Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
• • • • Merck Overview Merck Research Laboratories Partnerships and Licensing Policy and other 1 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 2 Merck-Medco Merck Research Managed Care Laboratories (MRL) Independently Operated and Managed Manufacturing Division J&J•Merck Consumer Pharmaceuticals Merial Limited Merck and Schering-Plough JVs Human Health Division • The Americas • Europe/Middle East/Africa • Asia Pacific Vaccine Aventis Pasteur MSD Division 3 Sales by Therapeutic Class 2001 Human Health Sales $21.3 Billion Ophthal HIV 2% Vaccine/ Antibiotics 3% Biologicals 3% 5% Asthma 6% Elevated Cholesterol 26% Other Merck 8% Osteoporosis 8% Arthritis 11% 2 of the top 5 products were discovered in the Montreal Lab of MRL VIOXX* and SINGULAIR* Hypertension/ Heart Failure 17% Anti Ulcerants 11% 4 Merck Research Laboratories and Product Development 5 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) 6 Merck Research Laboratories Locations Includes multi-billion dollar capital building campaign in West Point, Pa and New Jersey Montreal, Canada Rahway, N.J. • • • • • • Metabolic disorders Atherosclerosis Infectious Diseases Inflammation Endocrine/Metabolic Animal Sciences • Respiratory, Asthma, Allergy, Inflammation, Osteoporosis • Virology Oncology Neurosciences - Sibia Rosetta Inpharmatics, WA* • Genomics Terlings Park, UK • Neurosciences Chibret Lab, France • Madrid, Spain CIBE Coming in 2004 San Diego, CA* West Point , PA Cardiovascular Ophthalmics Bone Biology Vaccines & Antivirals Oncology Neurosciences • • Boston, MA* • • • • • • • IRBM, Italy • Screening Banyu Res. Labs, Japan • • • Cardiovascular Infectious Diseases Endocrine/Metabolic Plus Clinical Research Worldwide and Regulatory Safety Assessment 7 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 Licensed Products, Patents and Formulations ~ 32% 2001 Merck Human Health Sales $21.3 Billion Others 1017695 14 Merck’s Licensing Arrangements Important Therapeutic Areas 1999 – 2001 Complementing Current Areas • Cholesterol • Schering Plough • Respiratory • Schering Plough • HIV • CAT • Crucell • CytRx • Antibacterials • Elitra • Osteoporosis • Axys • Ophthalmics • Cole Eye Institute Expanding Into New, Large Areas • Diabetes • ISIS • Kyorin • Neuroscience • NeuroTargets • SIBIA • Influenza • Biodiem • HCV • ISIS 15 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 • Drug Delivery • Elan/Nanosystems • Flamel • Symyx • Lead Identification • NeoGenesis • Assay Development • Chromagen • Chemical Libraries • Array Biopharma, Chembridge, Discovery Partners • Knock Out Mice • Deltagen • Biologics • ProBioGen 16 Our Network of Relationships* AstraZeneca INVANZ® Yamanouchi / J&J PEPCID®/PEPCID AC®/ PEPCID COMPLETE® BMS (formerly Dupont Pharma) COZAAR®/HYZAAR® Gentili FOSAMAX® Preclinical/Clinical Development Schering-Plough Vical Isis Kyorin CSL Biodiem Basic CHOP/Wistar Institute Research Celltech Collaborations Formulation and Delivery Technologies CAT ProBioGen Elitra Elan/Nanosystems Celera KaroBio Isis RP Scherer Enabling/Platform Cole Eye Institute Kyorin Flamel Technologies NeuroTargets ® NOROXIN CytRx NeoGenesis Array Exelixis Aurora Symyx Osaka Univ. / Biken CMMT Cellomics Incyte Proteome DoubleTwist Lexicon Crucell VARIVAX® Chembridge LifeSpan Harvard Biogen/Chiron/Genentech Albany Molecular Sangamo Chromagen Amersham U. Cal/U. Wash/Inst. Pasteur Genzyme Evotec Deltagen Hep B vaccine/COMVAX® Discovery Partners Affymetrix *Disclosed agreements 17 Merck is a Flexible, Experienced, and Committed Partner Merck 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 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 • • • • • • • • 1017504 Molecular Profiling Neuroscience New Vaccine Technology Ophthalmic Research Technology Respiratory Urology/Dermatology Women's/Men's Endocrinology Worldwide Licensing & External Research Expertise to bring the best in science to Merck Mr. Richard Kender Dr. Bennett M. Shapiro Vice Pres. Corporate & Business Development Executive Vice Pres. Worldwide Licensing & External Research Dr. Greg Wiederrecht Ms. Barbara Yanni Transaction Leaders • Project Lead/Negotiator Executive Director External Scientific Affairs Information Group Chief Licensing Officer NCEs and New Biologicals [email protected] Research Technologies Relationship Management • Relationship Development and Management Transaction Services • Project/Company/Analysts Platform Research Technologies • Chemistry, Screening, Pharmacogenetics Dr. Lewis R. Mandel Emeritus Academic Programs 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 [email protected] 24 Back up 25 Policy Goal Stimulate Economic Development FEDERAL FACTORS Intellectual Property Protection Regulatory Approval Reasonable Pricing PROVINCIAL FACTORS Quality of R&D and R&D Infrastructure Market Access • Talent • Listing • Public $ Support • Recognize • Tax Incentives Innovation 26 Policy Goal Stimulate Economic Development RDP - BC Investment Performance PMPRB Reported Investments ($ millions) $80 Total Investment PMPRB per capita - 2000 $60 20.0 $40 14.4 15.0 $20 1 8 8.2 10.0 $0 9 18.2 9 1 9 9 0 1 9 9 1 1 9 9 2 BC 1 9 9 3 1 9 AB 9 4 1 9 9 5 SK 1 9 9 6 1 MB 9 9 7 1 9 9 8 1 BCXP 9 9 9 2 0 0 0 7.3 5.0 0.0 MB AB MB SK AB SK BC BC 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) 2001 2000 1999 1998 1997 1996 Sales $47.7 $40.4 $32.7 $26.9 $23.6 $19.8 Merck 21.3 20.2 17.3 15.3 14.2 12.7 Merck-Medco 26.4 20.2 15.4 11.6 9.4 7.1 R&D Net Income EPS $2.5 $2.3 $2.1 $1.8 $1.7 $1.5 $7.3 $6.8 $5.9 $5.2 $4.6 $3.9 $3.14 $2.90 $2.45 $2.15 $1.87 $1.56 Employees (000's) Total 78.1 Research 11.9 69.3 10.4 63.2 8.9 57.3 8.5 53.8 7.5 96/01 CAGR 19% 11% 30% 11% 13% 15% 49.1 7.0 29 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 30 Is Drug Discovery hard? 15 Introduction Registration Product Surveillance Phase IV 1 2 Years Development 2-5 Phase III Clinical Tests (Human) 5 Basic Research 0 Phase II Phase I 5,000 Substances Preclinical Tests (Animal) ????? Substances Synthesis Examination & Screening Source: PhRMA 31 Shrinking period of market exclusivity between introduction of a breakthrough medicine and competing innovators Innovative Drug/Year of Introduction Follower Drug Inderal - 1965 101978 Tagamet - 1977 1983 - Zantac 6 Capoten - 1980 - Lopressor 1985 - Vasotec 5 Seldane - 1985 4 1989 - Hismanal AZT - 1987 4 1991 - Videx (ddl) Mevacor - 1987 4 1991 - Pravachol Prozac - 1988 4 1992 - Zoloft Diflucan - 1990 1992 - Sporanox 2 Recombinate - 1992 1992 - Kogenate 1 Invirase - 1995 1996 - Norvir 0.25 0 2 4 6 8 10 32 The Mission of Merck Research Laboratories Discover & Develop Breakthrough Medicines in Major Areas of Unmet Medical Need 33 Alliances – A Critical Role Compound Field Mechanism NDA Submitted Zetia™ Cholesterol Cholesterol Absorption Inhibitor Phase III Arcoxia™ MK-869 MK-869 Arthritis Emesis Depression Second Entry Cox-2 Inhibitor Substance P Antagonist Substance P Antagonist Phase II or Later KRP-297 Anxiolytic Anti-Inflammatory Diabetes Anxiety COPD, Asthma Dual-acting Glitazone GABA-A α2/α3 Agonist PDE-IV Vaccines Herpes Zoster HIV/AIDS HPV Rotavirus Shingles AIDS Cervical Cancer Infant diarrhea Resulting from alliance/licenses 34