Medigen Biotech Company Spotlight. ~ Innovations for a Better Life ~

Transcription

1 Medigen Biotech Company Spotlight ~ Innovations for a Better Life ~

2 About Medigen Biotech (MBC) (2000) Established to develop novel cancer therapeutics (2013) Completed PI-88 phase III subjects recruitment (2006) Commenced molecular diagnostics business in China (2012) Perkin Elmer acquired MBC s subsidiary (Hao-Yuan) (2009) Started cell-based vaccine R&D projects (2012) Spin-off vaccine business into a subsidiary (2013) Found a new molecular diagnostic business in Xiamen (2014) MBC acquired Winston Pharma for drug production A publicly listed company in Taiwan Current market cap ~ US$ 1.5 B MSCI Global Small Cap Indices (05/2012~) Russell Global Indices (06/2013~) 2

3 Visions, Missions and Goals of MBC Compassion Integrity Innovation Professionalism Unmet medical needs of regional significance Becoming a global leader in HCC therapeutics Growing business by collaborations and M&A A full-brown BioPharma brand in Asia/globe ~ Innovations for a Better Life ~ 3

4 Medigen Group Business Medigen Medical Group NME discovery, Clinical development, Technology integrations, Generic Core Competence: Molecular Biology, Clinical Trials Design and Development, Medical Products Registration, PIC/S Manufacturing, manufacturing, and Regional Registrations Marketing Experience New Drug PI-88, OBP-301 Molecular Diagnostics HLA/HIV/HBV/HCV Vaccine Technology (Cell-based) Generic Drug, OTC Drug, Ophthalmological Drug and Device R&D Human Monoclonal Antibody Acquired USA TBG company (2005), and started to build own MDx brands 2012 Spin-off as Medigen Vaccinology Corp. Merged as a member of the Medigen Group

5 Unmet Medical Need of Treating Liver Cancer There are over 700,000 people died because of HCC; 60% of them resides in Asia! 2012 WHO:Age-Standardized Rate per 100,000 5

6 Medigen s Drug Development Pipeline Current liver cancer treatment Early stage (20-30%) surgery RFA transplant Intermediate stage (30-40%) TAE or TACE (90Y chemotherapy) Advanced (30%)/ Terminal Stage(10%) Nexavar/supportive Progen/AU Oncolys /JP PI-88 OBP-301 Phase III Phase I/II 6

7 Percentage Disease free survival PI-88 Phase II Efficacy Profiles PI-88 reduces tumor recurrence after surgery: PI-88 Study Group (160mg/day) showed a reduction of recurrence rate from 50% to 37% at the end of 12 months Recurrence free survival extends from 27 wks to 48 wks at 70 percentile 70% 60% 50% 40% 50% 37% % disease free % dropout Dose Control 160mg 30% % 20% 10% 0% Control 160mg 250mg Weeks 53.9% ~70 th percentile: Control = 27 weeks 160mg = 48 weeks 7

8 PI-88 Phase III HCC Trial: PATRON A prospective, randomized, double-blind, placebo controlled, parallel-group, international multicenter phase III trial of PI-88 in the adjuvant treatment of subjects with hepatitis virus related hepatocellular carcinoma after surgical resection (PATRON) Under the Auspice of TFDA, KFDA, CFDA, HKDOH 8

9 PATRON: Clinical Sites China (04) 0401 FDZH 0403 PUMCH 0405 PLA XYH-3 rd Korea (02) 0201 Severance 0202 AUH 0203 SMC 0204 AMC 0205 SNUH 0206 St. Mary s H G. Severance 0208 KUGH 0210 PNUYH 0211 PNUH 0212 KNUH Hong Kong (03) 0301 QMH Taiwan (01) 0101 NTUH 0102 CGMH-LK 0103 VGH-TPE 0104 VGH-TC 0105 CMUH 0106 CCH 0107 NCKUH 0108 CGMH-KS 0109 EDH 9

10 PI-88 with Attractive Market Size (by ITRI) MD News (biotech and medical device month reports) Aug 2010 ITRI s medical team predicts PI-88 market value: ASEAN market reach:~560 M USD / yr. Global market reach:~2.1 B USD / yr. 10

11 PI-88 with Attractive Market Size (by MS) 11

12 Medigen s Drug Development Pipeline Current liver cancer treatment Early stage (20-30%) Intermediate stage (30-40%) Advanced stage (40%) surgery RFA transplant TAE or TACE (90Y chemotherapy) Nexavar/other supportive treatments X PI-88/PATRON Phase III OBP-301/Phase I/II Sunitinib/Phase III X X X Sorafenib/STORM Phase III X CMS024/Phase III Sorafenib/Phase II X JX-594/Phase IIb Brivanib/Phase III X Everolimus/Phase III 12

13 Advantages of Medigen s over Traditional Approach Medigen s EBV Platform Traditional EBV Platform Labor Material cost Time for development 14~21 days > 28 days Immortalization rate Over 90% 1~10% B cell repertoires/populations Applications drug discovery and development poly native Igs for clinical use B cell repertories analysis in autoimmune diseases -- genetic study in academic research only 13

14 Medigen s Drug Development Pipeline Discovery Preclinical Phase I Phase II Phase III Liver Cancer Therapy PI-88 (early HCC) OBP-301 (intermediate HCC) Human Form mab Projects Infectious diseases Autoimmune diseases 14

15 Global Molecular Diagnostics Market 9% Source: Roche

16 Global Sales of HLA Sub-typing Kits The only Asian company producing A/B/C/DR/DQ HLA kits Products on the market in 25 countries worldwide ASHI certified HLA Sub-typing service lab in Taiwan High resolution SBT HLA kits approved by CE Mark/FDA510K 16

17 Xiamen Subsidiary (100% MBC Owns) New Drug Development company PI-88 license and sales management MDx (TBG) Subsidiary Pathogen detections HLA genotyping Cancer genotyping 17

18 High Productivity 40 Roller Bottles (10 8 ~ 10 9 cells) 25 BelloStages 1 BelloStage (10 9 cells) 1 TideCell (10L Matrix) A cost-effective, easy-to-use, space- & labor-saving system 18

19 Medigen Vaccine Plant 2012/Q4 2013/Q1~Q3 2013/Q4~2014/Q Conceptual Design Basic Design Detail Design/ Construction Commissioning/ Validation 19

20 PIC/S Certified Cell-based Vaccine Plant 2~3yrs 3~5 yrs. 5~10 yrs. Pandemic Influenza Vaccine (H5N1/H7N9) Process development Product registration Emergent outbreak EV71 Vaccine Process development Product registration Taiwan market Asia market Therapeutic Cancer Vaccines Protein Drugs Vaccine Plant 3M~5M doses 5M~10M 2500 萬劑 doses 20

21 Winston Medical & Biotech Group Company Overview Established 1974 as a generic manufacturer Main products are hormones and ophthalmic drugs Paid in capital: NTD265M Annual revenue: ~NTD300M ~150 employees Located at Yongkang, Tainan District PIC/s certification submitted 21

22 Winston s High Quality PIC/S Plant 103H1 certified at stage 1 103H2 certified at stage 2 3F clean room B section 1F Bulk material 4F airconditioning system 22 22

23 Current and Future Subsidiaries of Medigen mab Biologics 4 Products Global Brand Liver Specialty 3 Products Global Leader Vaccine Business 3 Products Asian Leader NAT Business 10 Products Asian Brand Pharmaceuticals Ophthalmic Specialty Asian Brand 23

24 2006 Taipei Biotech Award 2007 Taipei Biotech Award Thanks 2008 MOEA Collaboration Award 2007 National Biotech Award 2008 Executive Yuan Award