In November 2021, Pfizer and the Medicines Patent Pool signed a licence agreement to facilitate affordable access of Pfizer’s oral COVID-19 antiviral treatment candidate PF-07321332 in combination with low dose ritonavir in 95 countries.

PF-07321332 in combination with a low dose of ritonavir was found to reduce the risk of hospitalisation or death by 89% compared to placebo in patients treated within three days of symptom onset (primary endpoint) in an interim analysis of a Phase 2/3 trial of non-hospitalised high-risk adults with COVID-19.

MPP invites Expressions of Interest (EoI) from potential sublicensees based anywhere in the world for sublicences to manufacture and sell the co-pack of PF-07321332 ; ritonavir in the licensed territory:

Access the EoI portal

More information about the EoI process

Deadline for applying: 6 December 2021, 6pm CET

Key Features
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.

 

Country List
Afghanistan, Algeria, Angola, Armenia, Bangladesh, Belize, Benin, Bhutan, Bolivia (Plurinational State of), Botswana, Burkina Faso, Burundi, Cabo Verde, Cambodia, Cameroon, Central African Republic, Chad, Comoros, Congo, democratic Republic of the, Congo, Côte d'Ivoire, Djibouti, Egypt, El Salvador, Equatorial Guinea, Eritrea, Eswatini, Ethiopia, Gabon, Gambia (the), Georgia, Ghana, Guatemala, Guinea, Guinea-Bissau, Haiti, Honduras, India, Indonesia, Iran (Islamic Republic of), Jordan, Kenya, Kiribati, Korea (Democratic People's Republic of), Kosovo, Kyrgyzstan, Lao People's Democratic Republic (the), Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Micronesia (Federated States of), Moldova, Republic of, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Papua New Guinea, Philippines, Rwanda, Samoa, Sao Tome and Principe, Senegal, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Sudan, Syrian Arab Republic, Tajikistan, Tanzania, United Republic of, Timor-Leste, Togo, Tonga, Tunisia, Uganda, Ukraine, Uzbekistan, Vanuatu, Venezuela (Bolivarian Republic of), Viet Nam, Yemen, Zambia, 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