New York Pharma Forum General Assembly Innovation and R&D ／ Commoditization of pharmaceutical December 4, 2009 Dr. Hatsuo Aoki, Ph. D. Senior Advisor, Astellas Pharma Inc.
Drug’s Therapeutic Effect vs. Therapeutic Satisfaction 100% Peptic Ulcer Drug's Therapeutic Effect Tuberculosis 90% Hyperlipidemia Hypertension Gout Asthma 80% Angina Pectoris Diabetes Allergic Rhinitis 70% Epilepsia Arrhythmia Depression Myocardial Infarction Heart Failure Anxiety Neurosis BPH 60% Chronic Hepatitis B Functional Dyspepsia Liver Disease Glaucoma Chronic Hepatitis C RA Leukemia Liver Disease 50% Parkinson Disease MRSA Nephrosis Syndrome Diagnosis with Prostate Cancer IBD Endometrisis IBS 40% Atopic Dermatitis low therapeutic SLE Schizophrenia Cerebral Osteoporosis OAB COPD Infarction satisfaction Breast Cancer Chronic Glomerulonephritis AIDS Psoriasis 30% ICB(including Subarachnoid) Stomach Cancer Stress Urinary Colon Cancer Decubital Ulcer OS Incontinence Multiple Sclerosis Chronic Renal Failure Uterus Myoma 20% Diabetic Nephropathy Uterus Cancer Hepatic Cirrhosis Hepatic Cancer Diabetic neuropathy Lung Cancer Vascular Dementia SAS Diagnosis with lower 10% Age-related Macular Diabetic Retinopathy Drug’s therapeutic Degeneration Alzheimer effect than therapeutic 0% satisfaction 1 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Therapeutic Satisfaction （ evaluated by Physician) note ： Japan Health Science Foundation “Perspects on Medical Needs in Y2015”
Advancement of Life Science and Pharmaceutical R&D Future 1950- Late 1990’s Now -1950 Total Analysis of Genes Therapy Diseases High hurdle for further innovation Regenerative Medicine System Biology Antibody Medicine Pharmacogenomics/Toxicogenomics Control of chronic Nucleic acid Medicine diseases 2000 Sequencing human genes HMG-CoARI Genomics ・ Transcriptomics ・ Proteomics Efficient control of ACE inhibitors acute diseases Biomarker Molecules and Disease-related- Late1990’s Insulin, genes Interferon Gene Therapy 1990 H2-receptor antagonist PCR System 1983 ＮＳＡＩＤ 1973 Recombinant DNA Technology Neuroleptic Biochemistry Aspirin Molecular Biology Penicillin 1950 Biomedical Science 2 Medicinal Chemistry 20 th Century- Biology/Chemistry
“Innovation Policy“ pursued The nation (region) with infrastructure of breaking out innovation can realize the prominent growth . “Closed Type” ⇒ Considering policy in “Government - Industry Dialog” o Strengthening industries and/or companies with international competitiveness Seeds-oriented Policy → Concrete target of policy = R&D (Science & Technology) Policy = The 5-year strategy for creating of innovative drugs and medical equipment Advanced Science & Technology → Expectation and role of Industries = “ New Vision of the Pharmaceutical Industry ” o Rationalization & Efficiency of policy decision and management (Reform of government system) → Unification of management on budget and policy decision etc. (for example, DIUS in UK) “Open Innovation Type” Need-oriented Policy = Integrated Innovation Policy (R&D (Science & Technology) , educational talented people, market formation, etc.) Needs from Society & people Advanced Science &Technology 3
Improvement of Infrastructure for Innovation Improvement of Infrastructure for Basic and Clinical Research - Promotion of advanced basic research in universities/public research institutions R&D - Strengthening translational research Infrastructure - Reform of clinical research and clinical trial infrastructure - Educational training of talented people Collaboration with academia & government ・ Establishment of council for Environment to cooperation (budget allotment, Pricing System of Accelerate Drug New Drugs focusing issues, etc.) Development Evaluation of Innovation Regulatory Reform New drug Policy on Intellectual review/approval Property Rights system 4 Improvement of access to innovative NMEs
New York Pharma Forum 20 th Annual General Assembly December 4, 2009 Biopharma in 2029: A 20 th Anniversary Perspective James J. Dolan SVP, Licensing and Business Development Purdue Pharma L.P.
Specialty Pharma: Plays a Critical Role in the Global Biopharma Market • Perspective on “Specialty Pharma” vs. global big pharma / big biotech • Spec pharma sector thriving • Will need continuous innovation to survive until 2029 6 NY Pharma Forum – General Assembly
Specialty Pharma….has come a long way in 20 years…much to do in the next 20 years • Built high-performance, efficient, marketing / sales organizations which offer impressive avenues to market for specialty and GP products • Strong commercial expertise based on market exclusivity, labeling, positioning, deep understanding of physician/patient/payor needs, i.e. all aspects of commercial value proposition 7 NY Pharma Forum – General Assembly
Specialty Pharma….has come a long way in 20 years…much to do in the next 20 years • “Backward integrated” into R&D – looking for proprietary products to extend market positions…moved into NCEs…saw the benefit of development risk/reward and liked it; not just drug-delivery any more • Always dependent on licensing/partnering and all forms of sophisticated commercial/ development arrangements; willing/able to imagine creative partnerships in a few focused TAs 8 NY Pharma Forum – General Assembly
Specialty Pharma…where will the next 20 years take us? • Our product life cycles are getting shorter; high % of our markets are generic already • Our investment in marketing/sales demands longer periods of exclusivity for ROI – what to do? 9 NY Pharma Forum – General Assembly
Specialty Pharma…where will the next 20 years take us? • Development will be guided by clear medical/patient benefits in well-defined populations, outcomes data / managed care will dictate the new proprietary products of the future • Use our commercial expertise to convince private and gov’t insurance to pay for/recognize individual patient characteristics 10 NY Pharma Forum – General Assembly
Specialty Pharma….in 2029 • Innovation is the only answer; technical risk will increase; only the strong survive • Shoulder-to- shoulder with our biotech partners • Let biotech do what they do best…invent new medicines; leave them alone, i.e. Roche / Genentech models for our collaborations 11 NY Pharma Forum – General Assembly
Specialty Pharma….in 2029 • Spec pharma’s understanding of patient/physician needs and outcomes gets immediately translated back to the drug hunters in biotech • Development will be guided by well-defined patient populations; gene mutations can be addressed by new drugs with diagnostics; spec pharma will execute multiple drug combo clinical trial strategies for best outcomes in the commercial world • New proprietary medicines emerge because spec pharma and biotech are committed to novel, first-in-class drugs w/economic rationale 12 NY Pharma Forum – General Assembly
Biopharma in 2029: a 20th Anniversary Perspective Introduction to the 20th Annual General Assembly of the NYPF December 4, 2009 Dr. Sapan Shah President & CEO Shionogi USA Inc.
Today’s Program • Introduction and quick look at the past 20 years • Panelists thoughts on the next 20 years – Mr. Richard Van Duyne , Head of Global Business Development, Daiichi Sankyo Inc. – Dr. Hatsuo Aoki , former Chairman of both Astellas Pharma Inc. and Japan Pharmaceutical Manufacturers Association – Mr. Soichi Matsuno , Deputy President of Eisai Co., Ltd. – Mr. James Dolan , Senior Vice President, Licensing & Business Development of Purdue Pharma LLP 14
Why look back before looking ahead? • “The distinction between past, present, and future is only a stubbornly persistent illusion” – Albert Einstein • “To look backward for a while is to refresh the eye, restore it, and render it more fit for its prime function of looking forward” – Margaret Fairless Barber • “Learn from the past, live in the present, plan for the future" – Audrey Farrell 15
So let’s go back to…… 16
Tiananmen Square protests Launch of Sega Genesis The first GWB 1989 took office Exxon Valdez oil spill Nolan Ryan – 1 st pitcher to Collapse of Berlin Wall record 5000 strikeouts 17
How has the Pharmaceutical Industry changed since 1989? Commercial R&D/ Government/ Innovation Regulatory 18
Global pharmaceutical sales have experienced steady growth Global Pharmaceutical Sales $ Billion 774 716 560 604 646 CAGR 8% 498 201 224 236 245 280 291 295 300 334 358 391 428 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 Source: McKinsey & Company; IMS 19
North American market has captured a larger share over this period Global Pharmaceutical Sales 1991 2008 Total = $201B Total = $774B 5% 6% 34% 23% 26% 40% NA AAA AAA NA EU EU 34% 30% Source: McKinsey & Company; IMS 20
US Market Has Grown in Importance Percent of new compounds that are first marketed in the US Then Now 20% of new compounds 75% of new compounds * 1987-1989 period vs. 2005-2007 period Source: Tufts Center for the Study of Drug Development 21
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