2011 ANNUAL REPORTAND 10-YEAR REVIEW
2007Scaling Up for Larger StudiesFocused capacity-building efforts at five of IPM’s researchcenter partners in 2007 helped lay the complex groundworkfor expanded safety studies of the dapivirine ring and gel inAfrica in 2009-10, and the Phase III program now underway. Incollaboration with developing country partners, these efforts includedrenovating clinic space, updating medical and telecommunicationsequipment, hiring and training staff, and developingcommunity engagement strategies. In addition to helpingestablish 10 research centers in Africa, IPM has collaboratedwith more than 20 centers in all, benefitting from their expertiseconducting clinical trials in developing country settings andpartnering to advance the science of HIV prevention.Long-term benefits of capacity-building: IPM’s studies arealso benefitting the areas hardest hit by the HIV epidemic —by strengthening community understanding of HIV, expandingHIV testing and counseling, improving research capacity andaccess to health services, providing hundreds of employmentand professional development opportunities, and supportingthe development of frameworks such as community advisoryboards. These research centers continue to serve their communitiesafter trials end by conducting studies with other trialsponsors, expanding their research portfolios and supportingcommunity health needs.IPM has conducted productacceptability, HIV incidence andclinical research studies in morethan 10 countries to date.“Initiatives such as IPM’s new Ring Study, which allowswomen to actively participate in prevention of HIV infection,must be supported and emulated to ensure a measurabledecrease in the spread of HIV/AIDS in our communitiesand regions.”— Graça Machel, global advocate for women’s and children’s rightsIPM Expands Manufacturing Facility to SpeedRing DevelopmentThe MatCH research center inEdendale, South Africa, wasestablished in 2007 with supportfrom IPM. We also completedrenovations that year to threeother research centers in SouthAfrica: Madibeng Centre forResearch, the Prevention of HIV/AIDS Project, and the QhakazaMbokodo research center. Allfour centers have conducted IPMresearch studies and are nowparticipating in our Phase IIIRing Study.Which photo?To design a stable and affordable vaginal ring that couldprovide sustained release of dapivirine, IPM expanded itsmanufacturing facility in 2008 to develop microbicide rings.IPM manufactured both dapivirine rings and placebo ringsto supply Phase I/II safety trials over the next two years aswe worked in parallel to establish a scalable manufacturingprocess — overcoming a significant technical hurdle to speedthe ring’s development. Starting in 2010, IPM transferred thisprocess to QPharma in Malmö, Sweden, where rings areproduced at a larger scale to supply IPM’s Phase III clinicalprogram. Through our in-house ring development and manufacturingefforts, IPM gained valuable technical expertise thatcontinues to play a critical role in the program today as wework toward product licensure.2008A DECADE OF PROGRESS 3
2008In 2011, IPM coordinated a field-wideadvocacy effort to brand microbicidesacross Africa as a potential new HIVprevention product.Galvanizing Support Through AdvocacyIn 2008, IPM contributed to advocacy efforts at the G8International Parliamentarians’ Conference that led to a callfor all G8 countries to increase investment in new diseaseprevention technology development such as microbicides.The G8 statement is one of more than 10 multilateral globaldevelopment commitments and policies that include supportfor microbicide research as a result of efforts by IPM andour partners. Since our inception, IPM has helped develop anetwork of civil society partners across Europe, sub-SaharanAfrica and North America to galvanize political will, publicsupport and financial commitment for microbicide R&D andfuture product access.Ushering in ProgressWith Expanded Safety StudiesBetween 2009 and 2010, IPM began expanded Phase I/II safetytrials of dapivirine gel and ring, based on supportive datafrom earlier safety studies. During this time, we implementeda total of six studies evaluating the safety, acceptability andpharmacokinetic profile of the products. These studies tookplace in five African countries, Belgium and the United States.The gel studies piloted an innovative design called “dailymonitored adherence” or DMA, during which study participantshad daily contact with researchers either by home visitsor local drop-off centers where they returned the daily-use gelapplicators. Results from these studies showed dapivirine, inboth gel and ring form, was safe and well-tolerated in healthy,HIV-negative women, and supported the dapivirine ring’sadvancement to Phase III efficacy studies.HIV Incidence Studies Point The Way to Phase III2009Sharing Scientific ProgressIPM has added to the body of scientific contributions inmicrobicide research through publishing peer-reviewedjournal articles and presenting data at major internationalconferences, including the Conference on Retrovirusesand Opportunistic Infections, the International AIDSConference and the South African AIDS Conference. Forexample, in 2010 alone, IPM led or supported work thatwas featured in more than20 oral presentations and17 posters at the InternationalMicrobicides 2010Conference.Determining incidence — or the rate of new infections — incommunities most profoundly affected by HIV helps to supplyresearchers and national governments with needed data onthe size and scope of the epidemic in local communities sothey can effectively target prevention efforts. These studiesalso help determine possible locations for future HIVprevention trials to ensure the trials demonstrate meaningfulresults as quickly as possible. For example, a 2010 IPM studyat five sites in South Africa confirmed annual HIV incidencerates ranging between 4 percent and as high as 11 percent.IPM research center partners in theKwaZulu-Natal province of South Africa areparticipating in IPM’s Phase III study of thedapivirine ring. In all, IPM has conducteda total of 13 incidence studies since 2004,involving thousands of women across sub-Saharan Africa.2010IPM presenting at an InternationalAIDS Conference.4 2011 IPM ANNUAL REPORT
Milestonesin the HIV prevention fieldFrom Promise to Phase III in 7 years2011Landmark studies in the field since 2005 have shown thegreat progress made in HIV prevention, especiallywith ARV-based strategies.2005-6: Male circumcision found to reduce risk of HIVinfection in men by more than half2009: RV-144 study shows for the first time that the riskof HIV infection can be reduced by a vaccine2010: First proof-of-concept established for ARVbasedprevention: tenofovir microbicide gel forwomen, and Truvada as pre-exposure prophylaxis(PrEP) for men who have sex with men2011: Daily PrEP is found to reduce HIV infectionamong discordant heterosexual couples andadults by up to 73%2011: Early initiation of ARV therapy by HIV+ individualsprotects uninfected partners by 96%The year 2011 saw the culmination ofIPM’s clinical and community engagementefforts as we prepared to launchour lead product, the dapivirine ring,into Phase III clinical trials. In theseven years since we negotiated aroyalty-free license with Janssen, IPMconducted preclinical work on dapivirine,developed and optimized severalring designs, manufactured the productfor Phase I and Phase I/II clinical trials,conducted six clinical safety trials of the dapivirine ringalongside 25 other research studies through 2011, andlaunched the Phase III efficacy program for the ring,now underway. As a platform technology, the ring is alsobeing used to design a multipurpose prevention productthat combines an ARV with a contraceptive as well as acombination product that could deliver multiple ARVs.2011Joined Against a Global FoeIPM and the US National Institutes of Health-funded MicrobicideTrials Network (MTN) joined forces in 2011 to implementPhase III trials of the dapivirine ring. This partnership followsa formal agreement forged in 2005 by IPM and the National Instituteof Allergy and Infectious Diseases (NIAID), part of NIH,to accelerate microbicide development, opening the door toscientific cooperation and information-sharing. IPM and MTNalso jointly brought the first combination ARV microbicide, thedapivirine-maraviroc ring, into Phase I clinical safety trials in2011. This is the first study to evaluate the ARV maraviroc (anentry inhibitor) as amicrobicide (seechart p. 1). In addition,IPM and MTN collaboratedon a maletolerance study ofdapivirine gel.IPM Launches its LicensureProgram With First Efficacy Trialof a Microbicide RingIn 2012, IPM launched The Ring Study — the first efficacyand long-term safety study of a microbicide ring for HIVprevention, with results expected in 2015. The study willbe conducted among 1,650 women in South Africa, andpending in-country approvals, Rwanda. IPM’s ring slowlyreleases the ARV dapivirine over the course of a month toprovide discreet and easy-to-use protection against HIV.Regular use of prevention tools is essential to their effectiveness,and because IPM’s ring would be used monthly,it may help encourage women to use it consistently. TheRing Study is part of a broader licensure program beingconducted in partnership with the MTN, which alsoincludes MTN’s larger Phase III ASPIRE study, to launchin 2012. Together, these sister studies, along with othersmaller supporting safety studies, are designed to providethe strength of evidence needed for product licensure forthe dapivirine ring.2012A DECADE OF PROGRESS 5
What does the future hold?2012Access: Getting Ready TogetherIf results from the studies in IPM’s dapivirine ring licensureprogram show the ring to be effective and safe for long-termuse, we will seek regulatory approval for product licensure,and collaborate with key partners to help ensure it is madeavailable at low cost to women in developing countries assoon as possible. IPM and its network will continue to refineour access strategy throughout the ring licensure program toexpedite the product’s roll-out, availability and affordability,including potential distribution and financing mechanisms. Weare also working to optimize manufacturing processes andscale-up to minimize the cost of production. In addition, IPMis evaluating whether the ring could be used for 60 days orlonger to provide additional cost savings in the future.Multipurpose Prevention Technologies:Advancing Solutions That Meet MultipleHealth NeedsHigh rates of HIV and unintended pregnancy are significantcauses of health complications and death for youngwomen worldwide – demonstrating a clear need for discreet,long-acting tools women can use to address these issuesin tandem. Through a grant from USAID, IPM is developinga 60-day dual-purpose ring, currently in preclinical stages,that combines the ARV dapivirine with a contraceptive toaddress women’s urgent HIV prevention and reproductivehealth needs in a single product. The dual-purpose dapivirinecontraceptivering could empower women with a convenientand easy-to-use way to protect their health.“Bravo to team IPM for their decade of commitment developingtools to empower women with HIV prevention. IPM’s pioneeringwork on microbicides has been impressive to watch, and we werethrilled to see its expansion into family planning with research ona multipurpose ring to prevent HIV and pregnancy. Women Deliveris excited to see what the next decade brings with IPM’s efforts toprotect the health of women and girls around the world.”— Jill Sheffield, President, Women DeliverAdvancing a Diverse Product PipelineAs IPM oversees the dapivirine ring licensure program, preparesfor access, and expands its portfolio with multipurposeprevention technologies, we are also developing a pipeline ofother candidates in a variety of novel formulations to expandwomen’s options and move the science of HIV preventionforward. IPM is working on multiple active ARV drugs withdifferent mechanisms of action, including a gp120 binder andentry inhibitors such as maraviroc. IPM is formulating thesecompounds as gels, rings, films and tablets, both as singleagentsand combination products. Combination ARVproducts would target HIV at different points in its lifecycle and may provide greater protection againstHIV than a single drug alone.
IPM Donors since 2002Ackerman Family FoundationBelgian Development CooperationBill & Melinda Gates FoundationCanadian International Development AgencyEuropean CommissionFederal Ministry for Economic Cooperation and Development,GermanyIrish Aid, Department of Foreign AffairsM•A•C AIDS FundMagee-Womens Research Institute and FoundationMinistry for Foreign Affairs, SwedenMinistry of Foreign Affairs and Cooperation, SpainMinistry of Foreign Affairs, FranceMinistry of Foreign Affairs of DenmarkMinistry of Foreign Affairs, the NetherlandsNorwegian Ministry of Foreign AffairsOPEC Fund for International DevelopmentRockefeller FoundationSwedish International Development AgencyUnited Kingdom Department for International DevelopmentUnited Nations Population FundUnited States Agency for International DevelopmentWorld BankWith special thanks to Unit4 Business SoftwareBoard of DirectorsScientific Advisory BoardIPM LeadershipPeter B. Corr, PhD, ChairCeltic Therapeutics LLLP, United StatesEunice Brookman-Amissah, MBChBIpas, KenyaGeorgina Caswell, MAGlobal Network of People Living with HIV, SouthAfricaEveline Herfkens, MAUN Millennium Development Goals Campaign,SwitzerlandMaureen Lewis, PhDGeorgetown University MGHD, United StatesFlorence W. Manguyu, M.Med, MBChBAga Khan University Hospital; IAVI, KenyaJames McIntyre, MBChBAnova Health Institute, South AfricaTotsie Memela-Khambula, MPAEduloan, South AfricaAlbert Profy, PhDIronwood Pharmaceuticals, United StatesZeda F. Rosenberg, ScDIPM, United StatesAnandi Yuvaraj, MSc, MPhil, PGDGCInternational Community of Women Living withHIV/AIDS, IndiaBoard Observer:Stefano Bertozzi, MD, PhDBill & Melinda Gates Foundation, United StatesRobin Shattock, PhD, ChairImperial College London, United KingdomMichael Chirenje, MDUniversity of Zimbabwe, ZimbabweDavid R. Friend, PhDCONRAD, United StatesSharon Hillier, PhDMagee-Womens Hospital, University of PittsburghSchool of Medicine, United StatesRuth B. Merkatz, PhD, RN, FAANPopulation Council, United StatesThomas Moench, MDReProtect, Inc., United StatesEdith Nakku-Joloba, PhDMakerere University Kampala, UgandaDerek Newall, PhDGlaxoSmithKline, United KingdomLynn Paxton, MD, MPHUS Centers for Disease Control and Prevention,United StatesDeenan Pillay, MDUniversity College London School of Life andMedical Sciences, United KingdomDoug Taylor, PhDFHI 360, United StatesJens Van Roey, MDJanssen Infectious Diseases - DiagnosticsBBVA, BelgiumRobin Wood, PhDDesmond Tutu HIV Centre, South AfricaZeda F. Rosenberg, ScDChief Executive OfficerBríd Devlin, PhDExecutive Vice President, Product DevelopmentRonald Nardi, PhDExecutive Vice President, Regulatory Affairs andQuality AssuranceAnnalene Nel, MD, PhDExecutive Vice President and Chief MedicalOfficer, Clinical AffairsLMichael Green, MBASenior Director of Resource DevelopmentKaren McCordSenior Director of Strategic PlanningColleen Dove AuburgerDirector of AccountingKathy Flynn, MBADirector of Finance
Funding ConsiderationsIPM’s cash available balance entering 2012 was $43 million.In a climate of continued global recession and the resultingfinancial impact, IPM streamlined costs by refining our workmodel and cost structure, and by prudently managing theproduct pipeline. IPM contained costs, made staffing adjustmentsand enhanced existing financial and operational systemsto support management decision-making and programimplementation.Consistent with our ongoing efforts to match expenses withbudget realities, 2011 was a year of fiscal and operationalpreparation for implementation of the dapivirine ring licensureprogram in 2012. Conducting clinical trials in developingcountries requires substantial investments to improve infrastructureand train research center staff to support thousandsof trial participants over several years. Investment is alsorequired to maintain the program and operations supportneeded for product evaluation. To comply with the requirementsof in-country institutional review boards, IPM workedto ensure all necessary funds for the Phase III dapivirine ringtrial were in place in 2011.As IPM oversees the dapivirine ring licensure program, wewill also reemphasize pipeline and continue preparing foraccess, given the potential for the dapivirine ring to be provensafe and effective. With new partnerships, an experiencedmanagement team and a committed Board of Directors, IPMis well-positioned to advance its mission of developing HIVprevention tools for women in developing countries.Assets Dec. 31, 2011Cash and cash equivalents $11,717,269Investments $34,124,359Accounts receivables $1,998,497Prepaid expenses and other assets $1,188,891Property and equipment, net $4,603,968Total Assets $53,632,984Liabilities and Net AssetsLiabilitiesAccounts payable and accrued expenses $3,138,877Grants advances and deferred revenue $28,615,297Total liabilities $31,754,174Expenses by DepartmentResourceDevelopment3%ExternalRelations9%Clinical Programs26%Regulatory5%Quality Assurance3%Operations21%Net AssetsUnrestricted $21,878,810Temporarily restricted $0Total net assets $21,878,810Product Development33%Total liabilities and net assets $53,632,984To learn more about how to prevent HIV in women worldwide and help save millions of lives, visit www.IPMglobal.org.IPM Headquarters8401 Colesville RoadSuite 200Silver Spring, MD 20910 USATel: +1-301-608-2221Fax: +1-301-608-2241IPM South AfricaMain Street 121Paarl 7646, South AfricaP.O. Box 3460Tel: +27-21-860-2300Fax: +27-21-860-3208/1000IPM BelgiumRue du Trône, 911050 BrusselsBelgiumTel: +32 (0) 2 503 0182Fax: +32 (0) 2 280 4376