MOLNUPIRAVIR (MOL)
En octobre 2021, le Medicines Patent Pool (MPP) a signé un accord de licence avec Merck Sharp & Dohme (MSD) pour le molnupiravir (MK-4482/ EIDD-2801), un médicament antiviral oral contre la Covid-19.
En novembre 2021, MSD a présenté les derniers résultats obtenus dans le cadre de l’étude MOVe-OUT sur l’efficacité du molnupiravir (article en anglais). Le molnupiravir a fait passer le risque d’hospitalisation ou de décès de la population étudiée de 9,7 % dans le groupe sous placebo (68/699) à 6,8 % (48/709) dans le groupe ayant reçu du molnupiravir, avec une réduction du risque relatif de 30 %. Neuf décès ont eu lieu dans le groupe sous placebo, contre un dans le groupe ayant reçu du molnupiravir.
En décembre 2021,MSD a reçu une autorisation d’utilisation d’urgence délivrée par la FDA (article en anglais) pour soigner les adultes atteints de formes légères à modérées de CODIV-19 séropositifs après un test de dépistage direct du virus SARS-CoV-2, et qui présentent un risque élevé de développer une forme grave de la COVID-19.
L’accord de licence couvre 105 pays.


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 molnupiravir anywhere in the world. |
Geographical scope for sale | Allows for sale of molnupiravir in 105 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) misappropriate MSD Know-How. |
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 public sector purchases, and 10% of net sales for commercial entities. |
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. Unpublished patent applications, for the 18-month window from filing date, are redacted in the agreement available on MPP’s website. |
Appendix 1 – Countries in the Territory
LIC: low-income country
LDC: least developed country (UN Classification)
SSA: Sub-Saharan Africa
LMIC: lower-middle-income country
UMIC: upper-middle-income country
LIC+LDC+SSA |
|||
# |
Country |
Channels in scope of Agreement |
|
1 | Afghanistan | All | |
2 | Angola | All | |
3 | Bangladesh | All | |
4 | Benin | All | |
5 | Bhutan | All | |
6 | Botswana | All | |
7 | Burkina Faso | All | |
8 | Burundi | All | |
9 | Cabo Verde | All | |
10 | Cambodia | All | |
11 | Cameroun | All | |
12 | Central African Republic | All | |
13 | Chad | All | |
14 | Comoros | All | |
15 | Congo, Dem Rep. | All | |
16 | Congo, Rep. | All | |
17 | Côte d’Ivoire | All | |
18 | Djibouti | All | |
19 | Equatorial Guinea | All | |
20 | Eritrea | All | |
21 | Eswatini | All | |
22 | Ethiopia | All | |
23 | Gabon | All | |
24 | Gambia, The | All | |
25 | Ghana | All | |
26 | Guinea | All | |
27 | Guinea-Bissau | All | |
28 | Haiti | All | |
29 | Kenya | All | |
30 | Kiribati | All | |
31 | Korea, Dem.People’s Rep. | All | |
32 | Lao PDR | All | |
33 | Lesotho | All | |
34 | Liberia | All | |
35 | Madagascar | All | |
36 | Malawi | All | |
37 | Mali | All | |
38 | Mauritania | All | |
39 | Mauritius | All | |
40 | Mozambique | All | |
41 | Myanmar | All | |
42 | Namibia | All | |
43 | Nepal | All | |
44 | Niger | All | |
45 | Nigeria | All | |
46 | Rwanda | All | |
47 | São Tomé and Principe | All | |
48 | Senegal | All | |
49 | Seychelles | All | |
50 | Sierra Leone | All | |
51 | Solomon Islands | All | |
52 | Somalia | All | |
53 | South Africa | Public Sector Only | |
54 | South Sudan | All | |
55 | Sudan | All | |
56 | Syrian Arab Republic | All | |
57 | Tajikistan | All | |
58 | Tanzania | All | |
59 | Timor-Leste | All | |
60 | Togo | All | |
61 | Tuvalu | All | |
62 | Uganda | All | |
63 | Vanuatu | All | |
64 | Yemen, Rep. | All | |
65 | Zambia | All | |
66 | Zimbabwe | All |
LMIC (Ex-SSA) |
||
# |
Country |
Channels in scope of Agreement |
67 | Algeria | All |
68 | Bolivia | All |
69 | Egypt, Arab Rep | All |
70 | El Salvador | All |
71 | Honduras | All |
72 | India | All |
73 | Micronesia, Federated States | All |
74 | Moldova | All |
75 | Mongolia | All |
76 | Morocco | All |
77 | Nicaragua | All |
78 | Pakistan | All |
79 | Papua New Guinea | All |
80 | Philippines | All |
81 | Sri Lanka | All |
82 | Tunisia | All |
83 | Uzbekistan | All |
84 | Vietnam | All |
UMIC (Ex-SSA, ex-LDC) |
|||
# |
Country |
Channels in scope of Agreement |
|
85 | Belize | All | |
86 | Cuba | All | |
87 | Dominica | All | |
88 | Fiji | All | |
89 | Grenada | All | |
90 | Guatemala | All | |
91 | Guyana | All | |
92 | Indonesia | All | |
93 | Iran, Islamic Rep | All | |
94 | Iraq | All | |
95 | Jamaica | All | |
96 | Libya | All | |
97 | Maldives | All | |
98 | Marshall Islands | All | |
99 | Paraguay | All | |
100 | Samoa | All | |
101 | St. Lucia | All | |
102 | St. Vincent and the Grenadines | All | |
103 | Suriname | All | |
104 | Tonga | All | |
105 | Venezuela, RB | All |