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

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

R&D Progress 31

collagenase clostridium histolyticum - Drug Profile 32

Product Description 32

Mechanism of Action 32

R&D Progress 32

elagolix sodium - Drug Profile 35

Product Description 35

Mechanism of Action 35

R&D Progress 35

sufugolix - Drug Profile 37

Product Description 37

Mechanism of Action 37

R&D Progress 37

ulipristal acetate - Drug Profile 38

Product Description 38

Mechanism of Action 38

R&D Progress 38

mifepristone - Drug Profile 40

Product Description 40

Mechanism of Action 40

R&D Progress 40

Drug For Uterine Fibroids - Drug Profile 41

Product Description 41

Mechanism of Action 41

R&D Progress 41

KLH-2109 - Drug Profile 42

Product Description 42

Mechanism of Action 42

R&D Progress 42

BAY-1002670 - Drug Profile 43

Product Description 43

Mechanism of Action 43

R&D Progress 43

GnRH Antagonists - Drug Profile 44

Product Description 44

Mechanism of Action 44

R&D Progress 44

HSD Research Program - Drug Profile 45

Product Description 45

Mechanism of Action 45

R&D Progress 45

Gonadotropin-Releasing Hormone Antagonists - Drug Profile 46

Product Description 46

Mechanism of Action 46

R&D Progress 46

EVE-104 - Drug Profile 47

Product Description 47

Mechanism of Action 47

R&D 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 & 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