FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that in response to the rapid increase in COVID-19 cases in India, the company is providing its voluntary licensing partners with technical assistance, support for the addition of new local manufacturing facilities and the donation of active pharmaceutical ingredient (API) to rapidly scale up production of remdesivir. Remdesivir is approved in India for restricted emergency use for the treatment of suspected or laboratory confirmed COVID-19 in adults and children hospitalized with severe disease. In addition to providing support to its licensees to expand their local manufacturing capacity, Gilead will also donate at least 450,000 vials of Veklury® (remdesivir) to help address the immediate needs of Indian patients.
“The recent surge of COVID-19 cases in India is having a devastating impact on communities and has created unprecedented pressure on health systems,” said Johanna Mercier, Chief Commercial Officer, Gilead Sciences. “We are committed to doing our part to help tackle this crisis. Our immediate focus is to help address the needs of patients in India who may benefit from remdesivir as quickly as we can by working together with the government, health authorities and our voluntary licensees.”
All seven of Gilead’s licensees based in India have significantly accelerated production of remdesivir by scaling up their batch sizes, adding new manufacturing facilities and/or onboarding local contract manufacturers across the country. While these efforts are expected to increase availability of remdesivir in the coming weeks, Gilead will donate at least 450,000 vials of Veklury to the Government of India to help ease the immediate need for treatment.
To safeguard against disruption of generic remdesivir supply to other low- and middle-income countries included as part of the voluntary licenses, Gilead is also committed to providing support to voluntary licensees based outside of India to increase their production capacity. Gilead’s planned support will include the donation of API to licensees with a view to accelerate production.
Gilead’s voluntary licensing program for remdesivir, established in May 2020, has already enabled access to the drug for more than 2.3 million people in more than 60 low- and middle-income countries. The program, which builds on Gilead’s pioneering voluntary licensing model for its HIV and viral hepatitis medicines, provides long-term licenses to nine manufacturers, seven of which are based in India, to enable access to remdesivir in 127 countries, most of which are low- and low-middle income countries, including India. These licenses remain royalty-free, reflecting Gilead’s existing commitment to enabling broad patient access to remdesivir.
Remdesivir is a nucleotide analog invented by Gilead, building on more than a decade of the company’s antiviral research. Remdesivir has broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, SARS, Marburg, MERS and SARS-CoV-2, the virus that causes COVID-19.
Remdesivir has been approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide, including the United States, where it is available under the brand name Veklury®. In our continuing commitment to develop effective treatments for COVID-19, multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of remdesivir for the treatment of COVID-19, in different patient populations, formulations, and in combination with other therapies.
In the United States, Veklury is FDA approved for the treatment of adults and pediatric patients at least 12 years of age and weighing at least 40 kg requiring hospitalization for COVID-19. Veklury is contraindicated in patients who are allergic to Veklury or any of its components. For more information, please see the U.S. full Prescribing Information available at www.gilead.com.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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, including risks and uncertainties related to the COVID-19 pandemic; the manufacturing and distribution of remdesivir; and the voluntary licensing program for 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 Annual Report on Form 10-K for the year ended December 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.
U.S. full Prescribing Information for Veklury is available at www.gilead.com.
Veklury, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.