Japan funds R&D for tropical medicines for poor countries

Japanese drug manufacturers are increasing their efforts to ensure more accessible and effective medicines are brought to the developing world

The Japanese pharma sector may have previously lagged behind its counterparts in Europe and North America in helping the very poorest people in the developing world, but the enthusiasm with which five of Japan’s biggest pharmaceutical companies have embraced the Global Health Innovative Technology (GHIT) Fund indicates a sea change in policy. Set up in early 2013, the Tokyo-based fund is specifically designed to push Japanese firms’ considerable technologies and expertise in developing innovations for a range of infectious diseases, including HIV/AIDS, malaria, tuberculosis (TB) and neglected tropical diseases.

The fund brings together Astellas Pharma, Daiichi Sankyo, Eisai Co, Shionogi & Co and Takeda Pharmaceutical Co, and is primarily investing in medicines already at the product development stage. These could be brought to market in the near future and have significant potential.

‘There are certainly instances in which Japanese pharma companies have provided subsidised medicines to the world’s poorest of the poor,’ pointed out Dr B T Slingsby, GHIT CEO and former executive of Eisai. ‘That being said, the GHIT Fund actually represents the first time Japan pharma as a collective has stepped up to assume a leadership role in reducing the burden of disease in the developing world,’ he said. ‘It’s also the first time Japan’s research and development capacity has been tapped to tackle neglected diseases,’ he added.

Japan’s pharmaceutical sector is third only to the US and UK in terms of the discovery and development of new medicines. Meanwhile, it ranks second for new active ingredients.

Dr Slingsby told Manufacturing Chemist that Japan’s industry ‘has amassed a treasure trove of talent and resources’, but noted it has been slow to focus on the developing world. ‘To date, Japan pharma in general has operated in the markets of the US, Europe and Japan independently but have relatively relied on multinational corporation partners for sales of their innovations in the developing world,’ he said.

‘However, the common mid-to-long term strategy of a myriad of companies in Japan is to expand globally and proactively grow in more of the developing world independently,’ he said, adding that its companies are now ready to engage on the global level.

Participating companies emphasise their existing developing world track records, but admit the GHIT Fund will take that assistance to an entirely new level.

Astellas, for example, has been involved in global public-private partnerships in recent years, including collaborative research on neglected tropical diseases caused by protozoan parasites with the Switzerland-based Drugs for Neglected Diseases initiative and a number of Japanese universities and institutions. In addition, the company is working on paediatric formulations for the parasitic disease schistosomiasis with Merck Serono (Switzerland), Top Institute (TI) Pharma (Netherlands) and the Swiss Tropical and Public Health Institute.

Global health problems cannot be solved only by a company or by the government of a country

‘Partnerships, collaborations and win-win relationships are all important key words for success in the GHIT Fund,’ said Dr Minori Saito, within the Tokyo-based company’s corporate social responsibility (CSR) unit: ‘Global health problems cannot be solved only by a company or by the government of a country. All stakeholders, including citizens, must brainstorm and collaborate to create solutions.’

Encouraged in its global outlook by the appointment in 2010 of its Chairman, Masafumi Nogimori, as Vice-President of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Astellas ‘began to think more about what we could do to solve global health problems as a research-based pharmaceutical company utilising our knowhow in drug discovery research,’ Dr Saito said.

‘Astellas supports the fund’s goal to encourage innovation in Japan and to reinforce Japan’s contribution to global health through a public-private partnership in the research and development of new health technologies that will fight infectious diseases.’ At present, the company does not have any commercially available drugs that counteract the diseases targeted by the GHIT Fund, but Dr Saito emphasised that research programmes are underway.

Work has also begun at Shionogi & Co on a screening programme with the Global Alliance for Tuberculosis Drug Development to identify potential candidates from the company’s compound library. ‘Today, the number of critical priorities for global health continues to expand,’ a spokesman for the company explained. ‘A lack of universal health coverage in many nations, and the impact of climate change, mental illness, non-communicable diseases and other threats to human health are increasingly viewed as significant public health risks.’

It might be a long journey; however, we believe it is possible to address a lot of subjects of global health through this initiative

He added that there is a need to address global health issues across borders through international organisations, governments, non-governmental organisations and pharmaceutical companies – although he concedes that change will not happen overnight. ‘It might be a long journey; however, we believe it is possible to address a lot of subjects of global health through this initiative.’

The fund aims to assist in reaching a number of the United Nations (UN) Millennium Development Goals, which are also part of the corporate social responsibility efforts of Daiichi Sankyo, and include reducing child mortality, improving maternal health, combating HIV/AIDS, malaria and other tropical diseases, while strengthening global development partnerships.

‘We believe that with the ease of travel around the globe today, infectious diseases are no longer just a problem for developing countries,’ said Toshiya Kondo, Head of Public Relations at Daiichi Sankyo. ‘We need to consider these diseases as unmet medical needs due to the efficacy and tolerability of the limited treatment options.’

With the ease of travel around the globe today, infectious diseases are no longer just a problem for developing countries

The company believes it has already had success with several of its drugs, with the World Health Organisation (WHO) prescribing Daiichi Sankyo’s quinolones – Ofloxacin and Levofloxacin – for TB and leprosy (or Hansen’s disease), Kondo pointed out. ‘We feel this initiative marks the start of the Japanese pharmaceutical community’s contribution to global health,’ he added. ‘Until recently, most Japanese pharmaceutical companies’ business expertise was limited [as regards] India, Africa and Central and South America, but in recent years – with their expanded business reach – they have begun to have a fuller understanding of the issues facing these countries.

‘Additionally, we feel that the recently increasing opportunities for private-public and public sector-academia co-operation have also been a big factor.’

Furthermore, the Bill & Melinda Gates Foundation is a partner in the fund, which works in a slightly unconventional manner. Each of the five participating companies has committed to contributing to the fund US$1m each year for five years. With additional investments from the Gates Foundation and the Japanese government, the fund’s budget will top $100m. Of that total, $6m has already been funnelled into 18 new global partnerships developing drugs against malaria, TB and Chagas disease – the potentially fatal ailment that is spread by bloodsucking ‘kissing bugs’.

The fund has also developed and implemented a ‘compound screening platform’ and has created 12 new collaborations between Japanese compound library holders and international non-profit product development partnerships for screening unique Japanese compound libraries. ‘This shows results and speed – urgency and performance – and these we can say are practices of the private sector,’ said Dr Slingsby.

The money is being made available to partnerships between Japanese and foreign institutions, such as a collaboration between Osaka University and Gulu University in Uganda to enhance the effectiveness of a planned malaria vaccine. When the medicines that are presently in the development stage are ready to be distributed, they will be ‘affordable and accessible to the people who most need them,’ said Dr Slingsby.

This is not about creating profit for our pharma partners, but rather about access

‘This is not about creating profit for our pharma partners, but rather about access,’ he said. ‘Our fund first and foremost prioritises access, in that with each and every investment we first assess its potential accessibility – its ability to be affordable, available, adopted and used by the people in need of the technology.

‘If it cannot be – if it is seen to be overly expensive or overly difficult to distribute – then we will either decide not to invest in its development or ask the developers to improve its accessibility early in the development process,’ he added.

And while all of the companies involved in the fund are expressing the desire to assist in the healthcare that is available in developing countries, there are clearly opportunities to develop their global business reach. ‘There’s a broader perspective emerging in Japan in which leaders in the public and private sector view the country’s economic future as firmly tied to conditions in the more robust health and growth of the developing world,’ stressed Dr Slingsby.

The health and happiness of the rest of the world has a direct impact on the health and happiness of Japan’s people

‘We live in a global society with universal connections,’ he added. ‘True leaders, as exemplified by our GHIT partners, believe that Japan cannot achieve its own economic objectives if the burden of disease in such a large part of the world continues to stunt the ability of billions of people to pursue better health, wealth and prosperity.

‘The health and happiness of the rest of the world has a direct impact on the health and happiness of Japan’s people,’ he said.

A fund note added that the initiative helps ease companies’ R&D risks. Since companies heavily invest time and resources while ‘chances of success are extremely low... they are not in a position to innovate without concern for profits, because this is not a sustainable business model,’ it explained.

Companies