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Male Hypogonadism-Pipeline Review, H1 2015

Male Hypogonadism-Pipeline Review, H1 2015


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Executive Summary

Male Hypogonadism-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Male Hypogonadism-Pipeline Review, H1 2015', provides an overview of the Male Hypogonadism's therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Male Hypogonadism, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Male Hypogonadism and special features on late-stage 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, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct's team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

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

Scope

The report provides a snapshot of the global therapeutic landscape of Male Hypogonadism

The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved in the therapeutics development for Male Hypogonadism and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Male Hypogonadism products under development by companies and universities/research institutes based on information derived from company and industry-specific sources

Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages

A detailed assessment of monotherapy and combination therapy pipeline projects

Coverage of the Male Hypogonadism pipeline on the basis of target, MoA, route of administration and molecule type

Latest news and deals relating related to pipeline products

Reasons To Buy

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

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

Develop strategic initiatives by understanding the focus areas of leading companies

Identify and understand important and diverse types of therapeutics under development for Male Hypogonadism

Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

Devise corrective measures for pipeline projects by understanding Male 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

Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Male Hypogonadism Overview 9

Therapeutics Development 10

Pipeline Products for Male Hypogonadism-Overview 10

Pipeline Products for Male Hypogonadism-Comparative Analysis 11

Male Hypogonadism-Therapeutics under Development by Companies 12

Male Hypogonadism-Therapeutics under Investigation by Universities/Institutes 14

Male Hypogonadism-Pipeline Products Glance 15

Late Stage Products 15

Clinical Stage Products 16

Early Stage Products 17

Male Hypogonadism-Products under Development by Companies 18

Male Hypogonadism-Products under Investigation by Universities/Institutes 20

Male Hypogonadism-Companies Involved in Therapeutics Development 21

AlphaMab Co., Ltd 21

Antares Pharma, Inc. 22

Auxilium Pharmaceuticals, Inc. 23

Clarus Therapeutics, Inc. 24

Diurnal Ltd 25

EndoCeutics, Inc. 26

Ferring International Center S.A. 27

Forendo Pharma Oy 28

Lipocine Inc. 29

M et P Pharma AG 30

Merck & Co., Inc. 31

Monosol Rx, LLC 32

Novartis AG 33

Pantarhei Bioscience BV 34

Repros Therapeutics Inc. 35

SoluBest Ltd. 36

Male Hypogonadism-Therapeutics Assessment 37

Assessment by Monotherapy Products 37

Assessment by Target 38

Assessment by Mechanism of Action 40

Assessment by Route of Administration 42

Assessment by Molecule Type 44

Drug Profiles 46

BGS-649-Drug Profile 46

Product Description 46

Mechanism of Action 46

R&D Progress 46

corifollitropin alfa-Drug Profile 47

Product Description 47

Mechanism of Action 47

R&D Progress 47

enclomiphene-Drug Profile 49

Product Description 49

Mechanism of Action 49

R&D Progress 49

fispemifene-Drug Profile 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

follitropin alfa-Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

Kisspeptin-10-Drug Profile 54

Product Description 54

Mechanism of Action 54

R&D Progress 54

Libidua-Drug Profile 55

Product Description 55

Mechanism of Action 55

R&D Progress 55

LPCN-1111-Drug Profile 56

Product Description 56

Mechanism of Action 56

R&D Progress 56

T-2-Drug Profile 57

Product Description 57

Mechanism of Action 57

R&D Progress 57

Testavan-Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

testosterone-Drug Profile 59

Product Description 59

Mechanism of Action 59

R&D Progress 59

testosterone-Drug Profile 60

Product Description 60

Mechanism of Action 60

R&D Progress 60

testosterone-Drug Profile 62

Product Description 62

Mechanism of Action 62

R&D Progress 62

testosterone-Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

testosterone-Drug Profile 64

Product Description 64

Mechanism of Action 64

R&D Progress 64

testosterone-Drug Profile 65

Product Description 65

Mechanism of Action 65

R&D Progress 65

testosterone-Drug Profile 66

Product Description 66

Mechanism of Action 66

R&D Progress 66

testosterone enanthate-Drug Profile 68

Product Description 68

Mechanism of Action 68

R&D Progress 68

testosterone next generation-Drug Profile 69

Product Description 69

Mechanism of Action 69

R&D Progress 69

testosterone undecanoate-Drug Profile 70

Product Description 70

Mechanism of Action 70

R&D Progress 70

testosterone undecanoate-Drug Profile 72

Product Description 72

Mechanism of Action 72

R&D Progress 72

testosterone undecanoate-Drug Profile 73

Product Description 73

Mechanism of Action 73

R&D Progress 73

Male Hypogonadism-Recent Pipeline Updates 74

Male Hypogonadism-Dormant Projects 90

Male Hypogonadism-Discontinued Products 91

Male Hypogonadism-Product Development Milestones 92

Featured News & Press Releases 92

Jan 13, 2015: Antares Pharma Announces Update To Quickshot Testosterone Program 92

Dec 29, 2014: Court Rules Inventors Correctly Named on Androxal Patents 92

Dec 29, 2014: Repros Updates Androxal Global Regulatory Status 93

Dec 16, 2014: SOV Therapeutics announces Successful Phase IIb Study of Oral Testosterone Undecanoate for Treatment of Primary and Secondary Hypogonadism in Adult Males 94

Dec 16, 2014: SOV Therapeutics announces Successful Phase IIb Study of Oral Testosterone Undecanoate for Treatment of Primary and Secondary Hypogonadism in Adult Males 94

Dec 15, 2014: FDA Confirms Lipocine's Previously-Agreed Clinical Development Plan for LPCN 1021 95

Nov 25, 2014: Trimel Announces Issuance of Additional Patent Covering NATESTO 95

Nov 03, 2014: Antares Pharma Announces Last Patient Enrolled in Phase 3 QuickShot Study Evaluating Testosterone-Deficient Adult Males 96

Oct 27, 2014: Repros to Webcast Investor and Analyst Day on October 31st 96

Oct 21, 2014: Results From Long-Term Study of Androxal Exhibit Positive Safety Profile 97

Appendix 99

Methodology 99

Coverage 99

Secondary Research 99

Primary Research 99

Expert Panel Validation 99

Contact Us 99

Disclaimer 100

List of Tables

Number of Products under Development for Male Hypogonadism, H1 2015 10

Number of Products under Development for Male Hypogonadism-Comparative Analysis, H1 2015 11

Number of Products under Development by Companies, H1 2015 13

Number of Products under Investigation by Universities/Institutes, H1 2015 14

Comparative Analysis by Late Stage Development, H1 2015 15

Comparative Analysis by Clinical Stage Development, H1 2015 16

Comparative Analysis by Early Stage Development, H1 2015 17

Products under Development by Companies, H1 2015 18

Products under Development by Companies, H1 2015 (Contd..1) 19

Products under Investigation by Universities/Institutes, H1 2015 20

Male Hypogonadism-Pipeline by AlphaMab Co., Ltd, H1 2015 21

Male Hypogonadism-Pipeline by Antares Pharma, Inc., H1 2015 22

Male Hypogonadism-Pipeline by Auxilium Pharmaceuticals, Inc., H1 2015 23

Male Hypogonadism-Pipeline by Clarus Therapeutics, Inc., H1 2015 24

Male Hypogonadism-Pipeline by Diurnal Ltd, H1 2015 25

Male Hypogonadism-Pipeline by EndoCeutics, Inc., H1 2015 26

Male Hypogonadism-Pipeline by Ferring International Center S.A., H1 2015 27

Male Hypogonadism-Pipeline by Forendo Pharma Oy, H1 2015 28

Male Hypogonadism-Pipeline by Lipocine Inc., H1 2015 29

Male Hypogonadism-Pipeline by M et P Pharma AG, H1 2015 30

Male Hypogonadism-Pipeline by Merck & Co., Inc., H1 2015 31

Male Hypogonadism-Pipeline by Monosol Rx, LLC, H1 2015 32

Male Hypogonadism-Pipeline by Novartis AG, H1 2015 33

Male Hypogonadism-Pipeline by Pantarhei Bioscience BV, H1 2015 34

Male Hypogonadism-Pipeline by Repros Therapeutics Inc., H1 2015 35

Male Hypogonadism-Pipeline by SoluBest Ltd., H1 2015 36

Assessment by Monotherapy Products, H1 2015 37

Number of Products by Stage and Target, H1 2015 39

Number of Products by Stage and Mechanism of Action, H1 2015 41

Number of Products by Stage and Route of Administration, H1 2015 43

Number of Products by Stage and Molecule Type, H1 2015 45

Male Hypogonadism Therapeutics-Recent Pipeline Updates, H1 2015 74

Male Hypogonadism-Dormant Projects, H1 2015 90

Male Hypogonadism-Discontinued Products, H1 2015 91

List of Figures

Number of Products under Development for Male Hypogonadism, H1 2015 10

Number of Products under Development for Male Hypogonadism-Comparative Analysis, H1 2015 11

Number of Products under Development by Companies, H1 2015 12

Comparative Analysis by Late Stage Development, H1 2015 15

Comparative Analysis by Clinical Stage Development, H1 2015 16

Assessment by Monotherapy Products, H1 2015 37

Number of Products by Top 10 Targets, H1 2015 38

Number of Products by Stage and Top 10 Targets, H1 2015 39

Number of Products by Top 10 Mechanism of Actions, H1 2015 40

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 41

Number of Products by Top 10 Routes of Administration, H1 2015 42

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 43

Number of Products by Top 10 Molecule Types, H1 2015 44

Number of Products by Stage and Top 10 Molecule Types, H1 2015 45

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AlphaMab Co., Ltd

Antares Pharma, Inc.

Auxilium Pharmaceuticals, Inc.

Clarus Therapeutics, Inc.

Diurnal Ltd

EndoCeutics, Inc.

Ferring International Center S.A.

Forendo Pharma Oy

Lipocine Inc.

M et P Pharma AG

Merck & Co., Inc.

Monosol Rx, LLC

Novartis AG

Pantarhei Bioscience BV

Repros Therapeutics Inc.

SoluBest Ltd.

Male Hypogonadism Therapeutic Products under Development, Key Players in Male Hypogonadism Therapeutics, Male Hypogonadism Pipeline Overview, Male Hypogonadism Pipeline, Male Hypogonadism Pipeline Assessment


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