Faiz Kermani

The perception that these diseases are low on the list of global healthcare priorities, as well as the fragmented approach to researching treatments, has resulted in them being grouped under the umbrella term 'neglected diseases'. Although a universally accepted list does not exist, the World Health Organization (WHO) considers neglected diseases to be primarily infectious diseases that thrive in the heat and humidity of tropical climates. According to the WHO, considering these diseases as a group is important for control programmes, because many people are afflicted simultaneously by more than one of them.¹

Since 1975, pharmaceutical companies have been responsible for the launch of over 1400 new chemical entities as human therapeutics,² but relatively few of these have targeted neglected diseases. Subsequently, there has been considerable media and public pressure on the pharmaceutical industry to focus more attention on this area of drug development, as well as on governments to provide incentives for investment in neglected diseases.

Efforts to develop specific R&D programmes for neglected diseases have steadily increased, but this has required new approaches to traditional R&D challenges, as well as recognizing other factors that lead to the persistence of neglected diseases in affected regions. For example, although treatments do exist for some of the conditions, the healthcare infrastructure in the affected areas remains poor, and without local government backing, it is difficult for private companies and non-profit organizations to effectively intervene. Furthermore, a proper distribution network needs to be organized to transport medicines to the clinics and training is also required for healthcare personnel to administer the medicines. Aside from treatment options, there is the additional need for the development and implementation of prevention strategies, which necessitates government support.

One of the primary challenges of developing new treatments for neglected diseases is the fact that the drug development process is lengthy, expensive and risk intensive. A recent analysis of the pharmaceutical industry by CMR International found that it took approximately 11.5 years from the identification of a suitable drug target to the introduction of a new medicine,² while the Tufts Center for the Study of Drug Development has estimated the cost of successfully getting a drug to market at more than $1.3 billion (€979 million).³ Additionally, according to the Pharmaceutical Research and Manufacturers of America, only two in ten medicines ever produce revenues that match or exceed average R&D costs.⁴

Bearing this in mind, pharmaceutical companies embarking on R&D projects need to be confident that they can recoup their investment. Often, companies tend to focus commercial efforts on North America, Europe and Japan, because these markets represent more than 80% of global pharmaceutical sales and increase the likelihood of making a profit from discoveries. Because pharmaceutical companies have to answer to the demands of investors and the financial markets, it is difficult for their management to justify the expense of developing a medicine exclusively for use in developing countries, as a return on investment is unlikely. This dictates a new approach to tackling neglected diseases, whereby the experience of pharmaceutical companies in innovative R&D is linked to alternative financing mechanisms.