Gilead Sciences (GILD)’s clinical trial results for a potential coronavirus treatment is being heralded as a breakthrough, largely by blazing a trail for other drugs in the pipeline, and illuminating a path forward in the fight against a “scary” pandemic that’s infected over 3 million around the world.
Three separate studies of Gilead’s remdesivir — including a placebo trial by the National Institute of Allergy and Infectious Disease, which is carries far more influence — have helped backstop markets, and sparked hopes that the COVID-19 crisis can be managed. The encouraging results have also opened the door for Gilead to pursue an emergency use authorization from the U.S. Food and Drug Administration.
“There’s a big sense of urgency here, I think the FDA understands the importance of reacting quickly to this,” CEO Daniel O’Day said on an earnings call Thursday. “It’s intense right now and…we think the FDA will move quite quickly on their decision on the labeling side.”
He added he believes the regulatory authority will first approve the drug for emergency use, followed by full approval. But even with emergency use, the company could start collecting revenues on the drug, even though it hasn’t determined a price for it yet.
However, the CEO underscored that earning profits are not the goal just yet, as the company plans to donate its entire current supply, some 1.5 million doses, to clinical trials in the U.S. and around the world. Patients may also obtain the drug via existing compassionate use authorization.
Gilead also plans to produce enough doses to treat 1 million patients by the end of the year, and is working to expand its supply chain with larger industry partners — but it has to do so without jeopardizing its access to limited raw materials for the drug, O’Day said.
NIAID’s director, Dr. Anthony Fauci, said Wednesday that the agency’s study shows the virus does respond to drugs, which opens the door to more treatment options.
“The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recover…what it has proven is that a drug can block this virus,” Fauci said, even as he cautioned the data needed more rigorous, statistically-significant analysis.
A drug’s promise against a ‘scary’ problem
Gilead’s results showed slight improvements in recovery time of severe patients given the drug intravenously. Patients recovered in 11 days with the drug, compared to 15 without, and the mortality rate was 8% for those with the drug, compared to 11% without.
While there’s more work ahead, one thing is clear from the clinical trial results — the COVID-19 drug development landscape now has a clearer path forward. As Gilead’s CEO put it on Thursday, “one now has to compare with remdesivir or work with remdesivir.”
The drug’s encouraging test results have helped bolster investor psychology in a market that’s desperate for good news in the increasingly grim fight against the coronavirus — especially with hopes of ending the lockdown inextricably linked to effective COVID-19 testing and treatment options.
“Because it tells us a drug can work against this terrifying, scary, global problem,” Brad Loncar, a biotech investor and CEO of Loncar Investments, told Yahoo Finance.
Gilead’s study in severe patients showed a different aspect of the effectiveness of the drug. Patients who took a 5-day treatment course saw similar results as those on a 10-day course. Loncar estimates the company has enough to treat 280,000 people, and Gilead plans to invest $1 billion to ramp up manufacturing.
The studies have also provided a clue about how to attack the virus in order to create a tailor-made solution. It suggests pharmaceutical companies can create drug cocktails — like those used to treat HIV patients— with other treatments currently being studied.
For his part, Fauci expressed optimism that an anti-inflammatory drug currently being studied may be used in combination with remdesivir. “So as drugs come in, we’re going to see if we can add on that,” he said.
Both Kevzara, a drug co-developed by Regeneron (REGN) and Sanofi (SNY), and Actemra, a drug developed by Roche (RHHBY), are among those being studied as treatment options.
However, more information is still needed, as the NIH trial heads to a second phase in the summer. Sanofi recently said it amended the Kevzara study to focus on the most critical patients, saying it saw negative results in less-critical patients.
Gilead is also looking at the most critical patients, including those on ventilators, in an expansion of the current trial.
President Donald Trump called the Gilead “a beginning” that provides a good building block for the future.
Meanwhile, the FDA is working to get Gilead’s drug to the patients who need it most, but it is unclear how soon the regulatory body will issue an emergency use authorization, which was expected Wednesday, or how far away a full approval is.
In a statement to Yahoo Finance, an FDA spokesperson said, “the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate.”
Meanwhile, as that process moves along, an open question remains how politics may play a role. Gilead intends to distribute the drug globally — but the crisis has worsened bilateral ties between the U.S. and China, while putting severe strains on the global supply chain.
It will be essential for countries to work together to create enough supply for people all over the world and… we are in discussions with various groups about how we might bring remdesivir to the developing world,” Gilead’s O’Day wrote in his letter.
However, some observers like Loncar are concerned if the federal government could intervene in a way that hamstrings development.
“If U.S. protectionism and politics gets thrown into this…is Gilead only going to be able to be used only in the U.S., or will Trump use it as a political tool? Like sending it to allies like Italy and France but not sending it to Iran and China,” Loncar asked.
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