Female Contraception-Pipeline Review, H1 2016

Female Contraception-Pipeline Review, H1 2016


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Executive Summary

Female Contraception-Pipeline Review, H1 2016

Summary

Global Markets Direct's, 'Female Contraception-Pipeline Review, H1 2016', provides an overview of the Female Contraception pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Female Contraception, 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 Female Contraception 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 Female Contraception

The report reviews pipeline therapeutics for Female Contraception 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 Female Contraception therapeutics and enlists all their major and minor projects

The report assesses Female Contraception 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 Female Contraception

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 Female Contraception

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 Female Contraception 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



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Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Female Contraception Overview 8

Therapeutics Development 9

Pipeline Products for Female Contraception-Overview 9

Pipeline Products for Female Contraception-Comparative Analysis 10

Female Contraception-Therapeutics under Development by Companies 11

Female Contraception-Therapeutics under Investigation by Universities/Institutes 12

Female Contraception-Pipeline Products Glance 13

Late Stage Products 13

Clinical Stage Products 14

Early Stage Products 15

Female Contraception-Products under Development by Companies 16

Female Contraception-Products under Investigation by Universities/Institutes 17

Female Contraception-Companies Involved in Therapeutics Development 18

Agile Therapeutics, Inc. 18

ANI Pharmaceuticals, Inc. 19

Evofem, Inc. 20

Mithra Pharmaceuticals S.A. 21

Orbis Biosciences, Inc. 22

Female Contraception-Therapeutics Assessment 23

Assessment by Monotherapy Products 23

Assessment by Combination 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 33

(drospirenone + estetrol)-Drug Profile 33

Product Description 33

Mechanism Of Action 33

R&D Progress 33

(estradiol acetate + nestorone)-Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

(estradiol acetate + prasterone + progesterone)-Drug Profile 37

Product Description 37

Mechanism Of Action 37

R&D Progress 37

AG-200 ER-Drug Profile 39

Product Description 39

Mechanism Of Action 39

R&D Progress 39

AG-200 SP-Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

AG-20015-Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

Amphora-Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

etonogestrel ER-Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

EVE-106-Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

levonorgestrel-Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

LJ-102-Drug Profile 51

Product Description 51

Mechanism Of Action 51

R&D Progress 51

Monoclonal Antibody Conjugates for Contraception-Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

NOV-1003-Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

S-003296-Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

S-0101255-Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

Small Molecule 1 for Fertility Control-Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

Small Molecule 2 for Fertility Control-Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

Small Molecule to Modulate Progesterone Receptor for Fertility Control-Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

Synthetic Peptides for Contraception-Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

Female Contraception-Dormant Projects 60

Female Contraception-Discontinued Products 62

Female Contraception-Product Development Milestones 63

Featured News & Press Releases 63

Apr 05, 2016: FDA Feedback On Spa Estelle: A New Step Closer To The Launch Of Estelle Phase III Pivotal Clinical Studies 63

Apr 01, 2016: Topline Results Of Food Effect Study Of The Product Candidate Estelle, The New Combined Oral Contraceptive Composed Of 15 mg Of Estetrol (E4) And 3 mg Of Drospirenone 63

Mar 24, 2016: Already 4 European Countries Fully Approved Protocol Of MIT-ES001-C301 Estelle Phase III Clinical Study 64

Oct 19, 2015: Agile Therapeutics Announces Completion of Patient Enrollment in Twirla Phase 3 SECURE Clinical Trial 64

Oct 19, 2015: Agile Therapeutics Announces Completion of Patient Enrollment in Twirla Phase 3 SECURE Clinical Trial 65

Sep 22, 2015: Evofem Announces FDA Acceptance of New Drug Application for Amphora as a Contraceptive 65

Aug 31, 2015: Agile Therapeutics Announces Completion of Patient Recruitment in Twirla Phase 3 SECURE Clinical Trial 66

Aug 26, 2015: The European Journal Of Contraception And Reproductive Health Care Publishes Two Scientific Articles About E4 (Estetrol) Dinox Phase II Study: Two Of The Most Read Papers By The Scientific Community 67

Jul 13, 2015: Aquila Solutions,Partners with Evofem to Submit New Drug Application to U.S. FDA for Amphora as a Contraceptive 68

Jul 06, 2015: Evofem Submits New Drug Application to U.S. FDA for Amphora as a Contraceptive 68

Jan 13, 2015: Evofem Announces Pre-NDA Meeting With FDA for Amphora 69

Dec 01, 2014: Agile Therapeutics Announces Publication of Data on Low-Dose Investigational Contraceptive Patch 69

Sep 29, 2014: Agile Announces Dosing of First Patients in Twirla Phase 3 SECURE Study 69

Sep 16, 2014: Agile Initiates Phase 3 SECURE Study for Twirla 70

Jul 17, 2014: Agile Therapeutics Announces Allowance of Additional Patent Claims for Skinfusion 70

Appendix 72

Methodology 72

Coverage 72

Secondary Research 72

Primary Research 72

Expert Panel Validation 72

Contact Us 72

Disclaimer 73

List of Figures

Number of Products under Development for Female Contraception, H1 2016 9

Number of Products under Development for Female Contraception-Comparative Analysis, H1 2016 10

Number of Products under Development by Companies, H1 2016 11

Number of Products under Investigation by Universities/Institutes, H1 2016 12

Comparative Analysis by Late Stage Development, H1 2016 13

Comparative Analysis by Clinical Stage Development, H1 2016 14

Comparative Analysis by Early Stage Products, H1 2016 15

Assessment by Monotherapy Products, H1 2016 23

Assessment by Combination Products, H1 2016 24

Number of Products by Targets, H1 2016 25

Number of Products by Stage and Targets, H1 2016 25

Number of Products by Mechanism of Actions, H1 2016 27

Number of Products by Stage and Mechanism of Actions, H1 2016 27

Number of Products by Routes of Administration, H1 2016 29

Number of Products by Stage and Routes of Administration, H1 2016 29

Number of Products by Molecule Types, H1 2016 31

Number of Products by Stage and Molecule Types, H1 2016 31

List of Tables

Number of Products under Development for Female Contraception, H1 2016 9

Number of Products under Development for Female Contraception-Comparative Analysis, H1 2016 10

Number of Products under Development by Companies, H1 2016 11

Number of Products under Investigation by Universities/Institutes, H1 2016 12

Comparative Analysis by Late Stage Development, H1 2016 13

Comparative Analysis by Clinical Stage Development, H1 2016 14

Comparative Analysis by Early Stage Development, H1 2016 15

Products under Development by Companies, H1 2016 16

Products under Investigation by Universities/Institutes, H1 2016 17

Female Contraception-Pipeline by Agile Therapeutics, Inc., H1 2016 18

Female Contraception-Pipeline by ANI Pharmaceuticals, Inc., H1 2016 19

Female Contraception-Pipeline by Evofem, Inc., H1 2016 20

Female Contraception-Pipeline by Mithra Pharmaceuticals S.A., H1 2016 21

Female Contraception-Pipeline by Orbis Biosciences, Inc., H1 2016 22

Assessment by Monotherapy Products, H1 2016 23

Assessment by Combination Products, H1 2016 24

Number of Products by Stage and Target, H1 2016 26

Number of Products by Stage and Mechanism of Action, H1 2016 28

Number of Products by Stage and Route of Administration, H1 2016 30

Number of Products by Stage and Molecule Type, H1 2016 32

Female Contraception-Dormant Projects, H1 2016 60

Female Contraception-Dormant Projects (Contd..1), H1 2016 61

Female Contraception-Discontinued Products, H1 2016 62

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Agile Therapeutics, Inc.

ANI Pharmaceuticals, Inc.

Evofem, Inc.

Mithra Pharmaceuticals S.A.

Orbis Biosciences, Inc.

Female Contraception Therapeutic Products under Development, Key Players in Female Contraception Therapeutics, Female Contraception Pipeline Overview, Female Contraception Pipeline, Female Contraception Pipeline Assessment

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