Japanese pharmaceutical company Shionogi & Co. and the Medicines Patent Pool (MPP), a United Nations-backed public health organisation, reflecting a shared commitment to increase access to life-saving medicines for low- and middle-income countries (LMICs), announced that they have 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.

Takuko Sawada, Director and Vice Chairperson of the Shionogi Board said: “Shionogi is proud to work on such an innovative licence agreement with the Medicines Patent Pool. This licence agreement will allow people in LMICs to have rapid access to ensitrelvir, following appropriate regulatory approvals. We consistently strive to supply the best possible medicines to protect the health and wellbeing of the patients we serve. It is another great example of what partnerships can achieve to advance global health.”

Charles Gore, Executive Director of MPP said: “This public health-oriented licensing agreement has the potential to increase the affordable options for people living in LMICs to fight COVID-19 and support our collective efforts to put an end to the pandemic and its unacceptable death toll. Moreover, we are delighted to sign our first agreement with Shionogi – indeed our first with a Japanese company – and we hope this new partnership will encourage other companies to collaborate with us.” It is not the first connection between MPP and Shionogi, however, as dolutegravir, an HIV drug licensed from Shionogi to ViiV Healthcare, has been extensively provided to LMICs through MPP’s agreements with ViiV.

Dr Philippe Duneton, Executive Director of Unitaid, said: “Availability of oral antivirals, such as ensitrelvir, is a priority to prevent severity of disease and further deaths due to COVID-19. We welcome the licence agreement signed by Shionogi and MPP that will enable increased access to the oral antiviral ensitrelvir in low- and middle-income countries, once it is authorised by regulatory bodies. It is crucial to have a range of optimal treatments, alongside adequate testing, readily available and affordable everywhere in the world, including in resource-limited settings.”