Presentation is loading. Please wait.

Presentation is loading. Please wait.

Merck Overview Merck Research Laboratories Partnerships and Licensing

Similar presentations

Presentation on theme: "Merck Overview Merck Research Laboratories Partnerships and Licensing"— Presentation transcript:

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

2 Mission of Merck Research Laboratories
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 Slide 9 New RXs for VIOXX are almost equal to Celebrex now and we expect to exceed them. Merck believes that VIOXX is Best in Class and is truly a once-a-day, whereas Celebrex may require dosing twice-a-day. First in Class MEVACOR®; HMG - CoARI in cholesterol lowering COZAAR®/HYZAAR®; Angiotensin II antagonist in hypertension FOSAMAX®; bisphosphonate in osteoporosis PROSCAR®; Type 2 5a-reductase inhibitor for BPH Best in Class ZOCOR® introduced after MEVACOR® VASOTEC® introduced after Capoten® VIOXX® introduced after Celebrex The Mission of Merck Research Laboratories

3 J&J•Merck Consumer Pharmaceuticals Merck and Schering-Plough JVs
Merck-Medco Managed Care Merck Research Laboratories (MRL) Independently Operated and Managed Manufacturing Division J&J•Merck Consumer Pharmaceuticals Human Health Division If you discuss Merck-Medco, stress that while it is owned by Merck, it is managed independently. J&J•Merck and Merial are joint ventures in which Merck has a 50% interest in each. J&J•Merck primarily sells OTC products including Pepcid AC. Merial is an animal health joint venture with Rhone-Poulenc (now Aventis). Merck contributed its AgVet business to the JV.. The new Merck/Schering-Plough JV’s are related to ezetimibe and respiratory deals. The cholesterol JV is called Merck/Scheing-Plough pharmaceuticals and the respiratory JV is called Schering-Plough/ Merck pharmaceuticals. The Merck side of this organization chart just identifies the major operating groups. 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 Slide 5 Most notable difference is growth of Arthritis category due to the success of Vioxx. Does not include Merck-Medco sales which are sales of non-Merck prescription drugs or benefit services. They are not disclosed on a therapeutic basis. Elevated Cholesterol - Zocor and Mevacor Ophthalmolgicals - Primarily Trusopt/Cosopt and Timoptic Vaccines/Biologicals - Primarily Recombivax HB (HepB), MMRII (Measles, Mumps, rubella), and Varivax (chickenpox) HIV - Crixivan (protease inhibitor) and Stocrin (non-nucleoside reverse transcriptase inhibitor) Osteoporosis - Fosamax Antibiotics - Primaxin, Noroxin, Mefoxin Hypertension/Heart Failure - Vasotec/Vaseretic, Cozaar/Hyzaar and Prinivil/Prinizide Arthritis - Vioxx Asthma - Singulair Anti-ulcerents - Pepcid Other Merck - everything else (the 32% of Prilosec sales are included in this number) 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 Laboratories R&D $2.9bil 2002 (+16% ; CAGR 12% ‘85-’01)
11,900 research employees (over 2000 doctorals) with advanced degrees at MRL Montreal Several thousand publications per year (including joint) patent applications per year Global R&D efforts in a range of therapeutic classes Over 100 NDAs approved since 1963 (Regulatory) MF Canada: Approximately 300 researchers with advanced degrees Ph.D., M.Sc., B.Sc. Chemistry, Biochemistry Molecular Biology, Medicine Pharmacology, Pharmacy Computer Science “Merck is the most impressive company in this analysis The regulatory team at Merck is clearly one of Merck’s most valuable assets”

7 Merck Research Laboratories Locations Includes 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 Metabolic disorders Atherosclerosis Infectious Diseases Inflammation Endocrine/Metabolic Animal Sciences Virology Oncology Boston, MA* Coming in 2004 Madrid, Spain CIBE 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 Research interests Asthma & Allergies Biology of leukotrienes PDE4 inhibitors Inflammation Biology of prostaglandins Biology of apoptosis Osteoporosis CatK inhibitors Multi-billion dollar capital building program (Rahway and West Point) Sibia acquisition (San Diego) Rosetta acquisition Boston site Genomics Terlings Park, UK Plus Clinical Research Worldwide and Regulatory Neurosciences Chibret Lab, France Safety Assessment

8 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

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 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 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 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 ZOCOR® Scandinavian Simvastatin Survival Study (4S) Heart Protection Study (HPS) VIOXX® Vioxx Gastrointestinal Outcomes Research (VIGOR) COZAAR® Losartan Intervention for Endpoint Reduction in Hypertension (LIFE) RENAAL OPTIMAL FOSAMAX® Fracture Intervention Trial (FIT) SINGULAIR® Several ongoing outcomes studies

13 Licensing at Merck

14 2001 Merck Human Health Sales $21.3 Billion
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% Merck has been involved in many licensing arrangements and alliances since the early 1980s. We have numerous successes in achieving the ultimate goal -- getting a product to the worldwide market in an efficient and effective way. From this slide, you can see that currently over 1/3 of Merck’s human health sales are attributed to external relationships - some in fields where we are world renown (cardiovascular products, for example) and others in areas where we have created the market worldwide and set the standard for this therapeutic area. (such as osteoporosis) 2001 Merck Human Health Sales $21.3 Billion

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

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 Drug Delivery Elan/Nanosystems Flamel Symyx Biologics ProBioGen

17 Preclinical/Clinical
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 CAT ProBioGen Elitra Celera KaroBio Isis Cole Eye Institute NeuroTargets NeoGenesis CMMT Basic Research Collaborations CHOP/Wistar Institute Elan/Nanosystems RP Scherer Flamel CytRx Symyx Formulation and Delivery Technologies Celltech Enabling/Platform Technologies Array Exelixis Aurora Cellomics Incyte Proteome DoubleTwist Lexicon Crucell Chembridge LifeSpan Harvard Albany Molecular Sangamo Chromagen Amersham Genzyme Evotec Deltagen Discovery Partners Affymetrix Build 1: (existing partners) Over the years, we have developed a broad network of relationships, in various areas -including collaborations on compounds in preclinical and clinical development, basic research collaborations leading to compound discovery and development, numerous enabling and platform technologies, many in chemistry and genomics, and finally a variety of delivery technologies to enhance current products. Build 2: (overlay of licensed products that have been marketed) Now you see as well those products resulting from licensing that have been successfully commercialized. We believe we are very successful at arriving at this ultimate objective - to market products on a worldwide basis and optimize their commercial potential. We undertake global clinical development programs with a high degree of speed and accuracy to obtain the broadest claim structure possible. Then we support our products throughout their life cycle with additional claims as well as to demonstrate their economic value to payers, providers, and patients worldwide. *Disclosed agreements

18 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 Once we execute the agreement, we pride ourselves on giving each external relationship high priority at all levels of Merck, regardless of whether the agreement is in discovery research, development or marketing. Compounds that come from external relationships are fully integrated into the Merck drug development process with the same level of rigor and resources as internally discovered product candidates. Merck is Constantly and Proactively Seeking New External Opportunities Keen awareness and constant review of the discoveries and developments across the entire drug discovery and development community Formal review and response for every opportunity A well established and efficient process An expert group focused on the scientific and commercial aspects of each opportunity External Research Team mobilizes senior management from various disciplines Highly skilled personnel in the negotiation, structure and management of alliances

19 Review and Licensing Committees 17 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 Our process is well defined and clear. We focus on a constant review of all discoveries and developments across the entire drug discovery and development community. All opportunities are reviewed by 17 Review and Licensing Committees targeting all major therapeutic areas and technologies, including genomics and gene therapy. We formally review and respond to each and every opportunity. Once we select an opportunity to move forward on, we have very senior level personnel on both the scientific side and commercial side to move the negotiations forward quickly and efficiently to completion. We also have the full and focused attention of Senior Management to arrangements being brought forward.

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

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 We pride ourselves on being a preferred partner, with major benefits to offer. Our premier scientific research organization has great success in translating cutting edge science into breakthrough medicines, our industry leading product development group offers great efficiencies and an excellent track record with regulatory authorities around the world, we offer an extensive manufacturing infrastructure, and demonstrated worldwide and world class marketing capabilities (recently demonstrated by the launch of VIOXX). Finally, we’re an extremely stable partner with a dedicated focus on products, not mergers!

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 To sum up, external relationships will continue to be essential to Merck’s success, as they have been in the past. We believe the recent internal changes only further strengthen Merck’s commitment to partnering.

23 “We try never to forget that medicine is for the people
“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 For more about Merck & Co. and Merck Frosst Canada Ltd Patrick Lauzon Manager of Corporate Affairs Merck Frosst Canada Ltd 11131 Hammersmith Gate Richmond BC V7A 5E6 (604)

25 Back up

26 Intellectual Property Protection Quality of R&D and R&D Infrastructure
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 Public $ Support Tax Incentives Listing Recognize Innovation Governments must consider health and economic development policy goals simultaneously. They cannot ignore the fact that health policy can have a negative effect on economic development. As much as possible, win-win situations should be encouraged. In competing for R&D investment, international companies consider many factors when determining where to put limited investment dollars. There are a number of factors that are in the federal government arena: internationally competitive IPP, an effective and efficient regulatory process and reasonable pricing. Provincially, the research infrastructure and market access for innovative products are the two key areas examined when making investment decisions. BC has an excellent infrastructure for research and development and outstanding scientists. However, market access is a concern. The RDP creates a negative investment climate for biomedical research in BC as it treats innovative products as commodities, thereby not recognizing the value of innovation.

27 RDP - BC Investment Performance
Policy Goal Stimulate Economic Development RDP - BC Investment Performance 18.2 14.4 8.2 7.3 Since the introduction of the RDP British Columbia has lagged behind the other Western Provinces in the amount of Rx&D investments received. Alberta has increased its share of R&D investment, at the expense of BC. Even though BC has a larger population base there has been a cumulative investment gap between Alberta and British Columbia (PMPRB) = $82.3 million = $60.6 million (since introduction of RDP) BC receives the lowest per capita investment dollars of the Western provinces. PMPRB 2001

28 Merck Research Laboratories
2002 R&D Spending - Approx. US$2.9 Billion R&D 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 ($ in billions except EPS)
Financial Highlights ($ in billions except EPS)

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

32 Inderal Tagamet Capoten Seldane AZT Mevacor Prozac Diflucan Recombinate Invirase Lopressor Zantac Vasotec Hismanal Videx (ddl) Pravachol Zoloft Sporanox Kogenate Norvir Innovative Drug/Year of Introduction Follower Drug

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

34 Alliances – A Critical Role
What’s going to happen over the next several years? As you can see, 7 out of the 11 products in Merck’s late stage pipeline have resulted from licensing initiatives, once again demonstrating the ongoing importance of external relationships to Merck’s continued success. Resulting from alliance/licenses

Download ppt "Merck Overview Merck Research Laboratories Partnerships and Licensing"

Similar presentations

Ads by Google