Uterine Fibroids – Pipeline Review, H1 2013

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Date: 28-Mar-2013
No. of pages: 67
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Global Markets Direct’s, ‘Uterine Fibroids – Pipeline Review, H1 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.


  • 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.

Uterine Fibroids – Pipeline Review, H1 2013

Table of Contents

Table of Contents 2
List of Tables 4
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
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
ulipristal acetate - Drug Profile 36
Product Description 36
Mechanism of Action 36
R&D Progress 36
mifepristone - Drug Profile 38
Product Description 38
Mechanism of Action 38
R&D Progress 38
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
Non-Steroidal Progesterone Agonist - Drug Profile 42
Product Description 42
Mechanism of Action 42
R&D Progress 42
Uterine Fibroids Therapeutics - Drug Profile Updates 43
Uterine Fibroids Therapeutics - Discontinued Products 53
Uterine Fibroids Therapeutics - Dormant Products 54
Uterine Fibroids - Product Development Milestones 55
Featured News & Press Releases 55
Jul 30, 2012: FDA Schedules Meeting With Repros To Discuss Phase II Protocol For Proellex For Treatment Of Endometriosis 55
Jul 23, 2012: Repros's Proellex-V Shows Consistent Efficacy In Phase II Study Of Uterine Fibroids 55
Apr 30, 2012: Repros's Proellex-V Clears Hurdle In Uterine Fibroid Program 56
Mar 12, 2012: Watson Initiates US Phase III Clinical Trial Of Esmya 57
Feb 27, 2012: HRA Pharma's Esmya Receives European Commission Marketing Authorization For Pre-Operative Treatment Of Uterine Fibroids 58
Feb 02, 2012: PregLem Announces Full Results Of PEARL I And II Studies Of Esmya Published In New England Journal Of Medicine 59
Jan 04, 2012: FDA Accepts Repros's Investigational New Drug Application For Proellex-V For Treatment Of Uterine Fibroids 61
Jan 03, 2012: Repros Completes Dosing In Phase II Low-Dose Oral Proellex Trial 62
Dec 16, 2011: PregLem Receives Positive EMA/CHMP Opinion For Esmya For Pre-Operative Treatment Of Uterine Fibroids 63
Dec 15, 2011: CHMP Recommends Granting Of Marketing Authorization For Esmya 64
Appendix 66
Methodology 66
Coverage 66
Secondary Research 66
Primary Research 66
Expert Panel Validation 66
Contact Us 67
Disclaimer 67

List of Tables

Number of Products Under Development for Uterine Fibroids, H1 2013 8
Products under Development for Uterine Fibroids - Comparative Analysis, H1 2013 9
Number of Products under Development by Companies, H1 2013 11
Number of Products under Investigation by Universities/Institutes, H1 2013 12
Comparative Analysis by Late Stage Development, H1 2013 13
Comparative Analysis by Mid Clinical Stage Development, H1 2013 14
Comparative Analysis by Early Clinical Stage Development, H1 2013 15
Comparative Analysis by Discovery and Pre-Clinical Stage Development, H1 2013 16
Products under Development by Companies, H1 2013 17
Products under Investigation by Universities/Institutes, H1 2013 18
Takeda Pharmaceutical Company Limited, H1 2013 19
Neurocrine Biosciences, Inc., H1 2013 20
Kissei Pharmaceutical Co., Ltd., H1 2013 21
Bayer AG, H1 2013 22
Repros Therapeutics Inc., H1 2013 23
HRA Pharma, SA, H1 2013 24
Tokai Pharmaceuticals, Inc., H1 2013 25
Assessment by Monotherapy Products, H1 2013 26
Assessment by Stage and Route of Administration, H1 2013 28
Assessment by Stage and Molecule Type, H1 2013 30
Uterine Fibroids Therapeutics - Drug Profile Updates 43
Uterine Fibroids Therapeutics - Discontinued Products 53
Uterine Fibroids Therapeutics - Dormant Products 54

List of Figures

Number of Products under Development for Uterine Fibroids, H1 2013 8
Products under Development for Uterine Fibroids - Comparative Analysis, H1 2013 9
Products under Development by Companies, H1 2013 10
Products under Investigation by Universities/Institutes, H1 2013 12
Late Stage Products, H1 2013 13
Mid Clinical Stage Products, H1 2013 14
Early Clinical Stage Products, H1 2013 15
Discovery and Pre-Clinical Stage Products, H1 2013 16
Assessment by Monotherapy Products, H1 2013 26
Assessment by Route of Administration, H1 2013 27
Assessment by Stage and Route of Administration, H1 2013 28
Assessment by Molecule Type, H1 2013 29
Assessment by Stage and Molecule Type, H1 2013 30

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