The Paediatric HIV Treatment Initiative (PHTI) to Speed Development and Availability of Needed Formulations

1. The Paediatric HIV Treatment Initiative (PHTI) to Speed Development and Availability of Needed Formulations Sandeep Juneja Business Development Director Medicines Patent Pool AIDS 2014 Conference Melbourne – 22 July 2014

2. Regimens Required per 2013 Guidelines 1st line 2nd line Resistant patients Infants and children <3y ABC or AZT/3TC/LPV/r (P) ABC or AZT/3TC/NVP (A)   Infants and children <3y* No change or AZT or ABC /3TC/NVP AZT or TDF or ABC/3TC/LPV/r Regimens based on RAL and/or ETV and/or DRV/r Children >3y <10y ABC/3TC/EFV (P) ABC or TDF/3TC+NVP (A) TDF/3TC/EFV(A) AZT/3TC/NVP or +EFV (A)**     Children >3y <10y*** AZT/3TC/LPV/r AZT/3TC/LPV/r AZT/3TC/LPV/r ABC or TDF/3TC/LPV/r  Children >10y TDF/3TC/EFV (P) AZT/3TC/NVP or +EFV (A)** TDF/3TC/NVP (A)  Children >10y*** AZT/3TC/LPV/r ABC or TDF/3TC/LPV/r AZT/3TC/LPV/r  “/” is used when FDC exist or is possible, “+” is used when FDC is difficult due to size or different dosages. * EFV can only be used in >3y. **Most children on treatment are currently receiving this regimen (300,000 ch) and d4T/3TC/NVP (150,000 ch). In both cases, they will require ABC/3TC/LPV/r after failure. *** ATV/r can be used alternatively in children>6y. (P)= preferred, (A)= alternative

7. Coordinated Approach Needed Development Develop and validate infant-friendly formulation of ABC (or AZT)/3TC/ LPV/r DNDi/Cipla Optimized first-line regimen for children IP/data Address patent-related issues through voluntary licenses with ViiV and, in discussions, AbbVie Medicines Patent Pool Quality/regulatory Inform developers of expected needs for review; prioritize review as product becomes available WHO PQ Procurement Market shaping and preparation CHAI and Paediatric ARV Procurement Working Group Financing (e.g. UNITAID in case of DNDi/Cipla)

8. Priority products Recommended by ABC/3TC/EFV Formulations to be given priority Medium and long-term priorities for children (PADO) AZT or ABC/3TC/LPV/r DRV/r RTV pellets DTG New drugs to be given priority TAF COBI RAL (+AZT or ABC/3TC) TDF/3TC Other formulations identified in WHO Treatment guidelines as urgently needed TDF/3TC/EFV ATV/r

9. Status of IP licensing IP/MPP licensing ABC/3TC/EFV Licence obtained AZT or ABC/3TC/LPV/r In negotiations DRV/r Currently not in negotiation RTV pellets In negotiations DTG Licence obtained TAF In negotiations COBI Licence obtained RAL In negotiations TDF/3TC Licence obtained TDF/3TC/EFV Licence obtained ATV/r Licence obtained

10. Priority products Recommended by ABC/3TC/EFV Formulations to be given priority Medium and long-term priorities for children (PADO) AZT or ABC/3TC/LPV/r DRV/r RTV pellets DTG New drugs to be given priority TAF COBI RAL (+AZT or ABC/3TC) TDF/3TC Other formulations identified in WHO Treatment guidelines as urgently needed TDF/3TC/EFV ATV/r

11. …but other issues IP/MPP licensing Other issues…* ABC/3TC/EFV Licence obtained Need clarity on dosing AZT or ABC/3TC/LPV/r In negotiations Under development DRV/r Currently not in negotiation Need clarity on dosing RTV pellets In negotiations Under development DTG Licence obtained FDC? Which ones? TAF In negotiations FDC? Which ones? COBI Licence obtained FDC? Which ones? RAL In negotiations Low demand TDF/3TC Licence obtained No paediatric formulation TDF/3TC/EFV Licence obtained Appropriate strength reqd ATV/r Licence obtained No paediatric FDC * Identification of the needs for product delivery is part of the work of the PHTI. These are only examples.

12. Industry: patents and know-how IP/Knowledge Sharing Clinical Guidance Clinical/Product Development Manufacturing and Distribution National Treatment Programmes Children Living with HIV MPP World Health Organization PDPs PROs Industry (originator/gene ric) Industry (originator/gene ric) Financing organizations Financing organizations Market uptake and access UNITAID, other organizations for marketing shaping/funding and civil society The Paediatric HIV Treatment Initiative

13. Steps in product delivery PRELIMINARY ANALYSIS Analysis of of the the requirements requirements for for developing developing a a IP/Data Dosage clarity, pK studies and ddi Regulatory input Clinical development Formulation development and manufacturing Financing Project management Uptake Procurement financing product, that will serve to identify members of the groups in charge of product delivery serve to identify members of the groups in charge of product delivery PLANNING PHASE Detailed analysis of the needs and preparation of working plan for product delivery PRODUCT DELIVERY Once potential funding is in place, the product specific teams start their core work REPORTING AND IMPACT MEASUREMENT Specific teams report to the project coordinator on an regular basis who reports to the coordinators and stakeholders at a pre-decided frequency

14. Steps in product delivery PRELIMINARY ANALYSIS Analysis of the requirements for developing a IP/Data Dosage clarity, pK studies and ddi Regulatory input Clinical development Formulation development and manufacturing Financing Project management Uptake Procurement financing of the requirements for developing a product, that will serve to identify members of the groups in charge of product delivery serve to identify members of the groups in charge of product delivery PLANNING PHASE Detailed analysis of the needs and preparation of of the needs and preparation of working plan for product delivery for product delivery PRODUCT DELIVERY Once potential funding is in place, the product specific teams start their core work REPORTING AND IMPACT MEASUREMENT Specific teams report to the project coordinator on an regular basis who reports to the coordinators and stakeholders at a pre-decided frequency

15. Proposed operational framework of PHTI Product specific team– identification and resolution of specific development issues, financing of studies, market shaping External input from WHO and PAWG – selection of priority products UNITAID,MPP, DNDI, CHAI Pre-assessment of the needs and appointment of team members Products used and incorporated in the IATT formulary Stakeholders: are consulted for guidance and contain members that can potentially be called upon for specific work on products

16. Integrated approach Product specific teams (exploratory in the beginning) • Composition: experts, pharmaceutical companies, PHTI coordinator, chair person • Identify work needed to fill gap of formulation development • Develop work plans, timelines, budget • Perform the work from formulation to access Stakeholders WHO, PADO Reporting / feedback twice a year Strategic and coordination support Reporting and feedback quarterly Alignment with WHO/PADO priorities

17. Thank you

The Paediatric HIV Treatment Initiative (PHTI) to Speed Development and Availability of Needed Formulations

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