Oxytocin in Uniject – March 2008 Update Someday I’ll learn to stop predicting the future with such confident incompetence…

March 2008 POPPHI WG Meeting 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)

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 Outreach with hepatitis B and tetanus toxoid vaccines PATH/Carib Nelson PATH/Jhonky Aliman PATH/Glenn Austin March 2008 POPPHI WG Meeting

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