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Understand the evolving landscape of pharmaceutical licensing, crucial for industry growth and innovation. Explore key strategies, insights, and partnership models for navigating the complex world of pharmaceutical licensing in the global market.
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Licensing and Corporate Partnering… “Pharma-style” Jim Schaeffer Executive Director Worldwide Licensing and External Research April 10, 2013 The University of Texas at Austin 1
Pharma at a Glance • Big Pharma is BIG • Patent expiries are inevitable • Growth requires multiple blockbusters/year • (blockbusters are hard to come by) • Generics are growing • FDA is “challenging” • Fewer and fewer companies • Emerging markets are emerging • Most of the research is performed exPharma • Licensing-in is important but not a panacea
Largest Pharma in 2010 (prescription sales–$Bn) Pfizer (Wyeth) $ 47.1 (6.0%) Merck (SP) 46.3 (5.9) Novartis 46.0 (5.9) Roche (Genentech) 43.9 (5.6) Sanofi-Aventis 38.9 (5.0) GlaxoSmithKline 38.7 (4.9) Abbott Labs 26.1 (3.3) Johnson & Johnson 24.6 (3.2) AstraZeneca 22.1 (2.8) Teva Pharmaceutical 20.8 (2.7)
Patent Expiries (Sales at Risk) 2010 28 ($Bn) 2011 52 2012 50 2013 33 2014 48 2015 51 2016 33
FDA Approvals 2010 21* 2009 25 2008 24 2007 18 2006 22 2005 20 2004 38 *1 from JNJ, NVS, SNY, ROC *0 fromMRK, PFE, GSK, LLY, AZ, BMS
60 50 1950 1953 1956 1959 1962 1965 1968 1971 1974 1977 1980 1983 1986 1989 1992 1995 1998 2001 2004 2007 40 30 20 10 0 New Analysis Provides Cautionary Tale Cumulative NMEs by Selected Company Since 1950 Conclusions from the analysis: • Productivity has been constant for 60 years. • For each company, productivity is constant and stochastic. • Cost/NME has been rising at a CAGR of 13% since the 1950s. • Only 1 in 5 NMEs becomes a blockbuster. Cumulative Number of NMEs Merck Lilly Roche Source: Nature Reviews Drug Discovery, December 2009, p959-968
Pharma is Looking to “Enhance the Pipeline” • Pursuing fewer therapeutic targets • Less sites and increased out-sourcing • More sites • Mergers • Acquisitions • Increased academic relationships • Investing in “incubators” • Expanding in emerging markets • Venture funds (strategic, managed, independent) • CEDs and CEEDs • FIPCO → FIPNET • Licensing (early/late stage)
The Solution for All Pipeline Woes “Let’s In-License a Late-Stage Blockbuster!!” Pharma CEO in years gone by 9
Licensing within the Pharma Industry • Costly • License: • Early stage (single-digit MM) • Late stage (100s MM) • Development costs • Acquisition (don’t ask) • Low POS • Time to success (or failure) requires patience • Requires co-dependence on entrepreneurs/venture community and pharma/big biotech
Merck Leads the Field in Biotech Partnering *Used with permission from Deloitte Recap 11
Merck Licensing Strategy Results in High-Value Alliances Approximately 63% of Merck’s 2009 revenue* was attributable to alliance products and patents • COZAAR / HYZAAR • FOSAMAX • GARDASIL • ZETIA / VYTORIN • NEXIUM • VARIVAX • ROTATEQ • ZOSTAVAX Licensed Products or Patents: 63% of total sales * Includes 12 months of Merck human health revenue, 2 months of legacy human health Schering-Plough revenue, 50% of full year JV revenue (Sanofi-Pasteur MSD, Johnson&JohnsonoMerck) and 10 months of Merck/Schering-Plough revenue.
We Constantly Scan for Partnering Opportunities Key acquisitions & alliances signed 52 Confidentiality-In agreements 697 Opportunities reviewed at RLC 1290 Opportunities received 8672 2011 13
Disease Area Priorities • Asthma • Atherosclerosis • Diabetes • Hepatitis C virus (HCV) • Human immunodeficiency virus (HIV) • Rheumatoid arthritis • Vaccines • Alzheimer’s disease • Cancer • Specialty hypertension • Thrombosis 14
Overview of Merck’s Licensing Process Connecting with You UnderstandingYour Science WorkingTogether Doing the Deal • Worldwide scouts build relationships and seek out opportunities • Non-confidential information submitted for review • Initial non-confidential review by Review andLicensing Committees • Confidentiality disclosure agreement signed • Confidential review • Face-to-face scientific meetings • Commercial assessment • Term sheet negotiations conducted by Transaction Manager • Due diligence • Definitive agreements negotiated • Agreements executed • Alliance Management • Alliance managers assigned • Alliance launched • Monitor progress through-out the agreement • Basic Research Collaboration Implementation • Senior scientists dedicated to successful execution of the research collaboration 15
New & Expanded Areas of Interest for Partnering • Merck publishes our Areas of Interest twice each year. • For each of our therapeutic areas, we list the Mechanism of Actions that we are interested in and those that we are not. • Late-stage clinical compounds (phase 3-ready & beyond) are of interest in any therapeutic area. • Visit us at:www.merck.com/licensingto learn more! 16