remdesivir as a promising anti-COVID-19 treatment, and the World Health Organization labeled it as “the most promising” antiviral during the early days of the outbreak. But its effectiveness won’t be known until a slate of clinical trials reads out, with the first expected from China in the coming weeks.
Clinical trials represent one way patients can get the medicine before its approval, but not all can enroll in one, either because they don't meet the enrollment criteria or can’t travel to a participating hospital. Gilead had offered the med under compassionate use and provided it for over 1,000 patients.
But after Trump’s advertisement, Gilead saw an exponential increase in requests, overwhelming a system where each application needed to be reviewed individually, O’Day said. The company stopped that access program last week, but it's now transitioning to a process where hospitals and physicians can apply for multiple patients at a time.
“While it will take some time to build a network of active sites, this approach will ultimately accelerate emergency access for more people,” O’Day said in his letter. According to him, the first sites are already available in the U.S., with more to come soon.
The first batch of clinical data could be available in April, as Chinese scientists have been testing remdesivir in two trials in mild-to-moderate and severe COVID-19 patients in Wuhan, which until recently was the epicenter of the outbreak.
However, there have been concerns about whether those trial findings will be conclusive. As the virus was quickly contained in China, there simply may not be enough patients there—especially severely sick ones—for the remdesivir trial. Plus, hundreds of clinical trials are fighting for participants, including tests of other promising antivirals such as chloroquine, Fujifilm’s flu drug Avigan and AbbVie’s HIV combo Kaletra, as well as for meds that aim to manage potentially life-threatening complications, including Roche’s IL-6 inhibitor Actemra.
As SARS-CoV-2 spreads across the globe, evidence of remdesivir’s efficacy might also come from other studies. The NIH’s National Institute of Allergy and Infectious Diseases is recruiting patients for a phase 3 at multiple sites in the U.S., Japan, South Korea and Singapore. Gilead itself is conducting two studies in mild-to-moderate and severe patients separately. And the WHO is planning a megatrial of promising drugs, including one arm for remdesivir.