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Getting Maximum Benefit from Combination Products

Published by: Decision Resources

Published: May. 23, 2007 - 40 Pages


Table of Contents


Executive Summary

Strategic Considerations

Stakeholder Implications

The Breadth and Scope of Combination Products

From a Regulatory Perspective

Recent Biologic and Device Approvals

Drug-and-Device Combinations Going Strong

Strategic Use of Combination Products

Recent Market Success of Fixed-Dose Combinations

Fixed-Dose Combination Blockbusters

GlaxoSmithKline’s Advair/Seretide

AstraZeneca’s Symbicort and Boehringer Ingelheim’s Combivent

Merck/Schering-Plough’s Vytorin/Inegy

Novartis’s Lotrel

HIV/AIDS Combination Blockbusters

Antibacterial Combination Blockbusters

Combination Blockbusters in a Contraceptive Franchise

Significant Interest in Combination-Drug Markets

Brand Pharmaceutical Companies

Generics Pharmaceutical Companies

Notable Trends

More Timely Development of Combinations

Intercompany Collaborations on Fixed-Dose Combinations

Bristol-Myers Squibb and Gilead Sciences

AstraZeneca and Abbott

Schering-Plough and Novartis

Multiple Combinations

Greater Acceptance of Combination Products in Japan

Start-Up Companies Dedicated to Combinations in Novel Indications

CombinatoRx

Orexi 16

Vicus Therapeutics

Life-Cycle Management and Market Dynamics

Fragmented Diabetes Markets

Thiazolidinedione Franchises

Renaissance in NSAID Combinations Following COX-2 Inhibitor Troubles

AstraZeneca/Pozen

GlaxoSmithKline/Pozen

Fixed-Dose Combination Drugs in Development

Cardiovascular Combinations

Pfizer’s Torcetrapib/Lipitor Combination

Novartis’s Exforge

Merck/Schering-Plough’s Lipitor and Zetia

Daiichi Sankyo’s CS-8663

Merck’s MK-0524A and MK-0524B

Abbott’s Simcor

Cross-Indication Combination Therapies

Respiratory Combinations

Schering-Plough and Novartis LABA and Corticosteroid Combinations

Nycomed and Sanofi -Aventis’s Formoterol and Alvesco Combination

GlaxoSmithKline and Theravance’s Promising Fixed-Dose Combinations for COPD

Outlook

Appendix-World’s Best-Selling Combination Products by Therapeutic Category, 2006

Expert Commentary

Expert Commentary: Fixed-Dose Combinations of Antiretroviral Drugs in HIV Therapy

Regimens

Expert Commentary: Patent Expirations and the Availability of Generic-and-Generic

Combinations Loom Heavily Over Type 2 Diabetes Markets

Expert Commentary: Choosing the Right Drugs for the Combination Is of Paramount

Importance

Expert Commentary: Opportunities for Respiratory Fixed-Dose Combinations

Tables

1. Start-Up Companies Dedicated to Drug Repurposing

2. Summary Table: Key Opportunities and Challenges in Combination Product Development

According to Decision Resources Experts

Figures

1. Best-Selling Fixed Combination Blockbusters Worldwide, 2006

2. Best-Selling Combination Products by Therapeutic Category, 2006

3. Big Pharma’s Degree of Interest in Combination Products, 2006

4. Life-Cycle Management Through Fixed-Dose Combinations in Diabetes

2a. Fragmented Market Dynamics in Diabetes, 2000-2006

3a. Vytorin Enjoys Tremendous Success While Caduet Struggles

Experts Featured

John Earl, Ph.D., principal director, Cardium and Onkos, Decision Resources, Inc.

Sylvia Eash, Ph.D., analyst, Infectious Diseases, Decision Resources, Inc.

Melissa G. Stolper, director, Immune and Infl ammatory Diseases, Decision Resources, Inc.

Mark Thornton, M.Sc., Ph.D., consultant, Decision Resources, Inc.

Donny Wong, Ph.D., senior analyst, Metabolic Disorders, Decision Resources, Inc.

Abstract

Combination products are a lifeline in today’s pharmaceutical industry, but not all are created equal. Many companies use combinations late in the product life cycle to extend patent life or to maximize revenues, but more-successful combination product development addresses a market’s unmet need. Therefore, not all potential combination products will have equal value. We asked Decision Resources analysts to share their insights on combination products in various disease markets and integrated these insights into our analysis of the combination product market in this Spectrum Special Report.

Get the Answers You Need to Shape Your Strategy
Several fi xed-dose combinations were blockbusters in 2006 while others languished. • Why do combination products fare well in some markets and not in others? Why do similar products for similar indications fare very differently in the market?

Successful combinations are sometimes a result of a single company combining its blockbuster agents, • but several intercompany collaborations on combination products have proved very successful. Which partnerships have been most successful and why? Which markets are best suited to further intercompany development?

Combination products are becoming increasingly useful in product life-cycle management. • Which combination products are in development? What do the experts think of their chances for success?

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