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Depo-subQ in Uniject Overview and Update Increasing Community Access to Injectable Contraceptives September 30, 2009 About PATH PATH is an international nonprofit organization. PATH creates sustainable, culturally relevant solutions, enabling communities worldwide to break longstanding cycles of poor health. Our mission is to improve the health of people around the world by • Advancing technologies • Strengthening health systems • Encouraging healthy behaviors www.path.org What is Uniject*? The Uniject device is a prefillable injection system developed by PATH in 1987 in response to WHO’s call for improved injection delivery designs • Single dose for minimal waste of drug or vaccine • Prefilled and sterile for easy, safe use by a wide variety of health workers, including those not previously giving injections • Nonreusable to prevent the spread of HIV and other diseases • Sold by Becton Dickinson (BD) in bulk, prefillable (empty) form to pharmacuetical and vaccine producers • PATH owns certain Uniject intellectual property that it licensed to BD, but PATH receives no royalties or other income from sales of Uniject • PATH (and BD) working with select pharmacuetical and vaccine producers to encourage commercialization of key products in Uniject * Uniject is a registered trademark of BD. Uniject Components Blister Size varies with drug or vaccine Valve Prevents re-use by resisting refilling through needle Hub Needle Size varies with drug or vaccine Cap Successful Uniject Use Selected Examples • Hepatitis B Vaccine • Tetanus Toxiod UNICEF used 8,000,000 doses of Tetanus Toxiod in Uniject as part of Maternal and Neonatal Tetanus Elimination program • Oxytocin Oxytocin in Uniject identified by USAID and WHO as important new option for prevention of post partum hemorrhage 73,000,000+ Uniject injections given since 2000 UNICEF/Giacomo Pirozzi All newborns in Indonesia receive a dose of Hep B vaccine in Uniject at birth (5,000,000 doses/year) Uniject in action What do users think? • “With Uniject anybody can inject the vaccine. An illiterate midwife who’s never been trained in medicine or birthing can do an absolutely perfect job,” Dr. Francois Gasse, senior project manager for immunization at UNICEF. • 80% of service providers who gave contraceptive injections with Uniject preferred Uniject over standard vial and syringe Bahamondes L, et al. Uniject as a delivery system for the once-a-month injectable contraceptive Cyclofem in Brazil. Contraception. 1996;53:115–119. • 57% of women who self-administered contraceptive injections with Uniject said they would definitely continue to do so, and additional 30% said they would probably continue Bahamondes L, et al. Self-administration with Uniject of the once-a-month injectable contraceptive Cyclofem. Contraception. 1997;56:310–304. Making Drugs Available in Uniject The complex realities of prefilled syringes • Any change of primary packaging (even just vial size change) requires development investment and regulatory approval • Uniject is a more complex change than most (plastic vs. glass, new filling & packaging equipment) • 3-5 year minimum time for pharmacuetical or vaccine producer to complete all work to gain appropriate regulatory (FDA) approvals to sell a product in Uniject Injectable Contraceptives in Uniject Select Development History • USAID has funded PATH for 15+ years to catalyze a convergence between injectable contraceptives and Uniject • Applicaciones Farmacueticas (Mexico) did significant development of Cyclofem (once-a-month injectable contraceptive) in Uniject and nearly launched in mid 2000s • Pfizer (then Pharmacia & Upjohn) initially evaluated Depo Provera 150mg in Uniject 10 years ago -not feasible due to insufficient shelf life stability • Pfizer (then Pharmacia & Upjohn) incorporated Uniject into the lower dose, subcutaneous reformulation project starting early 2000s-which led to the opportunity at hand Depo-SubQ in Uniject What has kept us all motivated…for so long? The vision of Depo-SubQ Uniject as a “game changer” that increases both quality and quantity of provision of injectable contraceptives • Quality - Inherent safe use features (dose, sterility, non-reuse) - Additional potential program quality benefits (provider/client satisfaction from ease of use, logistics matching, disposal) • Quantity - Within traditional service delivery systems - Through expansion of non-traditional provision—CBD Depo-SubQ in Uniject When will it become available? • Limited supply for pre-introductory and acceptability studies 2nd half of 2010 • Regulatory approvals in USAID priority country submitted 4th quarter 2010 and completed by mid 2011 • Introduction can begin after country regulatory approval (assuming all stars align) 2009 Depo-subQ Uniject Availability Key Steps Toward Rollout Q1 Q2 Q3 2010 Q4 Q1 Q2 2011 Q3 Q4 Q1 Q2 Q3 2012 Q4 Q1 Q2 Q3 Q4 Depo-subQ Product Registration Glass pre-filled product registration (EMEA) Glass pre-filled product registration (USAID Priority Countries) Uniject Registration (EMEA) PFIZER PFIZER PFIZER Uniject Registration (USAID Priority Countries) Pre-Introductory Studies Country selection and planning for pre-introductory studies FHI Product Supplied for pre-introductory studies FHI Conduct and document pre-intoductory studies Country Selection - Initial rollout countries Assessment of selected USAID priority countries USAID Selection of USAID initial launch countries completed Introduction planning and preparation USAID Procurement Process Procurement planning USAID Place order for selected country introductions Production and packaging of DMPA in Uniject PFIZER DMPA in Uniject delivered Introduction--Initial countries Initial country rollout Global Rollout Global rollout 11 Thank You Steve Brooke Commercialization Advisor 206.285.3500 [email protected]