With remdesivir practically a household name today as the first therapeutic to be approved for the treatment of COVID-19 patients, Gilead chairman and CEO Daniel O’Day and Gilead vice-president and general manager of the Asia 5 region (Singapore, South Korea, Hong Kong, Taiwan, Malaysia) Andrew Hexter are determined to stress that there are no overnight successes in the world of biopharmaceutical drug development, highlighting the realities of the drug’s seemingly breakneck pace of development and market launch.
Remdesivir, Gilead’s antiviral agent, was the first therapeutic to be conditionally approved for the treatment of COVID-19 patients, with the first country to do so being Japan in late-May 2020. Prior to this, the drug was available to selected patients in the US and Japan through emergency use authorization. Remdesivir has gone on to receive a spate of conditional approvals in over 50 markets, including across the EU, Canada, and Brazil.
While having any therapeutic approved for a virus that only emerged nine months ago is an impressive feat, CEO O’Day wants to remind global audiences that this achievement did not develop overnight (or even within 2020). At the IFPMA September COVID-19 media briefing, he emphasized, “it’s important to note that this is not something that has come about in a short time frame. This is a result of decades of investment in research and very importantly, billions in antiviral research. Remdesivir is a story that started about 10 years ago due to our investments in emerging viruses. That level of investment and preparedness allowed us to move very, very quickly [in the case of COVID-19].” Remdesivir was first clinically evaluated for the Ebola virus in 2016.
Capitalizing on that background, the company moved quickly to assess the suitability of remdesivir as a potential COVID-19 therapeutic. O’Day revealed, “as soon as we knew of COVID-19, what we did is move rapidly to put this into a suite of trials that were designed to answer different questions. We now have the results of three very robust randomized trials [demonstrating] very consistent results for severe, hospitalized patients.” Remdesivir is currently administered in the acute care setting at this point in time. O’Day added, “we saw an improvement in clinical symptoms, a reduction in hospital stays, and as compared to real world data, [an] improvement in mortality.”
In our interview with Gilead Asia 5 VP and GM Andrew Hexter, who oversees some of the earliest markets to grant conditional approval to remdesivir, including Taiwan, Singapore and South Korea, he echoed CEO O’Day’s sentiments regarding the long-term investments behind the success of the drug. “Remdesivir applies decades of research, combined with years of experience and expertise harnessed from our work in HIV and hepatitis, to answer the urgent global need for treatment of COVID-19. [For instance] we have accelerated our Gilead-sponsored trials with top clinical centres around Asia to address scientific and clinical questions of interest.” Ultimately, he stressed, “our ability to move at an unprecedented pace can be attributed to the solid relationships that we have built with partners in Asia and globally.”
All of our previous learnings and experiences around partnerships, engagement and community outreach from our efforts in HIV, HBV, and HCV have become critical as we began to navigate the uncharted terrain of COVID-19
For Hexter, it is Gilead’s sustained decades-long efforts in other viral diseases like HIV, Hepatitis B and Hepatitis C that have positioned the company as a frontrunner in the battle against COVID-19 today. “All of our previous learnings and experiences around partnerships, engagement and community outreach from our efforts in HIV, HBV, and HCV have become critical as we began to navigate the uncharted terrain of COVID-19 where we must deliver solutions quickly to external stakeholders, partners and patients. We have established a long track record of making the impossible possible.”
In spite of this initial success, Gilead has pushed forward with more trials to uncover the full potential of remdesivir. CEO O’Day explained, “there are 36 other trials ongoing right now. We have a category of studies looking at remdesivir in combination with other medicines to see if a combination approach [could obtain] an even stronger [and] more durable effect for patients. This is characteristic with viral diseases, [like] HIV and hepatitis C.”
Another angle they are exploring is the potential to administer remdesivir in an outpatient setting, which could involve developing alternative formulations of the drug, with O’Day adding, “freeing up hospital resources is very important. We are looking for this to be delivered through an inhaled mechanism. It’s not a compound that’s suited for an oral mechanism because it’s metabolized very quickly by the liver but an inhaled mechanism, it gets directly into the lungs.”
Looking at the bigger picture, O’Day waxed philosophical, “we’re nine months [on from] identifying the disease. I think we all understand our responsibility here to patients and society, and it’s a very unique and unprecedented time.” While science and research can be accelerated to some extent to meet urgent societal needs, there is no magic bullet.