New Africa /
4 October 2022Muireann Bolger

Patent pool inks major COVID-19 deal with Japanese company

The  Medicines Patent Pool (MPP) and Japanese pharma company,  Shionogi, have entered a licensing agreement centring on an oral antiviral treatment to treat COVID-19.

The agreement, signed today, October 4, at a ceremony held at Shionogi’s headquarters in Osaka, will enable MPP to facilitate additional production and distribution of the antiviral, pending regulatory authorisation or approval.

The drug,  Ensitrelvir, is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called 3CL protease, which is essential for the replication of the virus. Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting 3CL protease.

The treatment is being evaluated for the treatment of COVID-19 to be administered as an oral tablet formulation taken once daily for five days.

The MPP is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries (LMICs).

If Ensitrelvir is approved, MPP will then be able to grant sub-licences to qualified generic manufacturers, with the goal of expanding access to people living in 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.

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.”

Takuko Sawada, director and vice chairperson of the Shionogi board, said: “Shionogi is proud to work on such an innovative licence agreement with the MPP. 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.”

MPP has invited expressions of interest from potential sublicensees based anywhere in the world for sub-licences to manufacture and sell ensitrelvir.

To date, MPP has signed agreements with 17 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, four long-acting technologies, three oral antiviral treatments for COVID-19 and 12 COVID-19 technologies.

MPP was founded by  Unitaid, which continues to be MPP’s main funder.

Commenting on this latest agreement, 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.”

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