Global Portfolio of Antimalarial Medicines

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Presentation transcript:

Global Portfolio of Antimalarial Medicines Translational Product development Access Human volunteers Patient exploratory Patient confirmatory Regulatory review Approved/ ERP Preclinical ▲ SAR121 Sanofi M5717 Merck KGaA P218 Janssen (Biotec Thailand) Artefenomel/ Ferroquine Sanofi Tafenoquine GSK/MMV GSK/US Army Arterolane- piperaquine Sun Pharma Artemether- lumefantrine Various Manufactures 1 AN13762 MMV253 Zydus Cadila SJ733 Kentucky/Eisai KAF156/ Lumefantrine Novartis Dihydroartemisinin- piperaquine dispersible Alfasigma/Pierre Fabre Rectal artesunate Strides Artemether- lumefantrine Dispersible Various Manufacturers 3 2 UCT943 H3D Cape Town SC83288 Heidelberg University ACT-451840 Actelion Cipargamin Novartis Co-trimoxazole ITM Antwerp Artesunate for Injection Guilin 3 NPC1161B Mississippi CDRI 9778 Ipca DSM265 Takeda (UTSW) Artemisinin- naphthoquine Kunming Pharma Co ▲ DM1157 DesignMedix Dihydroartemisinin- piperaquine Various manufacturers 4 MK4815 Merck N-tert butyl Isoquine LSTM/Liverpool/GSK Fosmidomycin Piperaquine Jomaa Pharma/GmbH Artemether sub-lingual spray MRC/Suda Pyronaridine- Artesunate Shin Poong 5 Methylene Blue/ amodiaquine Heidelberg Sulfadoxine- pyrimethamine+ Amodiaquine dispersible S Kant Pyronaridine- artesunate granules Shin Poong 5 6 SAR97276 Sanofi Artesunate- amodiaquine Various Manufacturers 6 Artemisone UHKST Artesunate- mefloquine Cipla AQ13 Immtech Sulfadoxine- pyrimethamine+ amodiaquine* Guilin 7 Sevuparin Dilaforette Sulfadoxine- pyrimethamine+ amodiaquine ** Guilin 7 MMV048 (UCT) Rectal artesunate Cipla/WHO-TDR

Footnotes: Global Portfolio Target Product Profiles and Target Candidate Profiles MMV has defined Target Product Profiles and Target Candidate Profiles for medicines to support the eradication campaign. Burrows JN et al., New developments in anti‑malarial target candidate and product profiles et al. Malar J (2017) 16:26 updates the previous profiles in Burrows J et al.; Malaria Journal 2013 12:187 Target Product Profiles indicated by bars at the bottom of each compound box Target Candidate Profiles activities for each individual molecule, indicated by symbols added to each compound in the translational portfolio Burrows Burrows et al., 2013 et al., 2017 Asexual blood stages (TCP-1,2) TCP-1 Relapse prevention (TCP-3a) TCP-3 Transmission reduction (TCP-3b) TCP-5 Chemoprotection (TCP- 4) TCP-4 3-day cure, artemisinin-based combination therapies Combinations aiming at a new Single exposure radical cure (TPP-1) Severe malaria treatment and pre-referral intervention Intermittent/seasonal malaria chemoprevention Products targeting prevention of relapse for P. vivax There are currently no products in the development portfolio meeting the single-exposure chemoprotection (SEC) TPP-2 Additional Symbols on Global Portfolio Brought into portfolio after approval; collaborations with DNDi No progress report in the last two years Global Fund Expert Review Panel (ERP) reviewed product – permitted for time-limited procurement, while regulatory/WHO prequalification review is ongoing. Paediatric formulation WHO Prequalified OR approved/positive opinion by regulatory bodies who are ICH members/observers. Approved in several countries but not approved by WHO pre- qualification nor regulatory bodies who are ICH members or observers Footnote for Generic names on Global Portfolio 1.  First approval: Novartis (Brand name: Coartem®).  Generics by Ajanta, Cipla, Ipca, Strides, Macleods, Mylan; First approval:  Novartis (Brand name: Coartem® Dispersible). Generic by Ajanta; Brand name: Artesun®; Brand name: Eurartesim®; Brand name: Pyramax® tablets and granules; First approval fixed-dose combination: Sanofi/DNDi (Brand name: ASAQ Winthrop). Generics by Ajanta, Cipla, Guilin, Ipca, Strides; Brand name: SPAQ-COTM; ▲ * For children 13 – 60 months; ** For infants 3 – 12 months.