licensing technology and intellectual property for the development of paediatric formulations n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Licensing Technology and Intellectual Property for the Development of Paediatric Formulations PowerPoint Presentation
Download Presentation
Licensing Technology and Intellectual Property for the Development of Paediatric Formulations

Loading in 2 Seconds...

play fullscreen
1 / 10

Licensing Technology and Intellectual Property for the Development of Paediatric Formulations - PowerPoint PPT Presentation


  • 120 Views
  • Uploaded on

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

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Licensing Technology and Intellectual Property for the Development of Paediatric Formulations' - penney


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
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

SandeepJuneja

Business Development Director

Medicines Patent Pool

why focus on paediatrics
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

when considering licences
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?
regimens required per 2013 guidelines
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

other future alternatives still in development
Other future alternatives still in development

MPP in negotiations

Licensed to MPP

Patented in L&MICs

treatment o ptions for paediatrics
Treatment Options for Paediatrics

Majority of the formulations required have more than one challenge from licensing to filing

role of stakeholders
Role of Stakeholders

Coordination required between several stakeholders;

Treatment uptake in particular community involvement will be key