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Merck Overview Merck Research Laboratories Partnerships and Licensing Policy and other

Merck Overview Merck Research Laboratories Partnerships and Licensing Policy and other . Merck’s Philosophy. Our philosophy is to bring medical excellence to the patient by being First in Class or Best in Class and Demonstrating the Value to Patient, Payor and Provider.

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Merck Overview Merck Research Laboratories Partnerships and Licensing Policy and other

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  1. Merck Overview • Merck Research Laboratories • Partnerships and Licensing • Policy and other

  2. Merck’s Philosophy Our philosophy is to bring medical excellence to the patient by being First in Class or Best in Class and Demonstrating the Value to Patient, Payor and Provider Mission of Merck Research Laboratories Discover & Develop Breakthrough Medicines in Major Areas of Unmet Medical Need

  3. Merck-Medco Managed Care Merck Research Laboratories (MRL) Independently Operated and Managed Manufacturing Division J&J•Merck Consumer Pharmaceuticals Human Health Division Merial Limited • The Americas • Europe/Middle East/Africa • Asia Pacific Merck and Schering-Plough JVs Vaccine Division Aventis Pasteur MSD

  4. Sales by Therapeutic Class 2001 Human Health Sales $21.3 Billion 2 of the top 5 products were discovered in the Montreal Lab of MRL VIOXX* and SINGULAIR*

  5. Merck Research Laboratories and Product Development

  6. Merck Research LaboratoriesR&D $2.9bil 2002 (+16% ; CAGR 12% ‘85-’01) • 11,900 research employees (over 2000 doctorals) - 300 with advanced degrees at MRL Montreal • Several thousand publications per year (including joint) • 250-300 patent applications per year • Global R&D efforts in a range of therapeutic classes • Over 100 NDAs approved since 1963 (Regulatory)

  7. Merck Research Laboratories LocationsIncludes multi-billion dollar capital building campaign in West Point, Pa and New Jersey Montreal, Canada Rahway, N.J. IRBM, Italy • Respiratory, Asthma, Allergy, Inflammation, Osteoporosis • Virology • Oncology • Metabolic disorders • Atherosclerosis • Infectious Diseases • Inflammation • Endocrine/Metabolic • Animal Sciences Boston, MA* Madrid, Spain CIBE • Coming in 2004 San Diego, CA* • Screening • Neurosciences - Sibia Banyu Res. Labs, Japan West Point , PA Rosetta Inpharmatics, WA* • Cardiovascular • Infectious Diseases • Endocrine/Metabolic • Cardiovascular • Ophthalmics • Bone Biology • Vaccines & Antivirals • Oncology • Neurosciences • Genomics Terlings Park, UK Plus Clinical Research Worldwideand Regulatory • Neurosciences Chibret Lab, France • Safety Assessment

  8. Research Project Selection • Development Costly successful new drug costs up to $800 MM • Most Projects turn out to be flawed • pathophysiology of many human diseases is complex in etiology & poorly understood • Picking the right project is the key to success • and the hardest if you want to be an innovator! • easy if you are a follower!

  9. Research Project Selection • Is there a medical need? • what is the size of the population involved? • how serious is the problem? • what are the available therapies? • Is there a rational scientific approach? • is there a genetic or biochemical insight? • is there a specific target or pathway? • is there “proof of concept” available? • can it be an early goal of MRL Research?

  10. Research Project Selection • Is it chemically feasible? • Some targets are difficult to approach with small molecules • What is the long-term perspective? • takes > 10 years to discover and develop a drug. • What is the competitive environment? • can we be first to develop an innovative product • Do we have in-house expertise? • If not, how can we develop it; can we collaborate?

  11. Guiding Compounds Through Development • Project teams (Merck and joint with partners) - implement drug development; project teams are little companies within a large company • Commercialization-type teams - are charged with assuring that all company areas are aligned to make the product candidate a success (clinical research/ manufacturing/regulatory/ marketing) • Other Committees – cross-divisional Senior Management oversight and approvals • Large Clinical Outcomes Studies - Demonstrate the Value of Merck Products

  12. Licensing at Merck

  13. Licenses played an important to critical role in 7 of the 17 new product approvals since 1995 About one-third of Human Health Sales are attributed to licensed products, patents or formulations Including: COZAAR / HYZAAR FOSAMAX PEPCID PRILOSEC RECOMBIVAX HB VARIVAX MAXALT RPD Formulation Others Licensed Products, Patents and Formulations ~ 32% 2001 Merck Human Health Sales $21.3 Billion 1017695

  14. Merck’s Licensing Arrangements Important Therapeutic Areas1999 – 2001 Complementing Current Areas • Antibacterials • Elitra • Osteoporosis • Axys • Ophthalmics • Cole Eye Institute • Cholesterol • Schering Plough • Respiratory • Schering Plough • HIV • CAT • Crucell • CytRx Expanding Into New, Large Areas • Diabetes • ISIS • Kyorin • Neuroscience • NeuroTargets • SIBIA • Influenza • Biodiem • HCV • ISIS

  15. Merck’s Licensing Arrangements Target Cutting Edge Science1999 – 2001 • Pharmacogenomics • Rosetta Inpharmatics • Genomics/Proteomics • DoubleTwist, LifeSpan, Amersham Pharmacia, Proteome • Gene Tools/Targeting • Lexicon, Sangamo, Affymetrix • Lead Identification • NeoGenesis • Assay Development • Chromagen • Chemical Libraries • Array Biopharma, Chembridge, Discovery Partners • Knock Out Mice • Deltagen • Drug Delivery • Elan/Nanosystems • Flamel • Symyx • Biologics • ProBioGen

  16. Basic Research Collaborations Formulationand Delivery Technologies CAT ProBioGen Elitra Celera KaroBio Isis Cole Eye Institute NeuroTargets NeoGenesis CMMT Elan/NanosystemsRP SchererFlamelCytRxSymyx Enabling/Platform Technologies Array Exelixis Aurora Cellomics Incyte Proteome DoubleTwist Lexicon Crucell Chembridge LifeSpan Harvard Albany Molecular Sangamo Chromagen Amersham Genzyme Evotec Deltagen Discovery PartnersAffymetrix Our Network of Relationships* AstraZeneca INVANZ® Yamanouchi / J&J PEPCID®/PEPCID AC®/ PEPCID COMPLETE® BMS (formerly Dupont Pharma) COZAAR®/HYZAAR® Gentili FOSAMAX® Kyorin NOROXIN® Osaka Univ. / Biken VARIVAX® Biogen/Chiron/Genentech U. Cal/U. Wash/Inst. Pasteur Hep B vaccine/COMVAX® Preclinical/Clinical Development Schering-Plough Vical Isis Kyorin CSL Biodiem CHOP/Wistar Institute Celltech *Disclosed agreements

  17. Merck is a Flexible, Experienced, and Committed PartnerMerck is Constantly and Proactively Seeking New External Opportunities • Each external relationship receives high priority at all levels of Merck, • Compounds resulting from external arrangements are fully integrated into the Merck drug development process with the same level of rigor and resources as internally discovered product candidates

  18. Review and Licensing Committees17 Review and Licensing Committees targeting Therapeutic Areas& Technologies • Molecular Profiling • Neuroscience • New Vaccine Technology • Ophthalmic • Research Technology • Respiratory • Urology/Dermatology • Women's/Men's Endocrinology • Anti-Infectives • Antiviral • Biologics and Antibodies • Cancer • Cardiovascular • Diabetes, Obesity and Atherosclerosis • Drug Delivery • Gastrointestinal • Immunology and Rheumatology 1017504

  19. Worldwide Licensing & External Research Expertise to bring the best in science to Merck Mr. Richard Kender Vice Pres.Corporate & Business Development Dr. Bennett M. Shapiro Executive Vice Pres. Worldwide Licensing & External Research Dr. Greg WiederrechtExecutive Director External Scientific Affairs Ms. Barbara Yanni Information Group Chief Licensing Officer NCEs and New Biologicals Transaction Leaders pamela_demain@merck.com • Project Lead/Negotiator Research Technologies Relationship Management • Relationship Development and Management Platform ResearchTechnologies • Chemistry, Screening, Pharmacogenetics Transaction Services Dr. Lewis R. MandelEmeritusAcademic Programs • Project/Company/Analysts

  20. Some other comments • Premier scientific research organization • Excellence in translating cutting-edge science into break-through medicines • Conferences, scientific meetings- two way • Journals, abstracts • Graduate school and post doc contacts important • Regulatory and access environment • Research a companies interests

  21. External Relationships Will Continue To Be Essential To Merck’s Success • Alliances at all stages of the discovery and development process will complement a robust and therapeutically diverse pipeline that will be a key driver to Merck’s success

  22. “We try never to forget that medicine is for the people. It is not for the profit. The profit follows, and if we have remembered that, they have never failed to appear” George E. Merck

  23. For more about Merck & Co. and Merck Frosst Canada Ltd merckfrosstlab.ca merckfrosst.ca merck.com Patrick Lauzon Manager of Corporate Affairs Merck Frosst Canada Ltd 11131 Hammersmith Gate Richmond BC V7A 5E6 (604) 536-4228 patrick_lauzon@merck.com

  24. Back up

  25. FEDERAL FACTORS PROVINCIAL FACTORS Intellectual Property Protection Regulatory Approval Quality of R&D and R&D Infrastructure Market Access Reasonable Pricing • Talent • Public $ Support • Tax Incentives • Listing • Recognize Innovation Policy Goal Stimulate Economic Development

  26. Policy Goal Stimulate Economic Development RDP - BC Investment Performance 18.2 14.4 8.2 7.3 PMPRB 2001

  27. Merck Research Laboratories • 2002 R&D Spending - Approx. US$2.9 Billion • 1985-2001 R&D Spending @ 12% CAGR • 8 (9) Basic Research Facilities Worldwide • >7000 Employees (>1600 doctoral) • Basic Research - >750 PhD-level Scientists • Global R&D Efforts Covering the Full Spectrum of Human Disease

  28. Financial Highlights ($ in billions except EPS)

  29. Merck FrosstCentre for Therapeutic Research • Research interests • Asthma & Allergies • Biology of leukotrienes • PDE4 inhibitors • Inflammation • Biology of prostaglandins • Biology of apoptosis • Osteoporosis • CatK inhibitors

  30. Introduction 15 Product Surveillance Phase IV Registration 1 Phase III 2 Clinical Tests (Human) Phase II 2-5 Development Years 5 Phase I Preclinical Tests (Animal) 5,000 Substances Synthesis Basic ????? Examination & Research Screening Substances 0 Source: PhRMA Is Drug Discovery hard?

  31. Innovative Drug/Year of Introduction Follower Drug Inderal - 1965 Tagamet - 1977 Capoten - 1980 Seldane - 1985 AZT - 1987 Mevacor - 1987 Prozac - 1988 Diflucan - 1990 Recombinate - 1992 Invirase - 1995 1978 - Lopressor 1983 - Zantac 1985 - Vasotec 1989 - Hismanal 1991 - Videx (ddl) 1991 - Pravachol 1992 - Zoloft 1992 - Sporanox 1992 - Kogenate 1996 - Norvir

  32. The Mission of Merck Research Laboratories Discover & Develop Breakthrough Medicines in Major Areas of Unmet Medical Need

  33. Alliances – A Critical Role Resulting from alliance/licenses

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