An Open Letter from Daniel O'Day, Chairman & CEO, Gilead Sciences
After receiving the green light from the FDA to move forward, Gilead is about to start trials of an inhaled version of remdesivir. We will screen healthy volunteers for Phase 1 trials this week and hope to begin studies in patients with COVID-19 in August. If the trials are successful, this could represent important progress. Remdesivir, our investigational antiviral medicine, is currently given to patients intravenously through daily infusions in the hospital. An inhaled formulation would be given through a nebulizer, which could potentially allow for easier administration outside the hospital, at earlier stages of disease. That could have significant implications in helping to stem the tide of the pandemic.
We have already learned a lot about how remdesivir works in a relatively short space of time. All of us at Gilead are grateful for the strong collaborations that helped to make this possible and to the thousands of patients who have taken part in clinical trials. Remdesivir is now being used to treat patients through emergency use authorizations and other access programs around the world. And yet, we still have some way to go in exploring the full potential of remdesivir to help against COVID-19.
As part of our next wave of clinical development, we will study remdesivir in treating earlier in the disease, in combination with other therapies and in additional patient groups.
So far, randomized controlled trials of remdesivir have been evaluating its safety and efficacy in hospitalized patients. In the NIAID study, remdesivir shortened recovery time by an average of four days and in the SIMPLE study of moderately ill patients (those in hospital but not requiring oxygen), individuals on a five-day course of remdesivir had better clinical outcomes than those receiving standard of care. The NIAID data also showed that treatment was most effective in patients who did not yet require medical ventilation, supporting further study in patients with earlier disease. The totality of these data shows that remdesivir has the potential to be of meaningful benefit to patients with COVID-19 and offers important hope. In our ongoing studies, we will work to deliver on that hope and potentially benefit more patients.
Next wave of studies
The inhaled formulation studies are one means of exploring the use of remdesivir in the earlier stages of COVID-19. We will also conduct trials using intravenous infusions in outpatient settings such as infusion centers and nursing homes. For patients who are at high risk of disease progression, it could be particularly beneficial to start treatment outside the hospital. Our hope is that earlier intervention could help patients avoid hospitalization altogether.
We are also exploring whether we can improve patient outcomes by combining remdesivir with other therapies.
Based on our knowledge of the disease so far, it seems that in the earlier stages of COVID-19, the virus itself is the primary driver of illness. In the later stages, the body’s inflammatory response may cause some of the most life-threatening aspects of the disease. It is important, therefore, to have tools that can work together to fight both aspects of the disease: an antiviral to target the virus itself and another therapy to tackle the inflammatory response. We have been keen to explore how remdesivir might work when combined with anti-inflammatory agents, particularly in the most severely ill patients.
Over the coming months we will see results from studies of remdesivir with two immune modulators. One study is looking at remdesivir with the JAK inhibitor, baricitinib, and a second is studying remdesivir in combination with the IL-6 receptor antagonist tocilizumab. Last week’s news on dexamethasone appears to further support the study of complementary approaches for treating COVID-19. Dexamethasone is a steroid that potentially reduces the body’s inflammatory response to the virus.
In addition to extending our focus to earlier treatment and combinations, our next wave of studies of remdesivir will include vulnerable patient populations. Last week, we announced that we are about to begin a clinical trial for children. The study will treat approximately 50 children, from newborns to adolescents who are hospitalized with COVID-19. We are also collaborating with an external group on a study in pregnant women, and we are planning a trial for patients with end-stage renal disease. Our continued aim in all our studies is to reflect the diverse demographics of the communities affected, including factors such as race, ethnicity and gender.
Our best hope of beating COVID-19 is with a set of tools at our disposal: complementary therapeutics, effective vaccines and widespread testing. Having already seen that science can deliver answers, we can be hopeful of continued progress. Gilead will do all it can to help drive that progress by exploring the full potential of remdesivir.
Increasing supply and ensuring access
As part of our aim to benefit as many patients as possible, we are focused on ensuring sufficient supplies of remdesivir and enabling access. We now expect to have more than two million remdesivir treatment courses manufactured by the end of the year and many millions more by 2021. Our scientists will stay focused on optimizing the manufacturing process, and we will continue to collaborate globally to ensure sufficient worldwide supply.
We donated our entire existing supplies of remdesivir through June. In keeping with Gilead’s longstanding commitment to access in the developing world, we have also set up voluntary licensing agreements with nine generic manufacturers. As we go forward, we will work to ensure that remdesivir is accessible and affordable to governments around the world. All of us at Gilead feel the full weight of our responsibility with remdesivir and this will continue to guide all our future actions.
Our ongoing commitment
Gilead has a long-term commitment to the study of emerging viruses, as part of our thirty-year presence in antivirals. In recent years, our scientists built up a library of compounds – one of which was remdesivir – that could potentially be used against future viruses.
Without years of research on remdesivir, we would not have been able to move so quickly in response to this outbreak. We were able to rapidly enter into clinical trials because we already had sufficient knowledge from studying remdesivir in other viruses to hope it might work against COVID-19. Research, iteration and perseverance have to be constant factors in scientific progress. The commitment has to be long-term.
Our commitment to remdesivir will continue now as we explore its full potential in the hope of helping many more patients with COVID-19. At the same time, our broader, ongoing research in emerging viruses continues. We are committed to doing everything we can to help with this pandemic, while ensuring we are prepared for the next.
Remdesivir is an antiviral product that is being studied in multiple ongoing international clinical trials. In recognition of the current public health emergency and based on available clinical data, the approval status of remdesivir varies by country. In countries where remdesivir has not been approved by the regional health authority, remdesivir is an investigational drug, and the safety and efficacy of remdesivir have not been established.
Remdesivir has not been approved by the U.S. Food and Drug Administration (FDA) for any use. In the U.S., the FDA granted remdesivir an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with severe COVID-19. This authorization is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process. For information about the authorized use of remdesivir and mandatory requirements of the EUA in the U.S., please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.
This statement includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors. Remdesivir is an investigational drug that has not been approved by the FDA for any use, and its safety and efficacy has not been established for the treatment of COVID-19. There is the possibility of unfavorable results from ongoing and additional clinical trials involving remdesivir and the possibility that Gilead and other parties may be unable to initiate and complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of remdesivir or that FDA and other regulatory agencies may not approve remdesivir, and any marketing approvals, if granted, may have significant limitations on its use. As a result, remdesivir may never be successfully commercialized. In addition, Gilead may face challenges related to the allocation, geographical distribution and accessibility of existing and future supply of remdesivir. If Gilead is unable to sufficiently scale up manufacturing of remdesivir in the currently anticipated timelines, Gilead may be unable to meet global supply needs. There is also the risk that Gilead may be unable to recoup the significant expenses incurred to date and in the future related to the development and manufacturing of remdesivir. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.