Words by Saskia Pronk
Strongly linked with the world’s most impoverished environments, neglected tropical diseases (NTDs) are often intensely painful and stigmatising for those affected. Once widely prevalent, some diseases have disappeared from significant parts of the world owing to developing economies and improved living conditions. Yet, a heavy NTD burden continues to linger in those left behind by socioeconomic development. As a key player in the movement to control NTDs, pharmaceutical companies are continuously striving to attain an equilibrium between their corporate social responsibility and their financial return on R&D investment.
Historically, the need for NTD control has been largely unrecognised by the international community because the diseases have rarely travelled beyond the confines of the less economically developed nations in which they exist. However, in 2012 a watershed event rebranded NTD control for the better: The World Health Organization’s (WHO) London Declaration set ambitious goals for eliminating many devastating tropical diseases as a public health problem by 2020.
Supporting the endeavour, 12 of the largest global pharma companies collectively committed to extend medicine donations through to 2020, a commitment valued at between $2 and $3 billion annually. At last, NTDs seem to be finally receiving the resources they so desperately require. But, with the current burden of disease still standing at >1 billion people, novel products are vital. Despite pharma’s contribution, finding the resources to develop new diagnostic tools and treatments has proven a formidable task. The level of R&D innovation still doesn’t mirror the scale of the global health crisis, which prompts Jerome Kim, General Director, International Vaccines Institute to ask: “Neglected disease targets are less than one-quarter of vaccine R&D programmes at top vaccine companies. Why?”
The blame is often pointed at the heavy commercial pressure weighing on pharma’s shoulders. Kim notes: “Risk of failure is critical; it is estimated that of 10 products that enter the pipeline, one marketable vaccine emerges.” He adds: “The cost of vaccine development ($500 million–1 billion) with a 10% success rate creates significant risk and partially explains the high cost of vaccines.” Thus, with NTD prevalence focussed in countries with low purchasing power, the market incentive is absent for the development of these drugs.
Ann Aerts, Head of the Novartis Foundation, explains: “NTDs are complex and require a broad spectrum of partners in a multifaceted approach to address the many challenges.” Emphasising one significant hurdle, she states: “There is a lack of resources to invest in infrastructure and new breakthrough solutions.” This problem is further compounded by the complex biological mechanisms associated with NTDs, thus making traditional drug discovery and diagnostic methods a challenge. So, what’s the solution? Throughout the industry today, ‘collaboration’ is a phrase echoed with acceleration and the NTD fight is no exception.
Risk of failure is critical; it is estimated that of 10 products that enter the pipeline, one marketable vaccine emerges
According to Aerts: “The challenge is so vast that combining resources and expertise through partnerships is the only way that we can possibly hope to end diseases, such as leprosy. This is why [at Novartis Foundation] we’re so excited to be entering into a new partnership with Microsoft that aims to use AI to speed up leprosy diagnosis.”
Other companies are progressively looking to tailor their business model to deliver on the NTD mission. ‘Open-source’ is a strategy that hopes to foster innovations in preventive, diagnostic, and therapeutic products for NTDs. Against the typical model, companies have opened their libraries and shared their expertise and capabilities in efforts to speed up research, reduce risks, and limit duplication. One open-innovation partnership formed by the Drugs for Neglected Diseases initiative (DNDi) together with eight pharma companies aims to develop treatments for both Chagas disease and leishmaniasis. Dr Bernard Pécoul, Executive Director, DNDi explains: “This experiment could significantly reduce the time and money it takes to find new, promising treatment leads, and echoes the great potential of innovative research and development collaborations.”
Another R&D incentive strategy formed by the FDA provides priority review vouchers (PRV) to incentivise drug discovery, allowing pharma to fast-track the review process for NTD medicines. The PRV scheme is important for research on medicines that might not otherwise have been profitable to develop; to date, five interventions have received the support of this programme.
We have the capability; we need the commitment, vision, and funding to see it through
However, both the DNDi and Doctors Without Borders have criticised the programme for allowing pharma to pocket the proceeds and side-step a sustainable access strategy, stating: “The PRV programme for NTDs doesn’t ensure that products will be accessible and affordable to patients in need.” As a recent winner of a voucher themselves, the DNDi set a true example to pharma and invested 50% of the reward back into an access plan for its drug, benznidazole, a move that pharma companies should emulate if they are to reach the WHO’s goals by 2020.
Despite the progress of the past decade, it is essential that all stakeholders in combating NTDs, from governments to pharma, take an innovative and open stance towards long term solutions to meet the multifaceted challenges that NTDs continue to present. As Kim states: “We have the capability; we need the commitment, vision, and funding to see it through.”