Post Menopausal Osteoporosis – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Post Menopausal Osteoporosis – Pipeline Review, H2 2016’, provides an overview of the Post Menopausal Osteoporosis pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Post Menopausal Osteoporosis, 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 Post Menopausal Osteoporosis 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 Post Menopausal Osteoporosis

The report reviews pipeline therapeutics for Post Menopausal Osteoporosis 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 Post Menopausal Osteoporosis therapeutics and enlists all their major and minor projects

The report assesses Post Menopausal Osteoporosis 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 Post Menopausal Osteoporosis

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 Post Menopausal Osteoporosis

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 Post Menopausal Osteoporosis 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

Amgen Inc.

BiologicsMD, Inc.

Eli Lilly and Company

Enteris BioPharma, Inc.

Intas Pharmaceuticals Ltd.

Ipsen S.A.

Ligand Pharmaceuticals, Inc.

NIBEC

Oncobiologics, Inc.

Paras Biopharmaceuticals Finland Oy

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

Post Menopausal Osteoporosis Overview 7

Therapeutics Development 8

Pipeline Products for Post Menopausal Osteoporosis - Overview 8

Post Menopausal Osteoporosis - Therapeutics under Development by Companies 9

Post Menopausal Osteoporosis - Pipeline Products Glance 10

Late Stage Products 10

Clinical Stage Products 11

Early Stage Products 12

Post Menopausal Osteoporosis - Products under Development by Companies 13

Post Menopausal Osteoporosis - Companies Involved in Therapeutics Development 14

Amgen Inc. 14

BiologicsMD, Inc. 15

Eli Lilly and Company 16

Enteris BioPharma, Inc. 17

Intas Pharmaceuticals Ltd. 18

Ipsen S.A. 19

Ligand Pharmaceuticals, Inc. 20

NIBEC 21

Oncobiologics, Inc. 22

Paras Biopharmaceuticals Finland Oy 23

Post Menopausal Osteoporosis - 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 33

abaloparatide - Drug Profile 33

Product Description 33

Mechanism Of Action 33

R&D Progress 33

blosozumab - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

BMD-1111 - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

calcitonin - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

denosumab - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

denosumab biosimilar - Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

denosumab biosimilar - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

Drugs for Postmenopausal Osteoporosis - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

lasofoxifene tartrate - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

romosozumab - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

Synthetic Peptide for Obesity and Post Menopausal Osteoporosis - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

teriparatide biosimilar - Drug Profile 67

Product Description 67

Mechanism Of Action 67

R&D Progress 67

teriparatide biosimilar - Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

Post Menopausal Osteoporosis - Dormant Projects 69

Post Menopausal Osteoporosis - Discontinued Products 70

Post Menopausal Osteoporosis - Product Development Milestones 71

Featured News & Press Releases 71

Sep 26, 2016: Amgen And UCB Announce U.S. FDA Acceptance Of Biologics License Application For Romosozumab 71

Sep 19, 2016: Radius Presents Abaloparatide Transdermal Patch Development Program at American Society for Bone and Mineral Research 2016 Annual Meeting 72

Sep 18, 2016: Radius Announces Publication of Additional Positive Results from the Phase 3 ACTIVE Trial of Abaloparatide-SC in JBMR 72

Sep 18, 2016: Results From Phase 3 FRAME Study Of Romosozumab Showed Significant Reductions In Both New Vertebral And Clinical Fractures In Postmenopausal Women With Osteoporosis 73

Sep 14, 2016: Amgen to present romosozumab at Investor Call 75

Sep 07, 2016: UCB to present results from Phase 3 FRAME Study at the American Society for Bone and Mineral Research Annual Meeting 75

Aug 16, 2016: JAMA Publishes Positive Phase 3 Data for Abaloparatide in Postmenopausal Women With Osteoporosis 77

Jul 21, 2016: Amgen And UCB Submit Biologics License Application For Romosozumab To The FDA 77

Jul 20, 2016: Radius Health Announces Multiple Presentations at the American Society for Bone and Mineral Research 2016 Annual Meeting September 16-19, 2016 78

Jun 08, 2016: UCB presents Phase 3 data from the STRUCTURE study of Romosozumab at the Annual European Congress of Rheumatology (EULAR 2016) 79

May 31, 2016: Radius Announces FDA Acceptance for Filing of New Drug Application for Abaloparatide-SC for the Treatment of Postmenopausal Women with Osteoporosis 80

May 03, 2016: Sermonix Pharmaceuticals Announces Dr. Anthony H. Wild as Board Chairman and Investor 80

Apr 15, 2016: Radius Announces Three Oral Presentations for Abaloparatide-SC at World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Disease 81

Apr 01, 2016: Radius Presents Analysis Results on Fracture Risk Reduction in Phase 3 ACTIVE Trial for Investigational Drug Abaloparatide-SC at the ENDO 2016 Annual Meeting 82

Apr 01, 2016: Amgen And UCB Present Positive Data At ENDO 2016 Comparing Romosozumab With Teriparatide 82

Appendix 84

Methodology 84

Coverage 84

Secondary Research 84

Primary Research 84

Expert Panel Validation 84

Contact Us 84

Disclaimer 85

List of Tables

List of Tables

Number of Products under Development for Post Menopausal Osteoporosis, H2 2016 8

Number of Products under Development by Companies, H2 2016 9

Comparative Analysis by Late Stage Development, H2 2016 10

Comparative Analysis by Clinical Stage Development, H2 2016 11

Comparative Analysis by Early Stage Development, H2 2016 12

Products under Development by Companies, H2 2016 13

Post Menopausal Osteoporosis – Pipeline by Amgen Inc., H2 2016 14

Post Menopausal Osteoporosis – Pipeline by BiologicsMD, Inc., H2 2016 15

Post Menopausal Osteoporosis – Pipeline by Eli Lilly and Company, H2 2016 16

Post Menopausal Osteoporosis – Pipeline by Enteris BioPharma, Inc., H2 2016 17

Post Menopausal Osteoporosis – Pipeline by Intas Pharmaceuticals Ltd., H2 2016 18

Post Menopausal Osteoporosis – Pipeline by Ipsen S.A., H2 2016 19

Post Menopausal Osteoporosis – Pipeline by Ligand Pharmaceuticals, Inc., H2 2016 20

Post Menopausal Osteoporosis – Pipeline by NIBEC, H2 2016 21

Post Menopausal Osteoporosis – Pipeline by Oncobiologics, Inc., H2 2016 22

Post Menopausal Osteoporosis – Pipeline by Paras Biopharmaceuticals Finland Oy, 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 32

Post Menopausal Osteoporosis – Dormant Projects, H2 2016 69

Post Menopausal Osteoporosis – Discontinued Products, H2 2016 70

List of Figures

List of Figures

Number of Products under Development for Post Menopausal Osteoporosis, H2 2016 8

Number of Products under Development by Companies, H2 2016 9

Comparative Analysis by Late Stage Development, H2 2016 10

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 Top 10 Mechanism of Actions, H2 2016 27

Number of Products by Stage and Top 10 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

Number of Products by Molecule Types, H2 2016 31

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

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