Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)-Pipeline Review, H2 2016

Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)-Pipeline Review, H2 2016


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Executive Summary

Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)-Pipeline Review, H2 2016

Summary

Global Markets Direct's, Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)-Pipeline Review, H2 2016', provides in depth analysis on Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11) targeted pipeline therapeutics.

The report provides comprehensive information on the Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11), targeted therapeutics, complete with analysis by indications, stage of development, 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 Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11) targeted therapeutics development 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 for Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)

The report reviews Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11) targeted therapeutics under development 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 in Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11) targeted therapeutics and enlists all their major and minor projects

The report assesses Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11) targeted therapeutics based on 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 and deals related to Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11) targeted therapeutics

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 the targeted therapy areas and indications for Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)

Identify the use of drugs for target identification and drug repurposing

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 Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11) development landscape

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



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Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11) Overview 8

Therapeutics Development 9

Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)-Products under Development by Stage of Development 9

Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)-Products under Development by Therapy Area 10

Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)-Products under Development by Indication 11

Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)-Pipeline Products Glance 12

Late Stage Products 12

Early Stage Products 13

Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)-Products under Development by Companies 14

Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)-Products under Development by Universities/Institutes 16

Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)-Therapeutics Assessment 18

Assessment by Monotherapy/Combination Products 18

Assessment by Mechanism of Action 19

Assessment by Route of Administration 20

Assessment by Molecule Type 22

Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)-Companies Involved in Therapeutics Development 24

Ablynx NV 24

AlphaMab Co., Ltd 25

Amgen Inc. 26

Astellas Pharma Inc. 27

Clonz Biotech Private Limited 28

Intas Pharmaceuticals Ltd. 29

Oncobiologics, Inc. 30

R-Pharm 31

Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)-Drug Profiles 32

ALX-0141-Drug Profile 32

Product Description 32

Mechanism Of Action 32

R&D Progress 32

AMG-161-Drug Profile 34

Product Description 34

Mechanism Of Action 34

R&D Progress 34

CDRI-99/373-Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

denosumab-Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

denosumab biosimilar-Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

denosumab biosimilar-Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

denosumab biosimilar-Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

denosumab biosimilar-Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

KN-012-Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

Monoclonal Antibody to Inhibit RANKL for Bone Disorders-Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

Proteins to Inhibit RANKL for Oncology and Osteoporosis-Drug Profile 51

Product Description 51

Mechanism Of Action 51

R&D Progress 51

RPH-203-Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

Small Molecules to Inhibit RANKL for Osteoclastogenesis-Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)-Dormant Projects 54

Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11)-Featured News & Press Releases 55

Mar 30, 2016: Daiichi Sankyo Announces Phase 3 Clinical Trial Results for AMG 162 (denosumab) Rheumatoid Arthritis Treatment 55

Oct 12, 2015: New Data Show Consistent Safety Profile For Up To 10 Years With Prolia In Postmenopausal Women With Osteoporosis 55

Oct 11, 2015: New Data Show Greater Bone Mineral Density Gains With Prolia Compared With Zoledronic Acid 56

Oct 06, 2015: Amgen To Present Data From Multiple Studies For Prolia On Osteoporosis Disease And Treatment At American Society For Bone And Mineral Research Annual Meeting 57

Jul 06, 2015: R-Pharm Group of Companies Develops Original drug for Treatment of Metastatic Bone Disease 59

Jun 01, 2015: Amgen Presents Phase 3 Data At ASCO Showing Prolia (Denosumab) Significantly Reduced Bone Fractures In Breast Cancer Patients Receiving Aromatase Inhibitors 60

May 13, 2015: Amgen Presents Data At ASCO 2015 On Prolia 61

Sep 15, 2014: Amgen Announces Results From Several New Exploratory Analyses Evaluating Long-Term Impact Of Treatment With Prolia (Denosumab) In Postmenopausal Women With Osteoporosis 61

Sep 10, 2014: Amgen Announces 18 Abstracts To Be Presented At The American Society for Bone and Mineral Research 2014 Annual Meeting 63

Oct 04, 2013: Amgen Presents Data From Several Prolia Studies At ASBMR 64

Jun 11, 2013: Daiichi Sankyo Launches Pralia Subcutaneous Injection 60mg Syringe For Treatment Of Osteoporosis 65

Mar 25, 2013: Daiichi Sankyo Receives Japanese Approval For Manufacture And Marketing Of Pralia For Treatment Of Osteoporosis 66

Nov 21, 2012: Amgen Canada Provides New Safety Information For Prolia 66

Oct 15, 2012: Daiichi Sankyo Announces Positive Phase III Study Results For Denosumab On Fracture Risk In Japanese Patients With Osteoporosis At ASBMR 67

Oct 14, 2012: Amgen Presents Several Sub-Analysis From Pivotal Phase III Prolia Fracture Trial At ASBMR 2012 67

Appendix 69

Methodology 69

Coverage 69

Secondary Research 69

Primary Research 69

Expert Panel Validation 69

Contact Us 69

Disclaimer 70

List of Tables

Number of Products under Development for, H2 2016 9

Number of Products under Development by Therapy Area, H2 2016 10

Number of Products under Development by Indication, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 12

Comparative Analysis by Early Stage Products, H2 2016 13

Number of Products under Development by Companies, H2 2016 14

Products under Development by Companies, H2 2016 15

Number of Products under Investigation by Universities/Institutes, H2 2016 16

Products under Investigation by Universities/Institutes, H2 2016 17

Assessment by Monotherapy/Combination Products, H2 2016 18

Number of Products by Stage and Mechanism of Action, H2 2016 19

Number of Products by Stage and Route of Administration, H2 2016 21

Number of Products by Stage and Molecule Type, H2 2016 23

Pipeline by Ablynx NV, H2 2016 24

Pipeline by AlphaMab Co., Ltd, H2 2016 25

Pipeline by Amgen Inc., H2 2016 26

Pipeline by Astellas Pharma Inc., H2 2016 27

Pipeline by Clonz Biotech Private Limited, H2 2016 28

Pipeline by Intas Pharmaceuticals Ltd., H2 2016 29

Pipeline by Oncobiologics, Inc., H2 2016 30

Pipeline by R-Pharm, H2 2016 31

Dormant Projects, H2 2016 54

List of Figures

Number of Products under Development for, H2 2016 9

Number of Products under Development by Therapy Area, H2 2016 10

Number of Products under Development by Top 10 Indication, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 12

Comparative Analysis by Early Stage Products, H2 2016 13

Assessment by Monotherapy/Combination Products, H2 2016 18

Number of Products by Stage and Mechanism of Actions, H2 2016 19

Number of Products by Routes of Administration, H2 2016 20

Number of Products by Stage and Routes of Administration, H2 2016 20

Number of Products by Molecule Types, H2 2016 22

Number of Products by Stage and Molecule Type, H2 2016 22

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Ablynx NV

AlphaMab Co., Ltd

Amgen Inc.

Astellas Pharma Inc.

Clonz Biotech Private Limited

Intas Pharmaceuticals Ltd.

Oncobiologics, Inc.

R-Pharm

Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11) Therapeutic Products under Development, Key Players in Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11) Therapeutics, Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11) Pipeline Overview, Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11) Pipeline, Tumor Necrosis Factor Ligand Superfamily Member 11 (Receptor Activator Of Nuclear Factor Kappa B Ligand or Osteoclast Differentiation Factor or TNF Related Activation Induced Cytokine or Osteoprotegerin Ligand or CD254 or TNFSF11) Pipeline Assessment

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