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. 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. The inhaled formulation studies are one means of exploring the use of remdesivir in the We are also exploring whether we can improve patient outcomes by 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.
At the same time, our broader, ongoing research in emerging viruses continues.
His career at Roche spanned more than three decades, during which he held a number of executive positions in the company's pharmaceutical and diagnostics divisions in North America, Europe and Asia. We will screen healthy volunteers for Phase 1 trials this week and hope to begin studies in patients with COVID-19 in August.
That could have significant implications in helping to stem the tide of the pandemic. 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. 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. Over the coming months we will see results from studies of remdesivir with two immune modulators. Prior to Gilead, Daniel served as the Chief Executive Officer of Roche Pharmaceuticals. In the U.S., the FDA granted remdesivir an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with severe COVID-19. 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. Prior to Gilead, Mr. O’Day served as the Chief Executive Officer of Roche Pharmaceuticals.
In addition to extending our focus to earlier treatment and combinations, our next wave of studies of remdesivir will include Our best hope of beating COVID-19 is with a set of tools at our disposal: complementary therapeutics, effective vaccines and widespread testing. Gilead's deal to buy Forty Seven is likely to be met warmly by investors, though some may balk at the price. We will screen healthy volunteers for Phase 1 trials this week and hope to begin studies in patients with COVID-19 in August. We have already learned a lot about how remdesivir works in a relatively short space of time. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements. All of us at Gilead feel the full weight of our responsibility with remdesivir and this will continue to guide all our future actions. Science & Medicine 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. 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.
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. Gilead has a long-term commitment to the study of emerging viruses, as part of our thirty-year presence in antivirals.
Daniel O’Day Chairman and Chief Executive Officer Mr. O’Day joined Gilead in 2019 to lead the biopharmaceutical company, which has more than 11,000 employees around the world. 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. O'Day will join Gilead at a critical moment for the three-decade-old biotech.
In the later stages, the body’s inflammatory response may cause some of the most life-threatening aspects of the disease.
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. 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. Daniel O’Day’s net worth is around $5.3 million.
In recognition of the current public health emergency and based on available clinical data, the approval status of remdesivir varies by country. Remdesivir has not been approved by the U.S. Food and Drug Administration (FDA) for any use.
Without years of research on remdesivir, we would not have been able to move so quickly in response to this outbreak.
Daniel O'Day holds a bachelor's degree in biology from Georgetown University and an MBA from Columbia University in New York.