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'An Open Letter from Daniel O'Day, Chairman & CEO, Gilead Sciences' -Company Post (Full Statement)

An Open Letter from Daniel O’Day, Chairman & CEO, Gilead Sciences Daniel O’Day - October 08, 2020 With today’s publication of new data on remdesivir in the New England Journal of

· 10/08/2020 17:34

An Open Letter from Daniel O’Day, Chairman & CEO, Gilead Sciences

Daniel O’Day - October 08, 2020

With today’s publication of new data on remdesivir in the New England Journal of Medicine, we have the clearest picture yet of the medicine’s impact on COVID-19. Over the past months, we had already generated a wealth of clinical data on the benefits of remdesivir, providing much-needed hope to patients and healthcare providers worldwide. On the basis of this data, remdesivir has been approved or authorized for temporary use to treat COVID-19 in more than 50 countries worldwide. Today’s peer-reviewed data come from the gold standard randomized, double-blind, placebo-controlled Phase 3 study led by the U.S National Institute of Allergy and Infectious Diseases (NIAID). They provide new information that expands on the benefits of remdesivir and offer greater hope than ever in the fight against COVID-19.

The preliminary results from the global NIAID study were published in May, but now we have the final dataset covering approximately 1060 hospitalized patients worldwide. These data tell us three things.

The first is that hospitalized patients receiving remdesivir recovered five days faster on average, and in patients with severe disease, seven days faster.  These severely ill patients made up 85% of the total study population. The second key takeaway is that remdesivir reduced the likelihood of patients progressing to more severe stages of the disease where they would require new or additional oxygen support. And thirdly, in the largest group of patients in the study, those on low-flow oxygen, there was a significant reduction in mortality in a post-hoc analysis. In the overall population, the results showed a trend in mortality reductionEach of these study outcomes is of critical importance to managing the pandemic and informing decisions made by healthcare workers on behalf of their patients. 

For patients who are hospitalized with COVID-19, the importance of speeding up recovery by five to seven days cannot be underestimated. Aside from the physical challenges, every day with the disease brings an emotional toll on patients and their families dealing with the separation and the worry. Some physicians have also raised the point that the longer a patient is in hospital, the greater the risk of getting a secondary infection. In the group of patients that required supplemental oxygen, those receiving remdesivir plus standard of care recovered one week faster than those treated with placebo plus standard of care. This represents a significant benefit in a disease where every day counts.

The latest data also include new results on reducing disease progression. In the group of patients receiving remdesivir, fewer progressed to the need for supplementary oxygen or higher levels of respiratory support, such as mechanical ventilation. Remdesivir works by reducing the ability of the virus to replicate in the body and ideally, we want to stop the replication as early as possible in the course of the disease. We know that for patients on a ventilator, the chances of survival are lower. By reducing disease progression, remdesivir may keep patients from entering this critical stage of illness.

The benefits of remdesivir in leading to faster recovery and a reduction in disease progression were seen broadly in the overall NIAID study results. In addition to the direct impact on patients, these outcomes represent clear benefit and value to healthcare systems. Remdesivir could help to lower the use of healthcare resources and reduce the number of days that patients are in the hospital.

The question of whether remdesivir provides a mortality benefit is one we have been looking forward to answering with peer-reviewed, placebo-controlled clinical data. It is important to note that the study enrolled a broad range of patients so there was significant heterogeneity in disease severity at baseline. Although the prespecified analysis of mortality in the total population showed only a numerical trend toward a reduction, there are additional findings on mortality in this study that provide valuable new information. In a post-hoc analysis of mortality rates for patients receiving low-flow oxygen, there were 70% fewer deaths among patients receiving remdesivir compared with the placebo group. Patients on low-flow oxygen made up approximately 40% of the overall patient population. This information is critically important for understanding remdesivir’s potential impact on mortality and maximizing the benefit to patients.

Today’s new results add to the totality of evidence on remdesivir that has been generated across three randomized controlled Phase 3 studies. All of us at Gilead are grateful that, along with the trial investigators and thousands of patients who have taken part in clinical trials, we have generated consistent data to help inform treatment decisions that will be taken on behalf of many more patients with COVID-19 in the future.

Meeting global demand
At the same time as receiving this additional evidence on the benefits of remdesivir, we have been able to significantly increase supplies. In the United States, we have enough remdesivir on-hand to treat all hospitalized patients, even in the event of a future spike in cases. Globally, we expect to meet demand this month, enabling the purchase of Veklury both to treat current hospitalized patients and to support national stockpiling. Earlier today, Gilead announced an agreement with the European Commission that enables 37 participating countries in the EU and the European Economic Area (EEA), as well as the UK, to purchase remdesivir for real-time demand and stockpiling needs, coordinated by the European Commission. The agreement covers purchases of remdesivir over the next six months with the option to extend further. In addition, Gilead’s voluntary licensing partners are currently supplying generic remdesivir in more than 40 countries, and their patient reach continues to grow.

It is remarkable that we are in this position today, given that remdesivir is such a complex medicine to manufacture with a typical lead time of 9-12 months. Gilead has left no stone unturned in the efforts to bring us to this point. We invested in ramping up manufacturing long before we knew whether remdesivir would work, we brought on more than 40 additional manufacturing partners and our teams worked day and night to find ways to shorten the lead time, without compromising on safety or rigor. I am grateful to the many Gilead employees, contract organizations and partner companies who worked so hard to make this happen, overcoming many challenges along the way.

Our journey with remdesivir has entered a new phase, with the potential to make an even greater impact on the pandemic. We have rich new data to show how it might best be used to benefit patients and, with the increase in supply, many more patients can now access remdesivir worldwide. At the same time, we continue to explore its potential. Ongoing studies include intravenous treatment in the outpatient setting and an inhaled solution that could potentially be taken earlier in the course of the disease. We are also looking forward to the results of combination studies where remdesivir is the backbone treatment, to which other therapies with complementary mechanisms of action may be added. As we move forward with remdesivir, we will continue to be guided by the most robust clinical data at each step of the way, in the hope that science will continue to deliver in the fight against COVID-19.