Coronavirus

Gilead Sciences Update On The Company’s Ongoing Response To COVID-19

Gilead is working closely with global health authorities to respond to the novel coronavirus (COVID-19) outbreak through the appropriate experimental use of the investigational compound remdesivir. Together with the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS), National Institute of Allergies and Infectious Diseases (NIAID) and Department of Defense (DoD) - CBRN Medical; the China CDC and National Medical Product Administration (NMPA); the World Health Organization (WHO); and individual researchers and clinicians; Gilead is focused on contributing our antiviral expertise and resources to help patients and communities fighting COVID-19.



About Remdesivir

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity – it is not approved anywhere globally for any use. Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are also coronaviruses and are structurally similar to COVID-19. The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19.



This is an experimental medicine that has only been used in a small number of patients with COVID-19 to date, so Gilead does not have an appropriately robust understanding of the effect of this drug to warrant broad use at this time.



Gilead’s Response to COVID-19 in Detail

Gilead’s response to COVID-19 entails three main areas:



Clinical Trials

Together with health authorities in China, Gilead has initiated two clinical trials in patients who have been infected with COVID-19 to determine the safety and efficacy of remdesivir as a potential treatment for the coronavirus. The two studies are being coordinated by the China-Japan Friendship Hospital and are being conducted at multiple sites in Hubei province. Gilead is providing study drug at no charge and provided input on study design and conduct.



One study is evaluating remdesivir in patients with confirmed disease who have developed more severe clinical manifestations such as a requirement for supplemental oxygen. The other study is evaluating remdesivir in patients with confirmed COVID-19 infection who have been hospitalized but are not displaying significant clinical manifestations of disease such as an oxygen requirement. The study in patients with severe disease began enrolling patients on February 6. The study in patients with moderate disease began enrolling patients on February 13. Clinical trial results are anticipated in April.





Compassionate Use

Gilead is working with government and non-government organizations and regulatory authorities to provide remdesivir to patients with COVID-19 for emergency treatment in the absence of any approved treatment options.



Compassionate use requests must be submitted by a patient’s treating physician. Gilead is currently assessing requests on an individual basis and require, at a minimum, that the patient be hospitalized with confirmed COVID-19 infection with significant clinical manifestations.



It is important to note that results in individual compassionate use cases are not sufficient to determine the safety and efficacy of remdesivir in treating COVID-19 – this can only be determined through prospective clinical trials.





Increasing Manufacturing Capacity and Supply

There are currently limited available clinical supplies of remdesivir but Gilead is working to increase its available supply as rapidly as possible.



In response to the Ebola outbreaks in West Africa in recent years, Gilead increased manufacturing of remdesivir to create a stockpile of product that could be used in response to future pandemics, as well as a stockpile of materials used to manufacture remdesivir. Gilead is now using this stockpile to address the supply needed for current compassionate use requests and the two clinical trials in China.



In anticipation of potential future needs, Gilead has accelerated manufacturing timelines to increase available supply as rapidly as possible. Gilead is doing this before knowing whether remdesivir will be determined to be safe and effective to treat patients with COVID-19.



To increase available clinical supplies of remdesivir, Gilead is also manufacturing two formulations of remdesivir, in both liquid and freeze-dried forms, expanding its network of manufacturing partners to increase capacity and production, and has begun internal manufacturing of remdesivir to supplement the capacity of the external manufacturing network. Gilead is actively collaborating with government agencies on COVID-19 response efforts, and is sharing regular updates with them on the company’s manufacturing scale-up.





Access to Remdesivir and Future Study

Gilead is mapping out options to make access to investigational remdesivir more widely available through appropriate channels for emergency use should it demonstrate the potential to be a safe and effective treatment option based on the results of preliminary clinical trials.



Gilead is also in discussions with regulatory agencies to determine the most appropriate pathway for submitting remdesivir for approval for the treatment of COVID-19 in the event the trial results are positive.



Finally, Gilead is in discussion with multiple organizations regarding the potential for future trials.



For More Information:

Please contact Gilead via email with any questions by clicking here.



Last Updated: February 18, 2020

A publicly traded Chinese drug developer, BrightGene Bio-Medical Technology Co., said today it has successfully manufactured the active pharmaceutical ingredients (APIs) of remdesivir (GS-5734), the Gilead Science antiviral candidate being tested in China human clinical trials as a treatment for the 2019-nCoV novel coronavirus.



“[BrightGene] actively responded to the national call to fight the new coronavirus (2019-nCoV) epidemic, and recently successfully developed and synthesized the technology and preparations for the drug synthesis of [remdesivir] technology,” the company stated today.



“The company successfully imitated the development and production of [remdesivir] APIs by virtue of its technical accumulation in the development of high-end APIs and special injections,” BrightGene added in its statement, issued through the Shanghai Stock Exchange. “The company has produced [remdesivir] bulk drugs, and the batch production of Remdesivir preparations is in progress.”



BrightGene acknowledged that its marketing of remdesivir “still needs to be authorized” by Gilead, adding, “There are many uncertainties in this process, such as drug approval.” BrightGene did not discuss in its statement what if any efforts the company has undertaken to pursue authorization from Gilead for the imitation product: “If the product can be approved for marketing, it will be supplied to relevant patients mainly through donations during the epidemic.”



“Therefore, considering production costs, pricing, sales volume and other considerations, this product is not expected to have a significant impact on the company’s operating performance in 2020,” BrightGene’s statement continued.



Shares of BrightGene closed 20% higher today on the news, rising to RMB 52.12 ($7.48) a share. The company has a market cap of RMB 21.369 billion (about $3.1 billion), according to Bloomberg.



BrightGene’s acknowledgement was the company’s second statement in recent weeks related to coronavirus. On January 28, BrightGene and its Founder and Executive Chairman Jiandong “J. D.” Yuan each donated RMB 1 million ($143,426) to the Wuhan Red Cross toward “urgently needed medical material procurement and personnel material protection.”



“The epidemic is a common enemy,” BrightGene stated, adding that the company “has always been with the people of the whole country, especially the people in Wuhan, where the epidemic situation is most severe, to overcome the difficulties.”



The theme of a national struggle against a common foe has been emphasized in recent public statements by Chinese President Xi Jinping, who has characterized China’s initial response as marked by “shortcomings and deficiencies.”

“China has the confidence and capability to secure full victory in the battle against the novel coronavirus pneumonia outbreak while also completing its socioeconomic tasks,” Xi was paraphrased by Xinhua as stating on Tuesday, a day after he was photographed as having his temperature taken while inspecting novel coronavirus pneumonia prevention and control work at the Anhuali community center in Beijing’s Chaoyang district.

44,653 Confirmed cases in China

According to updated coronavirus figures reported today by China’s National Health Commission, 97 deaths and 2,015 new cases of infections were confirmed on Tuesday. To date, 44,653 people have been confirmed as infected with 2019-nCoV, and 1,113 people have died—more than triple the 349 who died in the SARS outbreak of 2002–03—with 4,740 patients cured and discharged from hospitals.



Gilead is partnering with Chinese health authorities on human clinical trials of remdesivir that have already begun in Wuhan, the center of the novel coronavirus outbreak. China’s state-owned Xinhua news agency has reported that the trials have officially launched following approval by China’s National Medical Products Administration of applications by the China-Japan Friendship Hospital and the Chinese Academy of Medical Sciences to conduct the clinical studies.



Friendship Hospital plans to study a total of 761 patients in two trials—one trial to assess 308 with mild or moderate infection, the other 453 severely infected patients—at Jinyintan Hospital in Wuhan.



“Obviously we’re waiting for data, both in vitro and then in people to ensure that the drug actually works,” Gilead chairman and CEO Daniel O’Day said February 4, addressing analysts on his company’s conference call following release of fourth-quarter and full-year 2019 results, according to a transcript published by Seeking Alpha. “We are investing pretty heavily to make sure that we’re prepared as best as we can.”



“In terms of manufacturing, our team has really been working night and day,” O’Day added, “It’s been very impressive to watch this team over the past couple of weeks really ramp up to the extent that we can. If our capacity is going up every day, we’re looking at all the options we have expecting to be prepared for what may come.”



Also today, the World Health Organization (WHO) said it is renaming the 2019-nCoV virus as COVID-19, with director general Tedros Adhanom Ghebreyesus stating that the new name “did not refer to a geographical location, an animal, an individual or group of people, and which is also pronounceable and related to the disease”.



“Having a name matters to prevent the use of other names that can be inaccurate or stigmatizing. It also gives us a standard format to use for any future coronavirus outbreaks,” Tedros added.