Press Release: Voluntary Licensing Agreements for Remdesivir

"Ferozsons Laboratories from Pakistan is amongst the five companies to produce Remdesivirfor distribution in 127 countries".

Islamabad, May 13th, 2020, (Press Release): Gilead has signed non-exclusive voluntary licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of Remdesivir.

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.

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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.

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  1. The agreements permit distribution in the following countries:
  2. Afghanistan
  3. Algeria
  4. Angola
  5. Anguilla
  6. Antigua & Barbuda
  7. Armenia
  8. Aruba
  9. Azerbaijan
  10. Bahamas, The
  11. Bangladesh
  12. Barbados
  13. Belarus
  14. Belize
  15. Benin
  16. Bermuda
  17. Bhutan
  18. Botswana
  19. British Virgin Islands
  20. Burkina Faso
  21. Burundi
  22. Cambodia
  23. Cameroon
  24. Cape Verde
  25. Cayman Island
  26. Central Af R.
  27. Chad
  28. Comoros
  29. Congo Rep.
  30. Cook Islands
  31. Costa Rica
  32. Cote d’Ivoire
  33. Cuba
  34. Curacao
  35. Djibouti
  36. Dominica
  37. Dominican Republic
  38. Egypt
  39. El Salvador
  40. Equatorial Guinea
  41. Eritrea
  42. Eswatini (Swaziland)
  43. Ethiopia
  44. Fiji
  45. Gabon
  46. Gambia, The
  47. Georgia
  48. Ghana
  49. Grenada
  50. Guatemala
  51. Guinea
  52. Guinea Bis
  53. Guyana
  54. Haiti
  55. Honduras
  56. India
  57. Indonesia
  58. Jamaica
  59. Kazakhstan
  60. Kenya
  61. Kiribati
  62. Korea, Dem. People’s Rep. (North Korea)
  63. Kyrgyzstan
  64. Lao DR (Laos)
  65. Lesotho
  66. Liberia
  67. Libya
  68. Madagascar
  69. Malawi
  70. Maldives
  71. Mali
  72. Marshall Islands
  73. Mauritania
  74. Mauritius
  75. Micronesia, Fed. Sts.
  76. Moldova
  77. Mongolia
  78. Montserrat
  79. Morocco
  80. Mozambique
  81. Myanmar
  82. Namibia
  83. Nauru
  84. Nepal
  85. Nicaragua
  86. Niger
  87. Nigeria
  88. Pakistan
  89. Palau
  90. Panama
  91. Papua New Guinea
  92. Philippines
  93. Rwanda
  94. Samoa
  95. Sao Tome and Principe
  96. Senegal
  97. Seychelles
  98. Sierra Leone
  99. Sint Maarten (Dutch part)
  100. Solomon Islands
  101. Somalia
  102. South Africa
  103. South Sudan
  104. Sri Lanka
  105. St. Kitts and Nevis
  106. St. Lucia
  107. St. Vincent and the Grenadines
  108. Sudan
  109. Suriname
  110. Tajikistan
  111. Tanzania
  112. Thailand
  113. Timor-Leste
  114. Togo
  115. Tonga
  116. Trinidad & Tobago
  117. Tunisia
  118. Turkmenistan
  119. Turks & Caicos
  120. Tuvalu
  121. Uganda
  122. Ukraine
  123. Uzbekistan
  124. Vanuatu
  125. Vietnam
  126. Zambia
  127. Zimbabwe

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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.

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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.

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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.

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