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Hypogonadotropic Hypogonadism-Pipeline Review, H1 2015

Hypogonadotropic Hypogonadism-Pipeline Review, H1 2015


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Executive Summary

Hypogonadotropic Hypogonadism-Pipeline Review, H1 2015

Summary

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

This report provides comprehensive information on the therapeutic development for Hypogonadotropic 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 Hypogonadotropic 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 Hypogonadotropic 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 Hypogonadotropic Hypogonadism and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Hypogonadotropic 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 Hypogonadotropic 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 Hypogonadotropic Hypogonadism

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

Devise corrective measures for pipeline projects by understanding 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

Table of Contents

Table of Contents 2

List of Tables 4

List of Figures 4

Introduction 5

Global Markets Direct Report Coverage 5

Hypogonadotropic Hypogonadism Overview 6

Therapeutics Development 7

Pipeline Products for Hypogonadotropic Hypogonadism-Overview 7

Pipeline Products for Hypogonadotropic Hypogonadism-Comparative Analysis 8

Hypogonadotropic Hypogonadism-Therapeutics under Development by Companies 9

Hypogonadotropic Hypogonadism-Therapeutics under Investigation by Universities/Institutes 10

Hypogonadotropic Hypogonadism-Pipeline Products Glance 11

Late Stage Products 11

Clinical Stage Products 12

Early Stage Products 13

Hypogonadotropic Hypogonadism-Products under Development by Companies 14

Hypogonadotropic Hypogonadism-Products under Investigation by Universities/Institutes 15

Hypogonadotropic Hypogonadism-Companies Involved in Therapeutics Development 16

AlphaMab Co., Ltd 16

Forendo Pharma Oy 17

Merck & Co., Inc. 18

Novartis AG 19

Repros Therapeutics Inc. 20

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-Drug Profile 33

Product Description 33

Mechanism of Action 33

R&D Progress 33

fispemifene-Drug Profile 35

Product Description 35

Mechanism of Action 35

R&D Progress 35

follitropin alfa-Drug Profile 37

Product Description 37

Mechanism of Action 37

R&D Progress 37

Kisspeptin-10-Drug Profile 38

Product Description 38

Mechanism of Action 38

R&D Progress 38

testosterone undecanoate-Drug Profile 39

Product Description 39

Mechanism of Action 39

R&D Progress 39

Hypogonadotropic Hypogonadism-Recent Pipeline Updates 40

Hypogonadotropic Hypogonadism-Product Development Milestones 51

Featured News & Press Releases 51

Oct 27, 2014: Repros to Webcast Investor and Analyst Day on October 31st 51

Oct 21, 2014: Results From Long-Term Study of Androxal Exhibit Positive Safety Profile 51

Sep 26, 2014: FDA Schedules Type B Pre-NDA Meeting With Repros 52

Sep 25, 2014: Androxal Second Pivotal Study Achieves Superiority in Top Line Analysis for Both Co-Primary Endpoints Versus Marketed Topical Gel in the Treatment of Secondary Hypogonadism 52

Jul 16, 2014: FDA Confirms Sperm and Testosterone Endpoints as Key Parameters for Assessment of Androxal Versus Approved Topical Gel and Placebo 54

May 13, 2014: Repros Fully Enrolls Second Previously Announced Head to Head Study of Androxal(R) Versus the Leading Topical Testosterone Gel 55

Apr 30, 2014: FDA Recommends Sperm Endpoints as Key Parameters for Assessment of Androxal Versus Approved Topical Gel 55

Apr 14, 2014: Repros Fully Enrolls First of Two Previously Announced Head to Head Studies of Androxal Versus the Leading Topical Testosterone Gel 57

Jan 08, 2014: Repros Initiates Two Head to Head Studies of Androxal Versus the Leading Topical Testosterone Gel 57

Nov 25, 2013: FDA Schedules Face to Face Meeting With Repros to Discuss Androxal Efficacy 58

Appendix 59

Methodology 59

Coverage 59

Secondary Research 59

Primary Research 59

Expert Panel Validation 59

Contact Us 59

Disclaimer 60

List of Tables

Number of Products under Development for Hypogonadotropic Hypogonadism, H1 2015 7

Number of Products under Development for Hypogonadotropic Hypogonadism-Comparative Analysis, H1 2015 8

Number of Products under Development by Companies, H1 2015 9

Number of Products under Investigation by Universities/Institutes, H1 2015 10

Comparative Analysis by Late Stage Development, H1 2015 11

Comparative Analysis by Clinical Stage Development, H1 2015 12

Comparative Analysis by Early Stage Development, H1 2015 13

Products under Development by Companies, H1 2015 14

Products under Investigation by Universities/Institutes, H1 2015 15

Hypogonadotropic Hypogonadism-Pipeline by AlphaMab Co., Ltd, H1 2015 16

Hypogonadotropic Hypogonadism-Pipeline by Forendo Pharma Oy, H1 2015 17

Hypogonadotropic Hypogonadism-Pipeline by Merck & Co., Inc., H1 2015 18

Hypogonadotropic Hypogonadism-Pipeline by Novartis AG, H1 2015 19

Hypogonadotropic Hypogonadism-Pipeline by Repros Therapeutics Inc., H1 2015 20

Assessment by Monotherapy Products, H1 2015 21

Number of Products by Stage and Target, H1 2015 23

Number of Products by Stage and Mechanism of Action, H1 2015 25

Number of Products by Stage and Route of Administration, H1 2015 27

Number of Products by Stage and Molecule Type, H1 2015 29

Hypogonadotropic Hypogonadism Therapeutics-Recent Pipeline Updates, H1 2015 40

List of Figures

Number of Products under Development for Hypogonadotropic Hypogonadism, H1 2015 7

Number of Products under Development for Hypogonadotropic Hypogonadism-Comparative Analysis, H1 2015 8

Number of Products under Development by Companies, H1 2015 9

Comparative Analysis by Clinical Stage Development, H1 2015 12

Assessment by Monotherapy Products, H1 2015 21

Number of Products by Top 10 Targets, H1 2015 22

Number of Products by Stage and Top 10 Targets, H1 2015 23

Number of Products by Top 10 Mechanism of Actions, H1 2015 24

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 25

Number of Products by Top 10 Routes of Administration, H1 2015 26

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 27

Number of Products by Top 10 Molecule Types, H1 2015 28

Number of Products by Stage and Top 10 Molecule Types, H1 2015 29

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AlphaMab Co., Ltd

Forendo Pharma Oy

Merck & Co., Inc.

Novartis AG

Repros Therapeutics Inc.

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


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