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Reportlinker Adds Stakeholder Opinions: Sexual Dysfunction - The quest for the new Viagra continues

Wednesday, April 7, 2010 Sexual Health News J E 4


NEW YORK, April 6 Reportlinker.com announces that a new market research report is available in its catalogue:

Stakeholder Opinions: Sexual Dysfunction - The quest for the new Viagra continues

http://www.reportlinker.com/p0184975/Stakeholder-Opinions-Sexual-Dysfunction---The-quest-for-the-new-Viagra-continues.html

Introduction

Drug developers interested on the sexual dysfunction market are searching for the next Viagra. Companies are focusing on premature ejaculation and female hypoactive sexual desire disorder, which are suggested to be as prevalent as erectile dysfunction. As products advance through the pipeline, there are several challenges that will have to be addressed in order to succeed in these markets.

Scope

*Overview of erectile dysfunction, premature ejaculation and female sexual dysfunction disorders including epidemiology and key unmet needs.

*Summary of the drug classes currently used for the different sexual dysfunction disorders and an update of the latest proposed treatment guidelines.

*Evaluation of marketed brands and pipeline agents for erectile dysfunction, premature ejaculation and female sexual dysfunction disorders.

*Insights from interviews with seven leading US and European key opinion leaders in the field of male and female sexual dysfunction.

Highlights

The erectile dysfunction market will remain the most attractive and accepted one among the different sexual dysfunction disorders for the foreseeable future, although Johnson & Johnson is well positioned to develop the premature ejaculation area with the launch of Priligy (dapoxetine) in the EU.

Companies entering the sexual dysfunction market will have to follow the example of Viagra (sildenafil, Pfizer) and invest heavily in direct to consumer marketing in the US. A strong marketing message will be vital to raising awareness and beginning the campaign to destigmatize the different disorders.

There is high R&D risk in the associated with the development of drugs for female sexual dysfunction due to the lack of clear disorder definition and trial endpoints, the strong placebo effect of drugs and the scrutiny of regulatory bodies. As such Boehringer Ingelheim's flibanserin and BioSante's LibiGel (testosterone) approval is not guaranteed.

Reasons to Purchase

*Understand the prevalence of erectile dysfunction, premature ejaculation and female sexual dysfunction.

*Identify the key clinical unmet needs in the treatment of male and female sexual dysfunction as determined by interviewed key opinion leaders.

*Evaluate the potential of key strategies companies can employ to increase their presence in the sexual dysfunction disorder markets.

Overview 1

Catalyst 1

Summary 1

ABOUT DATAMONITOR HEALTHCARE 2

About the Genitourinary pharmaceutical analysis team 2

Executive Summary 3

Scope of the analysis 3

Datamonitor insight into the sexual dysfunction market 3

Related reports 5

TABLE OF CONTENTS 6

1. Sexual Dysfunction - Patient Potential 7

Key findings 7

Definition 8

Male sexual dysfunction 9

Erectile dysfunction 10

Premature ejaculation 13

Female sexual dysfunction 15

Etiology 17

Classification of female sexual dysfunction 19

Epidemiology 20

Seven major markets 20

Problems with sexual dysfunction epidemiology studies 20

Male sexual dysfunction 22

US - premature ejaculation is the most prevalent male sexual dysfunction 23

Japan - half of men over 40 years experience at least one sexual dysfunction 25

France - prevalence of premature ejaculation varies greatly 26

Germany - a over 8 million men are affected by at least one sexual dysfunction 28

Italy - premature ejaculation is the most common sexual complaint 29

Spain - over 3 million men have at least one sexual dysfunction 30

UK - over 5 million men have at least one sexual dysfunction 31

Female sexual dysfunction 33

US - over 25 million women in the US lack interest in sex 34

Japan - trouble lubrication is the most common complaint among Japanese women over 40 years 36

France - prevalence rates are similar across different types of female sexual dysfunction 37

Germany - Over 9 million women experience hypoactive sexual desire disorder 38

Italy -Women over 60 years are by far more likely to experience a type of sexual dysfunction than younger women 39

Spain - over 3 million women report to lack sexual interest 40

UK - the majority of women experiencing a sexual dysfunction will have trouble with desire or pleasure 41

Rest of the world epidemiology 42

Lack of studies limited the assessment of sexual dysfunction market in the BRIC countries 42

Current treatment options 44

Erectile dysfunction 44

Non pharmacological treatment 45

Pharmacological 46

Premature ejaculation 48

Non pharmacological - the recommended first-line treatment 49

Pharmacological 50

Female sexual dysfunction 51

Non pharmacological 57

Pharmacological 58

Unmet need in sexual dysfunction 59

Need for approved drugs for female sexual dysfunction and premature ejaculation 60

Approving drugs for these conditions will allow the market to be developed 61

Alternatives to the drugs currently used off-label need to be developed 62

Need to raise awareness among physicians and patients about sexual dysfunction 63

Reducing the stigma associated with sexual dysfunctions 64

Physicians need to be educated about sexual dysfunction 65

Patients need to be educated about the condition and therapies available 67

Celebrity spokespeople can destigmatize the disease 68

Need for universal definition of various sexual dysfunction disorders 69

Female sexual dysfunction remains poorly defined 69

Premature ejaculation prevalence differs according to the definition used 70

Need for better drugs for the treatment of erectile dysfunction 71

Better efficacy 71

Improved safety 72

Need for less expensive drugs 72

Currently therapy for premature ejaculation in the EU depends on what you can afford 72

Getting the drugs reimbursed is just as important as having them approved by the regulatory bodies 73

2. Sexual Dysfunction - Market Potential 74

Key findings 74

Market definition for this report 75

Current market overview 76

Sexual dysfunction market 76

Regional dynamics - the sexual dysfunction market has been displaying continuous growth across all regions 76

ATC class dynamics - the majority of the market is formed by the G4E (erectile dysfunction) ATC class 80

Erectile dysfunction 83

Regional dynamics - erectile dysfunction market continues to grow despite the small decrease in sales in the EU 83

Brand dynamics 86

Female sexual dysfunction 88

Over half of patients will receive some drug treatment for female sexual dysfunction 88

Counseling and education are the most common treatment 89

Rest of the world snapshot 92

The global erectile dysfunction market continues to display growth 92

Datamonitor's market attractiveness assessment 95

The female sexual dysfunction will be the toughest market to develop 99

Opportunities and threats 101

Opportunities 102

Limited competition in the market and high prevalence make this is an interesting market 102

Use Europe to start breaking the barriers 102

Target other sexual disorders 103

New market players can compete on cost 104

Over-the-counter switch bypasses embarrassing physician consultations 106

Threats 106

Increased FDA pharmacovigilance makes sexual dysfunction drugs high-risk projects 106

A proportion of physicians will be against medicalizing female sexual dysfunction 108

Off-label prescription is likely to remain high in premature ejaculation and female sexual dysfunction 109

Generic sildenafil competition from 2013 109

Approving drugs for female sexual dysfunction may be harder due to overlap of disorders 110

FDA increases scrutiny towards direct-to-consumer (DTC) advertising 111

Drug counterfeiting remains an issue in the sexual dysfunction market 112

Fear of recreational use of sexual dysfunction drugs may increase regulatory inspection 112

3. Brand Dynamics 115

Key findings 115

Overview of competitive landscape 116

Erectile dysfunction - Viagra (sildenafil; Pfizer) 116

Drug profile 116

Viagra patent expiry 117

Clinical trial data 118

Product positioning 118

SWOT analysis 120

Erectile dysfunction - Cialis (tadalafil; Eli Lilly) 121

Drug profile 121

Product positioning 122

SWOT analysis 124

Erectile dysfunction - Levitra (vardenafil; Bayer/GlaxoSmithKline/Merck-Schering-Plough ) 125

Drug profile 125

Marketing agreements 126

Product positioning 126

SWOT analysis 127

Premature ejaculation - Priligy (dapoxetine; Johnson & Johnson) 128

Drug profile 128

Development overview 129

Product positioning 131

First-to-market privilege is hindered by high cost 131

US approval 131

Safety concerns regarding SSRIs may hamper sales 133

SWOT analysis 134

Female sexual dysfunction - Intrinsa (testosterone patch, Procter & Gamble) 134

Drug profile 134

Product positioning 135

Launch in the US remains unlikely 137

SWOT analysis 137

4. Pipeline Analysis 139

Key findings 139

Pipeline overview 140

Erectile dysfunction - Avanafil (TA1790/Vivus) 144

Drug profile 144

Development overview 145

Product positioning 147

Short time to onset provides a differentiator but it will not secure a significant market share upon launch of generic Viagra 147

Clinical profile addresses some unmet needs 148

SWOT analysis 149

Premature ejaculation - PSD502 (lidocaine and prilocaine spray, Plethora Solutions/Shionogi Pharma) 150

Drug profile 150

Development overview 151

Product positioning 153

Favorable clinical profile compared to Priligy 153

PSD502 could be cheaper than Priligy 153

Second-to-market status could be an advantage 153

SWOT analysis 154

Female sexual dysfunction - Flibanserin (BIMT-17; Boehringer Ingelheim) 154

Drug profile 154

Development overview 155

Product positioning 159

Unimpressive clinical trial data may delay approval 160

Long-term safety remains unknown 161

SWOT analysis 162

Female sexual dysfunction - LibiGel (testosterone gel; Antares/BioSante) 162

Drug profile 162

Development overview 163

Product positioning 165

LibiGel may be the first testosterone product to be indicated for female sexual dysfunction in the US 165

High-risk project - the FDA is cautious about approving hormones in women... 165

...however, BioSante's efforts to work closely to the FDA are likely to pay off 165

SWOT analysis 166

Key early-stage compounds 168

5. Case Studies 169

Introduction 169

Case study: Viagra (sildenafil; Pfizer) 169

From 'impotence' to 'erectile dysfunction': a lesson in disease rebranding 169

Direct-to-consumer marketing is essential to creating brand awareness 170

Following Viagra's example, marketers in new sexual dysfunction disorders in the US have to concentrate on direct to consumer marketing 172

Similarly to when Viagra first launched, marketers in the premature ejaculation and female sexual dysfunction markets face numerous challenges 173

Maintaining market share when competition increases 174

Indication expansion - Viagra for pulmonary arterial hypertension 175

Indication expansion - Viagra for female sexual dysfunction 175

Bibliography 177

Journals 177

Websites 184

Datamonitor reports 187

Appendix A 188

Data definitions, limitations and assumptions 188

Methodology 188

Indication-specific sales calculations 188

Standard units 188

Country group definitions 189

Rest of EU 189

Middle East and North Africa (MENA) 189

Rest of World 189

Appendix B 190

Contributing experts 190

Report methodology 190

About Datamonitor 191

About Datamonitor Healthcare 191

About the Genitourinary analysis team 192

Disclaimer 194

List of Tables

Table 1: Classification of sexual dysfunctions 8

Table 2: General classification of male sexual dysfunction 10

Table 3: Classification of erectile dysfunction 10

Table 4: Causes of secondary erectile dysfunction 12

Table 5: Differences between erectile dysfunction and premature ejaculation 14

Table 6: Proposed etiology for premature ejaculation 15

Table 7: Causes of female sexual dysfunction 17

Table 8: Conditions, procedures and drugs that can cause female sexual dysfunction 18

Table 9: General classification of female sexual dysfunction 19

Table 10: Prevalence of sexual dysfunction across the seven major markets (000s), 2010 20

Table 11: Prevalence of DSM-IV sexual dysfunction disorders 21

Table 12: Prevalence of male sexual dysfunction across the seven major markets (000s), 2010 22

Table 13: Trends in the prevalence of male sexual dysfunction across the seven major markets (000s), 2010-2020 23

Table 14: Prevalence of male sexual dysfunction in the US (000s), 2010 24

Table 15: Trends in the prevalence of male sexual dysfunction in the US (000s), 2010-2020 25

Table 16: Prevalence of male sexual dysfunction in Japan (000s), 2010 26

Table 17: Trends in the prevalence of male sexual dysfunction in Japan (000s), 2010-2020 26

Table 18: Prevalence of male sexual dysfunction in France (000s), 2010 27

Table 19: Trends in the prevalence of male sexual dysfunction in France (000s), 2010-2020 27

Table 20: Prevalence of male sexual dysfunction in Germany (000s), 2010 28

Table 21: Trends in the prevalence of male sexual dysfunction in Germany (000s), 2010-2020 29

Table 22: Prevalence of male sexual dysfunction in Italy (000s), 2010 29

Table 23: Trends in the prevalence of male sexual dysfunction in Italy (000s), 2010-2020 30

Table 24: Prevalence of male sexual dysfunction in Spain (000s), 2010 31

Table 25: Trends in the prevalence of male sexual dysfunction in male population aged 40-79 years in Spain (000s), 2010-2020 31

Table 26: Prevalence of male sexual dysfunction in the UK (000s), 2010 32

Table 27: Trends in the prevalence of male sexual dysfunction in the UK (000s), 2010-2020 32

Table 28: Prevalence of female sexual dysfunction across the seven major markets (000s), 2010 33

Table 29: Trends in the prevalence of female sexual dysfunction across the seven major markets (000s), 2010-2020 33

Table 30: Prevalence of female sexual dysfunction in the US (000s), 2010 34

Table 31: Trends in the prevalence of female sexual dysfunction in the US (000s), 2010-2020 35

Table 32: Prevalence of female sexual dysfunction in Japan (000s), 2010 36

Table 33: Trends in the prevalence of female sexual dysfunction in Japan (000s), 2010-2020 36

Table 34: Prevalence of female sexual dysfunction in France (000s), 2010 37

Table 35: Trends in the prevalence of female sexual dysfunction in France (000s), 2010-2020 37

Table 36: Prevalence of female sexual dysfunction in Germany (000s), 2010 38

Table 37: Trends in the prevalence of female sexual dysfunction in Germany (000s), 2010-2020 38

Table 38: Prevalence of female sexual dysfunction in Italy (000s), 2010 39

Table 39: Trends in the prevalence of female sexual dysfunction in Italy (000s), 2010-2020 39

Table 40: Prevalence of female sexual dysfunction in Spain (000s), 2010 40

Table 41: Trends in the prevalence of female sexual dysfunction in women aged 40-79 in Spain (000s), 2010-2020 41

Table 42: Female sexual dysfunction prevalence rates from the Global Study of Sexual Attitudes and Behaviors (GSSAB) study, 2005 41

Table 43: Prevalence of female sexual dysfunction in women aged 20-69 years in the UK (000s), 2010 42

Table 44: Trends in the prevalence of female sexual dysfunction in the UK (000s), 2010-2020 42

Table 45: Review of male sexual dysfunction prevalence studies in Brazil, India and China, 2010 43

Table 46: Review of female sexual dysfunction prevalence studies in Brazil, Russia, India and China (BRIC countries), 2010 44

Table 47: Leading pharmacological treatments for erectile dysfunction, 2010 47

Table 48: Treatment for female sexual dysfunction disorders 52

Table 49: Approved pharmacological treatments for premature ejaculation and female sexual dysfunction in the seven major markets, 2010 60

Table 50: Examples of online information tools for physicians and patients on sexual dysfunction 67

Table 51: International Classification of Diseases 10th Revision (ICD-10) codes used to define the sexual dysfunction market 75

Table 52: Seven major markets sexual dysfunction sales ($m) dynamics, 2004-09 80

Table 53: Seven major markets sexual dysfunction sales ($m) by ATC class, 2004-09 82

Table 54: Seven major markets erectile dysfunction sales ($m) dynamics, 2004-09 86

Table 55: Erectile dysfunction sales ($m) for Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough in the seven major markets, 2004-09 88

Table 56: Percentage of women with female sexual disorders receiving each drug types as monotherapy or combination therapy in the US and five major EU markets, 2005 91

Table 57: Global erectile dysfunction sales for Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) ($m) split by region, 2004-09 95

Table 58: Datamonitor's sexual dysfunction market attractiveness assessment, 2010t 98

Table 59: Datamonitor's sexual dysfunction market advantages and disadvantages assessment, 2010 99

Table 60: Summary of opportunities and threats in the sexual dysfunction market across the seven major markets, 2010 102

Table 61: Ex-manufacturer price of Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough) in the US and five major EU markets ($/SU), 2004-08 105

Table 62: Intrinsa (testosterone patch, Procter & Gamble) price in the UK ($), 2010 106

Table 63: Summary of epidemiology studies regarding recreational use of sildenafil 114

Table 64: Leading pharmacological treatments for erectile dysfunction in the seven major markets, 2010 116

Table 65: Viagra (sildenafil, Pfizer) - drug profile, 2010 117

Table 66: Cialis (tadalafil, Eli Lilly) - drug profile, 2010 122

Table 67: Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck) - drug profile, 2010 126

Table 68: Priligy (dapoxetine; Johnson & Johnson) - drug profile, 2010 129

Table 69: Priligy: summary of key clinical trials 130

Table 70: Intrinsa (testosterone patch, Procter & Gamble) - drug profile, 2010 135

Table 71: R&D drug pipeline for erectile dysfunction, 2010 141

Table 72: R&D drug pipeline for premature ejaculation, 2010 142

Table 73: R&D drug pipeline for female sexual dysfunction, 2010 143

Table 74: Avanafil (TA1790, Vivus) - drug profile, 2010 145

Table 75: TA1790: summary of key clinical trials 146

Table 76: REVIVE (TA-301) results for avanafil, 2009 147

Table 77: Comparison of time on onset and duration of effect between avanafil and other marketed phosphodiesterase type 5 inhibitors 148

Table 78: PSD502 (lidocaine and prilocaine spray, Plethora Solutions/Shionogi Pharma) - drug profile, 2010 151

Table 79: PSD502: summary of key clinical trials 152

Table 80: Flibanserin (BIMT-17; Boehringer Ingelheim) - drug profile, 2010 155

Table 81: Flibanserin: summary of key clinical trials 157

Table 82: DAHLIA flibanserin Phase III clinical trial results, 2009 158

Table 83: DAISY flibanserin Phase III clinical trial results, 2009 158

Table 84: VIOLET flibanserin Phase III clinical trial results, 2009 159

Table 85: ORCHID flibanserin Phase III clinical trial results, 2009 159

Table 86: LibiGel (testosterone gel, Antares/BioSante) - drug profile, 2010 163

Table 87: LibiGel: summary of key clinical trials 164

Table 88: Key pre-clinical products in development for sexual dysfunction, 2010 168

Table 89: Marketing challenges in the premature ejaculation and female sexual dysfunction markets 173

List of Figures

Figure 1: Major causes of secondary erectile dysfunction in the US 13

Figure 2: Erectile dysfunction treatment guidelines, 2010 45

Figure 3: Premature ejaculation treatment guidelines, 2010 49

Figure 4: Proposed treatment algorithm for hypoactive sexual desire disorder (HSDD) 53

Figure 5: Proposed treatment algorithm for female sexual arousal disorder (FSAD) 54

Figure 6: Proposed treatment algorithm for female orgasmic disorder 55

Figure 7: Proposed treatment algorithm for female dyspareunia (introital and deep) 56

Figure 8: Proposed treatment algorithm for female dyspareunia (vaginismus) 57

Figure 9: Unmet needs in male and female sexual dysfunction, 2010 59

Figure 10: Eli Lilly's 40over40 erectile dysfunction information homepage, 2010 63

Figure 11: Sexual dysfunction market sales ($m) across the seven major markets, 2004-09 77

Figure 12: Sexual dysfunction market sales dynamics ($m) across the seven major markets, 2004-09 78

Figure 13: Sexual dysfunction market sales ($m) across the five major EU markets, 2004-09 79

Figure 14: Seven major markets sexual dysfunction ATC sales ($m) dynamics, 2004-09 81

Figure 15: Seven major markets sexual dysfunction by ATC class, 2009 83

Figure 16: Seven major market erectile dysfunction sales ($m), 2004-09 84

Figure 17: Seven major markets erectile dysfunction sales ($m) dynamics, 2004-09 85

Figure 18: Brand sales ($m) dynamics for erectile dysfunction in the seven major markets, 2004-09 87

Figure 19: Female sexual dysfunction treatment in the US and the five major EU markets (5EU), 2005 89

Figure 20: Non-pharmacological treatment for female sexual dysfunction breakdown in the US and five major EU markets (5EU), 2005 90

Figure 21: Global sales for Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) for erectile dysfunction ($m), 2004-09 93

Figure 22: Global sales for Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) for erectile dysfunction ($m) dynamics, 2004-08 94

Figure 23: Datamonitor's sexual dysfunction market attractiveness assessment, 2010 96

Figure 24: Datamonitor's sexual dysfunction market attractiveness assessment according to stakeholder acceptance, 2010 97

Figure 25: Overlap of female sexual disorders 110

Figure 26: Viagra (sildenafil, Pfizer) sales across the seven major markets for erectile dysfunction, 2004-09 119

Figure 27: Global sales for Viagra (sildenafil, Pfizer), 2007-09 120

Figure 28: Viagra (sildenafil, Pfizer) SWOT analysis, 2010 121

Figure 29: Cialis (tadalafil, Eli Lilly) sales across the seven major markets for erectile dysfunction, 2004-09 123

Figure 30: Global sales for Cialis (tadalafil, Eli Lilly), 2007-09 124

Figure 31: Cialis (tadalafil, Eli Lilly) SWOT analysis, 2010 125

Figure 32: Global sales for Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ), 2004-09 127

Figure 33: Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) SWOT analysis, 2010 128

Figure 34: Priligy (dapoxetine; Johnson & Johnson) SWOT analysis, 2010 134

Figure 35: Total brand sales for Intrinsa (testosterone patch, Procter & Gamble) across the five major EU markets, 2008 136

Figure 36: Intrinsa (testosterone patch, Procter & Gamble) SWOT analysis, 2010 138

Figure 37: Pipeline for sexual dysfunction, 2010 144

Figure 38: Avanafil (TA1790, Vivus) SWOT analysis, 2010 150

Figure 39: PSD502 (lidocaine and prilocaine spray, Plethora Solutions/Shionogi Pharma) SWOT analysis, 2010 154

Figure 40: Flibanserin (BIMT-17; Boehringer Ingelheim) SWOT analysis, 2010 162

Figure 41: LibiGel (testosterone, Antares/BioSante) SWOT analysis, 2010 167

Figure 42: Examples of Viagra promotions 171

Figure 43: Promotional expenditure ($m) of the leading brands in the sexual dysfunction market in the seven major markets, 2007 172

To order this report:

Pharmaceutical Industry: Stakeholder Opinions: Sexual Dysfunction - The quest for the new Viagra continues

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Nicolas Bombourg Reportlinker Email: nbo@reportlinker.com US: (805)652-2626 Intl: +1 805-652-2626

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