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Uterine Fibroids - Pipeline Review, H2 2013

  • September 2013
  • -
  • Global Markets Direct
  • -
  • 72 pages

Uterine Fibroids - Pipeline Review, H2 2013

Summary

Global Markets Direct’s, 'Uterine Fibroids - Pipeline Review, H2 2013', provides an overview of the indication’s therapeutic pipeline. This report provides information on the therapeutic development for Uterine Fibroids, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Uterine Fibroids. Uterine Fibroids - Pipeline Review, Half Year 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.

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

Scope

- A snapshot of the global therapeutic scenario for Uterine Fibroids.
- A review of the Uterine Fibroids products under development by companies and universities/research institutes based on information derived from company and industry-specific sources.
- Coverage of products based on various stages of development ranging from discovery till registration stages.
- A feature on pipeline projects on the basis of monotherapy and combined therapeutics.
- Coverage of the Uterine Fibroids pipeline on the basis of route of administration and molecule type.
- Key discontinued pipeline projects.
- Latest news and deals relating to the products.

Reasons to buy

- Identify and understand important and diverse types of therapeutics under development for Uterine Fibroids.
- Identify emerging players with potentially strong product portfolio and design effective counter-strategies to gain competitive advantage.
- Plan mergers and acquisitions effectively by identifying players of the most promising pipeline.
- Devise corrective measures for pipeline projects by understanding Uterine Fibroids 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

Uterine Fibroids - Pipeline Review, H2 2013
Table of Contents

Table of Contents 2
List of Tables 5
List of Figures 5
Introduction 6
Global Markets Direct Report Coverage 6
Uterine Fibroids Overview 7
Therapeutics Development 8
An Overview of Pipeline Products for Uterine Fibroids 8
Uterine Fibroids Therapeutics under Development by Companies 10
Uterine Fibroids Therapeutics under Investigation by Universities/Institutes 12
Late Stage Products 13
Comparative Analysis 13
Mid Clinical Stage Products 14
Comparative Analysis 14
Early Clinical Stage Products 15
Comparative Analysis 15
Discovery and Pre-Clinical Stage Products 16
Comparative Analysis 16
Uterine Fibroids Therapeutics - Products under Development by Companies 17
Uterine Fibroids Therapeutics - Products under Investigation by Universities/Institutes 18
Companies Involved in Uterine Fibroids Therapeutics Development 19
Takeda Pharmaceutical Company Limited 19
Neurocrine Biosciences, Inc. 20
Auxilium Pharmaceuticals, Inc. 21
Kissei Pharmaceutical Co., Ltd. 22
Bayer AG 23
HRA Pharma, SA 24
Quatrx Pharmaceutical Company 25
Uterine Fibroids - Therapeutics Assessment 26
Assessment by Monotherapy Products 26
Assessment by Route of Administration 27
Assessment by Molecule Type 29
Drug Profiles 31
relugolix - Drug Profile 31
Product Description 31
Mechanism of Action 31
RandD Progress 31
collagenase clostridium histolyticum - Drug Profile 32
Product Description 32
Mechanism of Action 32
RandD Progress 32
elagolix sodium - Drug Profile 35
Product Description 35
Mechanism of Action 35
RandD Progress 35
sufugolix - Drug Profile 37
Product Description 37
Mechanism of Action 37
RandD Progress 37
ulipristal acetate - Drug Profile 38
Product Description 38
Mechanism of Action 38
RandD Progress 38
mifepristone - Drug Profile 40
Product Description 40
Mechanism of Action 40
RandD Progress 40
Drug For Uterine Fibroids - Drug Profile 41
Product Description 41
Mechanism of Action 41
RandD Progress 41
KLH-2109 - Drug Profile 42
Product Description 42
Mechanism of Action 42
RandD Progress 42
BAY-1002670 - Drug Profile 43
Product Description 43
Mechanism of Action 43
RandD Progress 43
GnRH Antagonists - Drug Profile 44
Product Description 44
Mechanism of Action 44
RandD Progress 44
HSD Research Program - Drug Profile 45
Product Description 45
Mechanism of Action 45
RandD Progress 45
Gonadotropin-Releasing Hormone Antagonists - Drug Profile 46
Product Description 46
Mechanism of Action 46
RandD Progress 46
EVE-104 - Drug Profile 47
Product Description 47
Mechanism of Action 47
RandD Progress 47
Uterine Fibroids Therapeutics - Drug Profile Updates 48
Uterine Fibroids Therapeutics - Discontinued Products 61
Uterine Fibroids Therapeutics - Dormant Products 62
Uterine Fibroids - Product Development Milestones 63
Featured News and Press Releases 63
Jul 23, 2013: BioSpecifics Technologies Announces Data from Collaborative Uterine Fibroid Study Presented at 2013 Society for the Study of Reproduction Annual Meeting 63
Jun 25, 2013: Actavis Receives Canadian Approval To Market Fibristal For Treatment Of Symptoms Of Uterine Fibroids 64
May 22, 2013: Repros Therapeutics Receives FDA Recommendation To Conduct Phase IIb Trial Of Proellex-V For Treatment Of Severe Menstrual Bleeding Associated With Uterine Fibroids 64
Mar 27, 2013: Neurocrine Biosciences Initiates Phase IIb Study Of Elagolix For Treatment Of Uterine Fibroids 65
Feb 28, 2013: Repros Announces FDA Grants End Of Phase II Meeting To Discuss Proellex-V Phase III Study Design 65
Jan 03, 2013: Repros Reports Positive Topline Results From Phase II Study Of Proellex-V For Treatment Of Uterine Fibroids 66
Jul 30, 2012: FDA Schedules Meeting With Repros To Discuss Phase II Protocol For Proellex For Treatment Of Endometriosis 67
Jul 23, 2012: Repros's Proellex-V Shows Consistent Efficacy In Phase II Study Of Uterine Fibroids 67
Apr 30, 2012: Repros's Proellex-V Clears Hurdle In Uterine Fibroid Program 68
Mar 12, 2012: Watson Initiates US Phase III Clinical Trial Of Esmya 70
Appendix 71
Methodology 71
Coverage 71
Secondary Research 71
Primary Research 71
Expert Panel Validation 71
Contact Us 72
Disclaimer 72



List of Tables

Number of Products Under Development for Uterine Fibroids, H2 2013 8
Products under Development for Uterine Fibroids - Comparative Analysis, H2 2013 9
Number of Products under Development by Companies, H2 2013 11
Number of Products under Investigation by Universities/Institutes, H2 2013 12
Comparative Analysis by Late Stage Development, H2 2013 13
Comparative Analysis by Mid Clinical Stage Development, H2 2013 14
Comparative Analysis by Early Clinical Stage Development, H2 2013 15
Comparative Analysis by Discovery and Pre-Clinical Stage Development, H2 2013 16
Products under Development by Companies, H2 2013 17
Products under Investigation by Universities/Institutes, H2 2013 18
Takeda Pharmaceutical Company Limited, H2 2013 19
Neurocrine Biosciences, Inc., H2 2013 20
Auxilium Pharmaceuticals, Inc., H2 2013 21
Kissei Pharmaceutical Co., Ltd., H2 2013 22
Bayer AG, H2 2013 23
HRA Pharma, SA, H2 2013 24
Quatrx Pharmaceutical Company, H2 2013 25
Assessment by Monotherapy Products, H2 2013 26
Assessment by Stage and Route of Administration, H2 2013 28
Assessment by Stage and Molecule Type, H2 2013 30
Uterine Fibroids Therapeutics - Drug Profile Updates 48
Uterine Fibroids Therapeutics - Discontinued Products 61
Uterine Fibroids Therapeutics - Dormant Products 62



List of Figures

Number of Products under Development for Uterine Fibroids, H2 2013 8
Products under Development for Uterine Fibroids - Comparative Analysis, H2 2013 9
Products under Development by Companies, H2 2013 10
Products under Investigation by Universities/Institutes, H2 2013 12
Late Stage Products, H2 2013 13
Mid Clinical Stage Products, H2 2013 14
Early Clinical Stage Products, H2 2013 15
Discovery and Pre-Clinical Stage Products, H2 2013 16
Assessment by Monotherapy Products, H2 2013 26
Assessment by Route of Administration, H2 2013 27
Assessment by Stage and Route of Administration, H2 2013 28
Assessment by Molecule Type, H2 2013 29
Assessment by Stage and Molecule Type, H2 2013 30



Companies Mentioned

Takeda Pharmaceutical Company Limited
Neurocrine Biosciences, Inc.
Auxilium Pharmaceuticals, Inc.
Kissei Pharmaceutical Co., Ltd.
Bayer AG
HRA Pharma, SA
Quatrx Pharmaceutical Company

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