Global Portfolio of Antimalarial Medicines

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Presentation transcript:

Global Portfolio of Antimalarial Medicines Translational Product development Access Advanced Non-clinical Human volunteers Patient exploratory Patient confirmatory Regulatory review Approved/ERP SAR121 Sanofi P218 Janssen Artemisone UHKST Artefenomel/ Ferroquine Sanofi Dihydroartemisinin- piperaquine dispersible Alfasigma Arterolane- piperaquine Sun Pharma ▲ Artemether- lumefantrine Various Manufactures Artesunate- amodiaquine Various Manufacturers 1 6 3 AN13762 SJ733 Kentucky/Eisai AQ13 Immtech KAF156/ Lumefantrine Novartis Artemether- lumefantrine Dispersible Various Manufacturers Artesunate- mefloquine Cipla Co-trimoxazole ITM Antwerp 2 ACS Inhibitor GSK Wellcome Trust ACT-451840 Actelion Sevuparin Dilaforette Cipargamin Novartis Artemisinin- naphthoquine Kunming Pharma Co ▲ Artesunate for Injection Guilin Sulfadoxine- pyrimethamine+ amodiaquine Guilin 3 7 NPC1161B Mississippi CDRI 9778 Ipca MMV048 DSM265 Takeda Artemether sub-lingual spray MRC/Suda Dihydroartemisinin- piperaquine Various manufacturers Rectal artesunate Cipla 4 MK4815 Merck N-tert butyl Isoquine LSTM/Liverpool/GSK Rosiglitazone adjunct therapy Manhica, Toronto, Barcelona Fosmidomycin Piperaquine DMG Deutsche Malaria GmbH Sulfadoxine- pyrimethamine+ Amodiaquine dispersible S Kant Pyronaridine- Artesunate Shin Poong Rectal artesunate Strides Shasun 5 Novel DHODH University of Leeds M5717 Merck KGaA Immatinib HuLow, Purdue, Turin, Sassari and Hue Methylene Blue/ amodiaquine Heidelberg Artesunate- amodiaquine Sanofi Pyronaridine- artesunate granules Shin Poong Tafenoquine GSK/MMV Artemisinin-piperaquine Artepharm 8 5 MMV253 Zydus Cadila SAR97276 Sanofi Tafenoquine 60P/US Army 9 SC83288 Heidelberg University DM1157 DesignMedix 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. Isoxazolines Calibr TropIQ (Status of tafenoquine & Strides Shasun rectal artesunate updated September 2018)

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-5,6 Chemoprotection (TCP- 4) TCP-4 3-day cure, artemisinin-based combination therapies Combinations aiming at a new single-exposure radical cure (SERC) TPP-1 Severe malaria treatment and 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 Shasun, Macleods, Mylan   First approval: Novartis (Brand name: Coartem® Dispersible). Generics by Ajanta; Cipla; Strides Shasun; Ipca Brand name: Artesun® First approval: Alfasigma (Brand name: Eurartesim®). Generic by Guilin Brand name: Pyramax® tablets and granules First approval fixed-dose combination: Sanofi/DNDi (Brand name: ASAQ Winthrop). Generics by Ajanta, Cipla, Guilin, Ipca, Strides Shasun Brand name: SPAQ-COTM Brand names: Krintafel/Kozenis (Trademarks owned or licensed by GSK) Brand names: ARAKODATM/KODATEF 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 ▲