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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 This report is solely for the use of client personnel. No part of it may be circulated, quoted, or reproduced for distribution outside the

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Page 1: 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

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) inCommercial Assessment and Planning

Richard W. Martin, President and Chief Operating Officer

The Mattson Jack Group, Inc.

April 2008

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Confidential2

Introduction

Multiple slides

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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

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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

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Confidential5

Epidemiology non-oncology examples

Multiple slides

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Confidential6

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.

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Confidential7

Epidemiology oncology examples

Multiple slides

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Confidential8

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)

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Co-morbidity examples

Multiple slides

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Patient Behavior

Preferences

Embarrassed

What’s

“Normal?”

And so it goes

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Confidential11

Treatment Protocol

Economics

How

Aggressive?

Managed Care

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Commercial Environment

IP

Pricing and

Reimbursement

Me-toos and

Generics

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Competitive Environment

What’s in

Development?

Regional

PlayersParallel

Importation

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Regulatory Environment

Timeline,

Cost, P(s)

Acceptable

TPPsStudy

Requirements

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Confidential15

Commercialization Strategies

Partnering

HQ vs. Local

Planning

Promotion

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Confidential16

Partner Coordination

Pricing (again)

Unplanned

ExpensesPromotional

Bleed

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Confidential17

Logistics and Supply

Local

Incentives

Importation

Costs“Special”

Payments

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Confidential18

Financial Considerations

Taxation

Currency

Consolidation

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Confidential19

Richard W. MartinPresident and COOThe Mattson Jack Group, Inc.11960 Westline Drive, Suite 180St. Louis, MO 63146Tel: 314.469-7600 Fax: 314.469.6794

E-mail: [email protected] www.mattsonjack.com

Thank You!


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