Gilead Sciences Update on Veklury® (Remdesivir) Manufacturing Network
Foster City, Calif., August 6, 2020 – Since January, Gilead has taken multiple steps to ramp up production and rapidly build supply of our investigational COVID-19 treatment Veklury® (remdesivir), preparing for potential global demand at risk, in recognition of the lengthy manufacturing timeline. In addition to process improvements that have shortened the manufacturing timeline to six months, Gilead has expanded its global network of both internal manufacturing sites and external organizations, including partnering with industry peers, to add manufacturing capacity around the world. Our Veklury manufacturing network now includes more than 40 companies in North America, Europe and Asia.
By working together in a coordinated fashion, this network of partners is supporting us to meet global patient needs. We have increased supply more than 50-fold since January and anticipate being able to meet real-time global demand starting in October. We plan to produce more than two million treatment courses by the end of the year, and we anticipate producing several million more in 2021, if needed.
Beyond this network, Gilead has also entered into voluntary licensing agreements with nine generics manufacturers to further expand supply of remdesivir to 127 countries that represent nearly all low-income and lower-middle income countries. Gilead has completed technology transfers with these companies, and they are beginning the manufacturing process.
Gilead thanks its manufacturing partners and their dedicated employees for contributing their expertise to expedite the availability of Veklury for patients around the world.
About Veklury (remdesivir)
Veklury 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 Veklury varies by country. In countries where Veklury has not been approved by the regional health authority, Veklury is an investigational drug, and the safety and efficacy of Veklury have not been established.
Veklury has not been approved by the U.S. Food and Drug Administration (FDA) for any use. In the United States, the FDA granted Veklury an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with severe COVID-19. This authorization is temporary and may be revoked, and it does not take the place of the formal new drug application submission, review and approval process. For information about the authorized use of Veklury and mandatory requirements of the EUA in the United States, please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.
This press release 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. Veklury (remdesivir) is an investigational drug that has not been approved by the FDA for any use, and it is not yet known if Veklury is safe or effective for the treatment of COVID-19. There is the possibility of unfavorable results from ongoing and additional clinical trials involving Veklury and the possibility that Gilead and other parties may be unable to 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 Veklury or that FDA and other regulatory agencies may not approve Veklury, and any marketing approvals, if granted, may have significant limitations on its use. As a result, Veklury may never be successfully commercialized. In addition, Gilead and its manufacturing network may be unable to sufficiently scale up the production of Veklury in the currently anticipated timelines, and therefore may be unable to meet future supply needs. 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 periodic reports filed with the U.S. Securities and Exchange Commission, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.