R&D for TB: Updates & Opportunities for the Private Sector

1. R&D for TB: Updates & Opportunities for the Private Sector GBC Conference on TB, TB/HIV co-infection & Global Fund Partnership - Johannesburg, October 11-13, 2010 Christian Lienhardt Senior Scientific Advisor, Stop TB Partnership WHO, Geneva

2. Contents Context/Scene-Setting Brief “pipeline update” Role of PDPs in R&D Advocacy for TB R&D: what can the private sector do?

3. The global burden of TB in 2008 Estimated number of cases Estimated number of deaths 1.9 million (range 1.6–2.3 million) 9.4 million (range 8.9–9.9 million) All forms of TB HIV-associated TB 1.4 million (15%) (1.3–1.6 million) 520,000 (0.45–0.62 million) Multidrug-resistant TB (MDR-TB) 440,000 (0.39-0.51 million) 150,000 (0.05–0.27 million)

4. West Pacific 20% Africa 31% Americas 3% SE Asia 34% East Mediterranean 7% Europe 5% Estimated TB Incidence rates, 2008

5. TB Control Global Targets 2015:Goal 6: Combat HIV/AIDS, malaria and other diseases Target 8: to have halted by 2015 and begun to reverse the incidence… Indicator 23: incidence, prevalence and deaths associated with TB Indicator 24: proportion of TB cases detected and cured under DOTS 2015:50% reduction in TB prevalence and deaths relative to 1990 levels 2050: elimination (<1 case per million population)

6. A new strategy requires a new plan… The Global Plan 2011-2015 strengthens the fight The Global Plan 2006-2015 defines direction and costs 9.8 billion US$ to develop new tools 11 billion US$ to develop new tools

7. Today's tools for TB control are old tools – a struggle to cut deaths by half by 2015 and eliminate TB by 2050 VACCINE DIAGNOSTIC TREATMENT BCG Developed 1920s 1st-line TB drugs Discovered 1943-1970 Sputum smear microscopy Discovered 1882

8. Innovative action needed in 4 spheres"Moving beyond the TB box"

9. Needs for diagnostics in tiered health system

10. TB Drug Pipeline WGND, July 2010 Discovery Preclinical Development Clinical Development • Phenotypic screens • InhA Inhibitor • Tryptanthrins • LeuRS Inhibitor • Protein Kinase Inhibitors • Actinomycete • Metabolites • Fungal Metabolites • DNA metabolism • Novel compound evaluations • Nitroimidazoles • Mycobacterial Gyrase Inhibitors • Riminophenazines • Diarylquinoline • TL1 Inhibitor • MTopo • CPZEN-45 • SQ641 • SQ609 • DC-159a • Benzothiozinones • AZD5847 • SQ-109 • Oxazolidinone • TMC-207 • OPC-67683 • PA-824 • Rifapentine • Linezolid • LL3858 • Gatifloxacin • Moxifloxacin

11. TB Vaccine Pipeline Working Group on New vaccines - July 2010 Preclinical Phase I Phase II Phase IIb Phase III M vaccae* AERAS-rBCG Mtb [∆lysA ∆panCD ∆secA2] MTBVAC01 [∆phoP, ∆fad D26] HBHA Hybrid 56 HG85 A/B VPM 1002 rBCG30* AdAg85A Hybrid-I+CAF01 Hyvac 4/ AERAS-404 RUTI M smegmatis* Hybrid-I+IC31 M72 MVA85A/AERAS-485 AERAS-402/ Crucell Ad35 Prime Boost Post-infection Immunotherapy Preclinical vaccine candidates are not yet in clinical trials, but have been manufactured under Good Manufacturing Practice (GMP) for clinical use and have undergone some preclinical testing that meets regulatory standards. *indicates candidates that have been in clinical trials in the past, but are not currently being tested in clinical trials Source: Tuberculosis Vaccine Candidates – 2009; Stop TB Partnership Working Group on New TB Vaccines

12. Advocacy for TB R&D: what can the private sector do? direct investment in R&D patronage/sponsoring university research support innovative starts-ups (venture capital funding) Advocate for tax breaks for R&D offer incentives "champions" for promotion of innovation in R&D promote debates and discussions (roundtables)

13. Conclusion – the TB Research Movement TB Research Movement promotes the need for harmonized and complementary funding of TB research to target revolutionary discoveries that will foster better care and control for the elimination of TB. Development of a consensus-driven Roadmap for International Research to eliminate TB www.stoptb.org/researchmovement/

14. Thank you for your attention !