09 CeoMeeting- Session 4- Medicines for Malaria
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The document discusses product development partnerships (PDPs) that work to develop medicines and treatments for diseases that disproportionately impact developing countries and have limited commercial incentives. It provides Medicine for Malaria Venture (MMV) as a key example of a PDP focused on developing antimalarial drugs. MMV has developed over a dozen antimalarial candidates and products over its existence, including a pediatric-friendly version of Coartem through partnerships with Novartis. PDPs have grown substantially over the past decade and play a central role in driving neglected disease product pipelines.
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09 CeoMeeting- Session 4- Medicines for Malaria
- 1. ‘ Innovation Without Boundaries’ The Changing Face of Healthcare. Where are the Opportunities?
- 2. ‘ Innovation Without Boundaries’ Cooperative Models for R&D: Opportunities for Diseases of the Developing World:
- 3. Not talking about This But this
- 6. MMV’s was founded in the context of the Malaria Challenge as seen in the late 1990’s
- 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. Incidence of Malaria per 100,000 population in Malaysia
- 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
- 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
- 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
- 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
- 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.
- 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
- 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’.
- 19. MMV >100 partners across the world
- 20. 9 years work $450m & 1000s of man years spend: The strongest ‘balanced’ malaria R&D portfolio ever assembled Concept Proven
- 22. Some history Global fund
- 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
- 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
- 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
- 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
- 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
- 34. Thank You
Editor's Notes
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- It is clear from much of what I have already said that the pharmaceutical industry while at core a commercial sector like any other is also connected with and regulated by the public sector in ways that are both complex and pervasive. This has always been true but the nature of the relationship has never been the focus of so much interest and commentary as today. The balance of powers and interests are under intense scrutiny in every way from the rules governing IPRs globally to issues of ethics and informed consent in clinical trials to details of the compensation of Pharmaceutical CEO’s. Obviously this is not the topic of this lecture but it is fundamental to understanding the pressures which exist and are growing to bring public health interests a little more to the fore in the global drug R&D and to acknowledge that there is a strong mutual interest in achieving the right balances between the public good, the common good and the private good. This balance does not happen automatically and as we have seen when discussing the 10/90 gap large imbalanced can and do occur which are in fact detrimental to the interests of all. The public-private-partnerships that have been created mainly to undo the neglect of the neglected diseases are thus part of a broader phenomenon that includes other initiatives such as the Orphan drug legislation enacted in the USA and Europe and the specific initatives to help build research and clinical trials capacity in developing countries.
- Although the process illustrated by the example of mephloquine is as I have said often called a value chain - implying a linear series of steps – the truth is more complex. The long road to an new ICH type medicine is perhaps better described as a long and winding road or perhaps even a maze. One often has to circle around before one can move on and of course there are frequent technical problems which can never be overcome leading to an R&D program having to be stopped. This attrition is built into all financial models of drug development in that the cost of a success has to also carry the cost of failures. Furthermore for a commercial entity the fact that money is spent many years before any returns are possible through sales – the so called opportunity cost - must also be added. All of these cost together have been estimated to cost the Pharma industry as much as $800 million per successful drug registration.
- MMV was launched in some style on Nov 3rd, 1999 at the Geneva Headquarters of the WHO. The symbolic handshake between the public and private sectors was given by Dr Gro Harlen Brundtland (for WHO) and Sir Richard Sykes then president of the IFPMA (for the Pharma Industry)
- Given this fact it is not surprising that there had been between the end of the Vietnam war and the mid 1990’s a substantial pharmaceutical industry withdrawal from malaria drug R&D occurred . These negative trends occurred despite the fact that as has been well documented by the WHO and other public health agencies anti-malarial drugs have been one of humanity’s most precious and cost-effective public health resources – but resources that can only be kept effective and relevant by continuous innovation for new drugs and new drug combinations to stay ahead on encroaching drug resistance. The topic of malaria drug resistance, its causes and the ways we can mitigate and delay it have of course been both discussed in other lectures of this series and will not be covered here – but it would be remiss of me not to mention the important work done in Thailand on this topic. It is also not my intention to discuss in any detail the differences between the kind of anti – malarial drugs that are optimal for public health use compared to those designed to be used as prophylactics fot traveler of military use except to make the obvious point that the former must first and foremost be effective and affordable for routine caser management and ideally be useful for both P falciparum and P Vivax infections. I will return to this topic when I talk later about the role of MMV.
- The Win-Win partnering agreements we enter into are quite complex and often have many partners including academic and pharmaceutical industry partners. The terms of the agreements with the academic partners are fairly standard though they are quite exacting in terms of their performance requirements. These are not academic grants in the usual sense. Those with the pharmaceutical sector are by contrast fairly innovative. The aim is always to achieve joint R&D goals which emphasizes the common interests of the public and private sectors and which requires from each partner what it can most easily give while requiring that the public sector (through MMV) retains rights to any new drugs developed for the malaria endemic countries of the developing world. The private sector is always a net contributor to the financing of the R&D through its in kind contributions – effectively reducing its out of pocket costs. We predict that with this model new drugs for malaria can be discovered and developed for about $150m including the cost of failures.
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