PDP Funders Group Briefing Paper Background. 2. Methods

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1 PRODUCT DEVELOPMENT PARTNERSHIPS (PDPS): WORKING TOGETHER: COLLABORATIONS BETWEEN PDPS AND PHARMACEUTICAL BIOTECHNOLOGY COMPANIES BASED IN EMERGING AND DEVELOPING ECONOMIES 1. Background Product Development Partnerships (PDPs) are not- for- profit organisations focused on developing new products to diagnose, treat or prevent a range of diseases that seriously impact the health and livelihoods of people living in low- and middle- income countries. The common goals of all PDPs are to accelerate the development of one or more new medical products, and to ensure that they will be available in developing countries rapidly after being licensed, at affordable prices, and in sufficient quantities. Although PDPs vary in terms of focus and approach, all PDPs realise their mission by coordinating the contributions of the private, public, academic and not- for- profit sectors to address the scientific, economic, regulatory, legal and political challenges that exist in developing new health technologies for use in developing countries, and in ensuring their rapid and widespread use. This paper is the third in a series of briefing papers for funders documenting how PDPs work with different types of partners 1. This paper provides an overview of the formal relationships PDPs have entered into with pharmaceutical and biotechnology companies based in emerging and developing economies. This is the first iteration of the paper; it will be updated on an annual basis and expanded to incorporate other PDPs. 2. Methods This paper provides an overview of the formal relationships that 11 PDPs have entered into with pharmaceutical and biotechnology companies based in emerging and developing economies 2 between 2001 and December 31, Table 1 lists the PDPs. PDPs were asked to provide information on the relationships they had with pharmaceutical and biotechnology companies based in emerging and developing economies. The PDPs were asked to exclude Contract Research Organizations (CROs) and subsidiaries of companies where the parent company is based in a developed country. State or public sector manufacturing and research facilities were also excluded 4. There is, however, some ambiguity about the nature of a number of companies and in these cases the PDPs were asked to review the relationship and decide its eligibility. This paper focuses on the relationships between PDPs and pharmaceutical and biotechnology companies. These relationships may cover one or more agreements or different types of agreements. This paper differs from Briefing Paper 2 where each agreement with a company is treated separately. Data for the study were collected in a three- stage process. 1. Internet searches mapped the available relationships for each PDP. 2. The search results for each PDP were then circulated to the PDP for correction and updating. 3. A draft report was subsequently sent to the PDPs for their input. 1 The focus of these papers is on PDPs. For more information on the contribution of PDPs to neglected disease R&D see Developing New Drugs & Vaccines for Neglected Diseases of the Poor: The Product Developer Landscape (BVGH, 2012). This report looks at the different players working on the development of 374 drugs and vaccines for 23 neglected diseases. It identified 348 unique organizations, including 26 PDPs, participating alone or in partnerships with each other, and found that 40% of the products in development had a least one PDP developer. 2 The IMF definition of emerging and developing economies was used (World Economic Report, April 2011). 3 Agreements entered into before 1 January 2001 are not included. 4 Examples of state related organizations that were excluded are: Farmanguinhos/ FIOCRUZ (Brazil), BioManguinhos/ FIOCRUZ (Brazil), Instituto Butantan (Brazil), LAFEPE Pernambuco State Pharmaceutical Laboratory (Brazil), Brimex and CINVESTAV (Mexico), Institute of Vaccines & Medical Biologicals (Vietnam). 1

2 Information collated for each relationship included: commencement or start date, status (active or completed), and scope of activities covered (see Table 2). The data collected reflects only those agreements that PDPs are in a position to disclose. Agreements that are covered by strict confidentiality agreements are not included. Table 1. The PDPs included in the study. Aeras Global TB Vaccine Foundation Drugs for Neglected Diseases Initiative Foundation for Innovative New Diagnostics Global Alliance for TB Drug Development International AIDS Vaccine Initiative International Partnership for Microbicides Medicines for Malaria Venture OneWorld Health 5 PATH Malaria Vaccine Initiative PATH Vaccine Development Programme Sabin Vaccine Institute PDP Aeras DNDi FIND TB Alliance IAVI IPM MMV OWH MVI PATH - VAC Sabin Table 2. Classification of the scope of activities covered. R&D Research and Development Man Manufacturing CT Clinical trials Other 3. Results A total of 23 relationships were identified between the 11 PDPs and pharmaceutical or biotechnology companies based in emerging and developing countries, of which 15 were ongoing at the end of December 2011 (see Figure 1). The Annex provides a brief description of each of the identified relationships by PDP. Nine of the 11 PDPs 6 reported one or more agreements, and seven of the PDPs reported one or more active agreements as of December 31, A total of 20 companies from five countries were identified. Three companies were involved and are still involved with more than one PDP 7. China National Biotec Group (CNBG) is working with Aeras and PATH- VAC Bharat Biotech International Ltd (BBIL) is working with OWH and PATH- VAC Serum Institute of India Ltd. is working with Aeras and PATH- VAC 5 In December 2011 OWH became an affiliate of PATH 6 The two exceptions were IPM and the TB Alliance. 7 Relationships were ordered alphabetically by country and within each country by company name. 2

3 Sabin PATH - VAC MVI OWH MMV IPM IAVI TB Alliance Find DNDI Aeras Figure 1. each PDP reported having entered into between 2001 and December 2011 () and those that were still active as of December 31, 2011 (). Figure 2 shows the total number of relationships by country and the number that were ongoing as of December % of the relationships entered into were with an Indian based company and they account for two thirds of the ongoing relationships. Companies based in one of the BRICS 8 accounted for all bar one of the relationships 9. Tanzania South Africa Russian Federation India China Figure 2. by Country. The number of relationships entered into by year between the PDPs and pharmaceutical and biotechnology companies is shown in Figure 3. Starting in 2007 there was a noticeable increase in the number of PDPs entering into relationships with companies based in emerging and developing economies. 8 BRICS is the acronym for the leading emerging economies of Brazil, Russia, India, China and South Africa. 9 In Brazil the public sector plays a key role in the development and manufacture of vaccines and pharmaceuticals. For example, Farmanguinhos/ FIOCRUZ and LAFEPE Pernambuco Pharmaceutical Laboratory are working with DNDi and BioManguinhos FIOCRUZ and Instituto Butantan are working with Sabin. 3

4 The scope of activities covered varies. They range from material transfer agreements, co- development agreements, technology transfer agreements, to providing technical assistance with drug registration (see Annex) Figure 3. The number of relationships entered into by Year. One of the Aeras relationships is missing from the figure. 4. Discussion This paper provides an overview of the formal relationships between 11 PDPs and pharmaceutical or biotechnology companies based in emerging and developing economies over the last 11 years. Between 2001 and 2011: Nine of the 11 PDPs involve in the study had one or more agreements with a pharmaceutical or biotechnology company based in an emerging or developing economy 20 companies in five countries were identified that had entered into an agreement with a PDP Three companies had entered into agreement with more than one PDP A number of companies had entered into one or more agreements or different types of agreement with a PDP. One of the assumptions behind the PDP approach was that pharmaceutical or biotechnology companies based in emerging and developing economies would enter into deals with PDPs that would be mutually beneficial. Engaging with the pharmaceutical and/ or biotechnology companies based in emerging and developing economies was also seen as a desirable outcome for many PDP funders. The number, range and scope of relationships identified in this study suggest that both companies and PDPs are starting to work together; there is, however, considerable scope for further and deeper engagement. This paper probably underestimates both the number and the scope of the relationships between PDPs and pharmaceutical and biotechnology companies based in emerging and developing economies. Confidentiality clauses often limit what can be said. Generally, the more exciting the scope of work the greater the degree of confidentiality. In addition to the formal agreements discussed above a number of PDPs also have informal relationships. The current version of this paper focuses on only a subset of the organisations based in emerging and developing economies that work with PDPs to develop and test new products. In future iterations it may be worth broadening the range of players to include CROs, public sector facilities and academic institutions. For example a number of PDPs have commented on the important role that CROs based in developing countries play by providing high quality services at costs that are often less than those of CROs based in developed countries. In addition, in parallel to expanding the range of players it may also 4

5 be constructive to be more explicit about the nature of the relationships. For example, clarifying whether an organization is providing a service for a set fee or if it is entitled to share IP rights on the final product and/ or be part of the commercialisation and launch of the product. Acknowledgements This paper was written by Jane Rowley of the PDP Funders Group. The PDP Funders Group would like to thank everyone who provided information or commented on the various drafts of this paper. Financial support for the paper came from a grant to the PDP Funders Group from the Netherlands Directorate- General for International Cooperation. About the PDP Funders Group The PDP Funders Group was set up by a number of public and private organizations providing financial support to one or more of the product development partnerships (PDPs) developing health technologies for preventing, diagnosing or treating diseases of poverty. The PDP Funders Group is an informal network of public and private organizations providing financial support to one or more PDPs developing new health technologies. The PFG provides a forum where those responsible for managing an institution s PDP investments can: share information and experiences to make better informed funding decisions; and identify areas where it would be beneficial for funders to work together in a coordinated manner. The PDP Funders Group is also working to increase the overall resource base for R&D funding for neglected diseases, and more specifically to increase the funding available for PDPs. For more information about the PDP Funders Group or this series of papers please contact Jane Rowley ([email protected]). 5