wyeth Download Documentation Credit Suisse Group Healthcare Conference


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wyeth Download Documentation Credit Suisse Group Healthcare Conference

  1. 1. Credit Suisse Healthcare Conference Michael E. Kamarck, Ph.D. Executive Vice President, Technical Ops and Product Supply November 12, 2008
  2. 2. Forward-Looking Statement The statements in this presentation that are not historical facts are forward- looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to the NDA filings for Wyeth’s pipeline products referenced in this presentation), drug pricing and payment for Wyeth’s products by government and third-party payers, manufacturing, data generated on the safety and efficacy of Wyeth’s products, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, and other risks and uncertainties, including those detailed from time to time in Wyeth’s periodic reports filed with the Securities and Exchange Commission, including Wyeth’s current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, particularly the discussion in Wyeth’s annual report on Form 10-K under the caption quot;Item 1A, Risk Factors.quot; Wyeth assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
  3. 3. A Diversified Biopharmaceutical Company
  4. 4. Wyeth’s Diversification … A Key Asset Diverse Scientific Platforms n 100% 5% Pharmaceuticals, Biotechnology, 12% Vaccines 80% 7% 60% Non- % of Revenue Diverse Business Platforms n Traditional 60% 36% Biotech, Vaccines, Nutritionals, Pharma Consumer Healthcare, Animal Healthcare = 60% of Revenue in 40% 2008 20% Growing to 75% by 2012 40% Diverse Therapeutic n 0% Approaches YTD 2008 Treatment vs. Disease Prevention Preventative Therapies - Human and Animal Vaccines, Infant Formula, Vitamins, Supplements Pharma Biotech/Vaccines Nutritionals Consumer Animal Health
  5. 5. Core Biotech/Vaccine Franchises with High Growth Potential ® ~$6 Billion Global Sales in 2008 31 National Immunization n n Programs in Place … on the #1 Worldwide Biotech Brand n Market in 89 Countries $10 Billion RA/Psoriasis n Prevnar 13 Filing for Infants 2009; n Biological Market Expansion by For Adults 2010 2012 Manufacturing Capacity Strong n Maintain #1 Position in Category n and Growing Due to Established Safety and 60 Million Doses in 2008 Efficacy Profile Future Manufacturing Capacity growing to 120 Million Doses Wyeth - A Leading Biotech Company Globally Biotech/Vaccine Revenue YTD08 = $6.3 Billion, +20%
  6. 6. Wyeth Biopharma Manufacturing Diverse Manufacturing Platforms With Industry Leading Capacities and Capabilities
  7. 7. Traditional Pharma vs. Biotech Drugs/Vaccines Biotech Drugs & Traditional Pharma New Generation Vaccines Small Chemical Size and Complexity 100 to 1000X Larger Molecules Manufactured By Chemistry By Living Cells Chemical Conditions All Steps Support Sterility of Process Often Kill Bacteria Bacterial Growth Usually Tablets Injected or Other Delivery Mechanism or Capsules Special Delivery Maturity of Industry >100 Years ~25 Years Wyeth Has Been A Leader in Biotech Manufacturing Since 1983
  8. 8. Wyeth Biotech Network Algete Andover Grange Castle Pearl River Sanford Havant ESN Spain MA Ireland NY NC UK 3rd Parties We Have Invested Over $3.5 Billion in Network Infrastructure n Between 2000 and 2007 in Support of Product Launch and Growth In Parallel, We Have Focused on Process Development Working on n the Premise That “Biology Will Trump Stainless Steel” With These Improvements, the Existing Infrastructure Can Sustain n the Continued Growth
  9. 9. Biotech Process Development Over 25 Years of Biotech n Development Experience >500 R&D Scientists 30 Different Protein Products n Brought Into the Clinic Drug Substance and Drug Product n Development Facilities Research Labs – 140,000 Sq Ft Pilot Scale Laboratories in the U.S. and Ireland Clinical Manufacturing Facilities – in MA and NC
  10. 10. Cell Line Development Pre-adapted CHO Host n Industrialized and Automated Cell n Line Development and Construction Proprietary Fermentation n Technology Increases Outputs From: 0.5 – 1 g/l – 2001 1 – 3 g/l – 2002 3 – 5 g/l – 2004 10 g/l – 2007 “[in May this year] Wyeth recently created a cell culture system that can generate 9 grams of protein per liter of culture. Just four years ago, the standard was 1 gram per liter.” Nature Biotechnology, September 2006
  11. 11. Bioreactor and Purification Process Development Bioreactor Technology n Proprietary, Defined Medium (Animal Protein-free) Capable of Supporting Highest-density Cultures Purification Technology n Proprietary 2-column MAb Purification Process Seamless Technical Transfer of Process n From Lab Bench to Manufacturing
  12. 12. Clinical Production Suites 38,000 sq ft cGMP Multi- n product Manufacturing Equipment/cGMP Systems n to Manufacture Two Products Simultaneously Cell Culture Bioreactor Hall n 1 X 6000 L 2 X 2500 L 1 X 500 L Purification “Suites” Match Bioreactor Capacity n Support up to Ten Campaigns Per Year for Both Clinical n and Future Commercial Products
  13. 13. Industry-Leading Platform Technology Upstream and Downstream Standard Process Platform Established n All Cell Lines Derived From Same Host All Proteins Produced From the Identical Process Flow Using the Same Raw Materials, Filters, Buffers, Resins 35% Reduction in Gene to IND Timeline – Product Changeover in Days n Single Facility Configuration Can Manufacture All Pipeline and n Commercial Products Wyeth Received the 2008 ACS Industrial Biotechnology Award Given by n the Biotechnology Division of the American Chemical Society Honoring Distinguished Industrial Accomplishments in Biotechnology Awarded to Wyeth: “in Recognition of Their Achievements in n Implementing Industry-leading Platform Technology”
  14. 14. Biology Trumps Stainless Steel Our Investments Are in Process n Standardization and Upstream/downstream Process Efficiencies and Yields We Have Implemented the n Platform For All Our Pipeline Products We Have Established a n Proprietary Portfolio of Process Technologies We Have Utilized Our Technology n Advances in Improving Our Existing Commercial Products
  15. 15. Biology Trumps Stainless Steel: Commercial Examples Product New Yields Approval Date Feb 2008 - EMEA Enbrel 150% Feb 2008 - US Xyntha 200% Nov 2007 – EMEA BMP-2 >200% March 2008 - US Meets Projected Upside Demand Without Additional n Capital Investment Increases Capacity for Pipeline Products n Improves Plant and Product Cost Structure n
  16. 16. ® Have Developed Process for Prevnar 13v n Produced 13v Clinical Trial Material; Phase 3 Trials Have Been n Successfully Completed Invested in Staff and Equipment in Five Facilities in Support of n Launch In 2008, We Manufactured Launch Supply of 13v From All n Facilities We Have Completed 1200 Technical Documents in Support of Our n Filing for Infants … Planned by Early 2009 We Have Identified Process Improvements to Allow Us to n Ultimately Manufacture up to 120 MM Doses of 13v From Our Existing Facilities
  17. 17. Standardized Technology Platforms for Traditional Pharma Products Minimize Capital Investment Through Utilization of One n Multi-product Launch Module vs. Building Multiple Product-dedicated Modules Improve Existing Large Volume Asset Utilization by n Leveraging Existing Infrastructure Customizing API to Drive Standard Formulations n Improve Our Flexibility to Expand/Contract Capacity in n Alignment With Product Life Cycle Align With the Proven Value Demonstrated in Biotech n Standardization
  18. 18. Standard Platforms Selected Based on Long Term Manufacturing Ease and Network Fit H Tablet: Tablet: Wet Direct granulation compression Modify Excipients or Network API Properties (Co-Labs) Fit Capsule: Liquid filled Modify or Outsource Special Formulation Requirements L H Manufacturing Ease/Cost Advantage
  19. 19. Wyeth: Positioning Itself for Future Growth Diversified by Business n Prescription, Consumer, Animal Health Primary Product Engines Continue to Offer Growth Opportunities n Enbrel, Prevnar, Nutritionals New Product Launches Contributing to Revenue Growth n Proven Capability in Three R&D Platforms and Proven Ability to n Successfully Commercialize and Efficiently Manufacture Biotech, Vaccine and Traditional Pharma Pipeline Offers Range of Options Including Both Near-Term and n Blockbuster Candidates Positioned to Take Advantage of Global Growth Opportunities n Wyeth: A Diversified Biopharmaceutical Company