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The Global Alliance for TB Drug Development Gerald J. Siuta, Ph. D. , CLP 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

Global Tuberculosis Epidemic • One-third of the world’s population is infected with Mycobacterium tuberculosis 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

Current TB Drug Therapy • Active TB – Standard therapy – 4 drugs (isoniazid, 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

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

History of the TB Alliance • Cape Town Declaration – February 2000 – Hosts: 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

The TB Alliance • Independent, international Product Development Partnership founded in October 2000 • 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

Our Mission • Develop an entirely new therapeutic regimen that will shorten or simplify 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)

AAA Strategy • Affordability – Appropriate pricing in developing countries • Adoption – Ensure 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

Our Vision FDC s 10 Days 2 Months 6 Months Our Vision FDC s 10 Days 2 Months 6 Months

Profile of a New TB Drug • • • Shorten treatment to less than 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

Financial Support • Bill and Melinda Gates Foundation • Rockefeller Foundation • Netherlands Ministry 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

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

TB Alliance Portfolio TB ALLIANCE PROGRAMS Moxifloxacin TMC-207 PA-824 Nitroimidazoles Mycobact. Gyrase Inhibitors Riminophenazines TB Alliance Portfolio TB ALLIANCE PROGRAMS Moxifloxacin TMC-207 PA-824 Nitroimidazoles Mycobact. Gyrase Inhibitors Riminophenazines Inh. A Inhibitors Diarylquinoline Phenotypic Screening Tryptanthrins Leu. RS Inhibitors Gyr. B 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 DISCOVERY Lead Identification Lead Optimization CLINICAL DEVELOPMENT Preclinical Phase III

Industrial Partners • • Chiron Corporation/Novartis Bayer Healthcare AG Tibotec (Subsidiary of Johnson & Industrial Partners • • Chiron Corporation/Novartis Bayer Healthcare AG Tibotec (Subsidiary of Johnson & Johnson) Glaxo. Smith. Kline Anacor Pharmaceuticals Novartis Institute for Tropical Diseases Astra. Zeneca

Academic Partners • • • New York Medical College Rutgers University Colorado State University 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

May 3, 2010 TB Alliance and Astra. Zeneca announced that they have entered into May 3, 2010 TB Alliance and Astra. Zeneca 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.

The Collaboration • The TB Alliance and Astra. Zeneca will: – contribute promising TB The Collaboration • The TB Alliance and Astra. Zeneca will: – contribute promising TB drug discovery projects into a joint portfolio that will be codeveloped – focus on novel compound classes – create a seamless path to clinical-stage development – share resources

TB Alliance Commitment • The TB Alliance will contribute its ongoing collaborations with several 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

Astra. Zeneca Commitment • Projects will come from its TB research center in Bangalore, Astra. Zeneca 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 Astra. Zeneca’s TB research center in Bangalore, India

Global Alliance for TB Drug Development www. tballiance. org Global Alliance for TB Drug Development www. tballiance. org