ACIDE FUMARIQUE D’ENSITRELVIR
En octobre 2022, lâentreprise pharmaceutique japonaise Shionogi & Co., Ltd. et MPP ont annoncĂ© la signature dâun accord de licence volontaire sur lâacide fumarique ensitrelvir (S-217622), un antiviral oral dâintĂ©rĂȘt thĂ©rapeutique dĂ©veloppĂ© par Shionogi, tĂ©moignant de leur engagement commun en faveur dâun meilleur accĂšs Ă des traitements vitaux dans les pays Ă revenus faible et intermĂ©diaire. Cet accord, signĂ© lors dâune cĂ©rĂ©monie organisĂ©e au siĂšge de Shionogi Ă Osaka, permettra au MPP dâoctroyer des sous-licences Ă des fabricants de mĂ©dicaments gĂ©nĂ©riques agrĂ©Ă©s afin de faciliter lâaccroissement de la production et de la distribution de cet antiviral expĂ©rimental en attendant son homologation par les autoritĂ©s de rĂ©glementation, dans lâoptique dâamĂ©liorer lâaccĂšs Ă celui-ci dans les pays Ă revenus faible et intermĂ©diaire. Lâensitrelvir, actuellement Ă©valuĂ© pour le traitement de la COVID-19, se prĂ©sente sous la forme dâun comprimĂ© Ă prendre par voie orale une fois par jour pendant cinq jours.
ConformĂ©ment Ă lâaccord de licence conclu par Shionogi et le MPP, les fabricants de gĂ©nĂ©riques Ă©ligibles Ă une sous-licence du MPP pourront produire lâensitrelvir et le fournir Ă 117 pays. Pfizer ne touchera pas de redevances sur les ventes dans les pays Ă revenu faible et renoncera Ă ses redevances dans tous les pays couverts par lâaccord tant que la COVID-19 restera considĂ©rĂ©e comme une urgence de santĂ© publique de portĂ©e internationale par lâOrganisation mondiale de la SantĂ©.
| 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 ensitrelvir fumaric acid anywhere in the world. |
| Geographical scope for sale | Allows for sale of ensitrelvir fumaric acid in 117 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 (3) use or require the use of any of Shionogiâs Confidential Information, including where a compulsory licence has been issued. |
| 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. Shionogi 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. A licensee can request a temporary waiver of requirement to receive prior WHOâPQ or SRA approval to commercialise the Licenced Product if it satisfies conditions. |
| 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. |
