ENSITRELVIR FUMARIC ACID
In October 2022, Japanese pharmaceutical company Shionogi & Co., Ltd. and MPP signed a voluntary licence agreement for Shionogi’s antiviral candidate ensitrelvir fumaric acid (S-217622). The agreement will enable MPP to facilitate additional production and distribution of the investigational antiviral, pending regulatory authorisation or approval, by granting sublicences to qualified generic manufacturers, with the goal of expanding access to people living in LMICs. Ensitrelvir is being evaluated for the treatment of COVID-19 to be administered as an oral tablet formulation taken once daily for five days.
Under the terms of the licence agreement between Shionogi and MPP, qualified generic manufacturers that are granted sublicences by MPP will be able to manufacture and supply ensitrelvir to 117 countries. Shionogi will waive royalties on sales in all countries covered by the agreement while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.
| 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 Shionogi’s 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 WHO‑PQ 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. |
GENERIC PARTNERS AND PRODUCT DEVELOPERS
