En novembre 2021, Pfizer et le Medicines Patent Pool ont signé un accord de licence pour faciliter l’accès de l’ antiviral oral d’intérêt thérapeutique PF-07321332 de Pfizer contre la COVID-19 administré en combinaison avec une faible dose de ritonavir dans 95 pays.

Les analyses intermédiaires l’étude EPIC-HR de phase 2/3 ont montré une réduction de 89 % du risque d’hospitalisation ou de décès liés à la COVID-19 quelle qu’en soit la cause, par rapport aux résultats obtenus avec un placebo chez les patients soignés dans les trois jours qui ont suivi l’apparition des symptômes (critère principal).

Le MPP invite les fabricants de médicaments génériques de tous pays à lui envoyer une manifestation d’intérêt afin d’obtenir une sous-licence pour la fabrication et la commercialisation de l’association PF-07321332;ritonavir sur le territoire couvert par la licence :

Accéder au portail de manifestation d’intérêt (en anglais)

Plus d’informations sur la procédure de manifestation d’intérêt

Date limite de candidature : 6 décembre 2021, 18 heures (CET)

Principales caractéristiques
Eligibility for sublicences Sublicences can be issued to any qualified entity worldwide.
Manufacturing Allows manufacturing of the active pharmaceutical ingredient and the finished formulations of PF-07321332 anywhere in the world.
Geographical scope for sale Allows for sale of PF-07321332 in 95 countries.
Sales outside the licensed territory Nothing in this Agreement shall be construed to prevent the Licensee from engaging in activities inside or outside the Territory where such activities would not (1) infringe the Patents and/or any other intellectual property rights; and/or (2) use or misappropriate Licensed Know-How ; and/or use or require the use of any of Pfizer’s Confidential Information.
Royalties The licence is royalty free during the WHO Public Health Emergency of International Concern (PHEIC). After the PHEIC ends, royalties are 5% of net sales for sales to governmental authorities or Public Purchasers, and 10% of net sales for commercial entities. Pfizer will not collect royalties on sales to low-income countries or on sales of product made and sold in countries within the licensed territory where the product is not patented and does not benefit from regulatory exclusivity.
Quality assurance Licensees must obtain approval from the World Health Organization (WHO) Pre-qualification (WHO-PQ), or a Stringent Regulatory Authority (SRA). Where such approval is not yet available, provisional or emergency use authorisations available through WHO or an SRA may be obtained.
Data exclusivity Data exclusivity is waived in countries of the Territory with such form of protection, thus facilitating regulatory approval of generics.
Patent disclosure The licence discloses to MPP and the Licensee the list of patent applications worldwide at the time of licence signing.

 

Liste des pays
Afghanistan, Algérie, Angola, Arménie, Bangladesh, Belize, Bénin, Bhoutan, Bolivie (État plurinational de), Botswana, Burkina Faso, Burundi, Cabo Verde, Cambodge, Cameroun, République centrafricaine, Tchad, Comores, Congo, la République démocratique de, Congo, Côte d'Ivoire, Djibouti, Égypte, El Salvador, Guinée équatoriale, Érythrée, Eswatini, Éthiopie, Gabon, Gambie, Géorgie, Ghana, Guatemala, Guinée, Guinée-Bissau, Haïti, Honduras, Inde, Indonésie, Iran (République Islamique d'), Jordanie, Kenya, Kiribati, Corée (République populaire démocratique), Kosovo, Kirghizistan, Lao, République démocratique populaire, Lesotho, Libéria, Madagascar, Malawi, Mali, Mauritanie, Micronésie (États fédérés de), Moldova, la République de, Mongolie, Maroc, Mozambique, Myanmar, Namibie, Népal, Nicaragua, Niger, Nigéria, Pakistan, Papouasie-Nouvelle-Guinée, Philippines, Rwanda, Samoa, Sao Tomé-et-Principe, Sénégal, Sierra Leone, Îles Salomon, Somalie, Afrique du Sud, Soudan du Sud, Sri Lanka, Soudan, République arabe syrienne, Tadjikistan, Tanzanie, République-Unie de, Timor-Leste, Togo, Tonga, Tunisie, Ouganda, Ukraine, Ouzbékistan, Vanuatu, Venezuela (République bolivarienne du), Viet Nam, Yémen, Zambie, Zimbabwe

Appendix 3

Territory

LIC : Low-Income Country

LMIC : Lower Middle-Income Country

UMIC : Upper Middle-Income Country

 

Country Classification

Afghanistan LIC

Algeria LMIC

Angola LMIC

Armenia UMIC

Bangladesh LMIC

Belize UMIC

Benin LMIC

Bhutan LMIC

Bolivia LMIC

Botswana UMIC

Burkina Faso LIC

Burundi LIC

Cabo Verde LMIC

Cambodia LMIC

Cameroon LMIC

Central African Republic LIC

Chad LIC

Comoros LMIC

Congo, Dem. Rep. LIC

Congo, Rep. LMIC

Côte d’Ivoire LMIC

Djibouti LMIC

Egypt, Arab Rep. LMIC

El Salvador LMIC

Equatorial Guinea UMIC

Eritrea LIC

Eswatini LMIC

Ethiopia LIC

Gabon UMIC

Gambia, The LIC

Georgia UMIC

Ghana LMIC

Country Classification

Guatemala UMIC

Guinea LIC

Guinea-Bissau LIC

Haiti LIC

Honduras LMIC

India LMIC

Indonesia UMIC

Iran UMIC

Jordan UMIC

Kenya LMIC

Kiribati LMIC

Korea, Dem. People’s Rep. LIC

Kosovo UMIC

Kyrgyz Republic LMIC

Lao PDR LMIC

Lesotho LMIC

Liberia LIC

Madagascar LIC

Malawi LIC

Mali LIC

Mauritania LMIC

Micronesia, Fed. Sts. LMIC

Moldova LMIC

Mongolia LMIC

Morocco LMIC

Mozambique LIC

Myanmar LMIC

Namibia UMIC

Nepal LMIC

Nicaragua LMIC

Niger LIC

Nigeria LMIC

Pakistan LMIC

Papua New Guinea LMIC

Philippines LMIC

Rwanda LIC

Samoa UMIC

São Tomé & Principe LMIC

Senegal LMIC

Sierra Leone LIC

Country Classification

Solomon Islands LMIC

Somalia LIC

South Africa (Public Market) UMIC

South Sudan LIC

Sri Lanka LMIC

Sudan LIC

Syrian Arab Republic LIC

Tajikistan LIC

Tanzania LMIC

Timor-Leste LMIC

Togo LIC

Tonga UMIC

Tunisia LMIC

Uganda LIC

Ukraine LMIC

Uzbekistan LMIC

Vanuatu LMIC

Venezuela UMIC

Vietnam LMIC

West Bank and Gaza LMIC

Yemen, Rep. LIC

Zambia LMIC

Zimbabwe LMIC