Secondary (Hypogonadotropic) Hypogonadism – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Secondary (Hypogonadotropic) Hypogonadism – Pipeline Review, H2 2016’, provides an overview of the Secondary (Hypogonadotropic) Hypogonadism pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Secondary (Hypogonadotropic) Hypogonadism, 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 Secondary (Hypogonadotropic) Hypogonadism 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 Secondary (Hypogonadotropic) Hypogonadism

The report reviews pipeline therapeutics for Secondary (Hypogonadotropic) Hypogonadism 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 Secondary (Hypogonadotropic) Hypogonadism therapeutics and enlists all their major and minor projects

The report assesses Secondary (Hypogonadotropic) Hypogonadism 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 Secondary (Hypogonadotropic) Hypogonadism

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 Secondary (Hypogonadotropic) Hypogonadism

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 Secondary (Hypogonadotropic) Hypogonadism 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

Forendo Pharma Ltd

Merck & Co Inc

Mereo Biopharma Group Plc

Repros Therapeutics Inc

Takeda Pharmaceutical Company Ltd

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 5

Introduction 6

Global Markets Direct Report Coverage 6

Secondary (Hypogonadotropic) Hypogonadism Overview 7

Therapeutics Development 8

Pipeline Products for Secondary (Hypogonadotropic) Hypogonadism - Overview 8

Pipeline Products for Secondary (Hypogonadotropic) Hypogonadism - Comparative Analysis 9

Secondary (Hypogonadotropic) Hypogonadism - Therapeutics under Development by Companies 10

Secondary (Hypogonadotropic) Hypogonadism - Therapeutics under Investigation by Universities/Institutes 11

Secondary (Hypogonadotropic) Hypogonadism - Pipeline Products Glance 12

Late Stage Products 12

Clinical Stage Products 13

Secondary (Hypogonadotropic) Hypogonadism - Products under Development by Companies 14

Secondary (Hypogonadotropic) Hypogonadism - Products under Investigation by Universities/Institutes 15

Secondary (Hypogonadotropic) Hypogonadism - Companies Involved in Therapeutics Development 16

Forendo Pharma Ltd 16

Merck & Co Inc 17

Mereo Biopharma Group Plc 18

Repros Therapeutics Inc 19

Takeda Pharmaceutical Company Ltd 20

Secondary (Hypogonadotropic) Hypogonadism - Therapeutics Assessment 21

Assessment by Monotherapy Products 21

Assessment by Target 22

Assessment by Mechanism of Action 24

Assessment by Route of Administration 26

Assessment by Molecule Type 28

Drug Profiles 30

BGS-649 - Drug Profile 30

Product Description 30

Mechanism Of Action 30

R&D Progress 30

corifollitropin alfa - Drug Profile 31

Product Description 31

Mechanism Of Action 31

R&D Progress 31

enclomiphene citrate - Drug Profile 33

Product Description 33

Mechanism Of Action 33

R&D Progress 33

fispemifene - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

Kisspeptin-10 - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

MSS-722 - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

TAK-448 - Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

testosterone undecanoate - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

Secondary (Hypogonadotropic) Hypogonadism - Dormant Projects 51

Secondary (Hypogonadotropic) Hypogonadism - Discontinued Products 52

Secondary (Hypogonadotropic) Hypogonadism - Product Development Milestones 53

Featured News & Press Releases 53

Oct 05, 2016: Repros Announces Acceptance of Dossier for Enclomiphene for Secondary Hypogonadism by European Authorities 53

Sep 12, 2016: Repros Announces Submission of MAA to the European Medicines Agency for Enclomiphene in the Treatment of Secondary Hypogonadism 53

Aug 15, 2016: Repros Provides Six Month Interim Results for Enclomiphene Study in Obese Secondary Hypogonadal Men 54

Jun 01, 2016: Repros Provides Update on EU Submission of Enclomiphene for the Treatment of Secondary Hypogonadism and 3 Month Interim Results for Enclomiphene Study in Obese Secondary Hypogonadal Men 55

Mar 28, 2016: Apricus Reports Top-Line Phase 2b Data for Fispemifene in Symptomatic Secondary Hypogonadism 56

Mar 15, 2016: Repros Announces Initiation of Formal Approval Process by the European Medicines Agency 57

Feb 16, 2016: Repros Completes Randomization of Enclomiphene Phase 2 Proof of Concept Study in Obese Secondary Hypogonadal Men 57

Feb 08, 2016: Repros Holds Meeting With FDA to Discuss Complete Response Letter for Enclomiphene in the Treatment of Secondary Hypogonadism 58

Feb 02, 2016: Apricus Biosciences to Present at the 18th Annual BIO CEO & Investor Conference and Provide Update on Fispemifene 59

Jan 11, 2016: Repros Announces Court of Appeals' Affirmation of Summary Judgment in Favor of the Company 59

Jan 04, 2016: Repros Updates Enclomiphene Program 59

Dec 01, 2015: Repros Therapeutics Receives Complete Response Letter From FDA for Enclomiphene 59

Dec 01, 2015: Apricus Biosciences Confirms Clinical Strategy for Its Novel Treatment for Symptomatic Secondary Hypogonadism Fispemifene 60

Oct 29, 2015: Repros Therapeutics Announces Cancellation of FDA Advisory Committee Meeting to Review Enclomiphene for the Treatment of Secondary Hypogonadism 60

Jun 08, 2015: Repros Announces Date of FDA Advisory Committee Review of NDA 61

Appendix 62

Methodology 62

Coverage 62

Secondary Research 62

Primary Research 62

Expert Panel Validation 62

Contact Us 62

Disclaimer 63

List of Tables

List of Tables

Number of Products under Development for Secondary (Hypogonadotropic) Hypogonadism, H2 2016 8

Number of Products under Development for Secondary (Hypogonadotropic) Hypogonadism – Comparative Analysis, H2 2016 9

Number of Products under Development by Companies, H2 2016 10

Number of Products under Investigation by Universities/Institutes, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 12

Comparative Analysis by Clinical Stage Development, H2 2016 13

Products under Development by Companies, H2 2016 14

Products under Investigation by Universities/Institutes, H2 2016 15

Secondary (Hypogonadotropic) Hypogonadism – Pipeline by Forendo Pharma Ltd, H2 2016 16

Secondary (Hypogonadotropic) Hypogonadism – Pipeline by Merck & Co Inc, H2 2016 17

Secondary (Hypogonadotropic) Hypogonadism – Pipeline by Mereo Biopharma Group Plc, H2 2016 18

Secondary (Hypogonadotropic) Hypogonadism – Pipeline by Repros Therapeutics Inc, H2 2016 19

Secondary (Hypogonadotropic) Hypogonadism – Pipeline by Takeda Pharmaceutical Company Ltd, H2 2016 20

Assessment by Monotherapy Products, H2 2016 21

Number of Products by Stage and Target, H2 2016 23

Number of Products by Stage and Mechanism of Action, H2 2016 25

Number of Products by Stage and Route of Administration, H2 2016 27

Number of Products by Stage and Molecule Type, H2 2016 29

Secondary (Hypogonadotropic) Hypogonadism – Dormant Projects, H2 2016 51

Secondary (Hypogonadotropic) Hypogonadism – Discontinued Products, H2 2016 52

List of Figures

List of Figures

Number of Products under Development for Secondary (Hypogonadotropic) Hypogonadism, H2 2016 8

Number of Products under Development for Secondary (Hypogonadotropic) Hypogonadism – Comparative Analysis, H2 2016 9

Number of Products under Development by Companies, H2 2016 10

Comparative Analysis by Late Stage Development, H2 2016 12

Comparative Analysis by Clinical Stage Development, H2 2016 13

Assessment by Monotherapy Products, H2 2016 21

Number of Products by Top 10 Targets, H2 2016 22

Number of Products by Stage and Top 10 Targets, H2 2016 22

Number of Products by Mechanism of Actions, H2 2016 24

Number of Products by Stage and Mechanism of Actions, H2 2016 24

Number of Products by Routes of Administration, H2 2016 26

Number of Products by Stage and Routes of Administration, H2 2016 26

Number of Products by Molecule Types, H2 2016 28

Number of Products by Stage and Molecule Types, H2 2016 28

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