Building biotech solutions for diseases of the developing world

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Building biotech solutions for diseases of the
developing world

• Global Health Council
• June 1, 2006
• Washington, DC

Wendy Taylor Founder and Vice President Strategy
and Operations
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BVGHs Fundamental Premise

• The innovative drive and expertise of the
  biotech industry are integral to the mission of
  saving lives and treating diseases that afflict
  the world's poorest people.

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Key Barriers to Biotech Participation

• Market
• Disbelief that theres a market for global health
• Concern about opportunity costs and focus
• Funding
• Skeptical of investor support for global health
• Unable to access sufficient RD funding
• Information
• Unfamiliar with neglected diseases
• Unsure of developing world markets

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BVGH Mission
BVGH is breaking down barriers that hinder
development of new vaccines, drugs and
diagnostics to treat the urgent medical needs of
the developing world.
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BVGH Role Bridging Biotech Global Health

• Identify targets for biotech impact
• Create opportunities and incentives
• Build strategies
• Catalyze private sector RD through new
  partnerships and funding

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Reasons to Be Optimistic

• Revolution in scientific tools available
• Biotech industry is mature enough to tackle
  problems of this scale
• Funding increasingly there to develop new
  solutions
• Untapped markets that appeal to innovators

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1. Scientific Opportunity

• Biotech advances applied successfully to many
  diseases of developed world
• NO Reason these advances cant be used to make
  strides against neglected diseases

Rheumatoid arthritis Non-Hodgkin's
lymphoma Multiple sclerosis Breast
cancer Cardiovascular disease Respiratory
syncitial virus Gauchers Disease
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Targets for Biotech Impact

• Malaria drugs
• P. falciparum genome sequenced
• Multiple targets for HTS / RDD
• Diarrheal disease vaccines
• Several candidates in clinical trials
• Key test of dual-use rationale
• TB drugs
• Apply novel anti-infectives vs. TB
• Key targets IDed for rapid therapy
• Trypanosomatid Drugs
• All 3 genomes sequenced in 2005
• Increasing consensus on targets
• Diagnostics
• Critical need for improved POC IVD

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2. Technological Opportunity

• Industrys capable biotech companies DRIVE
  innovation
• Biotechs developing new technologies novel
  compounds
• VCs pouring in 4B/YR
• Big pharma signs dozens partnering deals buys
  best companies

• Huge advantage is industrys diversity
• 15 Big pharma 4000 biotechs
• Need lots of different ideas/approaches/co
  mpetition
• to sort winners/losers

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3. Funding Opportunity

• Funding opportunities have improved dramatically
• gt 35 billion committed over last 7 years
• Gates Foundation 6 billion
• Global Fund 4.8 billion
• PEPFAR 15 billion
• GAVI 3 billion

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4. Market Opportunity

• Potential untapped markets
• The 85 of the world NOT served by leading
  pharma/biotech
• Emerging market economies can and do pay

Global pharmaceutical sales focus on the
fastest-growing segments
Rest of the world
SE Asia China
North America
Latin America
Japan
EU
Total gt400 billion 75 in 12 countries
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BVGH Bridging biotech global health

• Create incentives and opportunities
• Build business cases for major product classes
• TB and ETEC vaccines
• Spearhead global Advance Market Commitments
  (AMCs)
• Build strategies
• Focus leading-edge discovery engines on key GH
  problems
• Help companies build business strategy
• Catalyze private sector RD
• Assemble sustainable partnerships around the most
  compelling projects
• Help secure financing

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Findings and Initial Actions from TB Vaccine
Business Case

• Identify markets that could potentially
  generate a return
• Quantify financial and social returns
• Define how public sector can enhance market and
  remove barriers

Approach

• Market size sufficient to attract innovators
  (450M - lt1B/year at peak)
• Potential impact justifies substantial public
  sector investment (millions saved)
• Clinical trial risk high gt7 years with
  thousands of patients
• Biggest impact on timelines/costs would be
  improved biomarkers

Findings

• Promote findings with vaccine companies
• Promote development of novel biomarkers
• Enhance developing world market to ensure
  access

Actions
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Booster Vaccine Cash Flow by Market
Profits by year and market for BCG boost (2013
2030)
Annual profit
Public mkt demand
(MM)
High income
Competitive event
Private mkt demand
Launch
Private mkt
China
India
Mid income
(970)
Low income
COGS
Upfront facility costs (250MM)
((infrastructure), adjusted for timing of
investment(1)
Maintenance
Facility
RD
-970
Represents all costs (638MM) incurred for RD,
adjusted for timing of investments(2)
Source BVGH/BCG analysis

NOTE Estimates for potential analysis only
information not provided by industry.
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Potential Impact of TB Vaccine
Over a million lives could be saved each year by
novel TB vaccines at low cost/DALY
Deaths (millions per year)
2.2
2.1
2.0
Baseline
2.0
-7
-12
1.8
-19
1.8
1.7
-17
BCG boost
-28
1.5
1.4
-32
1.2
-40
BCG Replacement
-48
1.1
0.8
-62
Prime-boost
Cost per DALY averted in Africa - BCG Replace
(6-10) - BCG Boost (21-26) - Prime
Boost (21-23)
Source BVGH TB Vaccine Business Case
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Building Markets Advance Market
Commitments (AMCs)

• Major shift in donor mindset
• Understand need for market-based solutions
• How they work
• Donors make legally-binding commitment to create
  viable markets for key vaccines
• Guarantee minimum price for certain volume of
  successful vaccines
• Technical specs for the product must be met
• Industry commits to lower long-term price

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AMCs BVGHs Role

• Ensure AMCs cost-efficient for donors and attract
  industrys capable innovators
• Consulted extensively with biotech industry
• Over 50 companies and 150 senior executives
• Issued two AMC reports
• Supported concept and outlined key issues
• to be addressed
• Industry response
• OVERALL Promising mechanism that should
• move forward
• Not magic bullet push funding still needed
• Must be competitive with other opportunities
• Concern about demand risk

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BIO Ventures for Global Health Building biotech
solutionsfor diseases of the developing world
www.bvgh.org
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TB Vaccine Business Case

• Approach
• Identify markets that could potentially generate
  a return
• Quantify financial and social returns
• Define how public sector can enhance market and
  remove barriers
• Findings
• Strong financial and social case for investment
• Est. annual global market gt450M for BCG
  replacement gt750M for boost
• Positive NPV, driven by developed world and
  emerging markets
• Potential impact justifies substantial investment
• SROI millions of deaths avoided cost
  19-63/DALY averted
• Clinical trial risk high gt5 years with thousands
  of patients
• Follow-Through
• Study embraced by industry first clear
  definition of markets value
• Companies newly attracted to work on biomarkers
  and vaccines
• Road show will promote findings value of
  deep dive approach

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BVGH Expertise

• Deeply networked with leading players in industry
• Broad convening power Bringing together the best
  science and the most skillful product developers
• Experience building successful product
  development organizations and partnerships
• Trusted partner Ability to advocate for global
  health without promoting particular products or
  strategies

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Landscape Analysis
High level assessment criteria
Burden
Global burden of disease in DALYs and deaths
Needs Gap
Adequacy of current solutions proxied by
mortality CAGR. Qualitative scan of gaps in
current drugs, vaccines, diagnostics
Status of Science
Quantitative scan of publication activity, state
of pipeline, and NIH funding review of key
publications, partic. rel. to targets
Relevance to Biotech
Match needs w/ key biotech assets Rx, Dx, Vx
discovery preclinical and clinical product
development capabilities
Availability of Funding
First pass review of a) hybrid and dual/use
markets b) other pull and push funding