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CPTR 2012 WORKSHOP

CPTR 2012 WORKSHOP . Dr. Wim Parys: Head Infectious Diseases Unit. Agenda. Industry perspective on challenges in TB drug development Finance: ROI and justification needed within companies to invest in these programs Clinical Trial: conducting trials mostly in developing countries

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CPTR 2012 WORKSHOP

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  1. CPTR 2012 WORKSHOP Dr. Wim Parys: Head Infectious Diseases Unit

  2. Agenda • Industry perspective on challenges in TB drug development • Finance: ROI and justification needed within companies to invest in these programs • Clinical Trial: conducting trials mostly in developing countries • Regulatory challenges: lack of harmonization • Post market arena: how to assure appropriate use • Supply chain: getting secure drug supply into HBC’s • Industry perspective on opportunities • Where has progress been made? • What would ease the burden for developing TB treatments • Incentives, include AMC’s and other innovative solutions To edit footers: "insert tab>header and footer" and apply to all

  3. Top Challenges in TB Drug development: Overview Industry Challenges

  4. Long Development timeline, even for a lean program Non Clinical Non-Clinical Phase I 11 trials C202 75 pts C208 Stage 1 47 MDR-TB pts Phase II C208 Stage 2, 160 MDR-TB pts C209, 233 MDR, pre-XDR, XDR-TB pts C210, ~600 MDR , pre-XDR-TB pts Phase III Phase III timeline based on traditional endpoints (treatment free cure) as per FDA requirements Privileged and Confidential

  5. Challenging Geography and Financials MDR-TB Estimated Cases 2010 PAC’s = Post approval Commitments Source: WHO 2011 N = ~ 650,000 Privileged and Confidential

  6. TMC207: Challenging Geography; Long regulatory timelines High Burden Countries Top 50 Countries 2012 2013 2014 2015 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Regulatory Approvals estimated Long timelines US EU China Russia India, S. Africa Further regulatory priorities will be developed for the remaining 23 high burden countries: Process to be repeated on a country by country basis Privileged and Confidential

  7. Ensuring appropriate use and supply chain?Global Source of 2nd line MDR TB DrugsDealing with small volumes + 40k treatments/year globally Global MDR Treatments- 2010 *GDF orders for 2009-2010. Many drugs ordered in 2009 were not delivered until 2010. Not-For-Profit Supplier of TB, HIV Drugs * • How well is it working??? • *GDF procurement agency for TB drugs Privileged and Confidential

  8. Hope in changing an antiquated, cumbersome, treatment paradigm On June 29, 2012, Janssen submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for bedaquiline (TMC207), as part of combination therapy for pulmonary multi-drug resistant tuberculosis (MDR-TB). This is the first NDA to seek an indication for MDR-TB. Priority review has been granted On August 31, 2012, Janssen announced submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking conditional approval for bedaquiline (TMC207), to be used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults. Opportunities: Where has progress been made? Photo courtesy of James Nachtwey 45 years since the introduction of the world’s last TB drug Privileged and Confidential

  9. How did we make it work? Part of Janssen’s mission is to ensure that its portfolio of HIV/TB medicine is accessible to patients in developing countries. Access issues in developing countries are complex and are made difficult by the lack of infrastructure, education, funding, trained medical professionals, and local government commitment. • Janssen is also committed to furthering healthcare access in developing countries. Examples include: • Voluntary licensing for local manufacturing for certain diseases of the developing world • Broad access programmes for diseases such as HIV/AIDS on a cost recovery basis in least developed countries and lower tier pricing for countries with developing economies • Early access programmes –(prior to drug approval and) administered under controlled conditions • Product donation programmes and other philanthropic efforts to address basic healthcare infrastructure needs where needed. • “Children without worms” provides 400million doses of mebendazole in support of global eradication efforts. 9

  10. Innovative financing mechanisms e.g. Advance Market Commitments Forward purchase agreements with numbers-of-patient laden incentives, etc. What would ease the burden for developing TB treatments: Better incentives Regulatory harmonization/mutual recognition Validated surrogate markers … Speeding up clinical trial testing and/or adaptive clinical trial design even in support of traditional approval Privileged and Confidential

  11. Thank you Janssen-Infectious Diseases BVBA

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