Premature Labor (Tocolysis) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Premature Labor (Tocolysis) – Pipeline Review, H2 2016’, provides an overview of the Premature Labor (Tocolysis) pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Premature Labor (Tocolysis), 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 Premature Labor (Tocolysis) 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 Premature Labor (Tocolysis)

The report reviews pipeline therapeutics for Premature Labor (Tocolysis) 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 Premature Labor (Tocolysis) therapeutics and enlists all their major and minor projects

The report assesses Premature Labor (Tocolysis) 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 Premature Labor (Tocolysis)

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 Premature Labor (Tocolysis)

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 Premature Labor (Tocolysis) 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

AMAG Pharmaceuticals, Inc.

GlaxoSmithKline Plc

Juniper Pharmaceuticals, Inc.

Kissei Pharmaceutical Co., Ltd.

Lipocine Inc.

ObsEva SA

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 5

Introduction 6

Global Markets Direct Report Coverage 6

Premature Labor (Tocolysis) Overview 7

Therapeutics Development 8

Pipeline Products for Premature Labor (Tocolysis) - Overview 8

Pipeline Products for Premature Labor (Tocolysis) - Comparative Analysis 9

Premature Labor (Tocolysis) - Therapeutics under Development by Companies 10

Premature Labor (Tocolysis) - Therapeutics under Investigation by Universities/Institutes 11

Premature Labor (Tocolysis) - Pipeline Products Glance 12

Late Stage Products 12

Clinical Stage Products 13

Early Stage Products 14

Unknown Stage Products 15

Premature Labor (Tocolysis) - Products under Development by Companies 16

Premature Labor (Tocolysis) - Products under Investigation by Universities/Institutes 17

Premature Labor (Tocolysis) - Companies Involved in Therapeutics Development 18

AMAG Pharmaceuticals, Inc. 18

GlaxoSmithKline Plc 19

Juniper Pharmaceuticals, Inc. 20

Kissei Pharmaceutical Co., Ltd. 21

Lipocine Inc. 22

ObsEva SA 23

Premature Labor (Tocolysis) - Therapeutics Assessment 24

Assessment by Monotherapy Products 24

Assessment by Target 25

Assessment by Mechanism of Action 27

Assessment by Route of Administration 29

Assessment by Molecule Type 31

Drug Profiles 32

bedoradrine sulfate - Drug Profile 32

Product Description 32

Mechanism Of Action 32

R&D Progress 32

hydroxyprogesterone caproate - Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

hydroxyprogesterone caproate - Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

OBE-001 - Drug Profile 38

Product Description 38

Mechanism Of Action 38

R&D Progress 38

OBE-022 - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

progesterone - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

retosiban - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

Small Molecule for Acute Inflammation and Premature Labor - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

Small Molecule to Agonize Progesterone Receptor for Preterm Birth - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

Small Molecules for Premature Labor - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

Premature Labor (Tocolysis) - Dormant Projects 46

Premature Labor (Tocolysis) - Discontinued Products 47

Premature Labor (Tocolysis) - Product Development Milestones 48

Featured News & Press Releases 48

Jul 28, 2016: ObsEva Initiates Phase 1 Clinical Program of OBE022, a First-in-Class Orally Active Prostaglandin F2a Antagonist, for the Treatment of Preterm Labor 48

Apr 04, 2016: AMAG Pharmaceuticals Announces the U.S. Commercial Launch of New Single-Dose, Preservative-Free Makena (hydroxyprogesterone caproate injection) 48

Feb 23, 2016: AMAG Pharmaceuticals Announces FDA Approval of New Single-Dose, Preservative-Free Makena (hydroxyprogesterone caproate injection) 49

Feb 16, 2016: Lipocine Reports Positive Results of Multi-Dose Pharmacokinetic Study of LPCN 1107 for the Prevention of Preterm Birth in Pregnant Women 50

Jan 11, 2016: Juniper Pharmaceuticals provides Update on JNP-0301 50

Nov 23, 2015: AMAG Pharmaceuticals Responds to Recent Complete Response Letter From the FDA for the Single-Dose, Preservative-Free Vial of Makena 51

Nov 18, 2015: AMAG Pharmaceuticals Receives Complete Response Letter From FDA for Single-Dose, Preservative-Free Vial of Makena (hydroxyprogesterone caproate injection) 51

Nov 04, 2015: ObsEva Presents Pharmacology Data Showing that OBE002, the First Orally Active Prostaglandin F2a Antagonist, is devoid of the side effects associated with NSAID treatment of Preterm Labor 52

Sep 01, 2015: ObsEva Presents Pharmacology Data Showing that OBE001, the First Orally Active Oxytocin Antagonist, Inhibits not only Uterine Contractions but also Preterm Labor Related Inflammation Pathways 52

Jun 23, 2015: ObsEva Announces Recruitment of the First Patient in TERM Phase 2 Study - Clinical Trial to Evaluate the Safety and Efficacy of OBE001 for Delaying Spontaneous Preterm Labor in Pregnant Women 53

May 28, 2015: AMAG Pharmaceuticals Receives Complete Response Letter From FDA for the Single-Dose Vial of Makena 54

May 20, 2015: AMAG Pharmaceuticals Expands Resources Dedicated to Reducing the Risk of Preterm Birth 54

Mar 17, 2015: GSK announces start of phase III programme to evaluate retosiban for spontaneous preterm labour 55

Feb 26, 2015: ObsEva Reports Positive Phase 1 Results for the First Orally Active Oxytocin Antagonist OBE001 to Treat Preterm Labour 56

Jul 02, 2012: FDA Issues Further Guidance On K-V Pharma's Makena 56

Appendix 59

Methodology 59

Coverage 59

Secondary Research 59

Primary Research 59

Expert Panel Validation 59

Contact Us 59

Disclaimer 6

List of Tables

List of Tables

Number of Products under Development for Premature Labor (Tocolysis), H2 2016 8

Number of Products under Development for Premature Labor (Tocolysis) – 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

Comparative Analysis by Unknown Stage Development, H2 2016 15

Products under Development by Companies, H2 2016 16

Products under Investigation by Universities/Institutes, H2 2016 17

Premature Labor (Tocolysis) – Pipeline by AMAG Pharmaceuticals, Inc., H2 2016 18

Premature Labor (Tocolysis) – Pipeline by GlaxoSmithKline Plc, H2 2016 19

Premature Labor (Tocolysis) – Pipeline by Juniper Pharmaceuticals, Inc., H2 2016 20

Premature Labor (Tocolysis) – Pipeline by Kissei Pharmaceutical Co., Ltd., H2 2016 21

Premature Labor (Tocolysis) – Pipeline by Lipocine Inc., H2 2016 22

Premature Labor (Tocolysis) – Pipeline by ObsEva SA, H2 2016 23

Assessment by Monotherapy Products, H2 2016 24

Number of Products by Stage and Target, H2 2016 26

Number of Products by Stage and Mechanism of Action, H2 2016 28

Number of Products by Stage and Route of Administration, H2 2016 30

Number of Products by Stage and Molecule Type, H2 2016 31

Premature Labor (Tocolysis) – Dormant Projects, H2 2016 46

Premature Labor (Tocolysis) – Discontinued Products, H2 2016 47

List of Figures

List of Figures

Number of Products under Development for Premature Labor (Tocolysis), H2 2016 8

Number of Products under Development for Premature Labor (Tocolysis) – 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 Clinical Stage Development, H2 2016 13

Comparative Analysis by Early Stage Products, H2 2016 14

Assessment by Monotherapy Products, H2 2016 24

Number of Products by Targets, H2 2016 25

Number of Products by Stage and Targets, H2 2016 25

Number of Products by Mechanism of Actions, H2 2016 27

Number of Products by Stage and Mechanism of Actions, H2 2016 27

Number of Products by Routes of Administration, H2 2016 29

Number of Products by Stage and Routes of Administration, H2 2016 29

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