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

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Presentation on theme: "1 Merck Overview Merck Research Laboratories Partnerships and Licensing Policy and other."— Presentation transcript:

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

2 2 Merck’s Philosophy Mission of Merck Research Laboratories Discover & Develop Breakthrough Medicines in Major Areas of Unmet Medical Need 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

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

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

5 5 Merck Research Laboratories and Product Development

6 6 Merck Research Laboratories R&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 7 Rosetta Inpharmatics, WA* Genomics Merck Research Laboratories Locations Includes multi-billion dollar capital building campaign in West Point, Pa and New Jersey Rahway, N.J. Metabolic disorders Atherosclerosis Infectious Diseases Inflammation Endocrine/Metabolic Animal Sciences Montreal, Canada Respiratory, Asthma, Allergy, Inflammation, Osteoporosis Cardiovascular Ophthalmics Bone Biology Vaccines & Antivirals Oncology Neurosciences West Point, PA Boston, MA* Coming in 2004 Terlings Park, UK Neurosciences Chibret Lab, France Safety Assessment IRBM, Italy Virology Oncology Madrid, Spain CIBE Screening Banyu Res. Labs, Japan Cardiovascular Infectious Diseases Endocrine/Metabolic Plus Clinical Research Worldwide and Regulatory San Diego, CA* Neurosciences - Sibia

8 8

9 9 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!

10 10 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?

11 11 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?

12 12 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

13 13 Licensing at Merck

14 1017695 14 Including: COZAAR / HYZAAR FOSAMAX PEPCID PRILOSEC RECOMBIVAX HB VARIVAX MAXALT RPD Formulation Others Licensed Products, Patents and Formulations ~ 32% 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 2001 Merck Human Health Sales $21.3 Billion

15 15 Merck’s Licensing Arrangements Important Therapeutic Areas 1999 – 2001 Cholesterol Schering Plough Respiratory Schering Plough Antibacterials Elitra Osteoporosis Axys Ophthalmics Cole Eye Institute Complementing Current Areas Expanding Into New, Large Areas Influenza Biodiem HCV ISIS Diabetes ISIS Kyorin HIV CAT Crucell CytRx Neuroscience NeuroTargets SIBIA

16 16 Merck’s Licensing Arrangements Target Cutting Edge Science 1999 – 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 Biologics ProBioGen Drug Delivery Elan/Nanosystems Flamel Symyx

17 17 Our Network of Relationships* *Disclosed agreements 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 ® CHOP/Wistar Institute Vical CSLBiodiem Kyorin Schering-Plough Preclinical/ClinicalDevelopment Isis Celltech CAT ProBioGen Elitra Celera KaroBio Isis Cole Eye Institute NeuroTargets NeoGenesis CMMT Basic Research Collaborations Enabling/PlatformTechnologies Array Exelixis Aurora Cellomics Incyte Proteome DoubleTwist Lexicon Crucell Chembridge LifeSpan Harvard Albany Molecular Sangamo Chromagen Amersham Genzyme Evotec Deltagen Discovery Partners Affymetrix Elan/Nanosystems RP Scherer Flamel CytRx Symyx Formulation and Delivery Technologies

18 18 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 Merck is a Flexible, Experienced, and Committed Partner Merck is Constantly and Proactively Seeking New External Opportunities

19 1017504 Review and Licensing Committees 17 Review and Licensing Committees targeting Therapeutic Areas & Technologies Anti-Infectives Antiviral Biologics and Antibodies Cancer Cardiovascular Diabetes, Obesity and Atherosclerosis Drug Delivery Gastrointestinal Immunology and Rheumatology Molecular Profiling Neuroscience New Vaccine Technology Ophthalmic Research Technology Respiratory Urology/Dermatology Women's/Men's Endocrinology

20 20 Worldwide Licensing & External Research Expertise to bring the best in science to Merck Mr. Richard Kender Vice Pres. Corporate & Business Development Information Group Project Lead/Negotiator Transaction Services Project/Company/Analysts Dr. Bennett M. Shapiro Executive Vice Pres. Worldwide Licensing & External Research Dr. Greg Wiederrecht Executive Director External Scientific Affairs NCEs and New Biologicals Research Technologies Dr. Lewis R. Mandel Emeritus Academic Programs Chemistry, Screening, Pharmacogenetics Platform Research Technologies Relationship Development and Management Relationship Management Ms. Barbara Yanni Chief Licensing Officer Transaction Leaders

21 21 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

22 22 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

23 23 “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

24 24 Patrick Lauzon Manager of Corporate Affairs Merck Frosst Canada Ltd 11131 Hammersmith Gate Richmond BC V7A 5E6 (604) 536-4228 For more about Merck & Co. and Merck Frosst Canada Ltd For more about Merck & Co. and Merck Frosst Canada Ltd

25 25 Back up

26 26 FEDERAL FACTORS Intellectual Property Protection Regulatory Approval Reasonable Pricing PROVINCIAL FACTORS Quality of R&D and R&D Infrastructure Market Access Talent Public $ Support Tax Incentives Listing Recognize Innovation Policy Goal Stimulate Economic Development

27 27 RDP - BC Investment Performance 18.2 14.4 8.2 7.3 PMPRB 2001 Policy Goal Stimulate Economic Development

28 28 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

29 29 Financial Highlights ($ in billions except EPS)

30 30 Merck Frosst Centre for Therapeutic Research Research interests Asthma & Allergies Biology of leukotrienes PDE4 inhibitors Inflammation Biology of prostaglandins Biology of apoptosis Osteoporosis CatK inhibitors

31 31 Is Drug Discovery hard? 0 15 Introduction Registration Development Basic Research 1 2 2-5 5 5,000 Substances ????? Substances Product Surveillance Clinical Tests (Human) Preclinical Tests (Animal) Synthesis Examination & Screening Phase IV Phase III Phase II Phase I Source: PhRMA Years

32 32 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 Innovative Drug/Year of IntroductionFollower Drug

33 33 The Mission of Merck Research Laboratories Discover & Develop Breakthrough Medicines in Major Areas of Unmet Medical Need

34 34 Alliances – A Critical Role Resulting from alliance/licenses

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