The Global Alliance for TB Drug Development Gerald J. Siuta, Ph.D., CLP
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The Global Alliance for TB Drug Development
Gerald J. Siuta, Ph.D., CLPConsultant, Business Development
Global Alliance for TB Drug Development
Biotechnology Industry Organization International ConventionChicago, ILMay 4, 2010
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Global Tuberculosis Epidemic• One-third of the world’s population is infected with
Mycobacterium tuberculosis (M.tb.)– 2 billion people
• 8-9 million develop active disease annually• 2 million deaths occur each year
– 1 person dies every 15 seconds• 400,000 cases of MDR-TB each year• Leading cause of death in HIV-positive people
– 12 Million people are TB/HIV co-infected
TB’s economic toll: $16 billion a year
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Current TB Drug Therapy• Active TB
– Standard therapy – 4 drugs (isoniazid, rifampin, pyrazinamide & ethambutol) for 2 months, followed by isoniazid and rifampin for 4 months
• Latent TB– Standard therapy – isoniazid for 9 months
• Multi-Drug Resistant TB (MDR-TB)– Individualized, prolonged therapy, few available drugs, poorly
tolerated and difficult to administer• TB/HIV Co-Infection
– Treatment as in active TB, but drug interactions with antiretroviral agents make simultaneous therapy difficult
• Extensively Drug Resistant TB (XDR-TB)– No treatment available
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The Need for New TB Drugs• Complex 6-9 months treatment with a
4 drug combination regimen• No new anti-TB drug in over 50 years• TB/HIV co-infections fueling each other• MDR-TB is on the rise• Unattractive market for private sector• No capitalization of public sector research
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History of the TB Alliance• Cape Town Declaration – February 2000
– Hosts: Rockefeller Foundation and the Medical Research Council of South Africa
– Over 120 organizations (health, science, philanthropy and private industry)
• Results – Support goals of Stop TB Initiative– Create Scientific Blueprint– Develop Pharmacoeconomic Analysis
Build a Global Alliance forTB Drug Development
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The TB Alliance• Independent, international Product Development
Partnership founded in October 2000• Non-profit organization• Headquarters in New York City
– Offices in Brussels and Cape Town• Entrepreneurial, virtual R&D approach
– Out-source R&D to public and private partners• Pro-active fundraising
– Over US $200 million raised• Support ~ 200 FTE worldwide and 50 FTE in-house
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Our Mission• Develop an entirely new therapeutic
regimen that will shorten or simplify the treatment of tuberculosis
• Coordinate and act as catalyst for global TB drug development activities
• Ensure Affordability, Adoption and Access (AAA Strategy)
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AAA Strategy• Affordability
– Appropriate pricing in developing countries• Adoption
– Ensure that new drugs are incorporated into existing treatment programs
• Access– Procurement and distribution to those patients
who need them most
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Our VisionFDCs
10 Days
2 Months
6 Months
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Profile of a New TB Drug• Shorten treatment to less than 2 months• Novel mechanism of action (MDR/XDR-TB)• Orally active• Once daily or intermittent therapy • Compatible with HIV treatment• Low cost of goods
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Financial Support• Bill and Melinda Gates Foundation• Rockefeller Foundation• Netherlands Ministry for Development
Cooperation• United States Agency for International
Development (USAID)• Governments of Great Britain and Ireland
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Types of Deals• In-Licensing• IP Assignment• Sponsored R&D• Collaborative R&D• Freedom to Operate• Clinical Trials
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TB Alliance PortfolioLead
Identification
Lead Optimizatio
nPreclinica
l Phase I Phase II Phase IIIDISCOVERYDISCOVERY CLINICALCLINICAL DEVELOPMENTDEVELOPMENT
Whole-Cell Screening
Phenotypic Screening
GyrB Inhibitors
InhA Inhibitors
Mycobact. Gyrase InhibitorsNitroimidazoles
Riminophenazines
TMC-207Moxifloxacin
TB ALLIANCE TB ALLIANCE PROGRAMSPROGRAMS
LeuRS Inhibitors
RNA Polymerase Inhibitors
Topoisomerase I Inhibitors
Tryptanthrins
Protease InhibitorsEnergy Metabolism Inhibitors
NITD Portfolio
Natural ProductsMenaquinone Syn InhibitorsMalate Synthase Inhibitors
PA-824
Diarylquinoline
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Industrial Partners• Chiron Corporation/Novartis• Bayer Healthcare AG• Tibotec (Subsidiary of Johnson & Johnson)• GlaxoSmithKline• Anacor Pharmaceuticals• Novartis Institute for Tropical Diseases• AstraZeneca
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Academic Partners• New York Medical College• Rutgers University• Colorado State University• Institute of Microbiology (China)• Institute of Materia Medica (China)• Korea Research Institute of Chemical Technology (Korea)• University of Auckland (New Zealand)• University of Pennsylvania• Johns Hopkins University• Infectious Disease Research Institute• University of Illinois at Chicago• Texas A&M University
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May 3, 2010
TB Alliance and AstraZeneca announced that they have entered
into a research collaboration agreement to accelerate the
discovery, development and clinical use of drugs against tuberculosis, especially drug resistant strains.
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The Collaboration• The TB Alliance and AstraZeneca will:
– contribute promising TB drug discovery projects into a joint portfolio that will be co-developed
– focus on novel compound classes– create a seamless path to clinical-stage
development– share resources
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TB Alliance Commitment• The TB Alliance will contribute its ongoing
collaborations with several world-leading researchers at:– University of Pennsylvania– Rutgers University– New York Medical College
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AstraZeneca Commitment• Projects will come from its TB research
center in Bangalore, India• The joint portfolio will be resourced by a
core group of scientists based at AstraZeneca’s TB research center in Bangalore, India
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Global Alliance for TBDrug Development
www.tballiance.org