1 |1 | Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010 Access to...

1 |Prequalification Programme – Stakeholders Meeting Geneva, 11-12 February 2010

Access to Assured-Quality Praziquantel for the Control of Human Schistosomiasis

Access to Assured-Quality Praziquantel for the Control of Human Schistosomiasis

Dr. Valerio Reggi - Department of Control of Neglected Tropical Diseases


Global distribution of schistosomiasisGlobal distribution of schistosomiasisGlobal 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


Control of schistosomiasis is based on preventive chemotherapy interventions targeting the entire at-risk population

Control of schistosomiasis is based on preventive chemotherapy interventions targeting the entire at-risk population


Schistosomiasis - estimated infected population and population treated in 2008*

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


How much praziquantel is required/committed? 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


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


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


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


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


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


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.


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


Thank you

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