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09 CeoMeeting- Session 4- Medicines for Malaria


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Session 4: Health & Wellness

Title: The Changing Face Of Healthcare:
Where Are The Opportunities?

Special Speaker: Dr Chris Hentschel, Medicines for Malaria Venture

Published in: Technology, Business
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09 CeoMeeting- Session 4- Medicines for Malaria

  1. 1. ‘ Innovation Without Boundaries’ The Changing Face of Healthcare. Where are the Opportunities?
  2. 2. ‘ Innovation Without Boundaries’ Cooperative Models for R&D: Opportunities for Diseases of the Developing World:
  3. 3. Not talking about This But this
  4. 4. In addition to Public and Private interest there is an area of ‘common good’ overlap <ul><li>Public Good Common Good Private Good </li></ul>The Common Good was rebranded as ‘Creative Capitalism’ by Bill Gates in Davos 2008 – but it is actually not a new idea
  5. 5. One Example of a PDP: Medicines for Malaria Venture (MMV): <ul><li>A Product Development </li></ul><ul><li>Partnership (PDP) </li></ul><ul><li>Discover Develop and Deliver </li></ul><ul><ul><li>Medicines for Treating </li></ul></ul><ul><ul><li>Preventing </li></ul></ul><ul><ul><li>& Now Eradicating Malaria </li></ul></ul>
  6. 6. MMV’s was founded in the context of the Malaria Challenge as seen in the late 1990’s
  7. 7. Current Global Strategy Reduce burden and encourage sustained control & elimination Sustained control SUFI Malaria-free Elimination Approximate country status in 2008 Elimination Endorse where feasible, and drive research Sustained Control Encourage sustainability SUFI Support rapid scale up Note: Preliminary analysis based on level of malaria transmission and assessment of control efforts – To be confirmed by the WHO and countries Source: WHO, Interviews, GMBP consultation meetings, BCG analysis
  8. 8. Incidence of Malaria per 100,000 population in Malaysia
  9. 10. Product Development Parnerships (PDPs) are the motor driving this portfolio growth HIV/AIDS TB Malaria NOID 2 Diarrhea 3 Respiratory Diagnostics Aeras: Aeras Global TB Vaccine Foundation DNDi : Drugs for Neglected Diseases Initiative FIND : Foundation for Innovative New Diagnostics GATB : Global Alliance for TB Drug Development IAVI : International AIDS Vaccine Initiative IOWH : Institute for One World Health IPM : International Partnership for Microbicides IVCC : Innovative Vector Control Consortium IVI : International Vaccine Institute MMV : Medicine for Malaria Venture MVI : Malaria Vaccine Initiative (PATH) MVP : Meningitis Vaccine Program (PATH) PDVI : Pediatric Dengue Vaccine Initiative PATH : PATH's Vaccine Development Program 1. PVS includes Rota Vaccine Program (RVP), Pneumo Vaccine Project (PVP), Enteric Vaccine Initiative (EVI), Influenza Vaccine Development Program (IVDP) 2. Includes HAT, visceral leishmaniasis, chagas, hookworm, and dengue 3. Includes cholera, typhoid, and rotavirus Sources: Combating Diseases Associated with Poverty, FSG, Nov 2004, Health partnership Review, Global Forum for Health Research, May 2008 Microbicides & preventatives Therapeutic product Vaccine Vaccine Development Program
  10. 11. Central Role of PDPs in DDW R&D Bringing partners together over the last decade… Funders Product Development Partnerships R&D Execution (Funders, PDPs, Basic Research Organizations & Industry Players - illustrative only - not comprehensive) Independent PDP-driven R&D World Bank Rockefeller Bill & Melinda Gates Wellcome Trust USAID DFID PEPFAR PMI Grand Challenges CIDA Global Fund GAVI Doris Duke Clinton Foundation Carter Center Basic Research Organizations TB medicines 2000 TB treatments 1998 Hookworm vaccines 2000 Rotavirus vaccines 2003 Pneumonia vaccines 2003 Malaria, rotavirus, JE, pneumococcal & meningitis vaccines 1977 Malaria vaccines 1999 Malaria medicines 2000 Dengue vaccines 2003 VL, malaria, diarrhoea & STH medicines 2000 HAT, VL, Chagas & malaria medicines 2003 TB vaccines 2003 Focus Since PDP Industry players
  11. 12. PDPs have experienced rapid growth, with total spend growing at 70% per year Total spend reported by Foundation-funded PDPs 1999 2000 2001 2002 2003 2004 2005 2006 2007 +68% $ M 1998 1. G&A includes senior management, HR, IT, Finance, Operations, Administrative Services, Communications and Legal. 2. R&D includes Research, Clinical & Site Development, Regulatory & QA, and Manufacturing. Note: Includes IAVI, IPM, GATB, Aeras, MMV, IVCC, MVI, MVP, PVS, DNDi, iOWH, FIND, PDVI, IVI (excl. PDVI). For MVI, IVCC and MVP, e xpenses not available via Annual Reports or 990 forms; given nearly 100% funding by Gates Foundation, assumes annual budget submitted to Foundation represents total expenses. For MVI, used 48% CAGR to calculate years 2000 and 2001 (given actual 1999 and 2003 expenses); Used 17% CAGR to calculate years 2006 and 2007 expenses (given actual 2004 and 2005 expenses, plus MVI's 2008 budget of $38M) Source: PDP Annual Reports and 990 forms (unless noted above); BCG analysis ...And need is expected to increase as pipeline matures # of PDPs Avg. expenses per PDP 2 4 6 7 7 11 12 13 14 14 $2M $3M $5M $7M $12M $12M $16M $17M $22M $28M +35% Per-PDP spend growth rate 387
  12. 13. The long and expensive road to a new ICH quality drug: $ $ $ $ $ $ $ $ $ $ Discovery Exploratory Development Full Development Registration Large Amounts of Candidate Medicine Synthesized Project Team and Plans Synthesis of Compounds Early Safety Studies Candidate Formulations Developed Extensive Safety Studies Screening Studies in Healthy Volunteers Phase I Candidate Medicine Tested in 3-10,000 Patients (Phase III) Studies in 100-300 Patients (Phase II) Clinical Data Analysis
  13. 14. Pipeline productivity goal depends on attrition and sustained investment: Source: MMV 30% 40% 55% 70% 90% 50% 65% 95% 30% 12% 7% 5% 4% 2% 1,5% 1,3% Phase length (quarters) 8 20 3 2 0 3 4 1 Phase cost (k USD) 250-500 1.00 2.000 1.5-2.0 6.00-9.00 6.000/drug 12.000 500 500 Cum POS POS Pipeline output Pipeline input Ph III Ph II Ph I Precl. Discov. Combination Regulatory Cumulative probability of completing pipeline is 1.3 % Phase II as single agent comes first then Phase II as combination Explor. Discov. Precl. Phase I Comb. Ph II Ph III Regul. Explor.
  14. 15. ‘ Market Failure’ = No commercial rationale for doing R&D <ul><li>The main victims of malaria: </li></ul><ul><ul><li>The bottom billion </li></ul></ul><ul><ul><li>The rural poor </li></ul></ul><ul><ul><li>Young children </li></ul></ul><ul><ul><li>Pregnant mothers </li></ul></ul>
  15. 16. The solution to ‘Market Failure’: A partnership between public and private sectors: Gro Harlem Brundtland representing the public sector and Richard Sykes representing the research based pharma industry (IFPMA/private sector) at the formal Launch of MMV on Nov 3rd, 1999
  16. 17. MMV as a ‘push’ R&D driver incentivizing malaria drug R&D: “ Push” e.g. MMV “ Pull” e.g. Global Fund Many “Push” and “Pull” public policy responses are possible – the most a PDP ‘push’.
  17. 18. The win/win proposition is at the heart of MMV’s operations and is contractual : Joint R&D <ul><li>MMV Input </li></ul><ul><li>$$$ </li></ul><ul><li>Background IPR </li></ul><ul><li>Link to RBM </li></ul><ul><li>Expertise </li></ul><ul><li>Pharma Input </li></ul><ul><li>Chemistry IPR* </li></ul><ul><li>Toxicology </li></ul><ul><li>Management </li></ul><ul><li>Know How </li></ul><ul><li>Assets in Kind </li></ul><ul><li>Technology </li></ul><ul><li>Liability Risk </li></ul><ul><li>MMV Gets </li></ul><ul><li>Rights in DEC </li></ul><ul><li>IPR in ‘Field’ </li></ul><ul><li>Drug Supply </li></ul><ul><li>Return on non DEC Sales </li></ul><ul><li>Pro rata rights to FDA PRV </li></ul><ul><li>Pharma Gets </li></ul><ul><li>Rights in non DEC </li></ul><ul><li>IPR outside ‘Field’ </li></ul><ul><li>PR Benefit </li></ul><ul><li>Goodwill </li></ul><ul><li>HR Benefit </li></ul><ul><li>FDA PRV </li></ul>Public Private
  18. 19. MMV >100 partners across the world
  19. 20. 9 years work $450m & 1000s of man years spend: The strongest ‘balanced’ malaria R&D portfolio ever assembled Concept Proven
  20. 21. Example of ‘repurposing’ - a product developed via the PDP Mechanism Coartem D <ul><li>1992 Combination was registered in China </li></ul><ul><li>1994 Ciba-Geigy licensed worldwide marketing rights to Coartem outside China </li></ul><ul><li>1998 (Swiss Regulatory Agency) regulatory approval </li></ul><ul><li>1999 MMV founded </li></ul><ul><li>2001 Mutual Recognition (EMEA procedure) </li></ul><ul><li>2001 WHO Novartis memorandum of understanding </li></ul><ul><li>2002 WHO Essential Drug list </li></ul><ul><li>2002 “European Launch” </li></ul><ul><li>2003 WHO prequalification </li></ul>
  21. 22. Some history Global fund
  22. 23. Putting 74 Million Treatments into Perspective : It’s Novartis largest product by volume!! 20 jumbo cargo planes full in 2008 97% cure rate Potential to cure as many patients as the population of France
  23. 24. The Need for Coartem Dispersible (Repurposing) Malaria and Children: The Challenge Saving Young Lives: Pediatric Malaria Facts 1,000,000 # of malaria deaths annually 700,000 # of children under 5 who die each year 0 # of child-sized ACTs* 30 Every 30 seconds a child dies from malaria * Refers to ACTs approved by stringent health authorities and WHO prequalified
  24. 25. Novartis and MMV enter into partnership in Nov 2003 <ul><li>&quot;This partnership with MMV signals our commitment to the global fight against malaria,&quot; said Dr. Daniel Vasella, Chairman and CEO of Novartis. &quot;We believe the most promising way to help increase access to life-saving therapies to the poorest people in the world is by working with partners such as MMV and the WHO with whom we already cooperate in the fight against malaria and leprosy.&quot; </li></ul>
  25. 26. Palatability Clinical Program: 2101 <ul><li>Randomized, single-center crossover (Tanzania) </li></ul><ul><li>Study objective: evaluate palatability of 3 formulations of artemether/lumefantrine for oral suspension </li></ul><ul><li>48 healthy children recruited from 1 primary school in Ifakara (24 boys, 24 girls; mean 8.6±0.7 years) </li></ul><ul><li>Subjects randomized to taste all 3 flavors in one day (strawberry, orange and cherry) </li></ul>
  26. 27. Palatability was assessed by a visual analogue scale (VAS) 0 Lowest 100 mm Highest <ul><li>“ How did you like: </li></ul><ul><ul><li>“ the flavor of the medicine?” </li></ul></ul><ul><ul><li>“ the smell of the medicine?” </li></ul></ul><ul><ul><li>“ the sweetness of the medicine?” </li></ul></ul><ul><ul><li>“ the medicine?” </li></ul></ul><ul><li>“ How do you like the taste in your mouth now ?” (2-5 minutes after the medicine was spat out) </li></ul><ul><li>“ Which medicine did you like the best?” (15-20 minutes after the third flavor was tested) </li></ul>
  27. 28. Cherry was overall preferred flavor Girls Boys Straw-berry Orange Cherry Straw-berry Orange Cherry Straw-berry Orange Cherry Straw-berry Orange Cherry Straw-berry Orange Cherry Flavor Smell Overall liking (immediate) Overall liking (after 2-5 mins) Sweetness
  28. 29. Participating countries Niger Ghana Ethiopi` Ethiopi` Tanzania Angola Namibia RSA Mali Burkina Faso Mozambique Senegal Zim- babwe Botswana DR Congo Somalia Sudan Chad CAR Gabon Congo Cameroon Nigeria Benin Guinea Sierra Leone Liberia Cote d’Ivoire Togo Madagascar Zanzibar Rwanda Uganda 8 sites Benin, Kenya, Mali, Mozambique & Tanzania/Zanzibar
  29. 30. CoArtem D – the only anti-malarial that ticks all the boxes <ul><li>Fixed Dose Combination ACT </li></ul><ul><li>WHO Treatment Guidelines </li></ul><ul><li>WHO Prequalified </li></ul><ul><li>WHO Essential Medicines List </li></ul><ul><li>Approved by SRA (Swissmedic) </li></ul><ul><li>Global Fund Approved List </li></ul><ul><li>Multilingual Educational Materials and Support </li></ul><ul><li>Safety Legacy > 200m treatments </li></ul><ul><li>Child Friendly Pediatric Formulation </li></ul><ul><li>Affordable </li></ul>
  30. 31. What the press has said worldwide Novartis hopes its new pediatric dose…is the next step toward the eventual eradication of a childhood killer. The drug launched this week in Maputo, Dakar and Dar-Es-Salaam, is expected to reduce significantly child mortality due malaria. Novartis et Medicines for Malaria Venture (MMV) semblent trouver le meilleur remède pour combattre le paludisme Coartem Dispersible, - first of its kind to dissolve in little water for easy administration vs the usual practice of crushing malaria drugs for children And many many more Geneva-based non-profit Medicines for Malaria Venture, launched a new version of the anti-malarial drug Coartem at a conference in Dakar
  31. 32. Bringing the Story to Life through Multimedia <ul><li>Compelling photos </li></ul><ul><li>Fighting Malaria documentary </li></ul><ul><li>B-roll </li></ul><ul><li>Video News Release </li></ul><ul><li>You Tube – </li></ul><ul><li>http:// =ZqNz5c8mEvk </li></ul>
  32. 34. Thank You