Secondary (Hypogonadotropic) Hypogonadism - Pipeline Review, H2 2016

Published: Nov, 2016 | Pages: 63 | Publisher: Global Markets Direct
Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

Summary

Global Markets Direct's latest Pharmaceutical and Healthcare disease pipeline guide Secondary (Hypogonadotropic) Hypogonadism - Pipeline Review, H2 2016, provides an overview of the Secondary (Hypogonadotropic) Hypogonadism (Male Health) pipeline landscape.

Hypogonadotropic hypogonadism (HH) is a form of hypogonadism that is due to a problem with the pituitary gland or hypothalamus. HH is caused by a lack of hormones that normally stimulate the ovaries or testes like gonadotropin-releasing hormone (GnRH), follicle stimulating hormone (FSH) and luteinizing hormone (LH). Symptoms include Lack of development at puberty, enlargement of the testes and penis, deepening of the voice, and facial hair. Treatment includes testosterone, estrogen and progesterone.

Report Highlights

Global Markets Direct's Pharmaceutical and Healthcare latest pipeline guide Secondary (Hypogonadotropic) Hypogonadism - Pipeline Review, H2 2016, provides comprehensive information on the therapeutics under development for Secondary (Hypogonadotropic) Hypogonadism (Male Health), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases.

The Secondary (Hypogonadotropic) Hypogonadism (Male Health) pipeline guide also reviews of key players involved in therapeutic development for Secondary (Hypogonadotropic) Hypogonadism and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Pre-Registration, Phase III, Phase II and Phase I stages are 1, 1, 4 and 1 respectively. Similarly, the Universities portfolio in Phase I stages comprises 1 molecules, respectively.Secondary (Hypogonadotropic) Hypogonadism.

Secondary (Hypogonadotropic) Hypogonadism (Male Health) pipeline guide 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. The guide 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. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

Note: Certain content / sections in the pipeline guide may be removed or altered based on the availability and relevance of data.

Scope

- The pipeline guide provides a snapshot of the global therapeutic landscape of Secondary (Hypogonadotropic) Hypogonadism (Male Health).
- The pipeline guide reviews pipeline therapeutics for Secondary (Hypogonadotropic) Hypogonadism (Male Health) by companies and universities/research institutes based on information derived from company and industry-specific sources.
- The pipeline guide covers pipeline products based on several stages of development ranging from pre-registration till discovery and undisclosed stages.
- The pipeline guide features descriptive drug profiles for the pipeline products which comprise, product description, descriptive licensing and collaboration details, R&D brief, MoA & other developmental activities.
- The pipeline guide reviews key companies involved in Secondary (Hypogonadotropic) Hypogonadism (Male Health) therapeutics and enlists all their major and minor projects.
- The pipeline guide evaluates Secondary (Hypogonadotropic) Hypogonadism (Male Health) therapeutics based on mechanism of action (MoA), drug target, route of administration (RoA) and molecule type.
- The pipeline guide encapsulates all the dormant and discontinued pipeline projects.
- The pipeline guide reviews latest news related to pipeline therapeutics for Secondary (Hypogonadotropic) Hypogonadism (Male Health)

Reasons To Buy

- Procure strategically important competitor information, analysis, and insights to formulate effective R&D strategies.
- Recognize emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage.
- Find and recognize significant and varied types of therapeutics under development for Secondary (Hypogonadotropic) Hypogonadism (Male Health).
- Classify potential new clients or partners in the target demographic.
- Develop tactical initiatives by understanding the focus areas of leading companies.
- Plan mergers and acquisitions meritoriously by identifying key players and it's most promising pipeline therapeutics.
- Formulate corrective measures for pipeline projects by understanding Secondary (Hypogonadotropic) Hypogonadism (Male Health) 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.
- Adjust the therapeutic portfolio by recognizing discontinued projects and understand from the know-how what drove them from pipeline.

 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

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