CONFIDENTIAL This report is solely for the use of client personnel. No part of it may be circulated, quoted, or reproduced for distribution outside the client organization without prior written approval from The Mattson Jack Group, Inc. Building Blocks (and the Devil) in Commercial Assessment and Planning Richard W. Martin, President and Chief Operating Officer The Mattson Jack Group, Inc. April 2008
Confidential 2 Introduction Multiple slides
Confidential 3 The Devils of Commercial Assessment and Planning Epidemiology Patient Behavior Treatment Protocols Regulatory Environment Competitive Set Logistics and Supply Commercialization Strategy Partner Coordination Financial Considerations Commercial Environment
Confidential 4 Epidemiology is the starting point in the pharmaceutical commercial market assessment and planning process. How many patients have the disease or condition and are eligible to be treated? Drug discovery prioritization Clinical trial planning Licensing Additional indications for in-line products Resource allocation and investment decisions Go / no-go decisions all along the way Too often, too little attention is paid to this critical element of business planning. Epidemiology is the first potential major trip up in the commercial assessment and planning process The impact of errors here are multiplied throughout the planning process
Confidential 5 Epidemiology non-oncology examples Multiple slides
Confidential 6 Changes in core disease rates can trip up the best planners. The previous examples show the effect of demographics when the rate of disease is static. What happens when the disease rate also changes? One must analyze the age-adjusted disease rate. An overall disease rate is dependent on demographic composition at the time the rate was determined. An age-adjusted rate corrects for changes in demographic composition.
Confidential 7 Epidemiology oncology examples Multiple slides
Confidential 8 Co-Morbid Considerations Why is it important to consider co-morbid diseases / conditions? To prevent double counting resulting in over- or under-estimating market size For example, many individual compounds are used to treat multiple psychiatric conditions Where should one be most careful regarding co-morbid diseases / conditions? (And, lets not forget about severity) Respiratory disease (asthma, COPD, allergic rhinitis) Multiple indications for a single product (e.g., Sanofi-Aventis rimonabant originally considered for smoking, obesity, hypertension and diabetes together) Psychiatric illnesses (depression, anxiety, others)
Confidential 9 Co-morbidity examples Multiple slides
Confidential 10 Patient Behavior PreferencesEmbarrassed Whats Normal? And so it goes
Confidential 11 Treatment Protocol Economics How Aggressive? Managed Care
Confidential 12 Commercial Environment IP Pricing and Reimbursement Me-toos and Generics
Confidential 13 Competitive Environment Whats in Development? Regional Players Parallel Importation
Confidential 14 Regulatory Environment Timeline, Cost, P(s) Acceptable TPPs Study Requirements
Confidential 15 Commercialization Strategies Partnering HQ vs. Local Planning Promotion
Confidential 16 Partner Coordination Pricing (again) Unplanned Expenses Promotional Bleed
Confidential 17 Logistics and Supply Local Incentives Importation Costs Special Payments
Confidential 18 Financial Considerations Taxation Currency Consolidation
Confidential 19 Richard W. Martin President and COO The Mattson Jack Group, Inc Westline Drive, Suite 180 St. Louis, MO Tel: Fax: Thank You!