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TB Alliance's presentation at the Partnering for Cures, December 2, 2009
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1
Improving Treatments Against TB
Partnering for Cures MeetingDecember 2, 2009
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TB Alliance Mission
• The TB Alliance is a humanitarian agency developing new, better and faster-acting drugs and treatments against tuberculosis (TB).
• Inherent in our mission is the need to ensure that the drugs and regimens are affordable, adopted for use, and made widely available.
• No new TB drug has been developed in over 40 years. The TB Alliance undertakes initiatives to catalyze TB drug development.
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TB Alliance Vision
10 days
FDCs
2 – 4 months6 – 30 months
The Organization
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TB Alliance
PHARMABIOTECH
ACADEMIA INSTITUTES
GOVERNMENTS
FOUNDATIONS
•Founded in 2000
•Not-for-profit Product Development Partnership (PDP) headquartered in New York, with offices in Brussels and Pretoria
•Entrepreneurial, virtual drug development approach
•Largest portfolio of TB drug candidates in history
TB – A Disease of the Past?• TB kills 2 million each year even today; that is 5,000 deaths everyday.
• It is the greatest infectious cause of maternal mortality and of death in people
with HIV/AIDS
• There are half a million cases of drug-resistant TB; resistance is rising
• TB perpetuates poverty; it is estimated to deplete the incomes of the world’s
poorest communities by US$ 12 billion
TB cannot be conquered without new and better treatments
Source: WHO
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Current TB Therapy and Unmet Needs
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Unmet Needs• Drug-sensitive TB
4 Drugs, >6 months
• M(X)DR-TB>2 years; poorly tolerated; less than 10% penetration
• TB/HIV co-infection Drug-drug interactions with
HIV/AIDS drugs
• Latent TB Infection9-month treatment
Shorter, simpler therapy
More effective, safer drugs; shorter, simpler therapy
Co-administration with ARVs
Shorter , more easily tolerated therapy
Current Therapy
TB Alliance Portfolio
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Anacor Pharmaceuticals
Lead Identification
Tibotec/J&J
Lead Optimization
Preclinical
GlaxoSmithKline
GlaxoSmithKline
Phase I Phase II Phase III
University of Auckland
NovartisBayer
Institute of Materia Medica
DISCOVERY CLINICAL DEVELOPMENT
University of Illinois
University of Pennsylvania School of Medicine
Infectious Disease Research InstituteNew York Medical College
Korea Research Inst of Chem Tech and Yonsei Univ
Rutgers, State University of New Jersey
GlaxoSmithKlineGSK Whole-Cell Screening
Bi-Functional Molecules
LeuRS Inhibitors
InhA Inhibitors
Mycobacterial Gyrase Inhibitors
Nitroimidazoles
Riminophenazines
PA-824
Moxifloxacin
TB ALLIANCE PROGRAMS
Phenotypic Screening
Protease Inhibitors
Topoisomerase I Inhibitors
Tryptanthrines
RNA Polymerase Inhibitors
Energy Metabolism Inhibitors
NITD Portfolio Novartis Institute for Tropical Diseases
Institute of Microbiology, Chinese Academy of Sciences Natural Products
Colorado State UniversityMenaquinone Synthesis Inhibitors
GlaxoSmithKlineMalate Synthase Inhibitors
TMC 207 Tibotec/J&J
Next Generation Diarylquinoline University of Auckland, Colorado State University
Clinical Development Program
• Moxifloxacin, Phase III, is one of the most advanced programs against active TB in over 40 years
• PA-824, Phase II, is the first program by a non-profit to reach clinical trials • TMC 207, Phase II, is the first program with parallel development tracks for drug
sensitive and drug resistant TB
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CLINICAL DEVELOPMENT
Phase I Phase II Phase III
Moxifloxacin
PA-824
TMC 207
Bayer
Novartis
Tibotec/J&J
Changing Development of TB Treatments
Testing regimens containing multiple novel agents
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ABCD BCDE CDEF DEFG EFGH
E A G C H DBFConventional Development Paradigm
ABCD CDEF EFGH
EF AB CDGHAlternative Development Paradigm
12 years
ABCD EFGH
ABCD EFGH
6 years
Alternative Development Paradigm
24 years
Optimizing Resources
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% Partner Contributions
Annual Expenses
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• Our early successes have created a need for larger funding
• Annual expenses are expected to increase as projects advance through development
• Funding gap over the next five years estimated at $150 million
Organizational LeadershipKey Staff Scientific Advisory Committee
Dr. Melvin Spigelman, President and CEO Dr. Stewart Cole , Ecole Polytechnique Federale de Lausanne
Dr. Marshall Burke, Sr. VP, External Affairs Dr. Frank L. Hurley, RRD International, LLC
Elizabeth Gardiner, VP, Market Access Dr. Stefan Kaufmann, Max Planck Institute for Infection-Biology
Dr. Ann Ginsberg, Chief Medical Officer Dr. Richard Losick, Harvard University
Stephen Jasko, Chief Financial Officer Dr. G. Lynn Marks, GlaxoSmithKline
Dr. Zhenkun Ma, Chief Scientific Officer Prof. Lester E. Mitscher, University of Kansas
Colleen Pero, Chief Administrative Officer Dr. Valerie Mizrahi, University of the Witwatersrand (S. Africa)
Dr. Paranji R. Narayanan, Formerly of TB Research Centre (India)
Dr. Philippe Prokocimer, Trius Therapeutics
Dr. Eric Rubin, Harvard School of Public Health
Dr. Christine Sizemore National Institute of Allergy and Infectious Diseases
Dr. Eve E. Slater, Columbia University College of Physicians and Surgeons
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Summary
• Current TB drugs are failing; drug resistance is on the rise• New drugs and regimens are urgently needed• The TB Alliance has built the largest portfolio of TB compounds in
history• This progress over the past few years has resulted in a pipeline of
products advancing towards the clinic
We are at an inflection point but only with donor support can we convert the early strides into new drugs and
regimens in the field
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Questions
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“I refuse to watch anotherpatient die because the treatment is simply too long and complicated…
Imagine what a two-month therapy would do for the Philippines, where 75 people die every day from tuberculosis.”
--Dr. Charles Yu, PhilCAT
Extra Slides
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TB Alliance Funders
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Operating Model A flexible, virtual R&D approach:• In-licensing and independent development
PA-824 (Chiron/Novartis)
• Collaborative R&D with affordability commitment
Moxifloxacin (Bayer); GSK mini portfolio (GSK); TB drug portfolio (Novartis); TMC-207 (J&J)
• Contracted R&D with IP rights
Quinolone (KRICT); Nitroimidazole (ACSRC); Riminophenazine (IMM); Phenotypic screening (UIC); Energy metabolism (UPenn); Protease (IDRI); Tryptanthrine (KRICT); RNAP (Rutgers); LeuRS (Anacor); Menaquinone (CSU); Topo I (NYMC); Natural products (IMCAS)
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• Built the largest single portfolio of TB drug candidates in history– 22 projects spanning discovery to clinical development– Three projects in late-stage clinical development– First new drug, reducing treatment time by a third, scheduled for launch in 2013
• Catalyzing the field of TB drug development– identification of biomarkers of treatment efficacy – global mapping of registration-standard clinical trial capacity – Testing new paradigm for development of TB treatments that can dramatically
compress development time– Working with regulatory authorities worldwide to develop guidelines for TB drug
development• Affordability, Adoption and Availability (AAA)
– Studies on TB-endemic markets to facilitate availability and adoption
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TB Alliance Accomplishments
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