Increasing the supply base of paediatric antimalarials MMV Case Study

Transcription

1 Increasing the supply base of paediatric antimalarials MMV Case Study Penny Grewal Daumerie Director, Global Access, MMV Consultation on Priority Essential Medicines for Child Survival, UNICEF, September 6-7, 2010

2 Structure Overview of Medicines for Malaria Venture (MMV) Developing new paediatric formulations Case study: Coartem Dispersible Understanding drug policy change process in countries

3 MMV at a Glance Established in 1999 by WHO and the Pharma Industry Public-Private-Partnership, with a public health focus Swiss Foundation based in Geneva Partners in 90 countries Largest-ever pipeline of antimalarial drugs Over 50 projects ranging from Discovery stage to Phase III Success of Partnership Model has been proved 1 co-developed drug launched (with Novartis), 2 registration dossiers submitted to EMA (with Sigma- Tau Pharma and Shin Poong Pharmaceuticals)

4 Medicines for Malaria Venture s Mission The 3 Ds : Discover, Develop, Deliver Discover new antimalarial medicines (ACT or next generation) Develop new ACTs to ICH standards (GMP GCP) Deliver new medicines to endemic countries through strong partnerships

5 Children are the hardest hit by malaria Malaria kills up to a million people every year, 90% in Africa 85% of those who die are under the age of 5 1,700 children each day with the disease accounting for 20% of child deaths in Africa Paediatric formulations for antimalarials are crucial to simplify dispensing and use

6 MMV is working with its Pharma partners on different paediatric formulations Risk of choking Dose uniformity and stability issues Granulate in a capsule Powder in a bottle Granulate in sachet Stability issues Dispersible tablets Suspension / Syrups

7 Case study: Coartem Dispersible

8 Coartem Dispersible developed in response to the unmet medical need for children The unmet medical need Crushing regular tablets Inconvenient: spilling, bitter taste ~50 million Coartem treatments (75% of all deliveries) were supplied for children 5 < 35kg body weight in 2007

9 Palatability testing: Cherry flavoured preferred among African children 0 Lowest 100 mm Highest Girls Boys Overall liking (immediate) Overall liking (after 2-5 mins) Strawberry Orange Cherry Strawberry Orange Cherry

10 Successful Phase III efficacy study in 899 patients between 5-35kg 8 sites Benin, Kenya, Mali, Mozambique & Tanzania/Zanzibar Senegal Mali Niger Chad Sudan Guinea Sierra Leone Burkina Faso Benin Gabon Nigeria Cameroon CAR DR Congo Ethiopia Kenya Somalia Uganda Rwanda Liberia Cote d Ivoire Ghana Togo Congo Angola Zambia Tanzania Zanzibar Showed equivalent efficacy and similar safety to the standard crushed tablet formulation Zimbabwe Namibia Botswana RSA

11 Appropriate packaging: Coartem Dispersible kept critical design elements, adapted for new formulation Tested and revised in an iterative process with caregivers and health care workers in Kenya and Uganda Original Revised Final 11

12 Coartem Dispersible approved by Swissmedic on December 4, 2008

13 Paediatric policy decision making process review in 5 countries Interviews with key stakeholders Senegal Mali Niger Chad Sudan Guinea Sierra Leone Burkina Faso Benin Gabon Nigeria Cameroon CAR DR Congo Ethiopia Kenya Somalia Uganda Rwanda Liberia Cote d Ivoire Ghana Togo Congo Angola Zambia Tanzania Zanzibar Zimbabwe Namibia Botswana RSA

14 Slow adoption of paediatric formulations in the field olicy adoption bottlenecks - sequence 1. Stakeholders informed about existence of alternative medicines? 2. Appropriate efficacy and resistance data available for current and alternative medicines? 3. Policy process clear? 4. Financial resources for medicines available? 5. Health system implementation secured? Source: Dalberg analysis

15 Concluding comments Developing paediatric drugs not straightforward Adoption process is complex Often not considered as specific category for procurement But paediatric formulations remain crucial