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1、H E A L T H C A R E Launching Combination Products Brand extension and franchise development strategies By Steven Seget ii Steven Seget Steven Seget is Principal at Delphi Pharma, and provides independent strategic consulting services to the pharmaceutical and biotechnology industries. Steven previo
2、usly managed the strategic healthcare consulting function at Datamonitor and has an MBA from the London Business School. Delphi Pharma provides strategic, financial and marketbased solutions to clients, focusing primarily on the portfolio management, business development and licensing functions. De
3、lphi Pharma combines an extensive research network, applied analytical expertise and an established track record to deliver high value results and measurable impact to its clients. Copyright 2007 Business Insights Ltd This Management Report is published by Business Insights Ltd. All rights reserved
4、. Reproduction or redistribution of this Management Report in any form for any purpose is expressly prohibited without the prior consent of Business Insights Ltd. The views expressed in this Management Report are those of the publisher, not of Reuters. Reuters accepts no liability for the accuracy o
5、r completeness of the information, advice or comment contained in this Management Report nor for any actions taken in reliance thereon. While information, advice or comment is believed to be correct at the time of publication, no responsibility can be accepted by Business Insights Ltd for its comple
6、teness or accuracy. REUTERS and dotted and sphere logos are the house trade marks of Reuters Limited in more than 25 countries world-wide. Printed and bound in Great Britain by FPC Greenaway. Ormolu House, Crimscott Street, London SE1 5TE. iii Table of Contents Launching combination products Execut
7、ive Summary 10 An introduction to combination products 10 Combination product strategies in the cardiovascular market 11 Combination product strategies in the respiratory market 12 Combination product strategies in the diabetes market 13 Combination product strategies in the HIV market 14 Combinatio
8、n product strategies in the womens health market 15 Combination product strategies in other therapeutic markets 16 Brand extension and franchise development strategies 17 Chapter 1 An introduction to combination products 20 Summary 20 Introduction 21 Therapeutic value 21 Combining therapies 21 Impro
9、ved convenience 22 Commercial value 22 Brand extension 23 Franchise development 23 Leading combination products 24 Key products 24 Key therapeutic categories 27 Key combination product strategies 28 Chapter 2 Strategies for cardiovascular products 32 Summary 32 Introduction 33 Leading combination pr
10、oducts 33 iv Recent combination product launches 35 Exforge 36 Future combination product developments 36 Simcor 38 Avandia/simvastatin 39 Key combination product launch strategies 39 Chapter 3 Strategies for respiratory products 42 Summary 42 Introduction 43 Leading combination products 43 Recent c
11、ombination product launches 45 Symbicort 45 Future combination product developments 46 Singulair/Claritin 46 Flutiform 47 Key combination product launch strategies 47 Chapter 4 Strategies for diabetes products 50 Summary 50 Introduction 51 Leading combination products 51 Recent combination product l
12、aunches 52 Janumet 53 Duetact 53 Future combination product developments 54 Avandia/simvastatin 54 Synordia 55 Key combination product launch strategies 55 Chapter 5 Strategies for HIV products 58 Summary 58 Introduction 59 Leading combination products 59 Recent combination product launches 60 Atrip
13、la 61 v Future combination product developments 61 Key combination product launch strategies 61 Chapter 6 Strategies for womens health products 64 Summary 64 Introduction 65 Leading combination products 65 Recent combination product launches 67 Lybrel 67 Angeliq 67 Future combination product develop
14、ments 68 Aprela 69 DUB-OC 69 Key combination product launch strategies 69 Chapter 7 Strategies for other therapeutic areas 72 Summary 72 Introduction 73 Leading combination products 73 Anti-infectives 75 Recent combination product launches 75 Combigan 76 Ziana 76 Pylera 77 Future combination product
15、 developments 77 Oncology 79 CNS and pain 80 Key combination product launch strategies 81 Chapter 8 Brand extension and franchise development strategies 84 Summary 84 Introduction 85 Case studies 85 vi Diovan, Diovan HCT/CoDiovan and Exforge 85 Avandia, Avandamet and Avandaryl 87 Advair/Seretide 88
16、Case study: Kaletra 91 Case study: Vytorin 93 Key success factors 95 Branding 96 Pricing 97 Positioning 97 Chapter 9 Appendix 100 Sources 100 Product sales data 100 Regulatory data 100 Specific sources 100 vii List of Figures Figure 1.1: Number of combination products by therapy area, 2006 28 Figure
17、 1.2: Key combination product strategies 29 Figure 2.3: Key cardiovascular combination product strategies 40 Figure 3.4: Key respiratory combination product strategies 48 Figure 4.5: Key diabetes combination product strategies 56 Figure 6.6: Key womens health combination product strategies 70 Figure
18、 8.7: Diovan, Diovan HCT/Co-Diovan sales, 2002-2006 86 Figure 8.8: Avandia, Avandamet and Avandaryl sales, 2002-2006 88 Figure 8.9: Advair/Seretide, Flovent/Flixotide and Serevent sales, 2002-2006 90 Figure 8.10: Kaletra sales, 2002-2006 92 Figure 8.11: Vytorin, Zetia and Zocor sales, 2002-2006 94 L
19、ist of Tables Table 1.1: Leading brand extension combination products, 2006 25 Table 1.2: Leading brand extension combination products, 2006 26 Table 1.3: Leading franchise development combination products, 2006 27 Table 2.4: Leading brand extension combination products in the cardiovascular market,
20、 2004- 2006 34 Table 2.5: Leading franchise development combination products in the cardiovascular market, 2004-2006 35 Table 2.6: Recently approved combination products in the cardiovascular market, 2005-2007 36 Table 2.7: Future combination products in development for the cardiovascular market, 20
21、07 38 Table 3.8: Leading brand extension combination products in the respiratory market, 2004-2006 44 Table 3.9: Leading franchise development combination products in the respiratory market, 2004- 2006 44 Table 3.10: Recently approved combination products in the respiratory market, 2005-2007 45 Tabl
22、e 3.11: Future combination products in development for the respiratory market, 2007 46 Table 4.12: Leading brand extension combination products in the diabetes market, 2004-2006 52 Table 4.13: Recently approved combination products in the diabetes market, 2005-2007 53 Table 4.14: Future combination
23、products in development for the diabetes market, 2007 54 Table 5.15: Leading franchise development combination products in the HIV market, 2004-200660 Table 5.16: Recently approved combination products in the HIV market, 2005-2007 61 Table 6.17: Leading brand extension combination products in the wo
24、mens health market, 2004- 2006 65 Table 6.18: Leading franchise development combination products in the womens health market, 2004-2006 66 Table 6.19: Recently approved combination products in the womens health market, 2005-2007 67 Table 6.20: Future combination products in development for the women
25、s health market, 2007 68 Table 7.21: Leading brand extension combination products in other therapeutic markets, 2004- 2006 74 viii Table 7.22: Leading franchise development combination products in other therapeutic markets, 2004-2006 75 Table 7.23: Recently approved combination products in other the
26、rapeutic markets, 2005-2007 76 Table 7.24: Future combination products in development for other therapeutic markets, 2007 78 9 Executive Summary 10 Executive Summary An introduction to combination products ? In areas where combination therapy has proven to be highly effective, such as HIV and asthma
27、, the use of combination products is now well understood and accepted. However, in therapeutic areas where combination therapies appear to provide, at best, incremental benefits, such as hypertension, the successful positioning of combination products is more difficult. ? Combination pharmaceutical
28、products, commonly referred to as fixed-dose combinations (FDC), are combinations of two or more active ingredients produced in a single formulation. Many drug classes offer benefits from combination relating to the additive nature of therapeutic effect and the reduced level of side effects associat
29、ed with their use. However, the core advantage provided by combining two or more therapies into one drug is an improvement in convenience and an associated reduction in the number of prescriptions required and associated administrative costs. ? The commercial value of combination products primarily
30、relates to maximizing market share and protecting that share following the expiry of key patents. Brand extension strategies involve the introduction of combination products as part of a more general product lifecycle development program for a key brand. Usually the combined products make an increme
31、ntal improvement over the original brand, and involve the addition of a generic product available for combinations across the product class. ? Franchise development strategies involve the launch of stand-alone combination product brands that serve to further develop an established therapeutic franch
32、ise. These combined products are usually considered to have significant therapeutic or commercial value over and above that of the constituent parts. 11 ? In 2006, a total of 34 pharmaceutical products generating global sales in excess of $500 million involved combination therapies. There were 22 di
33、fferent products involving brand extension combinations, with a further 12 combination drugs marketed as franchise developments under their own brands. Combination product strategies in the cardiovascular market ? The leading brand extension combination product by 2006 sales was Novartis Diovan and
34、Diovan HCT/Co-Diovan. The leading five cardiovascular brand extension combination products were leading antihypertensives available in combination with a thiazide diuretic. Seven out of the top eight cardiovascular brand extensions were antihypertensive/HCT combinations, with the only exception bein
35、g the availability of Bristol-Myers Squibbs (BMS) Pravachol in a copackage with aspirin. ? The recent approvals of Daiichi Sankyos Azor and Novartis Exforge have reinforced the perceived value of combining calcium channel blockers with leading antihypertensives, in this case angiotensin II receptor
36、antagonists. Other recent approvals include the thiazide diuretic combination for AstraZenecas antihypertensive Toprol and the heart failure drug BiDil, combining two generically available drugs. ? As well as continued development in the areas of dyslipidemia and hypertension, the future pipeline of
37、 combination products also includes drugs that begin to deal more generally with the range of cardiovascular risk factors, including diabetes. GlaxoSmithKline (GSK) is looking to combine their diabetes brand Avandia with the statin simvastatin. Merck, Novartis, Abbott, GSK, Actelion and Solvay all h
38、ave multiple cardiovascular combination projects in late stage development. ? Key combination product launch strategies appear to be concentrated in franchise development within an indication. Seven separate projects are currently in late stage development pursuing a franchise development strategy w
39、ithin a single indication, 12 while a further three franchise development projects are looking to expand into other cardiovascular risk factors such as diabetes. Combination product strategies in the respiratory market ? The leading franchise development combination product by 2006 sales was GlaxoSm
40、ithKlines (GSK) Advair/Seretide, a combination of bronchodilator and corticosteroid for the treatment of Asthma. The leading respiratory franchise development combinations were all treatments for asthma and chronic obstructive pulmonary disease (COPD), including AstraZenecas asthma combination Symbi
41、cort and Boehringer Ingelheims COPD combination Combivent. ? The recent approval of AstraZenecas Symbicort has reinforced the value of combining bronchodilators with corticosteroid in the treatment of asthma symptoms. There were no other major new combination drugs approved in the respiratory market
42、 in the last three years. ? As well as continued development in the combination of corticosteroids and bronchodilators in the treatment of asthma and COPD, the future pipeline of combination respiratory products also includes a combination of a leukotriene receptor antagonist and antihistamine for t
43、he treatment of seasonal allergic rhinitis. SkyePharma, Abbott, Mundipharma, Novartis and Schering-Plough are all involved in partnerships to develop combination asthma/COPD therapies. ? Key combination product launch strategies appear to be concentrated in franchise development within a single indi
44、cation. Three separate projects are currently in late stage development pursuing a franchise development strategy within a single indication. It could be argued that the combination of Singulair and Claritin provides the potential to expand the use of the combination beyond seasonal allergic rhiniti
45、s and into asthma, but this is not implied in the current submitted label claims. 13 Combination product strategies in the diabetes market ? The leading brand extension combination product by 2006 sales was GlaxoSmithKlines (GSK) Avandia, Avandamet and Avandaryl. The leading diabetes brand extension
46、 combinations include both combinations of glucose lowering drugs involving metformin and glimepiride and insulin mixes relating to the combination of short-acting and long-acting insulins. Avandia and Actos are both thiazolidinediones/glitazones, which reverse resistance to insulin, and are availab
47、le in combinations with generically available glucose lowering drugs metformin and glimepiride. ? The recent approvals of Mercks Janumet in 2007, Takedas Duetact in 2006 and GSKs Avandaryl and Takedas Actoplus Met in 2005 have reinforced the brand extension strategy relating to the addition of metfo
48、rmin and glimepiride to established sulfonylurea and novel DPP-4 inhibitor brands. All major approvals for diabetes combination products in the last three years related to the addition of generic metformin and glimepiride to market leading brands. ? As well as the continued addition of metformin to
49、established oral diabetes drugs, the future pipeline of combination diabetes drugs is concentrated on tackling associated cardiovascular risk factors, through the combination of diabetes and cardiovascular therapies. Two phase III projects are currently under investigation to tackle a broader range of associated diabetes and cardiovascular risk factors, including GSKs Avandia/simvastatin combination and Solvays Synordia combination. ? Key combination product launch strategies appear to be concentrated in