Malaria & the Multinationals: Public Private Partnerships APPMG All-Party Parliamentary Malaria Group BEAD Business Exchange on AIDS & Infectious Diseases

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  • Malaria & the Multinationals: Public Private PartnershipsAPPMG All-Party Parliamentary Malaria Group BEAD Business Exchange on AIDS & Infectious Diseases Monday 6 February 2006Peter Potter-LesageMMV Medicines for Malaria Venture

  • The Lessons learned from existing PPPs - Product Development Partnerships .. The example of MMV & antimalarial drugs The situation in 1999 Public Private Partnerships for R&D The example of MMV Market size, market failure, R&D costs Economics behind industry withdrawal Virtual drug R&D, partners and partnerships The Win/Win Solution . A joint R&D portfolio The Value Proposition of PPPs The Experiment is over

  • Public-Partnership Model: Fun in 2001

  • Bad Bugs, No DrugsAs for antimalarial drug R&D in 1999

    This area is now considering a PPP solution

  • Neglected diseases 1975 - 1999Tropical diseases are good examples of neglected diseases. Of the 1,393 total new drugs approved between 1975 and1999, only 1% (13 drugs) were specifically indicated for a tropical disease .

    Only 3 of these were for malaria

  • Number by Year & Product TypePublic-Private Partnerships for Product Development:Financial, Scientific & Managerial Issues as Challenges to Future Success / Research Report WHO/CIPR Commission on Intellectual Property Rights, Innovation & Public Health (Elizabeth Ziemba)Public-Private Partnerships for Product Development

  • 5 new Public Private Partnerships for product development since 2000DNDi - Drugs for Neglected Diseases (CH)

    EMVI - European Malaria Vaccine Initiative (EU)

    MMV - Medicines for Malaria Venture (CH)

    MVI - Malaria Vaccine Initiative (USA)

    iOWH - Institute for One World Health (USA)

  • MMV & DNDi in Switzerland & EuropeAn island in the heart of Europe

  • Deliverables ?

  • A dramatic sea-change in research into ten so-called neglected diseases, including malaria, tuberculosis (TB), leprosy and sleeping sickness, could result in at least eight new drugs being developed by 2010.

    After a barren period when very few therapies were introduced for these diseases, which kill millions of people a year and cause the loss of the equivalent of 92m years of healthy life, there are now over 60 drug research and development projects underway. The New Landscape in August 2005

  • Neglected DiseasesDrugs in development (2005) PPPs = 75%The New Landscape of Neglected Disease Drug Development - Dr Mary Moran LSE/Wellcome Trust 2005PPPs = 47

  • Social and Economic Impact of MalariaAfflicts more than 1/3 of the human population500 million cases per yearOver 1 million deaths of children under 5: Leading cause of death of children under 5 in AfricaMalaria is curable: 90% deaths are preventable Annual lost GDP for Africa: $12 billionCosts up to 40% of total public health expenditureUp to 50% of in-patient and out-patient careUp to 60% of total household expenditure

  • Antimalarial Drug Resistance Worldwide, 2001

  • MMV - A Partnership betweenPublic and Private sectorsMMV Launch Nov 3rd, 1999

  • Founding Bodies

    Netherlands Ministry of Foreign AffairsSwiss Agency for Development and CooperationUnited Kingdom Department for International DevelopmentGlobal Forum for Health Research World BankWorld Health Organisation (RBM / TDR)International Federation of Pharmaceutical Manufacturers

  • MMV to operate as a not-for-profit businessEstablishment of independent Foundation

    Small management team with operational freedomheaded by Chief Executive Officeranswerable to Board of public / private sector experts

    Virtual R&D approach

    Commercialisation through pharmaceutical companies

  • Market FailurePoor endemic populations cannot pay the fully-loaded discovery and development costsNew combination drugs costs moreNet present value analysis suggests pharma companies not likely to see positive returns from R&D investments 4 of the last 5 anti-malarial drugs developed have indeed not made a profitFinancial RiskReputational Risk

  • Economics behind industrywithdrawal from malaria drug R&D:Many Push and Pull public policy responses are possible.

  • A Virtual Pharma Company or Drug R&D Facility:Avoids Capital Investment, Promotes in-kind SupportShareholdersCustomersDonorsBill & Melinda Gates FoundationRockefeller FoundationU.K. SwitzerlandNetherlandsUSAIDWorld BankWellcome TrustWHO/RBMBHP BillitonExxonMobil Foundation

    Endemic CountriesNGOs (MSF, MSH etc.)Multi-lateral AgenciesPublic/Philanthropic FundersGlobal Fund

    PharmaOthersMMVAcademia

  • Medicines for Malaria VentureConception: Social VENTURE CAPITAL

    staged financing to correspond with milestones that mark a reduction in uncertaintysyndication of investment and portfolio management to gather more information and diversify riskcovenants and restrictions in critical areas to limit potential conflicts

    VC Investment firms offer much more than money. Their specialized knowledge of target industries, active involvement in the companies they support, and strategic techniques that align their own and their investees' interests help ensure that promising companies allocate resources effectively and have the best chance for success.

  • Joint

    R&D

    MMV Inputs $$$ Drug Profile Partner Management Link to WHO/RBM/Policy Malaria Expertise Evaluation / Monitoring

    PublicPrivateValue added through effective Public-Private Partnership . A Win/Win propositionPublic+Private = leveraged costFor the Public Good Industry Inputs Chemistry IPR Toxicology Know How Assets in Kind Technology Liability Insurance MMV GetsRights in DECIPR in FieldDrug SupplyReturn on non DEC Sales

    Industry GetsRights in non DECIPR outside FieldPR BenefitHR BenefitValidation of Technology Private Goods Staff satisfaction Corporate Citizenship and Responsibility

  • ExploratoryDiscovery PreclinicalClinical DevelopmentLeadLeadTransitionPhase IPhase IIPhase IIIIdentificationOptimizationOZ (synthetic peroxide)Dihydrofolate reductase (DHFR)Haem PolymerizationMMV Portfolio 2000

  • Portfolio October 2005

  • MMV Product Profiles MeetPublic Health Needs

    Efficacy against drug resistant strainsCure within three daysLow propensity to generate rapid resistanceSafe in small children (< 6 mos.) Safe in pregnancyAppropriate formulations and packagingLow cost of goods

  • Intermittent preventative treatment in pregnancyIntermittent preventative treatment in early infancyP. vivax malaria (including radical cure)Severe malariaProphylaxis

    MMVs Ultimate Goal: a single-dose cure

    MMV Product Profiles Meetspecific indications

  • MMVs principle Project Partners

  • A long road to a new medicineand expensive$$$$$$$$$$

  • Significant new commitments

  • Rising Global Spending ....Malaria R&D still lags behind

  • G8 Finance Ministers Conclusions on Development, London, 10-11 June 2005

    6.Tackling diseases that undermine growth and exacerbate poverty in developing countries will require not only strengthened health systems, but also improved treatment, including universal access for AIDS treatment by 2010 and development of vaccines, including for HIV and malaria. We have made progress this year in implementing the Global HIV Vaccine Enterprise agreed at Sea Island, and are committed both to taking this further; and to scaling up our support for vaccines and medicines research through the successful Public Private Partnerships model. We call for a report on progress by the end of the year. We recognise also that advance purchase commitments (APCs) are potentially a powerful mechanism to incentivise research, development and the production of vaccines for HIV, malaria and other diseases. We asked Minister Siniscalco to consult the relevant institutions, governments and industry, with the aim of developing concrete proposals by the end of this year.

  • New Funding announced October 2005 = + $136 million for MMVUK DFID ( 10 million) ( 10 million)

    $ 100 million$ 18 million$ 18 millionPrevious total received / pledged $ 113 millionNew total received / pledged $ 250 million

  • INCOME 2000 - 2005 by Funding SegmentPublic/Philanthropic in inverse proportion to Business Plan forecast

    Chart1

    0.45013414

    0.0954284377

    0.189758548

    0.0594177065

    0.0630187796

    0.045013414

    0.045013414

    0.0468139506

    0.0054016097

    MMV - Medicines for Malaria VentureFunding: from foundation to end-2006 [as of July 2003]

    (total - received and pledged $ 55 million)

    Chart1 (2)

    0.0059673537

    0.019880311

    0.0056353525

    0.1511636821

    0.7279950404

    0.0893582604

    Project-related Expenditure Total 2002 = 82.33%

    * Ancillary income offset 0.77% already deducted

    Research & Development

    Operational Expenses

    MMV - Medicines for Malaria VentureExpenditure 2002(Total $ 12'575'256.--)

    ESAC 0.6%

    Business Plan 1.99%[Exceptional Expense]

    Board & Stakeholders 0.56%

    Indirect Costs* 14.35%

    MMV Direct Project Financing 72.8%

    Project Related Variable Costs 8.95%

    Chart31

    0.0075792417

    0.0052920752

    0.1085503033

    0.8007532399

    0.0778251399

    * Ancillary income offset 0.57% already deducted

    Project-related Expenditure Total 2003 = 88.7%

    Chart1 (6)

    0.0075792417

    0.0052920752

    0.1085503033

    0.8007532399

    0.0778251399

    Project-related Expenditure Total 2