Medicines Patent Pool (MPP), a UN-supported international public health organisation, has signed seven sublicence agreements for Japanese pharmaceutical firm Shionogi & Co's Ensitrelvir fumaric acid.
Ensitrelvir is a COVID antiviral presently approved in Japan and being analysed in clinical trials outside of the country.
The sublicence agreements were inked with three generic manufacturing companies from China – Zhejiang Charioteer Pharmaceutical Co., Ltd., Zhejiang Lepu Pharmaceutical Co.,Ltd., and Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.; two from India – Hetero and Laurus Labs Limited; one each with Ukrainian company Joint Stock Company Lekhim and Vietnamese company Stellapharm J.V. Co., Ltd.
This announcement was made on the sidelines of a business briefing that was co-convened by MPP and global health partnership Unitaid in Tokyo, Japan.
An oral antiviral, Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively hindering the viral 3CL protease.
Called as Xocova in Japan, Ensitrelvir got emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the treatment of SARS-CoV-2 infection in November last year.
In April this year, it was given Fast Track designation by the US Food and Drug Administration.
In October 2022, the head licence agreement was signed between MPP and Shionogi and this was a first for MPP with a Japanese pharmaceutical company.
As per the terms of the licence agreement, the seven chosen generic manufacturers will be able to manufacture and supply Ensitrelvir in 117 low- and middle-income countries (LMICs), following regulatory authorisation or approval in those countries.
Shionogi representative director, president and CEO Isao Teshirogi said: “Shionogi is excited that these seven manufacturers across four countries have signed sublicences agreements with MPP, showing their commitment to making generic versions of ensitrelvir for LMICs. What has been important for Shionogi is to work upstream with MPP, as we believe that the public health-oriented licensing agreement we signed with MPP has the potential to increase affordable COVID-19 treatment options for people living in LMICs.
“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 executive director Charles Gore said: “We look forward to working closely with all seven generic manufacturing partners on developing generic versions of ensitrelvir and making it available soonest.
“Even though COVID-19 is no longer classified as a Public Health Emergency of International Concern, we see numbers ebb and flow across continents as we learn to live with the disease.
“So having quality effective treatments readily available in LMICs is still so important. I warmly welcome Lekhim JSC from Ukraine, and Zhejiang Charioteer and Lepu Pharma from China, as these are the first sublicence agreements that they have signed with MPP.”home