Depo-subQ in UnijectOverview 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*?

• 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 UseSelected Examples

UN

ICE

F/G

iacomo P

irozzi

• Hepatitis B VaccineAll newborns in Indonesia receive a dose of Hep B vaccine in Uniject at birth (5,000,000 doses/year)

• Tetanus ToxiodUNICEF used 8,000,000 doses of Tetanus Toxiod in Uniject as part of Maternal and Neonatal Tetanus Elimination program

• OxytocinOxytocin 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 actionWhat 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 UnijectThe 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 UnijectSelect 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 UnijectWhat 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 UnijectWhen 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)

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Depo-subQ Uniject Availability

Key Steps Toward Rollout Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 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)

Uniject Registration (USAID Priority Countries)

Pre-Introductory Studies

Country selection and planning for pre-introductory studies

Product Supplied for pre-introductory studies

Conduct and document pre-intoductory studies

Country Selection - Initial rollout countries

Assessment of selected USAID priority countries

Selection of USAID initial launch countries completed

Introduction planning and preparation

Procurement Process

Procurement planning

Place order for selected country introductions

Production and packaging of DMPA in Uniject

DMPA in Uniject delivered

Introduction--Initial countries

Initial country rollout

Global Rollout

Global rollout

2009 2010 2011 2012

PFIZER

FHI

FHI

USAID

PFIZER

PFIZER

USAID

PFIZER

USAID

Steve BrookeCommercialization Advisor206.285.3500sbrooke@path.org

Thank You