Reducing poverty: Do pharmaceutical companies deliver on R&D for neglected diseases in developing countries?

Industrys involvement in R&D for neglected diseases in developing countries

European Parliament, Brussels, May 30, 2012

Setting the picture

1 billion people affected worldwide/year by one of the 17 neglected tropical diseases (WHO) WHO affirmed achievability of NTDs elimination or control
(Sanitation, Diagnosis, Medicines, Vector control)

Long term commitment by Pharma industry to NTDs

Years of increased contribution to R&D (G-finder) Decades of drug donations Jan 2012, pledging to provide for 10 more years 1.4 billion treatments/year re. 9 NTD (more than 90% afflictions)

+ Capacity Building projects with WHO and other partners + 82 projects (individually or through PDPs) individual companies work on re. NTDs

R&D Trends impacting NTD financing

Maturing Pipeline Dead ends of Research

More projects entering expensive later stages (clinical trials) Need to invest in trial infrastructure &regulatory frameworks Regulatory delays can be significant (e.g. 4 years in Africa)

Return to Basic Research (e.g. Dengue) Implications for total funding and overall timeframe

New Funding Sources/ Incentives

Source : IFPMA 2011

Advanced Market commitments (AMC) Priority Review Vouchers (PRV) Recognition of Importance of DDW R&D

R&D for NTD needs...

Mixed, adequate and actively engaged stakeholders Patience and dedication Research
Passionate Scientist in well equipped labs Collaborative platforms to share knowledge Processes to identify the leading molecules

Development
Money to progress drug candidates Solid HC systems to conduct high quality clinical trials Good Regulatory Authorities

How can we - industry contribute to change the situation?

Industry can control: R&D, registration, manufacturing, marketing, donations, etc Industry can share expertise: Supply chain, regulations, etc Industry is open to new form of collaboration (PDPs, WIPO, etc) But it cant be involved in areas beyond its fields of expertise and legitimacy
Build efficient healthcare systems Close the funding gap Address, alone, issues of accessibility for new treatments

Industry proposed solutions

Responsible, sustainable and long-term solutions to make a lasting difference Capacity building A sound business plan for R&D and beyond, including sustainable funding And where market does not exist, innovative financing mechanisms required for R&D (push/pull incentives) and beyond Positive environment for collaboration and partnership

What could the EU do ?

EU has many important tools and policies
Promotes idea of equity in access to health worldwide Fosters investment in healthcare by
Supporting the enabling conditions in developing countries Seed funding for infrastructure Secondment of Experts Encourage development of partnerships

What else could be done?

Continuing level of historical investment Develop a joined-up approach with EU stakeholders Develop incentives for innovation in neglected diseases and neglected patients

Promote efficient regulatory approaches

Thank you

Emerging funding gaps for the projects entering clinical development

Number of Projects 60
TB Malaria 15 HAT Dengue VL Chagas
13

PRELIMINARY

Schistosomiasis Meningitis Diarrheal Diseases Shigella Rota-virus Onchocerciasis Cholera

Future Clinical funding needs

33

Helminths ETEC

Immediate Clinical funding needs

26 13 21 27
8 21 12

26 24 8 18 15
8

10

7
4

12 2 1 1
1 4 2 3 4

6 4 1 Early stage Lead Generation

4

4
2

1 1
1

2 1

1 2

Lead identificatio n

Lead Optimizatio n

Preclinic al

Phase I

Phase II

Phase III

Sources: Aeras website, Cholera Vaccine Initiative, DNDI Website, March 2010 Portfolio, GATB Website, Nov 2010, , IFPMA R&D Status Report 2010, Meningvax, MMV Portfolio 2010, MVP website, Sanofi-Aventis Website, Feb 2010, Sequella Website, Feb 2010, TDR Website, Working Group on New TB drugs Notes: Surface area does not reflect the size of the projects, which vary significantly based on stage of discovery and development. Other industry includes: Biotec, FASgen, J&J, Ranbaxy, Medevir, Bayer, Schering Plough, SciClone, Sequella, and Zenaris Other public includes: Colorado State,

10

A significant, yet fragmented, compound portfolio

PRELIMINARY
Number of Projects

85
Chicago Aeras

80

20

13

11 10 3 2 9
IOWH

DNDI

DNDI
SP Eisai Merck Abbott Pfizer IOWH

Sanofi

GATB

MMV

Dundee

Zentaris Merck

Astra-Zeneca GSK Sanofi Novartis Sanofi Novartis Merck Pfizer GSK

Novartis

Pfizer
GSK

Sanofi GSK

Sanofi

Novartis

Novartis Novartis

HATDengue VL Other Chagas Schisto Sources: Aeras website, Cholera Vaccine Initiative, DNDI Website, March 2010 Portfolio, GATB Website, Nov 2010, , IFPMA R&D Status Report 2010, Meningvax, MMV Portfolio 2010, MVP website, Sanofi-Aventis Website, Feb 2010, Sequella Website, Feb 2010, TDR Website, Working Group on New Helminths
TB drugs Notes: Surface area does not reflect the size of the projects, which vary significantly based on stage of discovery and development. Other industry includes: Biotec, FASgen, J&J, Ranbaxy, Medevir, Bayer, Schering Plough, SciClone, Sequella, and Zenaris Other public includes: Colorado State,

TB

Malaria

PATH
11

Otsuka Sequella

DNDI

Abbott

MVP