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

What is Uniject*? 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 The Uniject device is a prefillable injection system developed by PATH in 1987 in response to WHO’s call for improved injection delivery designs * Uniject is a registered trademark of BD.

Uniject Components Blister Needle Valve Cap Hub Size varies with drug or vaccine Prevents re-use by resisting refilling through needle Size varies with drug or vaccine

Successful Uniject Use Selected Examples UNICEF/Giacomo Pirozzi Hepatitis B Vaccine All newborns in Indonesia receive a dose of Hep B vaccine in Uniject at birth (5,000,000 doses/year) 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

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– % 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 2 nd half of 2010 Regulatory approvals in USAID priority country submitted 4 th quarter 2010 and completed by mid 2011 Introduction can begin after country regulatory approval (assuming all stars align)

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Steve Brooke Commercialization Advisor Thank You