Bacterial Vaginosis - Pipeline Review, H2 2016

Global Markets Direct
61 Pages - GMD16970
$2,000.00

Summary

Global Markets Direct’s, ‘Bacterial Vaginosis - Pipeline Review, H2 2016’, provides an overview of the Bacterial Vaginosis pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Bacterial Vaginosis, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Bacterial Vaginosis and features dormant and discontinued projects.

Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

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

Scope

- The report provides a snapshot of the global therapeutic landscape of Bacterial Vaginosis
- The report reviews pipeline therapeutics for Bacterial Vaginosis by companies and universities/research institutes based on information derived from company and industry-specific sources
- The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages
- The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities
- The report reviews key players involved Bacterial Vaginosis therapeutics and enlists all their major and minor projects
- The report assesses Bacterial Vaginosis therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type
- The report summarizes all the dormant and discontinued pipeline projects
- The report reviews latest news related to pipeline therapeutics for Bacterial Vaginosis

Reasons to buy

- Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Identify and understand important and diverse types of therapeutics under development for Bacterial Vaginosis
- Identify potential new clients or partners in the target demographic
- Develop strategic initiatives by understanding the focus areas of leading companies
- Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics
- Devise corrective measures for pipeline projects by understanding Bacterial Vaginosis 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

Companies Mentioned

Alfa Wassermann S.p.A
AmVac AG (Inactive)
Evofem, Inc.
Osel, Inc.
Starpharma Holdings Limited
Symbiomix Therapeutics, LLC

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Table of Contents
Table of Contents 2
List of Tables 5
List of Figures 5
Introduction 6
Global Markets Direct Report Coverage 6
Bacterial Vaginosis Overview 7
Therapeutics Development 8
Pipeline Products for Bacterial Vaginosis - Overview 8
Pipeline Products for Bacterial Vaginosis - Comparative Analysis 9
Bacterial Vaginosis - Therapeutics under Development by Companies 10
Bacterial Vaginosis - Therapeutics under Investigation by Universities/Institutes 11
Bacterial Vaginosis - Pipeline Products Glance 12
Late Stage Products 12
Clinical Stage Products 13
Early Stage Products 14
Bacterial Vaginosis - Products under Development by Companies 15
Bacterial Vaginosis - Products under Investigation by Universities/Institutes 16
Bacterial Vaginosis - Companies Involved in Therapeutics Development 17
Alfa Wassermann S.p.A 17
AmVac AG (Inactive) 18
Evofem, Inc. 19
Osel, Inc. 20
Starpharma Holdings Limited 21
Symbiomix Therapeutics, LLC 22
Bacterial Vaginosis - Therapeutics Assessment 23
Assessment by Monotherapy Products 23
Assessment by Target 24
Assessment by Mechanism of Action 25
Assessment by Route of Administration 26
Assessment by Molecule Type 28
Drug Profiles 30
Amphora - Drug Profile 30
Product Description 30
Mechanism Of Action 30
R&D Progress 30
AMV-100 - Drug Profile 32
Product Description 32
Mechanism Of Action 32
R&D Progress 32
astodrimer - Drug Profile 33
Product Description 33
Mechanism Of Action 33
R&D Progress 33
benzoyl peroxide - Drug Profile 37
Product Description 37
Mechanism Of Action 37
R&D Progress 37
LACTIN-V - Drug Profile 38
Product Description 38
Mechanism Of Action 38
R&D Progress 38
rifaximin - Drug Profile 39
Product Description 39
Mechanism Of Action 39
R&D Progress 39
secnidazole - Drug Profile 43
Product Description 43
Mechanism Of Action 43
R&D Progress 43
Small Molecule for Bacterial Vaginosis and Candidiasis - Drug Profile 45
Product Description 45
Mechanism Of Action 45
R&D Progress 45
subtilosin - Drug Profile 46
Product Description 46
Mechanism Of Action 46
R&D Progress 46
TOL-463 - Drug Profile 47
Product Description 47
Mechanism Of Action 47
R&D Progress 47
Bacterial Vaginosis - Dormant Projects 48
Bacterial Vaginosis - Discontinued Products 49
Bacterial Vaginosis - Product Development Milestones 50
Featured News & Press Releases 50
May 26, 2016: Symbiomix Therapeutics Announces Positive Results from Phase 3 Trial of SYM-1219 for Bacterial Vaginosis, and Pre-NDA Meeting with FDA Supportive of 2016 NDA Filing 50
May 11, 2016: Osel Lead Product LACTIN-V Enters Phase 2b Study to Prevent Recurrence of Bacterial Vaginosis 50
Mar 31, 2016: Evofem Files IND for Evaluation of Prevention of Recurrence of Bacterial Vaginosis 51
Jan 11, 2016: Evofem Holdings Announces Successful Completion of Pre-IND Meeting for Amphora 52
Oct 14, 2015: Additional US Patent granted for VivaGel BV 52
Sep 24, 2015: EU Marketing Approval Granted for VivaGel BV 53
Sep 21, 2015: Symbiomix Therapeutics Presents Data at ICAAC/ICC Demonstrating Oral Pharmacokinetics of Lead Product SYM-1219 Administered With and Without Food 53
Aug 27, 2015: Symbiomix Therapeutics Completes Enrollment in Second Pivotal Trial of SYM-1219 for Bacterial Vaginosis, and Receives FDA Fast Track Designation 54
Aug 06, 2015: Symbiomix Therapeutics' First Pivotal Trial Results for SYM-1219 for Bacterial Vaginosis Presented at IDSOG 55
Jun 09, 2015: Symbiomix Therapeutics Doses First Patient in Confirmatory Phase 3 Pivotal Study of Lead Drug Candidate SYM-1219 for Bacterial Vaginosis 56
May 05, 2015: Symbiomix Therapeutics Announces Positive Results from a Pivotal Phase 2 Trial of SYM-1219 for the Treatment of Bacterial Vaginosis 56
Mar 04, 2015: Symbiomix Therapeutics Studies Show Drug Candidate for Women's Health Infections is Safe and Well-Tolerated 57
Nov 21, 2014: SYM-1219 Chosen as one of the “Top Infectious Disease Projects” to Watch by Therapeutic Area Partnerships 58
Sep 09, 2014: Symbiomix Therapeutics Makes First Corporate Announcement: Completion of Enrollment in a Phase 2 Clinical Trial of SYM-1219 for Bacterial Vaginosis 58
Jul 14, 2014: FDA Grants SPA Agreement for Phase 3 Recurrent BV Trial 59
Appendix 60
Methodology 60
Coverage 60
Secondary Research 60
Primary Research 60
Expert Panel Validation 60
Contact Us 60
Disclaimer 61

List of Tables
Number of Products under Development for Bacterial Vaginosis, H2 2016 8
Number of Products under Development for Bacterial Vaginosis - Comparative Analysis, H2 2016 9
Number of Products under Development by Companies, H2 2016 10
Number of Products under Investigation by Universities/Institutes, H2 2016 11
Comparative Analysis by Late Stage Development, H2 2016 12
Comparative Analysis by Clinical Stage Development, H2 2016 13
Comparative Analysis by Early Stage Development, H2 2016 14
Products under Development by Companies, H2 2016 15
Products under Investigation by Universities/Institutes, H2 2016 16
Bacterial Vaginosis - Pipeline by Alfa Wassermann S.p.A, H2 2016 17
Bacterial Vaginosis - Pipeline by AmVac AG (Inactive), H2 2016 18
Bacterial Vaginosis - Pipeline by Evofem, Inc., H2 2016 19
Bacterial Vaginosis - Pipeline by Osel, Inc., H2 2016 20
Bacterial Vaginosis - Pipeline by Starpharma Holdings Limited, H2 2016 21
Bacterial Vaginosis - Pipeline by Symbiomix Therapeutics, LLC, H2 2016 22
Assessment by Monotherapy Products, H2 2016 23
Number of Products by Stage and Target, H2 2016 24
Number of Products by Stage and Mechanism of Action, H2 2016 25
Number of Products by Stage and Route of Administration, H2 2016 27
Number of Products by Stage and Molecule Type, H2 2016 29
Bacterial Vaginosis - Dormant Projects, H2 2016 48
Bacterial Vaginosis - Discontinued Products, H2 2016 49

List of Figures
Number of Products under Development for Bacterial Vaginosis, H2 2016 8
Number of Products under Development for Bacterial Vaginosis - Comparative Analysis, H2 2016 9
Number of Products under Development by Companies, H2 2016 10
Comparative Analysis by Late Stage Development, H2 2016 12
Comparative Analysis by Clinical Stage Development, H2 2016 13
Comparative Analysis by Early Stage Products, H2 2016 14
Assessment by Monotherapy Products, H2 2016 23
Number of Products by Routes of Administration, H2 2016 26
Number of Products by Stage and Routes of Administration, H2 2016 26
Number of Products by Molecule Types, H2 2016 28
Number of Products by Stage and Molecule Types, H2 2016 28

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