New Treatments to Reverse the Tide of TB Maria C. Freire, Ph.D. CEO & President

STATE OF THE FIELD Complex 6-9 months of 4-drug combination therapy HIV-TB co-infections fueling each other MDR TB on the rise No new class of TB drugs in 40 years Dwindling drug armamentarium We Need New TB Drugs

The TB Alliance

International Product Development Public- Private Partnership (PDP) Independent, Not-for-Profit Entrepreneurial, virtual R&D approach Strong Board, Stakeholders Association and Scientific Advisory Committee Who are we?

Mission Develop new, better treatment for TB Coordinate and catalyze TB drug development activities worldwide Ensure affordability, access and adoption (AAA)

Operating Principles Scientific, ethical, financial rigor Best business practices Flexible and collaborative Active portfolio management

130 DOSES10 DOSES VISION FDCs

Profile of New Drug Simplify/shorten treatment > 2 months Effective against MDR-TB Co-administered with ARVs Shorten/improve latent TB treatment Easily adopted in the field

Pipeline Strategy Two-Pronged Approach –Existing Compounds, Analogs, Derivatives –Novel Families or Classes Worldwide Sourcing –Companies, Academy, Compound Libraries, Natural Compounds Obtaining Rights –Licensing, Purchase, Donations, Co-development, Co-Investment, etc.

Process Public Announcement BOD – Formal Review Portfolio Committee SAC, Consultants BD, RFAs, Unsolicited Proposals DEAL Investment Approval Due Diligence & Negotiations Scientific and Technical Review Proactive Scouting

TB Alliance Portfolio 2006 DiscoveryPreclinicalClinical Testing Nitroimidazole Analogs (University of Auckland, Novartis Institute for Tropical Diseases, National Institute of Allergy & Infectious Diseases) Quinolones (KRICT/Yonsei University) Macrolides (University of Illinois at Chicago) Nitroimidazole PA-824 (Chiron) Compounds, Analogs and Derivatives Contracted Program Program in discussion Screening and Target Identification (AstraZeneca) Nitroimidazole OPC (Otsuka) Moxifloxacin (Bayer) Global Alliance for TB Drug Development March InhA inhibitors (GlaxoSmithKline) Isocitrate Lyase inhibitors (GlaxoSmithKline) Focused Screening (GlaxoSmithKline) Pleuromutilins (GlaxoSmithKline) Nitroimidazole Backup Compound (Otsuka) Proprietary (Pharmaceutical company)

Outsourcing of PA-824 Development RTI Project Management under NIAID Contract * *

Stakeholder Voices “I refuse to watch another patient die because the drug is simply too long and complicated… Imagine what a two-month therapy would do for the Philippines, where 75 people die every.” Dr. Charles Yu, PhilCAT