1. 1 |1 | Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010 Access to Assured-Quality Praziquantel for the Control of Human Schistosomiasis Dr. Valerio Reggi - Department of Control of Neglected Tropical Diseases

2. 2 |2 | Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010 Global distribution of schistosomiasis From: Gryseels et al. Human schistosomiasis. Lancet 2006; 368: 1106–18 90% of infected people 76% of population at risk disease caused by worms of the genus Schistosoma

3. 3 |3 | Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010 Control of schistosomiasis is based on preventive chemotherapy interventions targeting the entire at-risk population

4. 4 |4 | Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010 Schistosomiasis - estimated infected population and population treated in 2008* Proportion treated/infected Proportion of total treated Received treatment Estimated at risk of infection, 2008 Estimated infected, 2008 WHO Region 5.46%66.86%11,700,000582,000,000214,000,000Africa 19.0%15.23%2,660,000106,600,00014,000,000Eastern Mediterranean ~1%0.37%65,00051,000,0007,000,000Americas 235% (14.7%)17.54%3,060,00020,800,0001,300,000Western Pacific** 7.39%100%17,485,000760,400,000236,300,000Global * As reported to WHO/NTD ** China: estimated infected: 672,000 treated: 2,987,500

5. 5 |5 | Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010 How much praziquantel is required/committed? Estimated need/commitment in million tablets 20102011201220132014 Projected Need 286428486571? Donor funded190 Merck KGaA Donation20 donor-funded demand in recent years: ~ 50 million tablets* Sudden demand increase: from 50 to 210 million tablets/year * B&M Gates Foundation/Schistosomiasis Control Initiative and Merck KGaA

6. 6 |6 | Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010 Praziquantel is made in large 600mg tablets Each 600mg Praziquantel tablet requires 640mg of API (assuming 94% yield) ~135 tonnes of API required for ~210 million tablets/year

7. 7 |7 | Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010 API producers & tablet manufacturers API Producers Capacity at 80-120 US$/Kg Capacity at 350-400 US$/Kg 7150 tonnes These include: Merck KGaA, and Shin Poong – who manfacture PZQ API since the early 80's Merck declares: a) unable to quickly scale up manufacturing capacity; b) have identified one producer able to supply an API suitable for Merck tablets but full regulatory approval estimated to take 24 months. Shin Poong manufactures its own API and tablets and declares to have capacity to scale up production provided 'opportunity' concerns are satisfied. Virtually only 4 large-scale tablet manufacturers: Merck, Shin Poong, EIPICO, Cipla

8. 8 |8 | Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010 Current manufacturers of assured-quality API and finished product may be unable to match demand increase Key concerns substandard quality RISKS interruption of supply scale-up failure higher prices Donor-driven demand and tight deadlines draw 'new' manufacturers into play

9. 9 |9 | Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010 QUALITY ASSURANCE POLICY FOR THE PROCUREMENT AND PROVISION OF PRAZIQUANTEL TABLETS* Proposed approach * adapted from Global Fund Quality Assurance Policy For Pharmaceutical Products - http://www.theglobalfund.org/en/procurement/quality/?lang=enhttp://www.theglobalfund.org/en/procurement/quality/?lang=en JOINT PLANNING OF NATIONAL REQUIREMENTS COORDINATED PROCUREMENT OF PZQ Current players: DFID, USAID/RTI, WHO

10. 10 | Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010 QUALITY ASSURANCE POLICY FOR THE PROCUREMENT AND PROVISION OF PRAZIQUANTEL TABLETS FOR HUMAN SCHISTOSOMIASIS CONTROL (a) authorized for marketing by a stringent MRA; (b) listed as prequalified by the WHO Prequalification Programme; (c) positive opinion under Art. 58 of the EU Regulation 726/2004. Interim Measures a) expand to include MRA based in OECD and PIC/S countries; b) establish consultative mechanism enabling endemic countries MRAs to give advice on the selection of PZQ products on the basis of appropriate documentation; c) establish an expert review panel similar to that established by the Global Fund

11. 11 | Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010 Expected advantages and benefits of PQ of PZQ API and finished products PQ of APIs would attract more generic manufacturers and increase competition PQ of APIs would enable local manufacture in large endemic countries Compared to stringent MRA's regulatory approval, PQ (both API and FP) can be faster and more flexible (e.g. no jurisdiction limitations, technical advice, capacity building) PZQ used in preventive chemotherapy of assured quality is reassuring for national authorities engaging in mass treatment campaigns Donor and national funding not wasted on poor-quality PZQ PQ capacity building component leads to more effective involvement of MRAs of endemic countries in development of new NTD medicines.

12. 12 | Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010 1,400,000100,000 400,000 Pre-qualification PQ of PZQ API and finished products is cost-effective 100,000,00020,000,000 Procured and donated PZQ* TotalYear 5Year 4Year 3Year 2Year 1 Lost credibility of preventive chemotherapy interventions Incalculable public health damage

13. 13 | Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010 Thank you