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.

The majority of patients suffering from three major infectious diseases (HIV/AIDS, tuberculosis, and malaria) and Neglected Tropical Diseases (NTDs)* 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 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 communicable diseases is imperative in order to ensure both economic growths 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 communicable diseases. 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.

* Neglected Tropical Diseases (NTDs)
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)

In Japan, public-private partnerships have gradually been established to take the initiative in resolving communicable diseases 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. In 2013, the Global Health Innovation Technology Fund (GHIT Fund), Japan's first global health focused public-private partnership was established. It is a very innovative approach which private sector is taking initiative and participating as funding partners.

The GHIT Fund is the world's first product development fund for global health R&D. It is built on the strength of contributions from partners in the public, private, and civil sectors. Towards R&D and commercialization of pharmaceuticals, vaccines, and diagnostics which poorest of the poor in developing countries need, the GHIT Fund are investing in joint R&D projects of Japan and overseas related to the three major infectious diseases and NTDs. Companies participating in the GHIT Fund as a partner is as follows (As of June 2016).

Full Partners: Astellas Pharma Inc., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., FUJIFILM Corporation, Shionogi & Co., Ltd., Takeda Pharmaceutical Company Limited

Associate Partners: Otsuka Pharmaceutical Co., Ltd., Sysmex Corporation

Affiliate Partners: Glaxo Smith Kline K.K., Johnson & Johnson, Kyowa Hakko Kirin Co., Ltd., Merck Ltd., Mitsubishi Tanabe Pharma Corporation, Nipro Corporation, Sumitomo Dainippon Pharma Co., Ltd.

Through leveraging the advantages of new drug development based on our advanced science and technology to discover new drugs for infections in developing countries, the Japan Pharmaceutical Manufacturers Association 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) for free until the year 2020. Based on that agreement, Eisai used its factory in India to manufacture DEC tablets, and began providing them to countries where lymphatic filariasis is endemic in October 2013. In February 2016, a new public-private partnership has been initiated to provide diagnostic kits free of charge, for use in evaluating the success of mass drug administration (MDA) in LF elimination and helping to determine when MDA can stop. Eisai is also taking part in the partnership. Through the supply of DEC tablets and diagnostic kits, Eisai is contributing to the global program to eliminate lymphatic filariasis.
Development of medicine for treating HIV infections Over time, Shionogi and ViiV Healthcare have engaged in the joint research and development of dolutegravir, a new HIV integrase inhibitor. Starting in December 2012, ViiV Healthcare submitted New Drug Applications (NDAs) in the United States, Europe, Japan and other regions to have dolutegravir approved as a new drug. As of today, the drug has been made available for sale globally under the product name "Tivicay®.
Triumeq®, combines dolutegravir, an integrase inhibitor, with the nucleoside reverse transcriptase inhibitors abacavir and lamivudine, was approved for the indication of HIV infection in August 2014 in the US and in September 2014 in Europe, and is also being sold globally.
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 endemic.
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 in a consortium with Merck KGaA, Lygature, Swiss Tropical and Public Health Institute, Farmanguinhos and Simcyp. Astellas has created pediatric formulation by providing our formulation technology and transferred it to Farmanguinhos. The consortium is conducting Phase II clinical trial. Astellas continues providing its expertise and technology in the area of pediatric clinical development.
Joint research and development of medicine for treating and vaccines for malaria and NTDs Eisai is engaged in 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.
Collaborative research with the National Institute of Advanced Industrial Science and Technology (AIST) to Discover Anti-protozoan Parasite Drugs for the Treatment of Chagas disease Astellas conducts collaborative research with AIST to discover Anti-protozoan parasite drugs for the treatment of Chagas disease, one of Neglected Tropical Diseases. Under this collaborative research agreement, Astellas and AIST will work together to validate whether genes crucial for the survival of Trypanosoma cruzi can be pinpointed in a short period of time by using gene editing technology. Astellas will mainly be responsible for selecting appropriate genes to be verified, and AIST will lead the gene editing process. After the validation in this collaborative research initiative, the formation of AIST-driven research consortium, in which multiple research institutions will participate to conduct extensive genome editing studies and pursue discovery of new drugs for the treatment of Chagas disease in a larger framework is planned.
Participation in "WIPO Research Consortium" for developing medicine for treating tropical diseases As 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.
Development of vaccine for treating Chagas disease and Leishmaniasis Eisai is collaborating with the Sabin Vaccine Institute (Sabin), the Baylor College of Medicine and Aeras to develop a vaccine for Chagas disease. This research was originated from a jointly initiated collaboration research of Eisai and Sabin with the aim of developing a new vaccine for Chagas Disease and Leishmaniasis that utilizes Eisai's in-house discovered selective TLR4 agonist, E6020, as a novel adjuvant (a substance that enhances immune effects).
Participation in global partnerships for developing tuberculosis drugs Eisai participates in the "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 medicines 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 to screen for candidate compounds for treating malaria, leishmaniasis and Chagas disease.
  • Shionogi participates in a GHIT Fund-sponsored program to create new anti- tuberculosis drug candidates, and proceeds with a joint research to create lead compounds based on promising compounds found out from our compound library. Shionogi is also engaged in a GHIT Fund-sponsored programs for searching out drug candidates for treating leishmaniasis and Chagas disease.
  • 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.
  • Sumitomo Dainippon Pharma is part of a GHIT Fund-sponsored program for searching out drugs for treating tuberculosis and malaria.
  • Kyowa Hakko Kirin is participating as an Affiliate Partner and continues to support the GHIT Fund.
  • Mitsubishi Tanabe Pharma is part of a GHIT Fund-sponsored program for searching out candidate drugs for treating 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 endemic, 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.
Development of Vaccine for Tuberculosis Sumitomo Dainippon Pharma and Japan BCG Laboratory for the development of new tuberculosis vaccine businesses established a joint venture company, Create Vaccine Company. Create Vaccine is engaged in a joint development program together for the development of tuberculosis vaccines, using a novel recombinant human parainfluenza Virus type-2 vector technology through funding from the GHIT Fund with National Institute of Biomedical Innovation, Independent Administrative Agency and Aeras (NPO). This vaccine is categorized as a mucosal immunity induction vaccine which targets the patient's mucous membranes to prevent an invasion of tubercle bacillus into the lungs, and expected to contribute to preventing adult-onset pulmonary tuberculosis which is prevented insufficiently by existing vaccines.
Development of medicine for treating eumycetome Eisai and the Drugs for Neglected Diseases initiative signed an agreement to proceed with clinical development of Eisai's anti-fungal drug E1224 (fosravuconazole) for the treatment of eumycetoma, a fungal form of mycetoma, one of the world's most neglected diseases. E1224 will be investigated in a clinical trial in collaboration with the Mycetoma Research Center (MRC) of the University of Khartoum, Sudan. Mycetoma was designated as a new NTD and added to WHO's list of NTDs in 2016.
New Drug Series to be Developed for “Ideal Treatment”for Visceral Leishmaniasis DNDi and Takeda will collaborate on a “lead optimization program”of the aminopyrazole series, with the ultimate goal of identifying the best compound to treat VL, which will then move on to further preclinical development. They'll continue designing and making improved candidates based on the early aminopyrazoles, select the most promising 4-6 leads, then paring them down to 2-3, and then eventually one that best meets the goals for a new, more effective drug.
Development of medicine for treating malaria Eisai entered into a joint research agreement with St. Jude Children's Research Hospital and Medicines for Malaria Venture to develop a new antimalarial medicine. This partnership aims to develop a new medicine that will be rapidly effective, cure in a single dose and provide lasting protection against reinfection. A Phase I clinical study was initiated at St. Jude Children's Research Hospital.
Development of medicine for treating malaria Eisai joined a research program with the Liverpool School of Tropical Medicine and the University of Liverpool to develop E209, a new antimalarial. E209 is expected to be effective in patients for whom artemisinin-based malaria treatments are ineffective due to resistance.
Development of medicine for treating malaria Eisai is conducting exploratory research to find compounds that can selectively inhibit the function of GWT-1, a malaria drug target protein identified at Eisai. Compounds are being further assessed through a collaboration with Medicines for Malaria Venture.
Development of medicine for treating Filariasis Eisai commenced research in collaboration with the Liverpool School of Tropical Medicine and the University of Liverpool to jointly identify new drugs effective against lymphatic filariasis and onchocerciasis (river blindness), both major types of filariasis. The goal is to develop a treatment that can effectively eradicate the worms that cause filariasis by first eliminating theWolbachia bacteria inside them which the worms (filariae) depend upon for growth, development and survival.

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