Female Sexual Dysfunction – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Female Sexual Dysfunction – Pipeline Review, H2 2016’, provides an overview of the Female Sexual Dysfunction pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Female Sexual Dysfunction, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Female Sexual Dysfunction and features dormant and discontinued projects.

Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data.

Scope

The report provides a snapshot of the global therapeutic landscape of Female Sexual Dysfunction

The report reviews pipeline therapeutics for Female Sexual Dysfunction by companies and universities/research institutes based on information derived from company and industry-specific sources

The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved Female Sexual Dysfunction therapeutics and enlists all their major and minor projects

The report assesses Female Sexual Dysfunction therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type

The report summarizes all the dormant and discontinued pipeline projects

The report reviews latest news related to pipeline therapeutics for Female Sexual Dysfunction

Reasons to buy

Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand important and diverse types of therapeutics under development for Female Sexual Dysfunction

Identify potential new clients or partners in the target demographic

Develop strategic initiatives by understanding the focus areas of leading companies

Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics

Devise corrective measures for pipeline projects by understanding Female Sexual Dysfunction pipeline depth and focus of Indication therapeutics

Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline

Companies mentioned

Allergan Plc

Apricus Biosciences Inc

Emotional Brain BV

Fabre-Kramer Pharmaceuticals Inc

GlaxoSmithKline Plc

M et P Pharma AG

Palatin Technologies Inc

Re-Pharm Ltd

TherapeuticsMD Inc

Valeant Pharmaceuticals International Inc

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Female Sexual Dysfunction Overview 8

Therapeutics Development 9

Pipeline Products for Female Sexual Dysfunction - Overview 9

Pipeline Products for Female Sexual Dysfunction - Comparative Analysis 10

Female Sexual Dysfunction - Therapeutics under Development by Companies 11

Female Sexual Dysfunction - Therapeutics under Investigation by Universities/Institutes 12

Female Sexual Dysfunction - Pipeline Products Glance 13

Late Stage Products 13

Clinical Stage Products 14

Early Stage Products 15

Female Sexual Dysfunction - Products under Development by Companies 16

Female Sexual Dysfunction - Products under Investigation by Universities/Institutes 17

Female Sexual Dysfunction - Companies Involved in Therapeutics Development 18

Allergan Plc 18

Apricus Biosciences Inc 19

Emotional Brain BV 20

Fabre-Kramer Pharmaceuticals Inc 21

GlaxoSmithKline Plc 22

M et P Pharma AG 23

Palatin Technologies Inc 24

Re-Pharm Ltd 25

TherapeuticsMD Inc 26

Valeant Pharmaceuticals International Inc 27

Female Sexual Dysfunction - Therapeutics Assessment 28

Assessment by Monotherapy Products 28

Assessment by Combination Products 29

Assessment by Target 30

Assessment by Mechanism of Action 32

Assessment by Route of Administration 34

Assessment by Molecule Type 36

Drug Profiles 38

(sildenafil citrate + testosterone) - Drug Profile 38

Product Description 38

Mechanism Of Action 38

R&D Progress 38

AB-101 - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

alprostadil - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

bremelanotide - Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

estradiol acetate - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

FKW-00GA - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

gepirone hydrochloride ER - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

S1B-3006 - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

S1B-307 - Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

SIP-104 - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

Small Molecule for Sexual Dysfunction - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

Small Molecules to Agonize Dopamine D2 Receptor for Sexual Dysfunction - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

SPT-201 - Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

Synthetic Peptide to Agonize Melanocortin 4 Receptor for Female Sexual Dysfunction and Erectile Dysfunction - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

TBS-2 - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

WC-3011 - Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

Female Sexual Dysfunction - Dormant Projects 70

Female Sexual Dysfunction - Discontinued Products 72

Female Sexual Dysfunction - Product Development Milestones 73

Featured News & Press Releases 73

Nov 01, 2016: Bremelanotide Meets Co-Primary Endpoints in Palatins Phase 3 Trials for Hypoactive Sexual Desire Disorder 73

Sep 23, 2016: Palatin Technologies Presents Bremelanotide Neurobiology and Treatment Efficacy Review at World Meeting on Sexual Medicine 74

Sep 22, 2016: TherapeuticsMD Announces Multiple Presentations Related to Yuvvexy (TX-004HR) at Two Upcoming Medical Conferences 74

Sep 19, 2016: TherapeuticsMD Announces FDA Acceptance of New Drug Application and Prescription Drug User Fee Act (PDUFA) Date for Yuvvexy (TX-004HR) 76

Aug 04, 2016: Palatin Technologies Announces Completion of All Patient Visits In Phase 3 Clinical Trials of Bremelanotide for Hypoactive Sexual Desire Disorder 76

Jul 07, 2016: TherapeuticsMD Announces New Drug Application Submission for Yuvvexy (TX-004HR) 77

Jun 30, 2016: Catalent Announces Agreement To Commercially Supply Palatin Technologies’ New Bremelanotide Female Sexual Dysfunction Product In Pen Injectors 77

Jun 29, 2016: TherapeuticsMD Announces Filing Timeline for Yuvvexy (TX-004HR) New Drug Application 77

May 14, 2016: TherapeuticsMD Presents Poster at ACOG 2016 with Additional Secondary Endpoint Data from Phase 3 Rejoice Trial 78

Mar 02, 2016: TherapeuticsMD to Present Data from Phase 3 Rejoice Trial at Upcoming Investor & Medical Conferences 78

Feb 26, 2016: Palatin Technologies Presents Bremelanotide Alcohol Interaction Study at International Society for the Study of Womens Sexual Health Annual Meeting 79

Feb 18, 2016: TherapeuticsMD Announces Poster Presentations at International Society for the Study of Women’s Sexual Health Annual Meeting 79

Feb 08, 2016: Palatin Technologies Strengthens Intellectual Property Surrounding Use of Bremelanotide for Female Sexual Dysfunction 80

Dec 10, 2015: Palatin Technologies Achieves Target Patient Enrollment in Pivotal Phase 3 Studies for Bremelanotide for Female Sexual Dysfunction 80

Appendix 82

Methodology 82

Coverage 82

Secondary Research 82

Primary Research 82

Expert Panel Validation 82

Contact Us 82

Disclaimer 83

List of Tables

List of Tables

Number of Products under Development for Female Sexual Dysfunction, H2 2016 9

Number of Products under Development for Female Sexual Dysfunction – Comparative Analysis, H2 2016 10

Number of Products under Development by Companies, H2 2016 11

Number of Products under Investigation by Universities/Institutes, H2 2016 12

Comparative Analysis by Late Stage Development, H2 2016 13

Comparative Analysis by Clinical Stage Development, H2 2016 14

Comparative Analysis by Early Stage Development, H2 2016 15

Products under Development by Companies, H2 2016 16

Products under Investigation by Universities/Institutes, H2 2016 17

Female Sexual Dysfunction – Pipeline by Allergan Plc, H2 2016 18

Female Sexual Dysfunction – Pipeline by Apricus Biosciences Inc, H2 2016 19

Female Sexual Dysfunction – Pipeline by Emotional Brain BV, H2 2016 20

Female Sexual Dysfunction – Pipeline by Fabre-Kramer Pharmaceuticals Inc, H2 2016 21

Female Sexual Dysfunction – Pipeline by GlaxoSmithKline Plc, H2 2016 22

Female Sexual Dysfunction – Pipeline by M et P Pharma AG, H2 2016 23

Female Sexual Dysfunction – Pipeline by Palatin Technologies Inc, H2 2016 24

Female Sexual Dysfunction – Pipeline by Re-Pharm Ltd, H2 2016 25

Female Sexual Dysfunction – Pipeline by TherapeuticsMD Inc, H2 2016 26

Female Sexual Dysfunction – Pipeline by Valeant Pharmaceuticals International Inc, H2 2016 27

Assessment by Monotherapy Products, H2 2016 28

Assessment by Combination Products, H2 2016 29

Number of Products by Stage and Target, H2 2016 31

Number of Products by Stage and Mechanism of Action, H2 2016 33

Number of Products by Stage and Route of Administration, H2 2016 35

Number of Products by Stage and Molecule Type, H2 2016 37

Female Sexual Dysfunction – Dormant Projects, H2 2016 70

Female Sexual Dysfunction – Dormant Projects (Contd..1), H2 2016 71

Female Sexual Dysfunction – Discontinued Products, H2 2016 72

List of Figures

List of Figures

Number of Products under Development for Female Sexual Dysfunction, H2 2016 9

Number of Products under Development for Female Sexual Dysfunction – Comparative Analysis, H2 2016 10

Number of Products under Development by Companies, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 13

Comparative Analysis by Clinical Stage Development, H2 2016 14

Comparative Analysis by Early Stage Products, H2 2016 15

Assessment by Monotherapy Products, H2 2016 28

Number of Products by Top 10 Targets, H2 2016 30

Number of Products by Stage and Top 10 Targets, H2 2016 30

Number of Products by Top 10 Mechanism of Actions, H2 2016 32

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 32

Number of Products by Routes of Administration, H2 2016 34

Number of Products by Stage and Routes of Administration, H2 2016 34

Number of Products by Molecule Types, H2 2016 36

Number of Products by Stage and Molecule Types, H2 2016 36

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