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Development of New Drugs

Development of New Drugs Is a Major Factor in Solving the Access to Medicines Problem

It is difficult to solve the access to medicines problem unilaterally by a single pharmaceutical company or government or nonprofit organization. The problem of access to medicines has to be continually tackled through a partnership among governments, pharmaceutical companies, international organizations, and nonprofit organizations.
In particular, advanced countries were not enthusiastic to develop new drugs or vaccines for a number of NTDs and the three major infectious diseases (HIV/AIDS, malaria, tuberculosis)because demand is low in their countries. The result is that there are few effective new drugs for these diseases even today. Developing these drugs is challenging because it calls for extremely professional research and development as well as clinical testing.
Believing it a corporate mission for a pharmaceutical research and development company to produce new drugs for these diseases, Eisai is developing new drugs for many diseases through joint research with product development partners (PDPs), including organizations that aim to improve access to medicines by offering unique knowledge and drugs expertise.
Through these PDPs, Eisai provides chemical compounds, scientific expertise, and drugs for clinical trials, while its partners are in charge of basic research and clinical studies.

Mechanism for Joint Development with Product Development Partners (PDPs)

Eisai’s Major Joint Research with PDPs

Development of a New Cure for Chagas’ disease

Product Development Partners (PDPs)

DNDi(Drugs for Neglected Diseases initiative

Outline of Development

Although there are two types of drugs to treat Chagas’ disease, i.e., nifurtimox and benznidazole, they are not often used because of their toxicity for chronic patients. Given this situation, Eisai has begun developing a new drug to cure Chagas’ disease in partnership with DNDi, an independent, nonprofit organization.
Under the joint research contract, DNDi conducts clinical study of the chemical compound that Eisai has developed (ravuconazole or E1224), testing its effectiveness and safety. For its part, Eisai provides scientific expertise for the clinical testing of E1224 as well as drug products required for clinical trials.

 
Development of a New Vaccine for Chagas’ disease and the Leishmaniases

Product Development Partners (PDPs)

Sabin Vaccine Institute

Outline of Development

Eisai, in collaboration with the Sabin Vaccine Institute, has been developing a new vaccine for Chagas’ disease and the leishmaniases. In this partnership, Eisai provides the Sabin Vaccine Institute with an immunostimulant(E6020)and related information. Taking advantage of their respective strengths, the two organizations intend to quickly develop an effective vaccine.

 
Development of a New Drug and Vaccine to Cure Malaria

Product Development Partners (PDPs)

Oswaldo Cruz Foundation (Fiocruz)

Outline of Development

Eisai has been jointly researching drugs and vaccines to cure malaria, one of the world’s three major infectious diseases.
As of 2011, combined doses of quinine, chloroquine, pyrimethamine, and mefloquine—all based on artemisinin—were used to treat malaria. This combination helps to prevent insect drug resistance. Nonetheless, the emergence of a malarial parasite that tolerates artemisinin has been reported, making the development of new drugs an urgent need.
Eisai, with partner Brazil’s Oswaldo Cruz Foundation (Fiocruz), is jointly developing drugs and vaccines for malaria. Through this new partnership, Eisai aims to combine the strengths of Fiocruz in research and development for treating NTDs in Latin America with Eisai’s knowledge and expertise in new drug development. The goal is to develop and distribute, as soon as possible, drugs that will cure malaria and other NTDs. For its first project, the joint partnership has pursued the development of E6446, a drug to treat cerebral malaria.

 

What is DNDi and How is it Working to Develop New Drugs for NTDs?

The Drugs for Neglected Diseases initiative (DNDi) is an independent, nonprofit organization founded in 2003 by seven organizations: five governmental organizations and Medecins Sans Frontieres (MSF), a nongovernmental humanitarian aid organization, as well as The Special Programme for Research and Training in Tropical Diseases (TDR) as a permanent observer. Putting the top priority on the needs of patients, DNDi is developing new drugs for Chagas’ disease, the leishmaniases, human African trypanosomiasis, and malaria in cooperation with pharmaceutical companies and research institutions globally.
Through these partnerships, DNDi has built a large research and development portfolio for preclinical and clinical stage projects. In 2007 and 2008, DNDi marketed two types of malaria drugs.

References
DNDi-Drugs for Neglected Diseases initiative
http://www.dndi.org/