Marketing Strategic Plan and Distribution Logistics for Sanaria PfSPZ Vaccine against Malaria.

ABSTRACT The development of Sanaria s Plasmodium falciparumPfsporozoiteSPZbased vaccines is receiving overwhelming global support after the publication inin Science of clinical data showingprotection against controlled human malaria infectionCHMIfollowing intravenous administration ofdoses of SanariaPfSPZ Vaccinecomposed of purifiedasepticradiation attenuatedcryopreserved PfSPZ meeting all regulatory standardsThis success led to the formation of the International PfSPZ Consortiumwhich in collaboration with Sanariadeveloped and funded astage clinical development planCDPStageencompassing six trials and completed inshowed that direct venous inoculation of PfSPZ Vaccine was safe and well toleratedand demonstrated high level protection against CHMI afterdoses of vaccine and durablemonthprotection against naturally transmitted malaria in AfricaNownew trials involvingadult and pediatric subjects are underway or will soon start in the USAGermanyMaliBurkina FasoGhanaTanzaniaKenyaand Equatorial GuineaCDP StageThese trials extend testing to infants and children and aim to finalize highly protective regimens for PhasetestingCDP StageBy midSanaria will submit a Biologics License ApplicationBLAto the FDA for an initial indication to protect adult travelers from malariaand a year later will extend the indication for use in malaria endemic areasA major objective is to conduct mass vaccination administrationMVAcampaigns in endemic populations to achieve regional malaria eliminationthe first such campaign slated for the andgtresidents of Bioko IslandEquatorial GuineaStageof the CDPTo support this ambitious planSanaria is scaling up manufacturing and improving its manufacturing facility to meet phaseand launch complianceHowever there are critically importantunfunded components that are key to rapid uptake by the travelers market post licensureThese are addressed in this CRPP project through five specific aimsConduct a market assessment and develop a strategic planCreate a commercial development planDevelop infrastructure components and equipment for liquid nitrogen vapor phaseLNVPdelivery of PfSPZ VaccineModel distribution logisticsandTest LNVP cold chain distribution to travel clinics to establish operational readinessThe overarching goal is to position Sanaria to market and distribute vaccine immediately after BLA approval and thus to start generating funds as rapidly as possible in order to finance the increased scale up and delivery needed to support use of the vaccine in MVA campaigns in malaria endemic areasSales for use in travelers will initially target the DoDState DepartmentPeace Corpsmining and energy industry companiesand largemulti site travel clinicsFunding of this proposal will significantly shorten the time to market following product licensure and launch and will increase the likelihood of successThis will lead to salesincome and profits earlier than otherwise possibleand ultimately lead to saving many lives PUBLIC HEALTH RELEVANCEProject NarrativeMalaria affects over two billion peoplekilling more thanindividuals each year mostly children in Africaand is an ever present threat to travelers to malaria endemic regions of the worldA powerful tool is needed to eliminate Plasmodium falciparum malaria from defined geographical areas and the ideal tool would be a highly effectivelong acting vaccine that prevents infectiondisease and parasite transmissionSanariaPfSPZ Vaccine is the only candidate vaccine that has these characteristicsThis proposal focuses on the travel market because a vaccine for international travelers that produces income for Sanaria will generate the funds necessary to invest in scale up of vaccine manufacture and deployment of vaccine for the much larger and affected at risk populations of endemic areasThis proposal will accelerate to market Sanaria s PfSPZ Vaccine by providing support for development of a strategic plan for development and marketing of our malaria vaccineand a plan for distribution logistics for the vaccine