Gilead has signed non-exclusive voluntary licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir. The agreements allow the companies – Cipla Ltd., Ferozsons Laboratories, Hetero Labs Ltd., Jubilant Lifesciences and Mylan – to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access.

Under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly. The licensees also set their own prices for the generic product they produce. The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier.

The agreements permit distribution in the following countries:

Afghanistan
Algeria
Angola
Anguilla
Antigua & Barbuda
Armenia
Aruba
Azerbaijan
Bahamas, The
Bangladesh
Barbados
Belarus
Belize
Benin
Bermuda
Bhutan
Botswana
British Virgin Islands
Burkina Faso
Burundi
Cambodia
Cameroon
Cape Verde
Cayman Island
Central Af R.
Chad
Comoros
Congo Rep.
Cook Islands
Costa Rica
Cote d’Ivoire
Cuba
Curacao
Djibouti
Dominica
Dominican Republic
Egypt
El Salvador
Equatorial Guinea
Eritrea
Eswatini (Swaziland)
Ethiopia
Fiji
Gabon
Gambia, The
Georgia
Ghana
Grenada
Guatemala
Guinea
Guinea Bis
Guyana
Haiti
Honduras
India
Indonesia
Jamaica
Kazakhstan
Kenya
Kiribati
Korea, Dem. People's Rep. (North Korea)
Kyrgyzstan
Lao DR (Laos)
Lesotho
Liberia
Libya
Madagascar
Malawi
Maldives
Mali
Marshall Islands
Mauritania
Mauritius
Micronesia, Fed. Sts.
Moldova
Mongolia
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Nicaragua
Niger
Nigeria
Pakistan
Palau
Panama
Papua New Guinea
Philippines
Rwanda
Samoa
Sao Tome and Principe
Senegal
Seychelles
Sierra Leone
Sint Maarten (Dutch part)
Solomon Islands
Somalia
South Africa
South Sudan
Sri Lanka
St. Kitts and Nevis
St. Lucia
St. Vincent and the Grenadines
Sudan
Suriname
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tonga
Trinidad & Tobago
Tunisia
Turkmenistan
Turks & Caicos
Tuvalu
Uganda
Ukraine
Uzbekistan
Vanuatu
Vietnam
Zambia
Zimbabwe

Recently,Gilead Sciences, Inc. announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Veklury (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19, under an exceptional approval pathway. The exceptional approval was granted due to the COVID-19 pandemic and references the Emergency Use Authorization of remdesivir in the United States.

The approval is based on clinical data from the U.S. National Institute of Allergy and Infectious Diseases’ global Phase 3 trial, Gilead’s Phase 3 SIMPLE trial in patients with severe manifestations of COVID-19, and available data from Gilead’s compassionate use program, including patients in Japan.

“The Japanese approval of remdesivir is in recognition of the urgent need to treat critically ill patients in Japan. It is a reflection of the exceptional circumstances of this pandemic,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We thank the Japanese Ministry of Health, Labour and Welfare for their leadership and collaboration, as we together work to respond to this public health emergency.”

Due to the current public health emergency, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization for remdesivir for the treatment of COVID-19. In the United States, remdesivir is an investigational drug that has not been approved by the FDA for any use, and the safety and efficacy of remdesivir for the treatment of COVID-19 has not been established. The distribution of remdesivir in the United States has been authorized only for the treatment of hospitalized patients with severe COVID-19; please see below for additional important information about the authorized use of remdesivir in the United States.

Remdesivir is not yet licensed or approved outside of Japan and ongoing clinical trials continue to evaluate its safety and efficacy. Gilead continues to work with global regulatory authorities to ensure appropriate access to remdesivir