On June 26, 2023, the Japanese Pharmaceutical Company Shionogi & Co., Ltd and the Medicines Patent Pool (MPP), a United Nations-backed international public health organization, have announced the signature of seven sublicense agreements for Shionogi's ensitrelvir (fumaric acid), a COVID-19 antiviral currently approved in Japan and being evaluated in clinical trials outside of Japan.
The announcement was made on the sidelines of a business briefing in Tokyo co-convened by MPP and global health partnership Unitaid. The sublicense agreements were signed with the well-known Ukrainian Group of Pharmaceutical Companies “Lekhim” and their colleagues - generic manufacturing companies from China (Zhejiang Charioteer Pharmaceutical Co., Ltd., Zhejiang Lepu Pharmaceutical Co.,Ltd., and Fosun International Limited), from India (Hetero and Laurus Labs Limited); and from Vietnam (Stellapharm J.V. Co., Ltd.).
The signature of sublicense agreements with MPP on production of a generic version of the Shionogi’s oral antiviral drug ensitrelvir for COVID-19 increases access to the drug in low- and middle-income countries as under the license agreement the selected generic manufacturers will be able to produce and supply ensitrelvir in 117 countries after obtaining a regulatory approval or an authorization in their countries.
It should be noted that the head license agreement was concluded between MPP and Shionogi in October 2022, and for MPP this is the first contract with a Japanese pharmaceutical company.
Isao Teshirogi, authorized Director, President and CEO of Shionogi, noted that the signature of 7 sublicense agreements between drug manufacturer and MPP demonstrates the commitment to creation of generic versions of ensitrelvir for low- and middle-income countries and is an excellent example of strategic partnership for global health care improvement.
Charles Gore, MPP’s Executive Director, congratulated the Group of Pharmaceutical Companies “Lekhim” and six other drug manufacturers on conclusion of sublicense agreements with MPP and welcome Lekhim as this is the first sublicence agreements that they have signed with MPP.
Ensitrelvir (known in Japan as Xocova®), an oral antiviral drug for COVID-19 currently approved under the emergency regulatory approval system in Japan by the Ministry of Health, Labour and Welfare (MHLW) for the emergency use for SARS-CoV-2.
This medicinal product 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. This oral antiviral drug suppresses the replication of SARS-CoV-2 by selectively inhibiting the 3CL protease.
Ensitrelvir is the first antiviral agent to show both clinical symptomatic efficacy for 5 typical Omicron-related symptoms that has been a primary research endpoint and antiviral efficacy, key secondary endpoint, in a predominantly vaccinated population of patients with mild to moderate SARS-CoV-2 infection.
According to studies, most adverse events were mild in severity with no deaths. Among the most common treatment-related adverse events were temporary decreases in high-density lipoprotein and increased blood triglycerides, as observed in previous studies. Initial exploratory analyses indicated a potential reduced risk of development of long COVID and further evaluations in this regard are still ongoing.
In April 2023, the Food and Drug Administration (FDA) granted Fast Track designation to ensitrelvir for COVID-19. This status is used to facilitate the development and to expedite the review of potential new methods of treatments for serious diseases and those that satisfy unmet medical needs.
The Central Social Insurance Medical Council (Chuikyo) has officially listed encitrelvir on the COVID-19 Japanese Drug Price List (NHI) list of antiviral drugs that enables to put the drug on the list of drugs to be reimbursed for the population of Japan.
The Group of Pharmaceutical Companies “Lekhim” also hopes that, following the example of Japan, ensitelvir will be rapidly recognized at the national market and that this medicinal product will be included in the Ukrainian register of drugs to be reimbursed in Ukraine under the Affordable Medicines Program of State Guarantees of medical care for the population to make it maximum available to all segments of the population.
The Medicines Patent Pool (MPP) is a United Nations-backed public health organization working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organizations, industry, patient groups, and other stakeholders to prioritize and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.
To date, MPP has signed agreements with 18 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, 4 long-acting technologies, 3 oral antiviral treatments for COVID-19 and 12 COVID-19 technologies.
MPP was founded by Unitaid, which continues to be MPP's main funder. MPP's work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC). MPP's activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation and SDC.
Shionogi & Co., Ltd. is a leading global research-driven pharmaceutical company based in Japan dedicated to bringing benefits to patients based on its corporate philosophy of "supplying the best possible medicine to protect the health and well-being of the patients we serve."
The company has discovered and developed novel medicines for HIV, influenza and antimicrobial resistance and currently markets products in several therapeutic areas including anti-infectives with the first siderophore cephalosporin.
Today, the Group of Pharmaceutical Companies “Lekhim” is one of the leading pharmaceutical companies of Ukraine in the development, production and sale of medicinal products, the product portfolio of which includes more than 200 names of medicinal products from almost all therapeutic groups.
However, the company never rests on its laurels and launches a number of innovative projects to optimize business processes, expands and modernizes production, conducts actively research and develops and introduces new areas of the external economic activity.
The signature of the sublicense agreement for ensitrelvir is another step towards recognition and formation of sustainable partnerships with foreign companies that will make it possible to ensure access to this medicinal product in low- and middle-income countries.