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TB Alliance-Bayer Partnership Background Information
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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
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The TB Alliance To develop world-class, affordable medicines for the poor and cure a disease that kills someone every 15 seconds. Mission
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1.Active Disease 2.MDR-TB 3.TB/HIV Co-Infection 4.Latent TB Infection TB Alliance Priorities Based on impact and feasibility
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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
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Historic Opportunity to Develop New Therapeutic Options for TB 19502010 1952 1 st regimen: Streptomycin PAS Isoniazid 1963 Rifampin (RIF) discovered 1970 BMRC Trials add RIF 1974 BMRC Trials add RIF & PZA 2005 Trials substitute Moxifloxacin into regimen 1970 1960 1954 Pyrazainimide (PZA) discovered – but liver toxicity Rx lasts from 12-24 months Rx shortened to 9 months Rx shortened to 6 months Rx target: 3-4 months Standard Therapy 2 months: rifampin, isoniazid, pyrazinamide, ethambutol + 4 months: rifampin, isoniazid Standard Regimen by 1960s based on 1952 drugs 1980
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Bayer: A Strong Tradition in Anti-Infectives 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 ZEPHIROL 1935: External disinfectant that treat wound infections CONTOBEN (Thiacetazone) 1950: Treatment of tuberculosis NEOTEBEN (Isoniazid) 1952: Long-term therapy of tuberculosis (based on Dr. Domagk’s work) CIPROFLOXACIN 1987: Fluoroquinolone for treatment of urinary tract infections – 14 FDA-approved indications MOXIFLOXACIN 1999: Fluoroquinolone for treatment of respiratory tract infections – 7 FDA- approved indications
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Moxifloxacin Timeline (US) Complicated skin and skin structure infections Community acquired pneumonia due to multi-drug resistant Streptococcus pneumoniae Uncomplicated skin and skin structure infections Acute bacterial sinusitis (ABS), acute bacterial exacerbations of chronic bronchitis (ABECB), community-acquired pneumonia (CAP) Community acquired pneumonia due to Penicillin- Resistant Streptococcus pneumoniae 2001 2005 2004 2003 1999
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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)
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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 Moxifloxacin for TB Scientific Rationale
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In an animal study*, moxifloxacin regimen shortened treatment duration by 2 months 0 1 2 3 4 5 6 7 8 9 10 0123456 Duration of treatment (months) Log CFU in entire lung Untreated 2 months rifampin, isoniazid and pyrazinimide followed by 4 months rifampin and isoniazid 2 months rifampin, moxifloxacin and pyrazinimide followed by 4 months rifampin and moxifloxacin *In vivo data does not predict clinical response. Legend
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Overview of Clinical Development Program TrialStudy DesignLocationsPatient Size Status CDC #27 Moxifloxacin replaces Ethambutol USA, Canada, Uganda, South Africa 336Complete 6/05 CDC #28 Moxifloxacin replaces IsoniazidUSA, Canada, Uganda, South Africa as well as Brazil, Spain 410Recruiting to commence in 2005 JHU Moxifloxacin replaces Ethambutol Brazil170Trial initiated 2/05 UCL- BMRC Moxifloxacin replaces Ethambutol Moxifloxacin replaces Isoniazid Tanzania, SA, Zambia 1500Recruiting to commence in early 2006
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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
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Partnership Roles TB AllianceBayer Partial fundingSupply of Drug Strategy & coordinationConsultancy Facilitate compliance with regulatory standards Regulatory sponsor Assurance of AAA* *Affordability, Accessibility, Adoption Commitment to AAA
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TB Alliance-Bayer Partnership Background Information
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