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					Increasing Access Through Low-Cost Implant: Sino-implant
          Global Health Council - May 29, 2009
                  Markus J. Steiner, PhD
       Growing Team
           Core Team
• Markus Steiner    • David Asante
• Aida Cancel       • Haizhen Meng
• Heather Vahdat    • David Hubacher
• David Jenkins     • Diane Luo (consultant)

    Program Representatives
     • Karin Ganter (PROGRESS)
     • Trinity Zan (RESPOND)
     • Laura Raney (K4H)

       FHI Country Offices
            Growing Team - Partners

• Registration Partners     • Other Partners
  •   Pharm Access Africa     •   EngenderHealth
  •   DKT                     •   IntraHealth
                              •   Ipas
  •   Marie Stopes
                              •   Population Council
  •   Profamilia/DR           •   WHO
      Progyne/Colombia
  •   PSI
      Outline of the presentation


1)   Why focus on Implants
2)   Why Sino-implant (II)
3)   Quality Assurance
4)   Registration/Introduction
Why focus on Implants?
If 20% of OC users switched to implants in
   Africa…over next 5 years would avert:



                            1.8 million unplanned
                                pregnancies
                              576,000 abortions
                           10,000 maternal deaths

                                  Hubacher, Mavranezouli,
                                     and McGinn 2008




The impact would be even more dramatic with new users
Why Sino-implant (II)?
Contraceptive Costs per Year, 2009
                      IUD        $0.15



                    Zarin                      $2.30



                  DMPA                                 $3.50



                     OCs                                    $4.35



                 Jadelle                                                  $6.50



             Implanon                                                                             $10



                          $0.00          $2.00      $4.00        $6.00        $8.00       $10.00 $12.00

Costs from RH Interchange global procurement in 2009 as of mid-May; Jadelle and Implanon cost from Ethiopia which received largest
proportion of implants; Zarin cost is average landed cost to date. Couple years protection (CYP) from USAID.
Sino-implant (II) vs Jadelle
                        Sino-implant (II)             Jadelle




 Manufacturer      Shanghai Dahua           Bayer Schering Pharma
                   Pharmaceutical Co., Ltd.
 Formulation       2 rods;                  2 rods;
                   75 mg levonorgestrel     75 mg levonorgestrel
                   Total: 150 mg            Total: 150 mg
 Dimensions        2.4 mm x 44 mm           2.5 mm x 43 mm
 Labeled length    4 years                  5 years
 of use
 Trocars           Disposable               Autoclavable/Disposable
 Cost of implant   US$8                     US$23
           Eleven published papers


Demonstrate safety and effectiveness

•Annual pregnancy rate under 1%


•About 20,000 women studied for up to 7 years


•3 comparative trials with Norplant control arm
      •Fan 2004: 1,000 per group followed for 5 years
         •5-year cumulative pregnancy rate 0.7%
Quality Assurance
Manufactured exclusively by:
  Shanghai Dahua Pharmaceutical Company, Limited
Shanghai Dahua Pharmaceutical Co., Ltd.
Shanghai, China

• New facility opened 2004

• Built to GMP standards: Chinese State Drug
   Administration certified

• ISO 9001 and ISO 13485 certified: National Quality
   Institute (NQI, UK)

• Registered in China (1994), Indonesia (2002), Kenya
   and Sierra Leone (2008)

• Over 7 million implants distributed to date
                         PSI

                           DACAEthiopia




Prepared to pass Good Manufacturing Practices
              (GMP) inspections
Product Quality Evaluation
 • Shanghai Dahua Pharmaceutical Co, Ltd.:
      •Internal lot release quality control
      •4 validated tests (identification, content, dissolution
       and sterility)

 • 10 lots independently verified by FHI and SGS

 • Additional tests developed and validated by FHI
   (metal and organic impurities, sterilization residue,
   endotoxins, cytoxicity and package integrity) using
   USP,ASTM and ISO Test Methods

 • Disposable Trocar CE Mark

 • Quality evaluation on-going for next 5 years
Registration & Introduction
               Registered
                 Kenya
              Sierra Leone
               Indonesia
                 China



                                 In Progress
                             Burkina Faso    Zimbabwe
                                 Mali         Pakistan
                               Nigeria         Bolivia
         Under Review
                               Zambia Dominican Republic
       Burundi    Malawi                     Colombia
       Ethiopia  Rwanda
        Ghana     Uganda
      Madagascar Tanzania




Registration Status in 21 countries
           Shanghai                 Exclusive Distribution Agreement
            Dahua
     Pharmaceutical Co., Ltd.

                      Technical
                      Assistance

           Family Health
            International
       Global Coordinating Center     Price Ceiling
                                      Negotiation (Public
                                      and NGO)




Six year exclusive distribution agreement
                     Sino-implant
                     Introduction

               • One size doesn’t fit all
               • Implant train taken off
               • Significant saving for
                 implant programs
               • Partners need to guide
                 speed
Key Concepts
               • Introduction = Scale-up
Sino-implant (II) Initiative:
  2.2 million implants over 5 years
                                                 2.2 M

90,600 units in first four months of 2009:

                                                 1.5 M
  • 15,400 for Kenya
  • 5,000 for Sierra Leone
                                                 1.0 M
  • 70,200 for Ethiopia

Cost saving: US$1.36 million                     0.5 M




                                        90,600
              Dramatic increase in Ethiopia
                                       Implant orders in Ethiopia

        500,000
                                                                              448,000
        450,000
                                                                    405,800
        400,000

        350,000

        300,000
units




                                                      237,500
        250,000

        200,000

        150,000

        100,000
                                         58,160
         50,000
                     4,219
             0
                    1993-96                  2006      2007          2008      2009


 Actual figures for first 4 months of 2009
Thank

				
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