Transcript Oxytocin in Uniject – March 2008 Update

Oxytocin in Uniject –
March 2008 Update
Someday I’ll learn to stop predicting the
future with such confident incompetence…
HealthTech--PATH & USAID
Involvement in Oxytocin in Uniject
• Ensure commercial supply becomes available
from producers in Latin America and
Asia/South Asia.
• Generate near-term demand through as many
immediate field use opportunities as possible.
• Develop advocacy tools and educational
materials that will help catalyze future
demand.
• Build and maintain relationships and activities
that will lead to broader demand over time.
March 2008 POPPHI WG Meeting
BIOL of Argentina
Current Status
• Shipped 15,000 doses Oxytocin in Uniject to Mali
July 07
• Submitted Registration Dossier to Argentine FDA
August 07
• Completed 18month stability study timepoint
(excellent results so far)
• Ready to supply for additional evaluations and pilot
introductions
• Argentine registration due sometime between
tomorrow and August 31, 2008…
March 2008 POPPHI WG Meeting
Gland Pharma of India
Current Status
• Completed initial stability study with positive
results in Fall 06
• Progressing through development & stability
studies (somewhat slower than expected)
• Plan to supply ICMR and SEARCH
evaluations in 2008
• International registration dossier available
2009
March 2008 POPPHI WG Meeting
Oxytocin in Uniject Field Use Plans
• Argentina in 2008 (Tulane and IECS)
• India 2008 (ICMR, SEARCH)
• South Africa 2008 (PATH)
• WHO RCT beginning 2008/09
• And? can produce for more…
March 2008 POPPHI WG Meeting
Yes, its real!
March 2008 POPPHI WG Meeting
Qualifying to be a Routine Supplier
to UN Agencies
• Each producer must be evaluated for quality before
being offered the opportunity to sell to UN agencies
• The vendor quality qualification process is product
(Uniject/Oxytocin) and producer specific
• A producer can not request UN quality qualification
until after they first have home country FDA approval
• This system for qualifying Oxytocin producers is
transitioning from individual processes at each UN
agency to a single unified process managed by
WHO.
March 2008 POPPHI WG Meeting
WHO Prequalification for Oxytocin
• Once in place, WHO Prequalification becomes the
sole process for Oxytocin supplier quality qualification
for all UN agencies (UNICEF, UNFPA, etc)
• Oxytocin was included for the first time in the WHO
RFEI issued December 2007
• Submissions by producers are due by December
2008
• Evaluations to take place during 2009
• Only WHO Prequalified Oxytocin suppliers to UN
agencies from 2010 onward?
March 2008 POPPHI WG Meeting
Oxytocin in Uniject Summary
• Commercially available soon—possibly
this year, definitely next year
• Supply for field evaluation now possible
in Argentina and India
• Price range estimates of $.40 - $.60 per
dose still holding…(especially when
sales volume reaches 1 million+ annual
units)
March 2008 POPPHI WG Meeting
Vaccine Vial Monitors for Oxytocin
Successfully used on Oxytocin in Uniject in Mali!
What next?
March 2008 POPPHI WG Meeting
What is a VVM? (or TTI)
• Chemical time and
temperature cumulative
exposure indicator
• Rate of color change
calibrated for different
vaccine stability profiles
• Now in widespread use for
UN procured vaccines
March 2008 POPPHI WG Meeting
Successful use of VVMs
PATH/Carib Nelson
PATH/Glenn Austin
Outreach with hepatitis B and tetanus toxoid vaccines
PATH/Carib Nelson
March 2008 POPPHI WG Meeting
PATH/Jhonky Aliman
VVM’s and Oxytocin--possibilities
• Improvement in overall quality
assurance of programs—only effective
oxytocin would be used
• Flexible cold chain management—
oxytocin could move in and out of cold
chain, cool chain, room temperature
• Longer “out of cold chain” periods
possible than with other approaches
March 2008 POPPHI WG Meeting
VVM’s and Oxytocin—reality check
• Could add $.06-$.10 to cost per dose (if VVM used
on every dose)
• Must be accompanied with training on many levels
(health workers, stock managers, policy makers)
• Best if critical mass of use can be achieved—ie not
just as a niche option from one oxytocin producer
• Requires oxytocin producer cooperation and
investment in advance of actual sales revenue
• It took 10+ years before all UNICEF vaccine
producers finally met the “must have VVM”
requirement
March 2008 POPPHI WG Meeting
Steve Brooke
Commercialization Advisor
Uniject Applications Teams Leader
[email protected]
206.285.3500
www.path.org