Transcript EATG meeting - Global Campaign for Microbicides

Private sector involvement
IPM-Tibotec case study
EATG meeting Brussels
9 December 2005
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 www.ipm-microbicides.org
number
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 antiinfectives for diseases of high unmet medical need.
Affiliation: Johnson&Johnson Group of Companies
number
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
number
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
number
3 IPM-Tibotec agreement
Product - Goal
Environment
Agreement
Status
number
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
number
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.
number
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
number
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.
number
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….
number