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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.

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Oxytocin in Uniject – March 2008 Update

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

  2. HealthTech--PATH & USAIDInvolvement 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.

  3. BIOL of ArgentinaCurrent 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…

  4. Gland Pharma of IndiaCurrent 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

  5. 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…

  6. Yes, its real!

  7. 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.

  8. 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?

  9. 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)

  10. Vaccine Vial Monitors for Oxytocin Successfully used on Oxytocin in Uniject in Mali! What next? March 2008 POPPHI WG Meeting

  11. 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

  12. Successful use of VVMs Outreach with hepatitis B and tetanus toxoid vaccines PATH/Glenn Austin PATH/Carib Nelson PATH/Carib Nelson March 2008 POPPHI WG Meeting PATH/Jhonky Aliman

  13. 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

  14. 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

  15. Steve BrookeCommercialization AdvisorUniject Applications Teams Leadersbrooke@path.org206.285.3500 www.path.org

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