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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 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. CONFIDENTIAL Introduction Multiple slides Confidential 2 The Devils of Commercial Assessment and Planning Epidemiology Patient Behavior Treatment Protocols Commercial Environment Competitive Set Regulatory Environment Commercialization Strategy Partner Coordination Logistics and Supply Financial Considerations Confidential 3 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 4 Epidemiology non-oncology examples Multiple slides Confidential 5 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 6 Epidemiology oncology examples Multiple slides Confidential 7 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, let’s 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 8 Co-morbidity examples Multiple slides Confidential 9 And so it goes Patient Behavior Confidential 10 Treatment Protocol Confidential 11 Commercial Environment Confidential 12 Competitive Environment Confidential 13 Regulatory Environment Confidential 14 Commercialization Strategies Confidential 15 Partner Coordination Confidential 16 Logistics and Supply Confidential 17 Financial Considerations Confidential 18 Thank You! Richard W. Martin President and COO The Mattson Jack Group, Inc. 11960 Westline Drive, Suite 180 St. Louis, MO 63146 Tel: 314.469-7600 Fax: 314.469.6794 E-mail: [email protected] www.mattsonjack.com Confidential 19