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Uterine Fibroids - Pipeline Review, H2 2012 Product Image

Uterine Fibroids - Pipeline Review, H2 2012

  • Published: September 2012
  • 63 pages
  • Global Markets Direct

Uterine Fibroids – Pipeline Review, H2 2012

Summary

Global Markets Direct’s, 'Uterine Fibroids - Pipeline Review, H2 2012', 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 READ MORE >

2
List of Tables 4
List of Figures 5
Introduction 6
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
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
Kissei Pharmaceutical Co., Ltd. 21
Bayer AG 22
Repros Therapeutics Inc. 23
HRA Pharma, SA 24
Tokai Pharmaceuticals, Inc. 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
TAK-385 - Drug Profile 31
Product Description 31
Mechanism of Action 31
R&D Progress 31
telapristone acetate - Drug Profile 32
Product Description 32
Mechanism of Action 32
R&D Progress 32
ulipristal acetate - Drug Profile 34
Product Description 34
Mechanism of Action 34
R&D Progress 34
mifepristone - Drug Profile 36
Product Description 36
Mechanism of Action 36
R&D Progress 36
ulipristal - Drug Profile 37
Product Description 37
Mechanism of Action 37
R&D Progress 37
KLH-2109 - Drug Profile 39
Product Description 39
Mechanism of Action 39
R&D Progress 39
BAY-1002670 - Drug Profile 40
Product Description 40
Mechanism of Action 40
R&D Progress 40
GnRH Antagonists - Drug Profile 41
Product Description 41
Mechanism of Action 41
R&D Progress 41
Uterine Fibroids Therapeutics – Drug Profile Updates 42
Uterine Fibroids Therapeutics – Discontinued Products 49
Uterine Fibroids Therapeutics - Dormant Products 50
Uterine Fibroids – Product Development Milestones 51
Featured News & Press Releases 51
Jul 30, 2012: FDA Schedules Meeting With Repros To Discuss Phase II Protocol For Proellex For Treatment Of Endometriosis 51
Jul 23, 2012: Repros's Proellex-V Shows Consistent Efficacy In Phase II Study Of Uterine Fibroids 51
Apr 30, 2012: Repros's Proellex-V Clears Hurdle In Uterine Fibroid Program 52
Mar 12, 2012: Watson Initiates US Phase III Clinical Trial Of Esmya 53
Feb 27, 2012: HRA Pharma's Esmya Receives European Commission Marketing Authorization For Pre-Operative Treatment Of Uterine Fibroids 54
Feb 02, 2012: PregLem Announces Full Results Of PEARL I And II Studies Of Esmya Published In New England Journal Of Medicine 55
Jan 04, 2012: FDA Accepts Repros's Investigational New Drug Application For Proellex-V For Treatment Of Uterine Fibroids 57
Jan 03, 2012: Repros Completes Dosing In Phase II Low-Dose Oral Proellex Trial 58
Dec 16, 2011: PregLem Receives Positive EMA/CHMP Opinion For Esmya For Pre-Operative Treatment Of Uterine Fibroids 59
Dec 15, 2011: CHMP Recommends Granting Of Marketing Authorization For Esmya 60
Appendix 62
Methodology 62
Coverage 62
Secondary Research 62
Primary Research 62
Expert Panel Validation 62
Contact Us 63
Disclaimer 63

List of Tables
Number of Products Under Development for Uterine Fibroids, H2 2012 8
Products under Development for Uterine Fibroids – Comparative Analysis, H2 2012 9
Number of Products under Development by Companies, H2 2012 11
Number of Products under Investigation by Universities/Institutes, H2 2012 12
Comparative Analysis by Late Stage Development, H2 2012 13
Comparative Analysis by Mid Clinical Stage Development, H2 2012 14
Comparative Analysis by Early Clinical Stage Development, H2 2012 15
Comparative Analysis by Pre-Clinical Stage Development, H2 2012 16
Products under Development by Companies, H2 2012 17
Products under Investigation by Universities/Institutes, H2 2012 18
Takeda Pharmaceutical Company Limited, H2 2012 19
Neurocrine Biosciences, Inc., H2 2012 20
Kissei Pharmaceutical Co., Ltd., H2 2012 21
Bayer AG, H2 2012 22
Repros Therapeutics Inc., H2 2012 23
HRA Pharma, SA, H2 2012 24
Tokai Pharmaceuticals, Inc., H2 2012 25
Assessment by Monotherapy Products, H2 2012 26
Assessment by Stage and Route of Administration, H2 2012 28
Assessment by Stage and Molecule Type, H2 2012 30
Uterine Fibroids Therapeutics – Drug Profile Updates 42
Uterine Fibroids Therapeutics – Discontinued Products 49
Uterine Fibroids Therapeutics – Dormant Products 50

List of Figures
Number of Products under Development for Uterine Fibroids, H2 2012 8
Products under Development for Uterine Fibroids – Comparative Analysis, H2 2012 9
Products under Development by Companies, H2 2012 10
Products under Investigation by Universities/Institutes, H2 2012 12
Late Stage Products, H2 2012 13
Mid Clinical Stage Products, H2 2012 14
Early Clinical Stage Products, H2 2012 15
Pre-Clinical Stage Products, H2 2012 16
Assessment by Monotherapy Products, H2 2012 26
Assessment by Route of Administration, H2 2012 27
Assessment by Stage and Route of Administration, H2 2012 28
Assessment by Molecule Type, H2 2012 29
Assessment by Stage and Molecule Type, H2 2012 30

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