Increasing the supply base of paediatric
antimalarials
MMV Case Study
Penny Grewal Daumerie Director, Global Access, MMVConsultation on Priority Essential Medicines for Child Survival, UNICEF, September 6-7, 2010
Structure
Overview of Medicines for Malaria Venture (MMV)
Developing new paediatric formulations
• Case study: Coartem Dispersible
Understanding drug policy change process in
countries
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)
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
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
MMV is working with its Pharma partners on different
paediatric formulations
Granulate in a capsuleGranulate in sachet
Powder in a bottle
Dispersible tablets Suspension /
Syrups
Dose
uniformity and
stability
issues
Risk of choking
Stability issues
Case study: Coartem Dispersible
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
Palatability testing: Cherry flavoured preferred among African children
0Lowest
100 mmHighest
Girls
Boys
Straw-berry
Orange Cherry Straw-berry
Orange Cherry
Overall liking(immediate) Overall liking
(after 2-5 mins)
Niger
Ghana
Ethiopia
Kenya
Tanzania
ZambiaAngola
Namibia
RSA
Mali
Burkina
Faso
Senegal
Zim-
babwe
Botswana
DR Congo
Somalia
SudanChad
CAR
Gabon
Congo
Cameroon
Nigeria
Benin
Guinea
Sierra
Leone
Liberia
Cote d’Ivoire
Togo
Zanzibar
Rwanda
Uganda
Successful Phase III efficacy study in 899 patients
between 5-35kg
8 sites
Benin, Kenya, Mali,
Mozambique &
Tanzania/Zanzibar
Showed equivalent efficacy and
similar safety to the
standard crushed tablet
formulation
11
Appropriate packaging: Coartem Dispersible kept
critical design elements, adapted for new formulation
Original Revised Final
Tested and revised in an iterative process with caregivers
and health care workers in Kenya and Uganda
Coartem Dispersible approved by Swissmedic on
December 4, 2008
Niger
Ghana
Ethiopia
Kenya
Tanzania
ZambiaAngola
Namibia
RSA
Mali
Burkina
Faso
Senegal
Zim-
babwe
Botswana
DR Congo
Somalia
SudanChad
CAR
Gabon
Congo
Cameroon
Nigeria
Benin
Guinea
Sierra
Leone
Liberia
Cote d’Ivoire
Togo
Zanzibar
Rwanda
Uganda
Paediatric policy decision making process review in 5
countries
Interviews with key
stakeholders
Slow adoption of paediatric formulations in the field Policy adoption bottlenecks - sequence
Source: Dalberg analysis
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?
Concluding comments
Developing paediatric drugs not straightforward
Adoption process is complex
Often not considered as specific category for
procurement
But paediatric formulations remain crucial
