In June 2013, Japan’s largest research-based pharmaceutical company, Takeda Pharmaceutical Company Limited, joined forces with MMV to work on the development of two new antimalarial compounds from MMV's portfolio: DSM265 and ELQ300. This new partnership also involves screening Takeda’s drug compound library for new candidate compounds active against malaria and was made possible thanks to the support of the Global Health Innovative Technology Fund (GHIT Fund).
Takeda has been operating for over 230 years with a mission to work towards better health for people worldwide through leading innovation in medicine. With this in mind and recognizing the urgent need for new medicines for infectious diseases of the developing world, Takeda became a founding member of the GHIT Fund thereby expanding its activities beyond its continuing core focus of non-communicable diseases and vaccines.
Takeda recognized the urgent need to contribute to research in the field of infectious diseases like malaria, and so took the opportunity to make it reality through the GHIT fund. Masahiko Koike, Director, Pharmaceutical Technology R&D Laboratories, Chemistry, Manufacturing and Controls (CMC) Center, Takeda, who works on the development of both compounds, explains how the company is contributing to two exciting antimalarial drug projects and what it’s like to work with MMV.
1. What do you feel Takeda can bring to antimalarial drug research?
While Takeda is new to the malaria field, we have many years and considerable depth of experience in developing small molecule compounds for diseases such as diabetes and hypertension. Importantly, for our current collaboration with MMV, Takeda has a strong team capable of working on challenging compounds that need absorption enhancement technologies for formulation development to achieve effective plasma drug concentrations. An additional issue in the malaria area is that these technologies are often expensive, so Takeda is also trying to develop a low-cost product that will help ensure the final medicines will be affordable for patients in malaria-endemic countries.
2. What is exciting about the two compounds DSM265 and ELQ300?
We are of course excited to see both projects moving forward, with the possibility of one day becoming a component of an effective antimalarial combination therapy. But from a technical point of view both compounds provide an exciting challenge to overcome in their limited biopharmaceutical properties.
3. How are the projects progressing?
For DSM265, MMV experts have already selected the solid dispersion formulation, which has shown promising pharmacokinetics in its ongoing Phase I clinical study. The next step is to develop an alternative manufacturing process of the drug product ensuring it would be affordable and equally performing for later-stage clinical studies in conformity with a commercial formulation.
ELQ300 is in the preclinical stage and is less well absorbed in the gastrointestinal tract than DSM265. The MMV experts had already considered various formulation technologies for the compound before we began. Thus, to move the project towards Phase I studies the challenge will be to identify areas for improvement in the previous formulation studies and explore further formulation screening.
4. What is your role in the projects?
I am one of the MMV project team members in Takeda's CMC Center. I provide technical advice to MMV for resolution of formulation issues. I work with a team of up to four scientists depending on the needs of the projects.
5. What do you find most rewarding about working on these projects?
Working in a diverse team across different organizations that share Takeda's common goal of better health and a brighter future for all people is extremely rewarding. Takeda is striving to do its best as part of the DSM265 and ELQ300 teams to overcome the existing formulation issues and ensure the successful development of DSM265 and ELQ300. In addition, it is fulfilling to think that our work may lead to a new treatment for malaria and thereby positively contribute to communities in some of the most impoverished areas of the world.
6. What has it been like to work with MMV and specifically the project team?
The MMV team is small but highly scientifically minded, knowledgeable and passionate about the projects. The team always sets a clear objective during our discussions, which forms a good foundation for collaboration with a pharmaceutical company. Because of this, we have established a good working culture of trust and accountability.
* GHIT is a public–private partnership between five Japanese pharmaceutical companies, two government ministries and the Bill & Melinda Gates Foundation and was launched in April 2013 with a potential 5-year commitment of over US $100 million. Its goal is to facilitate international partnerships that enable Japanese technology, innovations and insights to play a more direct role in alleviating the burden of infectious disease in the developing world. For more information, visit the GHIT Fund website.