A full collection of the presentations made Wednesday, December 3, 2008 at Mississauga Living Arts Centre for From Research to Revenue IV: Capturing Business Opportunities in Asia.
9. Agenda 1. Introduction 2. Strategic context of outsourcing and location decisions in Asia 3. Moving up the value chain: the changing nature of pharma outsourcing in Asia 4. Evaluating the landscape: the location context for outsourcing decisions 5. Looking ahead
17. Moving up the value chain Manufacturing scales up • cost: India 50% cheaper than west • large pool of qualified talent to run manufacturing plants - India: > 100 FDA approved facilities - China: > source of APIs shipped globally > first FDA approved site for finished drug > increased effort of SFDA
18. Moving up the value chain Manufacturing scales up David Brennan, CEO AstraZeneca: “ all active pharmaceutical ingredients will be produced externally within a decade as part of the strategy of maximizing the efficiency of our supply chain while maintaining the highest possible standards of quality and security of supply.”* AstraZeneca plans to increase its outsourcing drastically from China and India. The firm has set up a dedicated sourcing centre in Shanghai. *Financial Times, 16 April 2008
20. Evaluating the landscape: the location context for outsourcing decisions Outsourcing index – ranking of Asian territories across all factors
21. Evaluating the landscape: the location context for outsourcing decisions Cost ranking of Asian territories
22. Evaluating the landscape: the location context for outsourcing decisions Risk ranking of Asian territories
23. Evaluating the landscape: the location context for outsourcing decisions Market Opportunity ranking of Asian territories
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25. Looking ahead “ For us, China is not about outsourcing and cheap labour…It’s about different science…Within 5 to 10 years we will be moving from 'made in China’ to ‘discovered in China’” Moncef Slaoui Chairman of Research and Development, GlaxoSmithKline
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28. Current market conditions expose new opportunities to reap significant financial and non financial benefits from alternate sourcing arrangements even in the face of market turmoil. Organizations would be well served to explore these opportunities in their strategic context and develop appropriate sourcing strategies that consider both short and long-term implications. Increased market complexity and risk are clear concerns requiring careful consideration and sharp focus, but they should not stop organizations from taking action that could build business flexibility and accelerate competitive advantage on the up-side of an economic recovery. CONCLUSION Source: Sourcing decisions during economic downturns, PwC Point of View Dec 2008
29. Thank you The changing dynamics of pharma outsourcing in Asia: Are you readjusting your sights? Madhav Murti Vice President - Global Sourcing Advisory [email_address]
30. From Research to Revenue IV: Capturing Business Opportunities in Asia From Research to Revenue IV: Capturing Business Opportunities in Asia
31. From Research to Revenue IV: Capturing Business Opportunities in Asia Analysis of Asian Markets Moderator: Gail Garland, Axela Inc. Sarah Frew, McLaughlin - Rotman Centre for Global Health Paul Stinson, CAPRA International Ron Choudhury, Aird & Berlis LLP Hadi Salah, Frost & Sullivan
32. Analysis of Asian Markets: Focus on India and China December 3, 2008 Hadi Salah [email_address]
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34. Key Healthcare Market Segments Healthcare Pharmaceuticals Biotechnology Medical devices Diagnostics Healthcare IT Patient care Clinical research Contract research/outsourcing
38. Investment in India: Drivers and Restraints Restraints Drivers High Med Low Low Med High Low cost of production * Length of arrow indicates relative impact Low cost man power, strong scientific base and talent Low healthcare per capita spending Highly fragmented market Government incentives Entry of large global pharma firms Rural penetration potential Emerging APAC healthcare hubs
42. Investment in China: Drivers and Restraints Restraints Drivers High Med Low Low Med High Rapid economic growth, increased purchasing power * Length of arrow indicates relative impact Increasing private investment is driving innovation Lack of clarity and policies Inadequate legal enforcement Government incentives and increased investment Insufficient IP protection Rural penetration potential Weaker management training
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44. The Indian and Chinese Health Biotech Industries: Competitors or Collaborators of Canadian Firms? December 3, 2008 Sarah E. Frew, Ph.D Sarah.frew@mrcglobal.org McLaughlin-Rotman Centre for Global Health Program on Ethics and Commercialization
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48. Private Sector Development in Developing Countries Nat. Biotechnol. 25 (4), 403-417 (2007). Nat. Biotechnol. 26 (1), 37-53 (2008). Brazil: Nature Biotechnology 26 (6), 627-644 (2008).
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50. New Delhi Panacea Biotec Lifecare Innovations Mumbai / Pune Wockhardt Serum Institute of India Bharat Serums and Vaccines Reliance Life Sciences SIRO Clinpharm Nicholas Piramal Hyderabad Shantha Biotechnics Bharat Biotech International Indian Immunologicals Dr. Reddy’s Laboratories Transgene Biotech Biological E Bangalore Biocon Syngene Clinigene International Bhat Bio-Tech India Strand Genomics Avestha Gengraine Gangagen Case Studies of 21 Indian Firms Including 10 of Top 20 Indian Biotech Firms
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53. Case Studies of 22 Chinese Health Biotechnology Firms Changchun GeneScience Beijing Beijing Wantai Biol. Bio-Bridge Science CapitalBio China PKU Bioway Fusogen Pharma Sinocells Biotech. SinoGenoMax Sinovac Biotech Starvax Internat’l. Shenzhen Beike Biotech Shenzhen Chipscreen Biosciences Shenzhen SiBiono GeneTech Shanghai HD Biosciences Fudan-Yueda Bio-tech Shanghai Genomics Genon Bio-engineering Huaguan Biochip Sunway Biotech United Cell Biotech WuXi PharmaTech Xiamen Amoytop
62. Thank You! Presentation Title / Date Additional funding partners for the McLaughlin-Rotman Centre for Global Health can be found at www.mrcglobal.org
63. China Biopharma – Open for Business! Paul Stinson CAPRA International December 3, 2008
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72. China is Open for Biopharma Business! www.caprainc.com [email_address]
73. ANALYSIS OF ASIAN MARKETS – THE LEGAL PERSPECTIVE Ron Choudhury Aird & Berlis LLP 416.865.3071 [email_address]
82. From Research to Revenue IV: Capturing Business Opportunities in Asia From Research to Revenue IV: Capturing Business Opportunities in Asia
83. From Research to Revenue IV: Capturing Business Opportunities in Asia International Commercial Collaborations: Moves for Success Moderator: David Shindler, BioDiscovery Toronto Stuart Wilson, ISTPCanada Adi Treasurywala, Arrowcan Partners Yu Zhang, CAPRA International Christopher Paige, Shanghai-Toronto Institute for Health Research
101. AN OVERVIEW OF ISTPCANADA December 3, 2008 Stuart Wilson, ISTPCanada
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114. From Research to Revenue IV: Capturing Business Opportunities in Asia Adventures in Emerging Markets Andrea Mandel-Campbell
115. From Research to Revenue IV: Capturing Business Opportunities in Asia From Research to Revenue IV: Capturing Business Opportunities in Asia
116. From Research to Revenue IV: Capturing Business Opportunities in Asia Mississauga: Canada's 3rd Largest Life Sciences Cluster Larry Petovello, City of Mississauga
117. From Research to Revenue IV: Capturing Business Opportunities in Asia From Research to Revenue IV: Capturing Business Opportunities in Asia
118. From Research to Revenue IV: Capturing Business Opportunities in Asia Strategic Case Studies Moderator: Joel Cheng, XPhase Pharmaceuticals Inc. Bin Huang, WEX Pharmaceuticals Fulong Qiao, Beijing Farmunity Inc. Sean Thompson, YM Biosciences
119. From Research to Revenue IV Capturing Business Opportunities in Asia December 3, 2008 Developing a new class of non-opioid analgesics for treatment of pain by Bin Huang, President & CEO
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132. 3.2 Poor quality products 85 |135-150 72-75 |135 Processing temperature ( o C) >30% (before 2007) No Reconstituted milk ? 5 – 10% of sale revenue Little Advertisements 20 - 40% 10% Package cost (percentage of retail price) Low Superior Nutrient value >16 | 4 -15 >15 | 2-5 Processing time (seconds) China Advanced Countries Criteria
142. Forage Eco-Producing Cooperative Forage Eco-Producing Cooperative Forage Eco-Producing Cooperative Forage Eco-Producing Cooperative High quality forage based rations Comfort bedding systems Sexed Semen & Embryo Transfer Advanced Milking Facility TMR Supply Facility Waste Management Semi-quarantine disease control Regional Centre Management & Service Centre OEM Dairy Processing Dairy Farm Dairy Farm Dairy Farm Dairy Farm 6.2“N+1”Kernel IEDC Model
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145. advancing drugs effectively Q4/2008 Sean Thompson VP Corporate Development Research to Revenue IV Mississauga Living Arts Centre December 3, 2008 S. Korea Japan Australia Singapore Indonesia EU USA Canada
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151. Nimotuzumab Affinity-Optimized™ mAb High Affinity anti-EGFR mAbs Activity of Nimotuzumab is Concentrated at Tumor Activity of High Affinity anti-EGFR mAbs is dispersed across all tissues, causing toxicity Tumor (High EGFR) Tumor (High EGFR) Nimotuzumab – Mechanistically Differentiated
152. 1 Information from four completed trials; data collection ongoing. 2 FDA Action Letter, June 2008 3 STEPP trial – 2008 – 29% post-preemptive treatment 4 Erbitux® Package insert. Revised: 11/2008 5 Article in Press: Giro C et al , Radiother Oncol (2008), doi:10.1016/j.radonc.2008.09.007 Erbitux ® and Vectibix ® Have Significant Toxicities NA NA VERY RARE 49% 5 Rad. Dermatitis—Grades 3 and 4 0% 62% 3 VERY RARE 25% 2 Rash - Grades 3 and 4 2% 57% VERY RARE 16% Pruritus 29% 35% 19% 49% 55% 4 87% Erbitux ® plus Radiation 12% 19% 14% Vomiting 9% 21% 14% Constipation 1% 21% 9% Diarrhea 16% 23% 22% Nausea 2% 39% VERY RARE Hypomagnesemia – all grades 6% 90% 9% Rash - All grades BSC Alone Vectibix ® plus BSC Nimotuzumab plus Radiation
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154. Clinical Evidence >30 Trials in Ten Tumor Types Overall survival placebo + RT = 8.67 months Nimotuzumab + RT = 16.43 months Interim analysis of 65/80 patients to complete the trial Phase III RT +/- nimotuzumab Glioma GBM Stratum Twenty patients (83%) – CR or PR. The median overall survival (n=24) was 51.7 months. In publication Phase II single-arm 100 and 200 mgs H & N (locally advanced) CR 91% vs. 52% at 17 weeks Marketing Approval by Health Regulatory Authorities in China Randomized Phase II RT +/- nimotuzumab Nasopharyngeal Significant tumor response rates (CR/ORR) compared to RT alone and to CT + RT alone. Marketing Approval by Health Regulatory Authorities in India Multi-modal 4-arm Phase II CT/CRT +/- nimotuzumab H & N Stage III & IVA unresectable (BEST trial) CR+PR+SD 92% vs. 44% OS 7 months vs. 2.5 months Preliminary analysis (EORTC/NCI/AACR October 2008) Randomized Phase II RT +/- nimotuzumab Brain Metastases from NSCLC Substantial radiological responses and meaningful clinical responses in each cohort. Median survival of three cohort equals 60 weeks. ASCO June 2008 & Preliminary data on 2 nd cohort Palliative Phase I/II Single-arm Patients unsuitable for radical therapy NSCLC
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156. Nimotuzumab – Preferential Positioning High Unmet Need – Low 5 Year Survival Large Markets – More than 1 million patients globally Target indications driven by mechanistic and clinical observations 29,000 114,000 171,000 25% Gastric 16,000 14,000 48,000 16% Esophageal 42,000 15,000 98,000 60% H&N 52,000 16,200 71,000 15% Brain Mets (NSCLC) 166,000 52,000 229,000 15% NSCLC 4,800 1,000 12,600 25% Glioblastoma NA Patients Japanese Patients European Patients 5 yr Survival Indication
157. Nimotuzumab – YM Global Marketing Rights Japan Korea Australia/New Zealand North America Southeast Asia Europe Africa YM BioSciences nimotuzumab marketing rights
158. Nimotuzumab – Business Development in Asia H&N (06) India Jun-04 India, PK not filed Jul-06 Japan Glioma (08) Indo, Philippines Nov-05 SE Asia not filed Jun-05 S Korea Indication Market Approval Date Territory Licensee
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160. Nimotuzumab Clinical Trials Ongoing trial Completed trial Indication Phase I Phase II Phase III Sponsor Pediatric Diffuse Intrinsic Pontine Glioma Phase III trial reporting mid-2008 Oncoscience AG Adult Glioma Oncoscience AG Pancreatic Cancer Oncoscience AG Head & Neck Cancer YM BioSciences Pediatric Glioma (High Grade) Phase II data submitted to EMEA Oncoscience AG Pancreatic Cancer Oncoscience AG Pediatric Diffuse Intrinsic Pontine Glioma YM BioSciences Colorectal Cancer YM BioSciences Non-Small Cell Lung Cancer YM BioSciences Japanese Safety Study Daiichi-Sankyo Pharmacodynamic Study YM BioSciences Esophageal Cancer CIM / Eurofarma Squamous Cell Carcinoma of the Head & Neck Innogene Kalbiotech Gastric Cancer (Advanced, Recurrent) Daiichi-Sankyo /Kuhnil Pediatric Brain Stem Tumors YM BioSciences Expanded Access Program - USA
163. From Research to Revenue IV: Capturing Business Opportunities in Asia From Research to Revenue IV: Capturing Business Opportunities in Asia
164. From Research to Revenue IV: Capturing Business Opportunities in Asia Impact of Regulations: How They Affect People on the Ground Moderator: John Kelly, MaRS Landing Valerie Bell, Bell Alliances International Ashley Roberts, Cantox Xuefeng Yu, sanofi pasteur Paul Jones, Jones & Company
172. CHINESE FOOD REGULATORY REQUIREMENTS Ashley Roberts, Ph.D. Cantox Health Sciences International From Research to Revenue IV: Capturing Business Opportunities in Asia Mississauga Living Arts Centre, Mississauga, Ontario December 3, 2008
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181. INTELLECTUAL PROPERTY PROTECTION IN CHINA: Best Practices 知识产权的保护在中国 : 最佳做法 Paul Jones Jones & Co. 钟保禄律师事务所 Джоунс и Ко. www.jonesco-law.ca Research to Revenue The Biotechnology Initiative December 3, 2008
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212. INTELLECTUAL PROPERTY PROTECTION IN CHINA: Best Practices 知识产权的保护在中国 : 最佳做法 Paul Jones Jones & Co. 钟保禄律师事务所 Джоунс и Ко. www.jonesco-law.ca Research to Revenue The Biotechnology Initiative December 3, 2008
213. From Research to Revenue IV: Capturing Business Opportunities in Asia From Research to Revenue IV: Capturing Business Opportunities in Asia