Stakeholders meeting for priority medicines for Europe and the world

Role of Public Private Partnerships

4 October 2004Brussels

Dr. Frans Van den Boom, MBA

Executive Director Europe

High incidence and prevalence of infectious diseases in developing countries

Enormous impact (life expectancy; economic growth; security threat)

Market mechanism works: no private sector investments in absence of a market

Insufficient product development efforts for poverty related diseases

15 – 20 year delay before products are made available for poorest countries

Global Problem

•>70 million HIV infections

• >28 million AIDS deaths

• 0 cured

• 14,000 new infections/day, >95% in developing world

The world needs an AIDS vaccine

•>70 million HIV infections

• >28 million AIDS deaths

• 0 cured

• 14,000 new infections/day, >95% in developing world

The world needs an AIDS vaccine

Photos by WHO/UNAIDS

World Impact

By the year 2050 the world will have

480 million less people

as a result of the AIDS epidemic…

Opportunities and challenges in global health

New Interest in Global Health Window of opportunity

United Nations: Security council, Commission on Macro Economics and Health, UNGASS, Priority Medicines

Global Fund G8 EC Plan of Action on Poverty Related Diseases President’s Bush 18 b initiative Increase in # PPP’s Increased industrial interest and involvement Increased resources (public and private, notably BMGF) Increased involvement of developing countries (e.g. EDCTP)

Health not defined only in technical terms, but also in terms of: Economics Moral / Humanitarian imperative Security issue Development issue

Global Health as well as global health interventions defined as global public goods Repositioning of private and public sector

Challenges in global health Too little effort to tackle developing countries problems (90-10 gap, market

mismatch) Lack of infrastructure in developing countries Too little involvement of developing countries Emphasis very much on treatment Insufficient resources Competing priorities (bio-terrorism, SARS) Sustainability of effort (GAVI, GF, CVF, PPP’s) Unease between public and private sector Humanitarian imperative vs business imperative No global health R&D funding mechanism Uncoordinated effort and counterproductive competition (national/regional vs

global) Lack of political will

AIDS vaccines account for less than 1%of total global spending on health R&D

AIDS vaccine R&DUS$540-570 million

Total health-related R&DUS$70 billion+

Estimated Worldwide HIV Expenditures*(2002 in Millions of Dollars)

Research &Development 20-25%

Prevention & Care 75-80% Vaccines $540-570 M

(LDC effort <$40–50M)

Prevention

Care

Basic research, therapeutic& other

* Source: IAVI estimates & AIW IIGlobal Total = $20+ Billion

Global Expenditures on HIV Vaccines(Success or Failure?)

1994 2002

Product

Development

$ 20 M (?$ 70-90 M)

Developing Country Specific

$ 1-2 M (?$ 40-50 M)

Total $ 125 M $ 540-570 M

Source: IAVI Estimates

Challenges (continued) PD is expensive (~ US$ 800 million) Science is complex: high risk investments Numerous IP challenges (e.g. Numerous broad ‘umbrella’

patents and vaccine component patents; Stacking of patent royalties)

Access issues (Pricing, Financing, Manufacturing, Delivery, Acceleration of regulatory consideration, Provision of non negligent liability protection )

Decreased attention for vaccines (global market for drugs: $ 450 billion

for vaccines: $ 6 billion)

Sci

enti

fic

Co

mp

lexi

ty

Market Attractiveness(Based on Developed Country Markets)

High

Low High

Low

Orphan ZoneHigh Risk-Low Return

Probable OrphansLow Risk-Low Return

Possible ProductHigh Risk-High Return

Market ProductLow Risk-High Return

Mening A/C

Malaria

Hookworm,Schisto

CancerTherapeutic

RotavirusPneumo

TB, AIDS*

Source: MVI, Patricia Atkinson Roberts

Delivery device

A modern vaccine is protected by multiple levels of IP licensed from multiple partners

Antigen

Adjuvant

Excipient

ExpressionDNA seq

Vehicle

Immunostim

vaccine

Platform/process

Source: Martin Friede, WHO

PPP as mechanism to address problems:

Necessity of new mechanisms

Market Issue: Private Industry doesn’t have the incentives; but needs to be included as they have all of the skills

Public sector is best at funding “R” rather than ”D” and is often national in its outlook

UN agencies do not have the flexibility/agility to rapidly move with different corporate partners

Response has to be global: engaging the world’s best scientists, companies, testing sites

Global Product Development Public Private Partnerships in Health

Partnerships seen as the way to overcome market and government failure

Interest in experimenting with partnership strategies and mechanisms that might overcome these failures to produce global public goods

Global advocacy has resulted in more € from public sector and legislative proposals to promote R&D (tax incentives)

i a v i

Efficacy Trials

Licensed vaccine

Basic Research

Applied Vaccine Research

Vaccine Design

Project management

Regulatory affairs, QA, QC

Phase I/II

Pilot manufacturing

Process development

International clinical trialsinfrastructure

Scale-upmanufacturing

The Road to an AIDS Vaccine

Product Development PPP’s Multi-candidate/portfolio approach Focus on translational research: translate basic research discoveries into products

that can be tested in humans Bring industrial expertise into the public sector and small biotech (QA/QC;

regulatory expertise; process development and manufacturing; project management; GLCP; GMP; data management; IP management; business rigor to cancel struggling projects early)

Primary objective: public health rather than commercial goal Want to get there as fast as possible, without compromising safety Not tied to any one company: interface with other organisations in the R-D-A

continuum Have a global perspective Work with developing countries and build sustainable capacity Focus on product development, manufacturing and access

Industrial involvement in IAVI programme

Targeted Genetics (rAAV) Bioption (SFV) Therion (MVA) IDT (MVA) Berna (salmonella) Cobra (DNA) Crucell (Adeno)

IAVI R&D TeamProject Management

Business Develop. & Strategic Planning

Research & Design

Development & Mfg.

Medical Affairs

Regulatory Affairs

GSK, CSL, Aventis,

Hale & Dorr, Holland & Knight, Merck,

NIH, Scripps, Penn, Cornell, Oxford, Harvard

Wyeth, Connaught, GSK, Merck

Aviron, Aventis, Chiron,VaxGen, Merck

FDA, EMEA, WHO, Biologics Consulting, GSK, Wyeth, Genetics Institute

Mechanism Proven

7 Vaccine Development Partnerships 5 vaccines into the clinic in five years (5x5) Clinical trials in 9 countries Quality across all sites: network of accredited labs Development of sustained capacity in the South Prioritise and stop programmes on basis of data Full participation of affected communities and DC’s Developing countries can deliver excellent work Strong support for AIDS vaccines from 8 OECD governments Increased political leadership in North and South All was done with small amounts of money

Optimising strategies

Long-term commitment to a systematic problem-solving agenda Redundancy of similar candidates needs to give way to cooperative

selection of better candidates Attack basic issues in vaccine research through cooperative approaches Creative mechanisms linking basic research scientists with vaccine

designers - Multidisciplinary involvement Increase resource intensity to quickly get generally useful clinical data

Frame of reference in order to make resource allocation decisions (e.g. public health impact, absence of market, scientific complexity, availability of other effective preventive interventions): Priority Medicines report, Copenhagen Summit

Full involvement of developing countries

Implications Effort has to be programmatic (e.g. Malaria Vaccine Initiative,

International AIDS Vaccine Initiative) Create mechanisms that facilitate global health R&D If the rules don’t allow for it, change the rules Willingness to pool resources and knowledge and stimulate global co-

ordination (NIH, ANRS, MRC, DG Research, Global Vaccine Enterprise etc.)

IP should not be a barrier for vaccine R&D and delivery to developing countries

Industry willing to share technologies if roadmap for effective vaccine is designed

A vaccine that is not used is meaningless: think through access issues now!

Implications for Europe Accept differentiation between solving a global health problem and

strengthen European competitiveness Accept the fact that PD PPP’s are adding value Act accordingly - Create mechanism for translational research that also

would be accessible to global PD PPP’s as well Take responsibility in closing US $ 1,2 – 2.2 billion gap by 2007 The time is right now: Technology Platforms for Innovative Medicines

and Chemistry; 7th framework, EDCTP, 3% target Create a better European infrastructure through structural funds (and not

through funds for development cooperation) Consortia and consensus quality, evidence, effectiveness and efficiency Make more money available: long term programmes

Preliminary Estimates 2002: Funding by Sector

Estimated Total Spending: $540 – $570 million

Biotech7%Pharma

14%

Public Sector: Europe

6%

Foundations/Private donor

1%

Public Sector: Other U.S.

8%

Public Sector:U.S. NIH

59%

Public Sector: Other/ non-Europe/U.S.

3%

The best time to plant a tree was twenty years ago. The next best time is today

African saying