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CPTR Workshop, Oct. 2012 TB Drug Co-Development Roundtable Perspective from Bayer

CPTR Workshop, Oct. 2012 TB Drug Co-Development Roundtable Perspective from Bayer. Dr. Martin Springsklee MD Head Global Medical Affairs Therapy Areas Anti-Infectives, Men’s Healthcare. 1950. 1970. 1980. 2012 and beyond. 1960. 1974 BMRC Trials add RIF & PZA.

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CPTR Workshop, Oct. 2012 TB Drug Co-Development Roundtable Perspective from Bayer

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  1. CPTR Workshop, Oct. 2012TB Drug Co-Development RoundtablePerspective from Bayer Dr. Martin Springsklee MD Head Global Medical Affairs Therapy Areas Anti-Infectives, Men’s Healthcare Page 1 • •

  2. 1950 1970 1980 2012 and beyond 1960 1974 BMRC Trials add RIF & PZA 1963Rifampin (RIF) discovered 1970 BMRC Trials add RIF • 1952 • 1st regimen: • Streptomycin • PAS • Isoniazid 2006 onward Trials substitute Moxifloxacin into regimen 1954 Pyrazinamide (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 A “Historic” Opportunity to Improve Anti-TB Therapy: we’re getting closer Page 2 MS@CPTR Workshop Arlington VA Oct. 4,2012 2

  3. The REMoxTB – Study:RapidEvaluationofMoxifloxacin inTB Overall Goal: • Demonstrate that Moxifloxacin can shorten treatment duration to 3-4 months with optimized combination regime – uses non-inferiority hypothesis Treatment regimens: 3 arm study, randomized, double-blind, double-dummy, • Standard regimen: 2 mo EHRZ /4 mo HR • MoxitoreplaceEthambutol: 2 mo MHRZ / 2 mo HRM / 2 moplac. • MoxitoreplaceIsoniazid: 2 mo EMRZ / 2 mo MR / 2 moplac Current Status: • Total no. ofpatientsenrolled: 1931 • First patient in: Q3 2008 – Last patient in: Febr. 21, 2012 • Last patient last treatmentday: Aug 21, 2012 • Expecttoplineresults: Dec. 2013 • First regulatorysubmissionplannedfor2014 Page 3MS@CPTR Workshop, Arlington VA, Oct 4,2012

  4. CPTR: 1st Novel Combination Regimen Pa-M-ZTopline results Trial NC001e-published in Lancet July 23rd, 2012 * • First clinical study under the CPTR novel combinations development paradigm (“test more than one novel compound at a time”) • 14d EBA study Phase IIa clinical proof-of-concept • Moxifloxacin plus PA824 plus Pyrazinamide • Study also evaluatedBedaquiline (TMC207) aloneand in combinationswith PA824 andwithPyrazinamide • Main resultsforMoxicontaining arm: • EBA 0 – 2 days: 0.315 log10/cfu/d • EBA 0 -14 days: 0.233 log10/cfu/d • Activecontrol arm HRZE: • EBA 0-2 days: 0.177 log10/cfu/d • EBA 0 -14 days: 0.140 log10/cfu/d • Pa-Z arm (withoutMoxi) • EBA 0 – 2 days: 0.170 log10/cfu/d • EBA 0 – 14 days: 0.154 log10/cfu/d * Diaconet al: The Lancet , published online July 23, 2012 http://dx.doi.org/10.1016/S0140-6736(12)61080-0 Page 4 MS@CPTR Workshop, Arlington VA, Oct 4,2012

  5. Study NC001 Main Result:Log cfu Reduction Day 0 – Day 14 Page 5 MS@CPTR Workshop, Arlington VA, Oct.4, 2012

  6. CPTR: Outlook Pa-M-Z regimen • Resultsachieved in NC001 a successful „proofofconcept“ forthe CPTR regimenbaseddevelopmentparadigm • Phase IIbstudy NC002 isunderway(n=89 ptsenrolled) • Main outcome variable: rate ofchange in CFU (SSCC) • Secondary variable: time tocultureconversion • 230 ptstobeenrolled, 4 treatmentgroups , treatmentduration 8 weeks • 3 armstoberandomized (n=60 each, drug-sensitive TB) • PA824 100mg + Moxi 400mg + Z 1500mg • PA824 200mg + Moxi 400mg + Z 1500mg • Rifafour e-275 (HRZE) activecontrol • 1 arm open label (max. n =50 ptswith MDR-TB): • PA824 200mg + Moxi 400mg + Z 1500mg • Expectresults in Q3/2013 Bayer iscommittedtofurthersupporttheclinicaldevelopmentofthePaMZcombo via the CPTR coalitionagreement – in additiontoourcontinuedcommittmenttoREMoxTB Page 6 MS@CPTR Workshop, Arlington VA, Oct. 4, 2012

  7. THANK YOU ! Page 7 • •

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