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TB Alliance-Bayer Partnership

TB Alliance-Bayer Partnership. Background Information. Tuberculosis – a Global Epidemic. 2 billion people are infected with M. tb 12 million persons are TB/HIV co-infected 8-9 million new active TB cases/year 2 million people die/year ~400,000 cases of Multi-Drug Resistant-TB/ year

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TB Alliance-Bayer Partnership

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  1. TB Alliance-Bayer Partnership Background Information

  2. Tuberculosis – a Global Epidemic • 2 billion people are infected with M. tb • 12 million persons are TB/HIV co-infected • 8-9 million new active TB cases/year • 2 million people die/year • ~400,000 cases of Multi-Drug Resistant-TB/ year • Biggest killer of women of childbearing age

  3. The TB Alliance Mission To develop world-class, affordable medicines for the poor and cure a disease that kills someone every 15 seconds.

  4. TB Alliance Priorities Based on impact and feasibility • Active Disease • MDR-TB • TB/HIV Co-Infection • Latent TB Infection

  5. Reaching Patients: AAA Strategy • Affordability • Appropriate pricing for developing countries • Leverage/access IP rights • Adoption • Orally available, easy to use, compatible with ARVs • Leveraging WHO treatment protocol for TB • Access • Procurement & distribution • Funding via Global Fund to Fight AIDS, TB, Malaria or IFFFm

  6. Historic Opportunity to Develop New Therapeutic Options for TB 1950 1970 1980 2010 1960 1974 BMRC Trials add RIF & PZA 1963 Rifampin (RIF) discovered 1970 BMRC Trials add RIF • 1952 • 1st regimen: • Streptomycin • PAS • Isoniazid 2005 Trials substitute Moxifloxacin into regimen 1954 Pyrazainimide (PZA) discovered – but liver toxicity Standard Therapy 2 months: rifampin, isoniazid, pyrazinamide, ethambutol + 4 months: rifampin, isoniazid Standard Regimen by 1960s based on 1952 drugs Rx target: 3-4 months Rx shortened to 6 months Rx shortened to 9 months Rx lasts from 12-24 months

  7. Bayer: A Strong Tradition in Anti-Infectives NEOTEBEN (Isoniazid) 1952: Long-term therapy of tuberculosis (based on Dr. Domagk’s work) MOXIFLOXACIN 1999: Fluoroquinolone for treatment of respiratory tract infections – 7 FDA-approved indications ZEPHIROL 1935: External disinfectant that treat wound infections PRONTOSIL 1935: Sulphonamide therapy that drastically reduced death caused by infectious diseases; research led by Nobel Prize winner and Bayer scientist, Professor Dr. Gehard Domagk CONTOBEN (Thiacetazone) 1950: Treatment of tuberculosis CIPROFLOXACIN 1987: Fluoroquinolone for treatment of urinary tract infections – 14 FDA-approved indications

  8. 2005 Complicated skin and skin structure infections 2004 Community acquired pneumonia due to multi-drug resistant Streptococcus pneumoniae 2003 Community acquired pneumonia due to Penicillin-Resistant Streptococcus pneumoniae 2001 Uncomplicated skin and skin structure infections Acute bacterial sinusitis (ABS), acute bacterial exacerbations of chronic bronchitis (ABECB), community-acquired pneumonia (CAP) 1999 Moxifloxacin Timeline (US)

  9. Moxifloxacin Basics • Description • Discovered and manufactured by Bayer • Antibiotic in the fluoroquinolone class • Approved in 1999 in Germany and by U.S. FDA • Currently approved in 104 countries (oral and/or IV formulation) • Safety • More than 42 million patient uses worldwide for all indications • Generally well-tolerated • Most common, mild side effects include nausea, diarrhea, and dizziness • Current Indications • Acute bacterial sinusitis (ABS) • Acute bacterial exacerbations of chronic bronchitis (ABECB) • Community acquired pneumonia (CAP) • Uncomplicated and complicated skin and skin structure infections (uSSSI, cSSSI)

  10. Moxifloxacin for TB Scientific Rationale • Investigators at Johns Hopkins University found that substitution of moxifloxacin for isoniazid in a mouse model decreased treatment time by two months • Moxifloxacin has demonstrated activity against mycobacterium tuberculosis in both in vitro and in vivo published studies • Moxifloxacin has an excellent oral bioavailability & long biological half-life (T1/2) • Moxifloxacin has a low potential for drug-drug interaction because it is not metabolized by the cytochrome P-450 enzyme system • Moxifloxacin has a demonstrated safety record: 42 million patient uses for all indications worldwide

  11. In an animal study*, moxifloxacin regimen shortened treatment duration by 2 months 10 Legend 9 Untreated 8 7 2 months rifampin, isoniazid and pyrazinimide followed by 4 months rifampin and isoniazid 6 5 Log CFU in entire lung 4 2 months rifampin, moxifloxacin and pyrazinimide followed by 4 months rifampin and moxifloxacin 3 2 1 0 0 1 2 3 4 5 6 Duration of treatment (months) *In vivo data does not predict clinical response.

  12. Overview of Clinical Development Program

  13. TB Alliance-Bayer Relationship • Goals • Coordinate clinical trials to support registration of moxi-based regimen for TB at affordable price • Common GCP/GMP-based clinical trial standards • Unified safety data base • Clinical data-sharing • Affordability • For patients most “in need” • By-products for drug development • Chart regulatory path • Evaluate/validate potential surrogate markers • Build clinical trial capacity

  14. Partnership Roles

  15. TB Alliance-Bayer Partnership Background Information

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