1. The Global Alliance for TB Drug Development
Gerald J. Siuta, Ph.D., CLP
Consultant, Business Development
Global Alliance for TB Drug Development
Biotechnology Industry Organization International Convention
Chicago, IL
May 4, 2010

2. 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

3. 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

4. The Need for New TB Drugs
Complex 6-9 months treatment with a 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

5. 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 for
TB Drug Development

6. 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

7. 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)

8. AAA Strategy Affordability Adoption Access
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

9. Our Vision
FDCs
10 Days
2 Months
6 Months

10. 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

11. 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

12. Types of Deals In-Licensing IP Assignment Sponsored R&D
Collaborative R&D
Freedom to Operate
Clinical Trials

13. TB Alliance Portfolio TB ALLIANCE PROGRAMS DISCOVERY
CLINICAL DEVELOPMENT
Lead Identification
Lead Optimization
Preclinical
Phase I
Phase II
Phase III
Moxifloxacin
TMC-207
PA-824
Nitroimidazoles
Mycobact. Gyrase Inhibitors
Riminophenazines
InhA Inhibitors
Diarylquinoline
Phenotypic Screening
Tryptanthrins
LeuRS Inhibitors
GyrB Inhibitors
Whole-Cell Screening
Malate Synthase Inhibitors
Menaquinone Syn Inhibitors
Natural Products
RNA Polymerase Inhibitors
Energy Metabolism Inhibitors
Protease Inhibitors
Topoisomerase I Inhibitors
NITD Portfolio

14. Industrial Partners Chiron Corporation/Novartis Bayer Healthcare AG
Tibotec (Subsidiary of Johnson & Johnson)
GlaxoSmithKline
Anacor Pharmaceuticals
Novartis Institute for Tropical Diseases
AstraZeneca

15. 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

16. 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.

17. 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

18. 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

19. 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

20. Global Alliance for TB
Drug Development