The pharmaceutical industry's steep patent cliff forces strategy and development executives to uncover opportunities for sustainable growth. One opportunity for growth lies in combination therapies with branded products to extend patent life. Fixed dose combination (FDC) products, which have been around for many years, can have clinical and commercial advantages. For the drug manufacturer, an FDC product can extend the therapeutic advantage and becomes part of lifecycle management. For the patient, FDC products can address unmet medical needs and reduce pill burdens. Best Practices ®, LLC’s timely study identifies successful strategies and innovative practices for developing and bringing FDC products to market. Through executive insights and advice, the study also addresses the pitfalls and obstacles to avoid in this work.

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Fixed Dose Combination Products
Benchmarking Research

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 Project Overview
 Key Insights
 Detailed Findings
 Appendix
Table of Contents

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Project Methodology and Study Objectives
The economic advisability of developing fixed dose combination products can be difficult
to determine owing to the many associated development and commercial challenges.
 This benchmarking study explores the logic, decisions, and strategies
involved in developing and commercializing fixed dose combination
(FDC) products
 Primary research was conducted through an online survey instrument and
in-depth interviews
 Primary research goals
 To identify successful strategies and innovative practices for developing
and bringing FDC products to market
 To understand the pitfalls and obstacles to avoid in this work

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Participating Companies
Fifty-one representatives from 34 biopharmaceutical companies participated in this
primary research. Eight participating companies are in the top 20 according to 2008
global pharma sales.
Policlinica Dr. Luis
Rodriguez Carrasquillo

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Job Titles of Respondents
From seasoned executives to innovative managers, the range of respondent titles reflects
depth and breadth of perspective in developing and/or commercializing FDC products.
Respondents have an average of nearly 10 years of experience in working with FDCs.
• Analyst, Business Intelligence
• Analyst, Sales
• Associate Principal Scientist
• Research Administrator
• Research Fellow, Pharmaceutical Development
• Medical Science Liaison
• Associate Manager, Marketing Analytics & Business
Insights
• Associate Manager, Training & Development
• Product Manager
• Group Product Manager
• Senior Product Manager
• Manager, Business Development
• Manager, Market Research
• Manager, Marketing
• Manager, Sales & Marketing
• Project Leader, Discovery Medicine
• Therapy Area Leader
• Medical Director
• Scientific Director
• Unit Director, Clinical Research
• Director, Commercial Analysis
• Director, Global Marketing
• Director, Global Product Strategy
• Director, New Product Planning
• Director, Oncology Clinical Development
• Director, Strategy
• Director, US Marketing
• Executive Director, Commercial Development & Ops
• Executive Director, Managed Markets
• Senior Director, Clinical Development
• Senior Director, Commercial Development
• Senior Director, Pharmaceutical Development Services
• Senior Director, Pharmaceutical Sciences
• Senior Director, Worldwide Pharmaceutical Sciences
• Head, Intellectual Property
• Head, International Pricing & Reimbursement
• Vice President, Clinical Development
• Vice President, Global Business Development
• Vice President, New Business Development
• Senior Vice President, Clinical Development &
Regulatory Affairs

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Most Respondents Currently Active in the Field
Are you currently engaged in managing activities that involve FDC products or working to develop FDCs?
Yes, 84%
No, 16%
(n=51) % of Responses
Eighty-four percent of respondents currently manage activities that involve FDC products.

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Most Recognize FDC as a Lifecycle Management Play
Nearly two-thirds of respondents say their company pursued FDC development as part of
a lifecycle management strategy geared to extend therapeutic as well as commercial
advantage. One-third say FDC development addressed an unmet medical need.
What was the chief reason for pursuing FDC development? (Please check all that apply.)
(n=51)
33%
22%
10%
61%
61%
Extend therapeutic advantage
Part of lifecycle management
Unmet medical need
New therapy (e.g., to address
multiple pathways)
Other (Please specify)
% of Responses
Other:
• Convenient for Patient
• Diuretic added
• Improve pill burden,
competitive advantage
• Standard of care are FDC
(oral contraceptives)
• Synergistic compounds

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FDC Products Raise Issues for Portfolio Strategy
Please rank order the following areas in terms of the difficulty of bringing this FDC to market
(1 = most problematic, 6 = least problematic).
% of n Responses per Ranking
n =
1 – Most
Problematic
2 3 4 5
6 – Least
Problematic
Portfolio Strategy 37 35% 8% 3% 11% 19% 24%
Alliances/Partners 36 19% 14% 25% 17% 14% 11%
Marketing/Positioning 41 15% 10% 2% 17% 22% 34%
Clinical 38 13% 21% 29% 8% 18% 11%
Regulatory 41 7% 10% 29% 29% 12% 12%
CMC/Manufacturing 39 5% 36% 10% 13% 21% 15%
Portfolio strategy and CMC/manufacturing are the most problematic areas as agreed on
by 43 percent and 41 percent of respondents respectively. Most found that Marketing and
Positioning is a relatively lesser concern when bringing a combination product to market.

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Best Practices, LLC
6350 Quadrangle Drive, Suite 200
Chapel Hill, NC 27517
www.best-in-class.com
919-767-9226
bestpractices@best-in-class.com
About Best Practices, LLC
Best Practices, LLC is a research and consulting firm that conducts work based on the
simple yet profound principle that organizations can chart a course to superior economic
performance by studying the best business practices, operating tactics, and winning
strategies of world-class companies.
Link for Report: Successful Strategies for Launching FDC Products