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Licensing Technology and Intellectual Property for the Development of Paediatric Formulations

Licensing Technology and Intellectual Property for the Development of Paediatric Formulations. July 1, 2013 Sandeep Juneja Business Development Director Medicines Patent Pool . Why Focus on Paediatrics. General impression is that the paediatric market is small

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Licensing Technology and Intellectual Property for the Development of Paediatric Formulations

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  1. Licensing Technology and Intellectual Property for the Development of Paediatric Formulations July 1, 2013 SandeepJuneja Business Development Director Medicines Patent Pool

  2. Why Focus on Paediatrics • General impression is that the paediatric market is small • It is: at 0.63Mn on treatment, <7% of all PLHIV treated • And fragmented: multiple regimens; standalone formulations • Under new guidelines, all children <5y and all >5y with CD4<500 • Increased treatment gap • Paediatric treatment options unfortunately remain complex • 9 possible regimens (6 triple FDCs) required in first-line if all recommendations are to be covered • Of which only 1 triple FDC exists presently • Treatments need to be adapted for children and RLS • And IP issues need to be resolved All above throws up challenges unique to paediatrics Justifies special focus

  3. When Considering Licences Questions to consider when seeking licences • Obvious, first question: extent of IP coverage in L&MICs • Possible formulations? FDCs possible? Dose of the FDC in different weight bands? • Is technology available for the FDC or can be made available? Source? • Would there be a viable generic market? How many generics can it sustain? • Would efficacy trials be required? If so, who will conduct them? Financing?

  4. Regimens Required per 2013 Guidelines • “/” 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 Licensed to MPP Patented in L&MICs

  5. Other future alternatives still in development MPP in negotiations Licensed to MPP Patented in L&MICs

  6. Treatment Options for Paediatrics Majority of the formulations required have more than one challenge from licensing to filing

  7. Potential First Line and Second Line Options

  8. Potential Future Options

  9. Role of Stakeholders Coordination required between several stakeholders; Treatment uptake in particular community involvement will be key

  10. Thank You

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