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Global Portfolio of Antimalarial Medicines

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Presentation on theme: "Global Portfolio of Antimalarial Medicines"— Presentation transcript:

1 Global Portfolio of Antimalarial Medicines
Translational Product development Access Human volunteers Patient exploratory Patient confirmatory Regulatory review Preclinical Approved/ERP SAR121 Sanofi P218 Janssen AQ13 Immtech Artefenomel/ Ferroquine Sanofi Dihydroartemisinin- piperaquine dispersible Alfasigma Arterolane- piperaquine Sun Pharma Artemether- lumefantrine Various Manufacturers Artesunate- amodiaquine Various Manufacturers 3 6 1 GSK701 GSK SJ733 Kentucky/Eisai Sevuparin Modus Therapeutics Ganaplacide/ Lumefantrine Novartis Co-trimoxazole ITM Antwerp Artesunate- mefloquine Cipla Artemether- lumefantrine Dispersible Various Manufacturers NPC1161B Mississippi ACT Actelion MMV048 MMV Cipargamin Novartis Artemisinin- naphthoquine Kunming Pharma Co 2 Sulfadoxine- pyrimethamine+ Amodiaquine dispersible Various Manufacturers Artesunate for Injection Various Manufacturers MK4815 Merck CDRI 9778 Ipca Rosiglitazone adjunct therapy Manhica, Toronto, Barcelona DSM265 Takeda Artemether sub-lingual spray MRC/Suda 7 3 Rectal artesunate Various Manufacturers Dihydroartemisinin- piperaquine Various Manufacturers SC83288 Heidelberg University M5717 Merck KGaA Imatinib HuLow, Purdue, Turin, Sassari and Hue Fosmidomycin Piperaquine DMG Deutsche Malaria GmbH Artemisinin- piperaquine Artepharm 8, 9 4 Tafenoquine GSK 10 Isoxazolines Calibr TropIQ DM1157 DesignMedix Methylene Blue/ amodiaquine Heidelberg Tafenoquine paediatric GSK Pyronaridine- Artesunate Shin Poong Artesunate- amodiaquine Sanofi 5 Tafenoquine 60P/US Army 11 MMV370 MMV371 Janssen MMV253 Zydus Cadila Pyronaridine- artesunate granules Shin Poong 5 Footnotes: Included in MMV portfolio after product approval and/or development. DNDi and partners completed development and registration of ASMQ and ASAQ. │ Global Fund Expert Review Panel (ERP) reviewed product – permitted for time-limited procurement, while regulatory/WHO prequalification review is ongoing. │ WHO Prequalified OR approved/positive opinion by regulatory bodies who are ICH members/observers. │ Paediatric formulation.

2 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 :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 compounds in the translational or product development 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-5,6 Prophylaxis (TCP- 4) TCP-4 3-day cure, artemisinin-based combination therapies Uncomplicated malaria treatments aiming at a new single-exposure radical cure (SERC) TPP-1 Severe malaria treatment / pre-referral intervention Intermittent/seasonal malaria chemoprevention Products targeting prevention of relapse for P. vivax Single-exposure chemoprotection (SEC) TPP-2 Footnote for Generic names on Global Portfolio 1. First approval: Novartis (Brand name: Coartem®). Generics by Ajanta, Cipla, Ipca, Strides Pharma, Macleods, Mylan   First approval: Novartis (Brand name: Coartem® Dispersible). Generics by Ajanta; Cipla; Strides Pharma; Ipca Brand names: Artesun® (Fosun Pharma), Larinate® 60mg (Ipca) First approval: Alfasigma (Brand name: Eurartesim®). Generic by Fosun (ERP only) Brand name: Pyramax® tablets and granules First approval fixed-dose combination: Sanofi/DNDi (Brand name: ASAQ Winthrop). Generics by Ajanta, Cipla, Fosun, Ipca, Strides Pharma Brand name: SPAQ-COTM 100mg Artesunate Rectocaps ArtecapTM Brand names: Kozenis/Krintafel (Trademarks owned or licensed by GSK) Brand names: ARAKODATM/KODATEF (60 Degrees Pharmaceuticals) 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 In partnership with MMV


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