Global Portfolio of Antimalarial Medicines

Slides:



Advertisements
Similar presentations
Consultative Expert Working Group on Research and Development
Advertisements

Selection of malaria treatments & diagnostics Presentation by Rémy Prohom RBM Partnership Secretariat, Malaria Medicines & Supplies Services Anglophone.
Malaria treatment (Current WHO recommendations & guidelines)
Innovative medicines for the control and elimination of malaria Timothy N.C Wells, ScD Chief Scientific Officer Defeating Malaria Together.
Challenges & responses for malaria in Asia
Malaria treatment. Dr abdulrahman al shaikh.. Introduction million patients died because of malaria every year. Most deaths due to Plasmodium Falciparum.
Malaria Global update, progress, priorities Steve Taylor GLHLTH701 Sept
World Health Organization
Update from the WHO Global Malaria Programme Update from the WHO Global Malaria Programme Silvia Schwarte Diagnosis, Treatment and Vaccines (DTV) Global.
Malaria medicines and diagnostics WHO/UNICEF TBS Access to medicines 19 November Geneva Silvia Schwarte Global Malaria Programme.
1 Global Malaria Programme Update from the Global Malaria Programme Update from the Global Malaria Programme Silvia Schwarte Diagnosis, Treatment and Vaccines.
Choice of antimalarial drugs Malaria Medicines & Supplies Services RBM Partnership Secretariat.
1 Procurement of ACT's Informal Workshop on Prequalification of Antimalarial Drug Products Geneva, 5 th May 2004 WHO/UNICEF JOINT REQUEST FOR PROPOSALS.
Antimalarial Drug Quality in Mekong Region by Krongthong Thimasarn Coordinator RBM Mekong UN-ESCAP Bangkok Acting Regional Advisor for Malaria SEARO Prepared.
1 Financing and R&D for neglected diseases Role of Product Development Partnerships First meeting of Consultative Expert Working Group on Research and.
Access to Medicines: Antimalarials WHO/UNICEF Technical Briefing Seminar 10 October 2007 Silvia Schwarte Supply Chain Management Global Malaria Programme.
Generic Name: combination of artemether and lumefantrine Brand Name: Coartem Dosage form : tablet Manufuctuing: Novartis is used to treat a parasitic.
1 |1 | Prequalification Programme – Stakeholders Meeting Geneva, February 2010 Access to Assured-Quality Praziquantel for the Control of Human Schistosomiasis.
Business environment for WHO prequalified medicines Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances Amman, Jordan, 13 June 2013.
Supply and quality of antimalarial medicines and diagnostics: introduction of issues Dr Andrea Bosman Global Malaria Programme Geneva, 9 July 2009 RBM.
1 Towards the future: medicines and the elimination of malaria Defeating Malaria Together Timothy N.C. Wells PhD ScD Chief Scientific Officer MMV.
La recherche avance, la vie progresse. MEDICINE AND HEALTH IN THE TROPICS Plenary Session 3 « The Pharmaceutical Industry’s R&D Drive and the issue of.
Synthetically Engineered Artemisinin Lianne Ryan.
Approval Mechanism for Suppliers of Malaria Drugs and Nets Presentation by Dr Maryse Dugué RBM Partnership Secretariat, Malaria Medicines & Supplies Services.
Access to Artemisinin-Based Antimalarial Products Dr Clive O Ondari Essential Drugs and Medicines Policy Dept & Roll Back Malaria (RBM) Department World.
WHO Workshop on Assessment of Bioequivalence Data Addis Ababa, 31. August – 3. September 2010 Artemisinin-based Products Dr. Henrike Potthast
UN / WHO Prequalification Programme for Priority Medicines
WHO Prequalification of Medicines Programme Raul Kiivet, MD, PhD Manager, Prequalification of Medicines Programme Quality Assurance and Safety: Medicines.
Philippe Duneton11 February 2009 Deputy Executive Secretary 5th Consultative Stakeholder Meeting UN Prequalification of Diagnostics, Medicines & Vaccines.
Building blocks to success in malaria elimination
MONITORING MEDICINE AVAILABILITY AND PRICES IN UGANDA By Denis Kibira HEPS Uganda.
MMV’s Supported Projects
Malaria Global update, progress, priorities Steve Taylor GLHLTH310 Sept
Global Portfolio of Antimalarial Medicines
Dr. Pogány - Geneva 1/30 PREQUALIFICATION OF ANTIMALARIAL DRUG PRODUCTS János Pogány, pharmacist, Ph.D. Geneva, 03 May 2004
MMV: Medicines for Treating, Preventing & Eradicating Malaria Penny Grewal Daumerie Director, Global Access, MMV.
MMV in ACCESS-SMC PARTNERS MEETING JANUARY 2016 KAMPALA.
1 © The Liverpool School of Tropical Medicine Accelerating Anti-infective Drug Discovery: Lessons from ten years working in PDPs STEVE WARD November 2013.
Malaria Prevention and Treatment Javier F Sevilla Mártir, MD Associate Professor, Department of Family Medicine, IU School of Medicine AAFP Global Health.
Malaria Prevention and Treatment Javier F Sevilla Mártir, MD Associate Professor, Department of Family Medicine, IU School of Medicine Kristal Williams,
ANTI – MALARIALS HEPATIC CYCLE Radical cure: Primaquine Causal Prophylaxis: Prevent Initial Hepatic Cycle. Primaquine, Proguanil (Weak), Doxycycline.
1 Evolution of MMV Portfolio. 2 MMV Portfolio May Dihydroorotate dehydrogenase inhibition (DHOD) Dihydrofolate reductase (DHFR) Falcipains Lactate.
Antimalarial Drugs.
1 |1 | Quality of Active Pharmaceutical Ingredients Beijing, 31 March 2010 Access to Assured-Quality Praziquantel for the Control of Human Schistosomiasis.
Update from GMP – Malaria Prevention, Diagnostics and Treatment Silvia Schwarte Prevention, Diagnostics and Treatment Interagency.
Seasonal Malaria Chemoprevention: WHO Policy and Perspectives
Dr. André Tchouatieu MMV ACCESS department
Global Portfolio of Antimalarial Medicines
MMV-supported projects
Access to Antimalarial Medicines EDM-RBM Collaboration
Malaria Prevention & Treatment in Pregnancy
Table 1 Characteristics of patients at enrollment who received artesunate-amodiaquine (ASAQ) or artemether-lumefantrine (AL) for treatment of malaria.
World Health Organization
Seasonal Malaria Chemoprevention: “Rebound”
Access to Antimalarial Medicines
Access to Artemisinin-based Antimalarial Medicines
Malaria Global update, progress, priorities
Volume 369, Issue 9563, Pages (March 2007)
Comparison of current lowest global price vs estimated generic price, for medicines for diseases with large international treatment programmes. Comparison.
MMV-supported projects
Global Portfolio of Antimalarial Medicines
Quality Problems with Antimalarials
MMV: Origins, Mission & Vision
Global Portfolio of Antimalarial Medicines
What do our youngest patients need?
MMV-supported projects
Supply Chain Management for Community-Directed Interventions (CDIs)
Novel Population-Level Malaria Treatment Strategies for the 2020s
MMV-supported projects
Where are we with AMR? – the human perspective
Presentation transcript:

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-451840 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.

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 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