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
About Remdesivir
Remdesivir is an investigational antiviral drug that is being studied in multiple ongoing international clinical trials, and the safety and efficacy of Remdesivir for the treatment of COVID-19 are not yet established. Remdesivir has not been approved by the U.S. FDA for any use. For information about the authorized use of Remdesivir and mandatory requirements of the Emergency Use Authorization in the U.S., please review the Fact Sheet for Healthcare Providers and FDA Letter of Authorization available at www.gilead.com/remdesivir.
Forward Looking Statement
This statement 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. Remdesivir is an investigational drug that has not been approved by the FDA for any use, and it is not yet known if remdesivir is safe or effective for the treatment of COVID-19. There is the possibility of unfavorable results from ongoing and additional clinical trials involving remdesivir 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 remdesivir or that FDA and other regulatory agencies may not approve remdesivir, and any marketing approvals, if granted, may have significant limitations on its use. As a result, remdesivir may never be successfully commercialized. In addition, Gilead may face challenges related to the allocation and geographical distribution of existing and future supply of remdesivir. If Gilead and its manufacturing partners are unable to sufficiently scale up the production of remdesivir in the currently anticipated timelines, Gilead may be unable to meet global 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 current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-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.
