Global HealthPharmaceutical Regulations in Japan

Three Major Infectious Diseases and Neglected Tropical Diseases (NTDs)

Efforts to improve the healthy lives of over one billion patients in 149 countries and territories worldwide through new partnerships to break the vicious cycle that binds poverty and communicable diseases.

Innovation

The majority of patients suffering from HIV/AIDS, tuberculosis, malaria, and NTDs1 (Neglected Tropical Diseases) are concentrated in developing countries or among the poverty class. According to WHO, it is estimated that more than one billion people are affected worldwide. In particular, as communicable diseases (CDs) continue to spread among the poverty class, the diseases themselves are doubling as a cause of poverty in numerous countries and territories. Breaking this vicious circle that binds poverty and CDs is imperative in order to ensure both economic growth in developing countries and human security for all. To overcome this global health issue, a number of various countermeasures are required, including reinforcing public health care systems, health insurance systems and other components of healthcare infrastructure in developing countries; establishing distribution systems to ensure that medicines and vaccines reach patients; and developing an environment for accelerating the development of new drugs and vaccines for patients suffering from CDs. In turn, to promote those countermeasures, it is essential to realize flexible partnerships between the public sector and private sector-including participation by the pharmaceutical industry-as well as other forms of cooperation within the various stakeholders involved in improving public healthcare across the world.

In Japan, public-private partnerships have gradually been established to take the initiative in resolving CDs issues being faced by developing countries. In the past, national governments, UN organizations, charity organizations and other similar entities were the key providers of funding for research and development in the global health sector. Currently, however, the Global Health Innovation Technology Fund ("GHIT Fund")2, Japan's first global health focused public-private partnership, is taking the initiative in providing such funding with a number of private enterprises as its founding members. Comprising a portion of those private enterprises are Japanese pharmaceutical companies, who participate in the GHIT Fund in the capacity of fund-contribution partners. (As of December 2013, the following five Japanese enterprises had joined the GHIT Fund: Astellas Pharma Inc., Eisai Co.,Ltd., Shionogi & Co., Ltd., Daiichi Sankyo Co., Ltd. and Takeda Pharmaceutical Co., Ltd.)

1
NTDs: (Neglected Tropical Diseases)
NTDs are infections caused by parasites, bacteria and viruses that are mainly endemic in tropical areas of developing countries. It is estimated that over 1 billion people are affected worldwide with the 17 NTDs that WHO is currently focusing on.
17 focus diseases in the NTDs area
The WHO is currently focused on treatments for the following NTDs Buruli ulcer, Chagas disease (American trypanosomiasis), cysticercosis, dengue/severe dengue, dracunculiasis (guinea-worm disease), echinococcosis, foodborne trematode infections, human African trypanosomiasis, leishmaniasis, leprosy, lymphatic filariasis, onchocerciasis, rabies, schistosomiasis, soil transmitted helminthiasis, trachoma, and endemic treponematoses (including yaws)
2
The GHIT Fund is Japan's first public-public partnership focused on global health issues and was founded to promote the creation of new drugs for infections in developing countries. GHIT aims to serve as a bridge linking basic research and clinical development and promote the development of new drugs through facilitating partnerships between research institutions within and outside Japan and disbursing grants for promising research that is consistent with the objectives of the fund.
GHIT Fund: http://ghitfund.org/
Through leveraging the advantages of new drug development based on our advanced science and technology to discover new drugs for infections in developing countries, we seek to strengthen Japan's international contributions to global health.

Initiative by member companies

Provision of medicine to treat lymphatic filariasis free of charge
In November 2010, Eisai agreed to provide 2.2 billion tablets of diethylcarbamazine (DEC), a medicine for treating lymphatic filariasis, to the World Health Organization (WHO) at no cost until the year 2020. Based on that agreement, Eisai used its company-owned factory in India to manufacture DEC tablets, and began providing them to countries where lymphatic filariasis is prevalent in October 2013. Going forward, the company will supply DEC tablets to such countries over a seven-year period in accordance with group medication programs of the WHO.
Development of medicine for treating HIV infections
Over time, Shionogi and ViiV Healthcare Ltd. ("ViiV") have engaged in the joint research and development of Dolutegravir, a new HIV integrase inhibitor. Starting in December 2012, ViiV applied to screening agencies in the United States, Europe, Japan and other regions to have Dolutegravir approved as a new drug. Having already been approved in the United States and Canada, the drug has been made available for sale there under the product name "Tivicay®."
Development of medicine for treating tuberculosis
For more than 30 years, Otsuka Pharmaceutical has engaged in the research and development of treatment drugs aimed at eliminating tuberculosis. Based on the results of Phase II clinical testing for delamanid, a new anti-tuberculosis drug for multiple drug-resistant tuberculosis, the company applied to have the sale of the drug approved in Europe. In November 2013, Otsuka Pharmaceutical received the recommendation of the CHMP to have the drug approved for sale in Europe. The company then applied to have the sale of the drug approved in Japan in March 2013. The company presently continues to engage in international Phase III testing. In 2013, the registration of clinical testing for multiple drug-resistant tuberculosis in small children also commenced.
Development of medicine for treating dengue fever
Takeda Pharmaceutical is engaged in the development of vaccines for dengue fever. "DENVax" a tetravalent vaccine that covers all four virus forms causing dengue fever, is currently undergoing Phase II testing.
Development of medicine for treating Chagas disease
Alongside the Drugs for Neglected Diseases initiative ("DNDi"), an international independent non-profit group, Eisai is currently conducting Phase II clinical testing for E1224, a new drug candidate compound for Chagas disease pathogens. In terms of the division of roles in this endeavor, Eisai provides the information on E1224 needed in clinical development as well as the drug formulation needed in clinical testing, and DNDi conducts clinical development in territories where Chagas disease is prevalent.
Development of medicine for treating malaria
Takeda Pharmaceutical engages in joint research and development with the Medicines for Malaria Venture (MMV) for the development of the antimalarial drug DSM265 and the formulation of ELQ-300.
DSM265 currently exhibits a favorable safety profile in Phase I clinical testing.
Expectations are being placed on ELQ-300 as a next-generation drug that will enable the prevention and treatment of malaria in small doses. The drug is currently in the clinical testing phase.
Development of drug formulations for treating schistosomiasis in very young children
Astellas engages in the development of a pediatric formulation for the treatment of Schistosomiasis through an international public-private partnership (PPP) between TI Pharma, Merck KGaA, Astellas Pharma Inc. and the Swiss Tropical and Public Health Institute.
Joint research and development of medicine for treating and vaccines for malaria and NTDs
Eisai has entered a comprehensive joint research and development agreement with The Oswaldo Cruz Foundation in Brazil for medicine to treat and vaccines for malaria and NTDs. For their initial project, these two entities commenced joint research and development of "E6446," an active TLR9 antagonist, and analogous compounds as forms of medicine for treating cerebral malaria.
Joint drug-discovery research and development for searching out anti-parasitic protozoa drugs (for Chagas disease, leishmaniasis and African sleeping sickness) and anti-dengue virus drugs
Astellas Pharma has established an industry-government-academic framework consisting of five Japanese research institutions; namely The University of Tokyo, the Tokyo Institute of Technology, Nagasaki University, the National Institute of Advanced Industrial Science and Technology ("AIST") and the High Energy Acceleration Research Organization ("KEK") as well as the international NPO DNDi. Together, these entities apply advanced drug-discovery research approaches to revolutionary, open-innovation drug development efforts targeting anti-parasitic protozoa drugs (for Chagas disease, leishmaniasis and African sleeping sickness) and anti-dengue virus drugs.
Participation in "WIPO Research Consortium" for developing medicine for treating tropical diseases
Having become a member of the "WIPO Research Consortium," an international joint venture organized by the World Intellectual Property Organization (WIPO) for developing medicine for treating tropical diseases, Eisai supplies information on seven compounds to a publicly-available database. The intellectual property registered in this database is provided free of royalties for use in the development of medicine for treating tropical diseases as well as the eventual sale of products in developing countries that adopt those drugs at a later date.
Participation in global partnerships for developing tuberculosis drugs
Eisai has joined "Tuberculosis Drug Accelerator" ("TBDA"), a partnership that aims to conduct revolutionary drug discovery for tuberculosis. Jointly established by seven global pharmaceutical enterprises and six research institutions and endorsed by the Bill & Melinda Gates Foundation, TBDA seeks to develop new medicine with the potential to fully treat tuberculosis with a one-month dose relative to the six months currently required by existing methods of treatment.
Joint research and development for developing new drugs for tuberculosis and NTDs
Eisai is engaged in joint research for the development of new drugs for Neglected Tropical Diseases ("NTDs") and tuberculosis with the Broad Institute, a joint research facility under Harvard University and the Massachusetts Institute of Technology.
Screening programs for containing infections in developing countries (GHIT Fund programs)
-Eisai is part of a GHIT Fund-sponsored program for searching out candidate drugs for treating malaria, leishmaniasis and Chagas disease.
-Shionogi is part of a GHIT Fund-sponsored program for searching out drugs for treating tuberculosis.
-Takeda Pharmaceuticals is part of a GHIT Fund-sponsored program for searching out candidate drugs for treating tuberculosis, malaria, leishmaniasis, Chagas disease and African sleeping sickness.
Daiichi Sankyo is part of a GHIT Fund-sponsored program for searching out candidate drugs for treating agent-resistant tuberculosis and malaria.
Participation in London Declaration on Neglected Tropical Diseases
Eisai has established international public-private partnerships with twelve major global pharmaceutical corporations, the Bill & Melinda Gates Foundation, the World Health Organization (WHO), the governments of the United States and the United Kingdom, the World Bank and governments of countries where NTDs are prevalent, and issued the joint "London Declaration" to collectively fight to contain ten NTDs by 2020.
Development of drug-discovery research database for Neglected Tropical Diseases
Together with the Tokyo Institute of Technology and the University of Tokyo, Astellas Pharma developed the world's first drug-discovery research database for NTDs, called the "Integrated Neglected Tropical Disease Database.," or "iNTRODB." This database makes full use of super computers and Web technology to integrate a plethora of information that includes that on parasitic protozoa genetics, biochemistry, drug discovery and illnesses. By virtue of being freely accessible by researchers around the world, the iNTRODB will go on to contribute to the acceleration of NTDs research across the globe.
Research and development for medicine for treating tuberculosis, etc
Over time, Shionogi has focused on research and development for medicine for treating infections. In 2013, Shionogi established an Emerging Infections Group within its company-owned research institute, through which it is working to accelerate research activities for medicine to treat tuberculosis and other NTDs.

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