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Menopausal Disorders – Pipeline Review, H1 2013

  • March 2013
  • -
  • Global Markets Direct
  • -
  • 87 pages

Menopausal Disorders – Pipeline Review, H1 2013

Summary

Global Markets Direct’s, 'Menopausal Disorders - Pipeline Review, H1 2013', provides an overview of the indication’s therapeutic pipeline. This report provides information on the therapeutic development for Menopausal Disorders, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Menopausal Disorders. Menopausal Disorders - 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 Menopausal Disorders.
- A review of the Menopausal Disorders 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 Menopausal Disorders 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 Menopausal Disorders.
- 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 Menopausal Disorders 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

Menopausal Disorders - Pipeline Review, H1 2013
Table of Contents

Table of Contents 2
List of Tables 5
List of Figures 6
Introduction 7
Global Markets Direct Report Coverage 7
Menopausal Disorders Overview 8
Therapeutics Development 9
An Overview of Pipeline Products for Menopausal Disorders 9
Menopausal Disorders Therapeutics under Development by Companies 11
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
Menopausal Disorders Therapeutics - Products under Development by Companies 17
Companies Involved in Menopausal Disorders Therapeutics Development 19
Eisai Co., Ltd. 19
Noven Pharmaceuticals, Inc. 20
Pfizer Inc. 21
Paladin Labs Inc. 22
Bionovo, Inc. 23
Pantarhei Bioscience BV 24
Concert Pharmaceuticals, Inc. 25
PharmaNova Inc. 26
EndoCeutics, Inc. 27
Pherin Pharmaceuticals, Inc. 28
Ausio Pharmaceuticals, LLC 29
Menopausal Disorders - Therapeutics Assessment 30
Assessment by Monotherapy Products 30
Assessment by Combination Products 31
Assessment by Route of Administration 32
Assessment by Molecule Type 34
Drug Profiles 36
gabapentin ER - Drug Profile 36
Product Description 36
Mechanism of Action 36
RandD Progress 36
gabapentin ER - Drug Profile 38
Product Description 38
Mechanism of Action 38
RandD Progress 38
paroxetine mesylate - Drug Profile 40
Product Description 40
Mechanism of Action 40
RandD Progress 40
RAD-1901 - Drug Profile 42
Product Description 42
Mechanism of Action 42
RandD Progress 42
E-4 - Drug Profile 44
Product Description 44
Mechanism of Action 44
RandD Progress 44
E-4 - Drug Profile 46
Product Description 46
Mechanism of Action 46
RandD Progress 46
(estradiol + testosterone) - Drug Profile 48
Product Description 48
Mechanism of Action 48
RandD Progress 48
MF-101 - Drug Profile 49
Product Description 49
Mechanism of Action 49
RandD Progress 49
(bazedoxifene acetate + estrogens, conjugated) - Drug Profile 51
Product Description 51
Mechanism of Action 51
RandD Progress 51
CTP-347 - Drug Profile 53
Product Description 53
Mechanism of Action 53
RandD Progress 53
AUS-131 - Drug Profile 55
Product Description 55
Mechanism of Action 55
RandD Progress 55
(estradiol + progesterone ) - Drug Profile 57
Product Description 57
Mechanism of Action 57
RandD Progress 57
PH-80HF - Drug Profile 58
Product Description 58
Mechanism of Action 58
RandD Progress 58
BLACE - Drug Profile 59
Product Description 59
Mechanism of Action 59
RandD Progress 59
(prasterone + acolbifene) - Drug Profile 60
Product Description 60
Mechanism of Action 60
RandD Progress 60
TX-12001HR - Drug Profile 61
Product Description 61
Mechanism of Action 61
RandD Progress 61
TX-12002HR - Drug Profile 62
Product Description 62
Mechanism of Action 62
RandD Progress 62
TX-12003HR - Drug Profile 63
Product Description 63
Mechanism of Action 63
RandD Progress 63
FP-101 - Drug Profile 64
Product Description 64
Mechanism of Action 64
RandD Progress 64
Menopausal Disorders Therapeutics - Drug Profile Updates 65
Menopausal Disorders Therapeutics - Discontinued Products 76
Menopausal Disorders Therapeutics - Dormant Products 77
Menopausal Disorders - Product Development Milestones 78
Featured News and Press Releases 78
Nov 12, 2012: Noven Pharma Announces FDA Acceptance Of New Drug Application For Investigational Nonhormonal Therapy For Menopausal Vasomotor Symptoms 78
Oct 15, 2012: Depomed Announces Serada NDA Acceptance And FDA Advisory Committee Meeting 78
Oct 03, 2012: Depomed Announces Presentation Of Phase III Trial Data Of Serada At 2012 North American Menopause Society Annual Meeting 78
Oct 03, 2012: Noven Pharma Announces Positive Phase III Results For Investigational Non-Hormonal Therapy For Treatment Of Menopausal Vasomotor Symptoms 80
Sep 26, 2012: Eaton Scientific Highlights International Potential For Tropine 3 As Globally Accepted Non-Hormonal Treatment For Hot Flash Symptoms 82
Sep 25, 2012: Eaton Scientific Provides Outline On Market Potential Of Tropine 3 For Non-Hormonal Treatment Of Hot Flashes 83
Sep 13, 2012: Eaton Scientific Teams Up With Urologist Dr Jennifer Berman To Advance Tropine 3 Trials And Marketing 83
Sep 06, 2012: Eaton Scientific Completes Study Protocol For Phase I/II Study Of Tropine 3 For Treatment Of Hot Flashes 84
Sep 04, 2012: Eaton Scientific Enters Agreement With RoxSan Pharmacy To Provide Tropine 3 For Upcoming Clinical Trial Participants 84
Aug 29, 2012: Noven Submits New Drug Application For Investigational Non-Hormonal Therapy For Menopausal Vasomotor Symptoms 85
Appendix 86
Methodology 86
Coverage 86
Secondary Research 86
Primary Research 86
Expert Panel Validation 86
Contact Us 87
Disclaimer 87



List of Tables

Number of Products Under Development for Menopausal Disorders, H1 2013 9
Products under Development for Menopausal Disorders - Comparative Analysis, H1 2013 10
Number of Products under Development by Companies, 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 Pre-Clinical Stage Development, H1 2013 16
Products under Development by Companies, H1 2013 17
Products under Development by Companies, H1 2013 (Contd..1) 18
Eisai Co., Ltd., H1 2013 19
Noven Pharmaceuticals, Inc., H1 2013 20
Pfizer Inc., H1 2013 21
Paladin Labs Inc., H1 2013 22
Bionovo, Inc., H1 2013 23
Pantarhei Bioscience BV, H1 2013 24
Concert Pharmaceuticals, Inc., H1 2013 25
PharmaNova Inc., H1 2013 26
EndoCeutics, Inc., H1 2013 27
Pherin Pharmaceuticals, Inc., H1 2013 28
Ausio Pharmaceuticals, LLC, H1 2013 29
Assessment by Monotherapy Products, H1 2013 30
Assessment by Combination Products, H1 2013 31
Assessment by Stage and Route of Administration, H1 2013 33
Assessment by Stage and Molecule Type, H1 2013 35
Menopausal Disorders Therapeutics - Drug Profile Updates 65
Menopausal Disorders Therapeutics - Discontinued Products 76
Menopausal Disorders Therapeutics - Dormant Products 77



List of Figures

Number of Products under Development for Menopausal Disorders, H1 2013 9
Products under Development for Menopausal Disorders - Comparative Analysis, H1 2013 10
Products under Development by Companies, H1 2013 11
Late Stage Products, H1 2013 13
Mid Clinical Stage Products, H1 2013 14
Early Clinical Stage Products, H1 2013 15
Pre-Clinical Stage Products, H1 2013 16
Assessment by Monotherapy Products, H1 2013 30
Assessment by Combination Products, H1 2013 31
Assessment by Route of Administration, H1 2013 32
Assessment by Stage and Route of Administration, H1 2013 33
Assessment by Molecule Type, H1 2013 34
Assessment by Stage and Molecule Type, H1 2013 35

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