1. Private sector involvement IPM-Tibotec case study
EATG meeting Brussels
9 December 2005

2. 1. Parties involved : IPM
International Partnership for Microbicides (IPM)
Not-for-profit venture established in 2002
Mission:
To accelerate the discovery, development and accessibility of microbicides to prevent transmission of HIV.
Origin: Rockefeller Foundation, European Union
Donors: see ipm website at

3. 1. Parties involved: Tibotec
Pharmaceutical research and development company. At the forefront of HIV research, with 3 anti-HIV compounds in clinical development and several discovery programs for compounds highly active against resistant HIV strains.
Mission : to be a world leader in the discovery and development of innovative HIV/AIDS drugs and superior anti-infectives for diseases of high unmet medical need. 
Affiliation: Johnson&Johnson Group of Companies

4. Tibotec’s commitment
To be part of the international response to the HIV pandemic by
providing therapeutic options
Antiretroviral compounds
Treatment for opportunistic infections
providing preventive options
Adapted to all needs and
Affordable to all populations

5. 2. Motivation to engage Basic commitment of Tibotec
Additional motivation for staff being able to exploit their scientific expertise for humanitarian cause (while remaining in the HIV focus)
Retain rights to humanitarian activities in the developing world
Right to make the product commercially available in the first world
Bring others to the table

6. 3 IPM-Tibotec agreement
Product - Goal
Environment
Agreement
Status

7. The Product / The goal The Product: TMC 120
Belongs to the class of NNRTI’s
Tibotec already developed a TMC-120 containing gel which was in Phase I clinical testing
The goal : to develop a female controlled method for preventing sexual transmission of HIV, to be used w/ or w/out condoms, containing TMC 120 both alone and in combination with other active ingredients

8. Agreement (1)
A sole, royalty free license on Patent and Know-how with respect to TMC 120 and related formulation technology
in order to develop, register, make, manufacture, hold/keep, formulate, optimize a vaginal microbicide Product containing TMC 120
and to make such Product available in the Territory (resource poor countries) on an Affordable Basis.

9. Agreement (2) Responsibility of IPM
Overall development of vaginal microbicide containing compound as active ingredient
If successfull, distribution in Territory ( 82 resource pour countries) on an affordable basis.
Responsibility of Tibotec
To supply free of charge compound through Phase II testing
To assist with scientific and medical expertise in field of HIV drug development, GCP and clinical trial management

10. Agreement (3) Tibotec retained rights:
Developing commercial and humanitarian activities in Territory, including making available Product purchased from IPM
Option to obtain exclusive royalty bearing license to exploit Product outside the Territory.

11. … the hope is to have a product available
Status
Basic data on drug substance and drug product available
Pre-clinical selection criteria for a potential vaginal microbicide met
Advanced pre-clinical programme including required safety and reproductive toxicology data
Initial Phase I safety trials with gel and ring done in Belgium, larger safety trial with gel ongoing in 4 different African sites (South Africa, Tanzania and Rwanda)
Clinical trial site preparation for large scale efficacy trials started, including preliminar HIV incidence studies
… the hope is to have a product available
in 5 years time….