Market access in some Asian markets. Some facts about China Japan

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Jeffery Kennedy
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1 Market access in some Asian markets Some facts about China Japan Jan M. Bult President & CEO Bioplasma World Asia 2014 Singapore, July 1, November 2010 WFH--Rio de Janeiro, Brazil

2 PPTA Global Members 2

3 Experiences Some hurdles for market access China Japan 3

4 Article 49 (85) 卫药字第 49 号 Article (85) MoH Drug No. 49 卫生部海关总署关于禁止 VIII 因子制剂等血液制品进口的通知 MoH & Custom Notice in Prohibiting the Importation of Factor VIII & Plasma Products 4

5 Article 49 Article 49 restricts the import of plasma protein therapies Albumin only from US plasma European plasma is banned 5

6 6 Source: Alan Chit, HPC Consulting

7 7 Source: Alan Chit, HPC Consulting

8 China facts 4,000 ton plasma annually Average per manufacturer 150,000 5 manufacturers: FVIII, IG and HAS Others: PCC and Fibrinogen, IG and HSA 8 Prof Hou Jifeng

9 Regulations since 90 s, focus on safety China facts Strict separation of blood and plasma collection - No plasma collection when there is blood collection - No recovered plasma Manufacturers need to have dedicated plasma collection centers - No shipment between manufacturers of plasma and/or intermediates 9 Prof Hou Jifeng

10 China facts Safety steps in China Donor selection Testing Inventory Hold Physical, HBV, HCV, HIV HBV, HCV, HIV, Syphylis, ALT 60 days or 90 days 23 manufacturers use ELISA : 90 days 5 manufacturers use NAT: 60 days Virus Inactivation / removal 2 separate methods Manufacturing process GMP Batch release Cohn fractionation, Chromatography 10 Prof Hou Jifeng

Risk Reduction is the Result of Combined Measures Donor Donation Management Patient Safety Step 1: Screening Safety Step 9: Post-Marketing Surveillance Safety Step 5 & 6: Quality Assurance GMP Safety

11 Risk Reduction is the Result of Combined Measures Donor Donation Management Patient Safety Step 1: Screening Safety Step 9: Post-Marketing Surveillance Safety Step 5 & 6: Quality Assurance GMP Safety Step 2: Testing Donation Safety Step 3: Inventory Hold/ Lookback Safety Step 4: Plasma pool testing Manufacturing Safety Step 8: Quality Assurance Packaging Guidance Complete Manufacture Safety Step 7: Virus Inactivation/ Removal TSE/CJD Removal 11

screening tests Standard Applies to New & Returning (> 6 months) Donors

12 Qualified Donor Standard Prior to Qualifying, Donors Must Successfully Pass at least two health history interviews and two panels of required screening tests Standard Applies to New & Returning (> 6 months) Donors Units from Applicant Only Donors may not be Shipped for use in Therapeutic Products 12

$Information Sero-conversion Managed by fractionation organization Audit includes site inspection$

13 Inventory Hold Hold Source Plasma 60 Days following collection prior to pooling Post-donation Information Sero-conversion Managed by fractionation organization Audit includes site inspection 13

14 JAPAN 14

1984 1986 1988 1990 1992 GLOBAL IVIG SALES FROM 1984 TO 2010 (Metric

2% per year since 2000 81.90 94.89 68.20 47.40 52.82 58.15 35.50 36.

15 GLOBAL IVIG SALES FROM 1984 TO 2010 (Metric Tons) IVIG + SCIG! +10.3% per year since 1984! +7.2% per year since S1 15

16 IG Distribution in USA and Europe 60,000 50,000 40,000 30,000 20,000 10,000 0 US Immune Globulin Europe: IG (iv + sc) 16

17 Plasma for Fractionation Japan *MHLW Blood Committe on December 26, Source: MHLW Blood Committee on December 26, 2012

Self-sufficiency rate 2004 2005 2006 2007 2008 2009 2010 2011E 2012E 2013E Anti-Thrombin III 88.0 94.9 96.3 97.4 98.1 100.0 100.0 100.0 100.0 100.0 Immunoglobulin 87.5 88.6 91.2 95.9 95.9 95.1 95.

18 Self-sufficiency rate E 2012E 2013E Anti-Thrombin III Immunoglobulin Tissue sealant Factor VIII, incl rfviii Albumin, excl rec ALB Anti HBs IG Blood Committee December 26,

19 SELF SUFFICIENCY Every country has the right and obligation to provide its population with safe and effective medicines Self sufficiency is a goal Self sufficiency is not a dogma Globally we need to talk about sufficiency 19

Plasma as a Strategic Resource: perspectives and potential solutions in the public sector

Plasma as a Strategic Resource: perspectives and potential solutions in the public sector Dr Paul Strengers Executive Director International Plasma Fractionation Association ISdS and IFBDO Conference Be