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HCV ECAB, 20 May 2016 Brussels Urbano Sbarigia Global Market Access Leader.

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Presentation on theme: "HCV ECAB, 20 May 2016 Brussels Urbano Sbarigia Global Market Access Leader."— Presentation transcript:

1 HCV ECAB, 20 May 2016 Brussels Urbano Sbarigia Global Market Access Leader

2 Content Introduction Our approach Pipeline update Hepatitis Access Framework Our partnerships For Janssen HCV Community Advisory Board use only. Do not duplicate, modify or distribute. Janssen Scientific Affairs, LLC Proprietary and Confidential

3 Our holistic approach to infectious diseases DiagnosisPrevention TreatmentCure 3

4 Our heritage in infectious diseases ^ Marketed as INCIVEK ® in the US by Vertex * COMPLERA ® / EVIPLERA ® is manufactured by Gilead Sciences and Janssen Therapeutics # Part of the Janssen Global Public Health Portfolio. SIRTURO ® has been approved by the US FDA and is awaiting approval by the EMA ◊ Marketed as OLYSIO™ in the US and GALEXOS™ in Canada 19601976198020062008201120122013 ◊ * ^ # Hepatitis B vaccine HEPAVA X-GENE ® 2014 2015 4

5 The World Health Organization and Others Have Called for Action A world where viral hepatitis transmission is stopped and everyone living with hepatitis has access to safe, affordable and effective care and treatment 5 The goal: Eliminate viral hepatitis as a serious public health concern by 2030 The Vision Key Strategies Targets for 2030 Sixty percent (60%) reduction in deaths Ninety percent (90%) of eligible people treated, with 90% of those treated cured Essential, quality services and interventions, including national hepatitis strategies Equity and impact in narrowing service gaps Innovation for acceleration of prevention, screening, medicines, and service delivery Financing for sustainability

6 Our Call to Action At Janssen, we have an ambitious goal. We strive to bring forth transformational medical innovations to improve the lives of people affected by viral hepatitis and ensure future generations can live without fear of the disease. With a goal like this, there’s no time to waste. That is why we partner with organizations around the world, connecting our own expertise with that of others. Because, only together can we Make Hepatitis History. 6

7 Our Approach 7 Collaboration We have established and continue to foster partnerships with diverse stakeholders to effectively address the burden of viral hepatitis worldwide Innovation We focus on transformational medical innovations to improve the lives of people with viral hepatitis

8 Hepatitis C: A Significant Global Public Health Challenge There remains an unmet medical need for: High pan-genotypic efficacy Convenient dosing A shorter treatment duration Increased baseline testing to optimize treatment regimens 150 million infected with hepatitis C worldwide 8

9 HCV Has a Major Impact on Patients’ Lives – and Healthcare Systems 9 Every year, 350,000 people die from the hepatitis C virus (HCV), which is also the leading cause of liver cancer, liver disease and liver transplantation. The presence of a diverse mix of hepatitis C genotypes around the world, in combination with the limited availability of genotype testing in many regions, underscores the need for a simple, effective, pan-genotypic treatment. Ensuring the availability and appropriate use of new treatment options may create significant long-term cost savings for healthcare systems by reducing chronic conditions that can result from not treating the disease.

10 We aim to provide a new therapeutic option with: High pan-genotypic efficacy Convenient dosing A shorter duration of treatment Our Combination Regimen Approach 10 Our goal Our hepatitis C development program aims to provide a novel, simplified treatment option for people with hepatitis C through combining direct- acting antivirals with different modes of action, to further our commitment to optimizing treatment outcomes for patients.

11 HCV: Potential for New Simplified Treatment Options Note : RVR and ETR were defined as HCV RNA < LLOQTND at Week 4 of treatment and at the end of treatment (Week 8), respectively. SVR4, SVR8 and SVR12 were defined as HCV RNA < LLOQ 4, 8 and 12 weeks after the completion of treatment, respectively. EASL, 2015 Exclusive Worldwide License and Collaboration with Achillion 1 : ACH-3102 NS5A inhibitor ACH-3422 NS5B RNA polymerase inhibitor Sovaprevir NS3/4A protease inhibitor ACH-3102, FDA Fast Track Designation ACH-3102 + Sofosbuvir (‘Proxy’ Study) 6-week Treatment: Final Efficacy Results Optimization of NS5A Inhibitors Against Resistance End groups of ACH-3102 were optimized to retain activity against resistant variants 11

12 HCV: Future Clinical Development Complete multiple ascending dose study of AL-335 Phase 2a study ongoing combining our assets with Achillion compounds Move regimen into Phase 3 next year 12

13 Bringing Simeprevir to market and providing a new options for HepC patients including INF-free / ribavirin- free regimens Provide patient support services to improve adherence to therapy, guide patients through HCV journey Generate evidence of SMV efficacy / safety in special patient populations Bringing Simeprevir to market and providing a new options for HepC patients including INF-free / ribavirin- free regimens Provide patient support services to improve adherence to therapy, guide patients through HCV journey Generate evidence of SMV efficacy / safety in special patient populations Janssen will bring new medicines and services that contribute to improvement of treatment outcomes for patients with hepatitis C, today and in the future. Accelerate access to simeprevir Implement Equity-based Tiered pricing framework and "6 principles for public health initiatives" according to specific criteria Work in partnership with stakeholders to enhance optimal access to hepatitis C Care Accelerate access to simeprevir Implement Equity-based Tiered pricing framework and "6 principles for public health initiatives" according to specific criteria Work in partnership with stakeholders to enhance optimal access to hepatitis C Care Early engagement on access framework with leading hepatitis C voices - collect external insights to improve our access strategy Generate evidence and enhance awareness of HCV burden of disease/need for (early) treatment Early engagement on access framework with leading hepatitis C voices - collect external insights to improve our access strategy Generate evidence and enhance awareness of HCV burden of disease/need for (early) treatment Janssen is a committed partner working toward supporting the eradication of hepatitis C. Janssen will demonstrate its commitment to supporting optimal access to hepatitis C care across diverse healthcare systems and sub-populations. Janssen will catalyze meaningful conversations with a full range of stakeholders to drive commitment to the global goal of eradicating hepatitis C, thus reducing the burden and stigma of hepatitis C around the world. Our Goals: Ensure we maximize evidence of differentiation of Janssen (bringing innovative products) Ensure timely access across the three pillars Build strong partnership with payers Our Goals: Ensure we maximize evidence of differentiation of Janssen (bringing innovative products) Ensure timely access across the three pillars Build strong partnership with payers SMV approved in ~70 countries R&D commitment in HCV (new therapeutic options) SMV approved in ~70 countries R&D commitment in HCV (new therapeutic options) 13

14 Our Partnerships 14 Janssen remains committed to working with the global health community and to being an effective partner in the elimination of viral hepatitis as a serious public health concern. Patient Advocacy Groups Public Health Bodies Professional Organizations Thought Leaders

15 15 Thank you!


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