Moxifloxacin Development in TB Dr. Martin Springsklee VP, Therapeutic Area Head, Clinical Development Anti-Infectives Bayer HealthCare AG GATB Annual Stakeholder.

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Moxifloxacin Development in TB Dr. Martin Springsklee VP, Therapeutic Area Head, Clinical Development Anti-Infectives Bayer HealthCare AG GATB Annual Stakeholder Meeting, Paris October 17, 2005

GATB Annual Stakeholder Meeting,Oct TB – A Growing World Health Problem One third of world’s population infected - 2 billion people carry TB One person dies every 15 seconds Leading cause of mortality in AIDS patients TB Drugs are > 30 years old, treatment takes 6-9 months and requires close supervision, access to and compliance with treatment remains major issue Incomplete or improper treatment is major cause for alarming rise of MDR-TB

GATB Annual Stakeholder Meeting,Oct Bayer HealthCare's Quinolone Antibacterial Moxifloxacin has shown potential against TB Moxifloxacin has demonstrated excellent in vitro and in vivo activity, against M. tuberculosis, with bactericidal activity similar to Isoniazid. Data from a TB mouse model, conducted at Johns Hopkins (Prof. Grosset) show that combination regimens containing Moxifloxacin have faster sterilizing activity than standard regimens, indicating a potential to shorten treatment duration. Potential to shorten TB treatment with Moxifloxacin is supported by recent phase II clinical data from TBTC study 27

GATB Annual Stakeholder Meeting,Oct Moxifloxacin Basic Facts Description 4th generation fluoroquinolone antibatcerial discovered and manufactured by Bayer First regulatory approval 1999 Germany and FDA Currently approved in 104 countries (oral and/or IV formulation) Microbiology rapid bactericidal activity vs. broad range of gram-pos. and gram-neg.bacteria Safety More than 40 million patient uses worldwide 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) Clinical studies have shown faster symptom relief and better cure rates versus comparator compounds.

GATB Annual Stakeholder Meeting,Oct Regimens with Moxifloxacin have Greater Sterilizing Activity than Standard Regimens in Murine TB Nuermberger et al. AJRCCM, 2004;169:421

GATB Annual Stakeholder Meeting,Oct Nuermberger et al. AJRCCM 2004; 170:1131 Regimens with Moxifloxacin Have the Potential to Shorten Overall Treatment Duration for TB

GATB Annual Stakeholder Meeting,Oct Rationale to proceed with the development of Moxifloxacin in TB There is substantial preclinical and initial clinical data suggesting that Moxifloxacin has excellent anti-TB properties Moxifloxacin is the most advanced candidate compound in the global portfolio of potential new TB treatments (Phase IIA data available) Reduction of treatment duration seems possible, e.g. by replacing Ethambutol or Isoniazid with Moxifloxacin. This needs to be confirmed in Phase IIB and III of development.

GATB Annual Stakeholder Meeting,Oct Development Strategy Overall Goal: -Demonstrate that Moxifloxacin can shorten treatment duration to 3-4 months with optimized combination regime Development Partners: -TB Trials Consortium at CDC -Johns Hopkins University -University College-London -British Medical Research Council -FDA OPD -EDCTP Treatment regimens tested in Phase IIB: -Moxi to replace Ethambutol -Moxi to replace Isoniazid Total no. of patients in Phase IIb: ca. 2000

GATB Annual Stakeholder Meeting,Oct Planned Clinical Development Milestones Best case timeline Start of Phase IIb late 2005/early 2006 Start of Phase III confirmatory studies2008 Regulatory approval 2010

GATB Annual Stakeholder Meeting,Oct A Public Private Partnership is the best way to ensure further development of Moxifloxacin in TB The Global Alliance for TB Drug Development and Bayer HealthCare will announce today that a partnership has been formed focusing on Moxifloxacin's development in TB If development is successful, Moxifloxacin could become the first truly novel anti-TB agent after more than 35 years Bayer HealthCare is committed to support the fight against one of the most burning issues of Global health and well-being: Tuberculosis.