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 |Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010
Global distribution of schistosomiasisGlobal 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 |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 |Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010
Schistosomiasis - estimated infected population and population treated in 2008*
WHO RegionEstimated infected, 2008
Estimated at risk of infection, 2008
Received treatment
Proportion of total treated
Proportion treated/infected
Africa214,000,000582,000,00011,700,00066.86%5.46%Eastern Mediterranean
14,000,000106,600,0002,660,00015.23%19.0%
Americas7,000,00051,000,00065,0000.37%~1%Western Pacific**1,300,00020,800,0003,060,00017.54%235% (14.7%)
Global236,300,000760,400,00017,485,000100%7.39%
*As reported to WHO/NTD
**China: estimated infected: 672,000 treated: 2,987,500
5 |Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010
How much praziquantel is required/committed?
Estimated need/commitment in million tablets
20102011201220132014
Projected Need286428486571?
Donor funded190190190190190
Merck KGaA Donation2020202020
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 |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 |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 tonnes150 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 |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 |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=en
JOINT PLANNING OF NATIONAL REQUIREMENTS
COORDINATED PROCUREMENT OF PZQ
Current players: DFID, USAID/RTI, WHO
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 Measuresa) 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 |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 |Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010
Pre-qualification400,000400,000400,000100,000 100,0001,400,000
PQ of PZQ API and finished products is cost-effective
Procured and donated PZQ*20,000,00020,000,00020,000,00020,000,00020,000,000100,000,000
Year 1Year 2Year 3Year 4Year 5Total
Lost credibility of preventive chemotherapy interventions
Incalculable public health damage
13 |Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010
Thank you