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Hypogonadotropic Hypogonadism - Pipeline Review, H1 2015

  • February 2015
  • -
  • Global Markets Direct
  • -
  • 60 pages

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

Hypogonadotropic Hypogonadism - Pipeline Review, H1 2015
Table of Contents
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 and 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
RandD Progress 30
corifollitropin alfa - Drug Profile 31
Product Description 31
Mechanism of Action 31
RandD Progress 31
enclomiphene - Drug Profile 33
Product Description 33
Mechanism of Action 33
RandD Progress 33
fispemifene - Drug Profile 35
Product Description 35
Mechanism of Action 35
RandD Progress 35
follitropin alfa - Drug Profile 37
Product Description 37
Mechanism of Action 37
RandD Progress 37
Kisspeptin-10 - Drug Profile 38
Product Description 38
Mechanism of Action 38
RandD Progress 38
testosterone undecanoate - Drug Profile 39
Product Description 39
Mechanism of Action 39
RandD Progress 39
Hypogonadotropic Hypogonadism - Recent Pipeline Updates 40
Hypogonadotropic Hypogonadism - Product Development Milestones 51
Featured News and 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 and 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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