Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC 2.7.11.22) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC 2.7.11.22) – Pipeline Review, H2 2016’, provides in depth analysis on Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC 2.7.11.22) targeted pipeline therapeutics.

The report provides comprehensive information on the Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC 2.7.11.22), 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 Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC 2.7.11.22) 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.

Updated report will be delivered in 48 hours of order confirmation.

Scope

The report provides a snapshot of the global therapeutic landscape for Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC 2.7.11.22)

The report reviews Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC 2.7.11.22) 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 Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC 2.7.11.22) targeted therapeutics and enlists all their major and minor projects

The report assesses Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC 2.7.11.22) 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 Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC 2.7.11.22) 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 Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC 2.7.11.22)

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 Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC 2.7.11.22) 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

Companies mentioned

Beta Pharma Inc

Eli Lilly and Company

FLX Bio, Inc.

G1 Therapeutics Inc

Jiangsu Hengrui Medicine Co Ltd

Novartis AG

Onconova Therapeutics Inc

Pfizer Inc

Teijin Pharma Ltd

ViroStatics srl

XuanZhu Pharma Co Ltd

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC

2.7.11.22) Overview 9

Cell division protein kinase 6 (CDK6) is an enzyme encoded by the CDK6 gene. It is involved in initiation and maintenance of cell cycle exit during cell differentiation, prevents cell proliferation and regulates negatively cell differentiation. It is required during thymocyte development. It promotes the production of newborn neurons, probably by modulating G1 length, changes in the actin cytoskeleton including loss of stress fibers, and enhanced motility during cell differentiation. It prevents myeloid differentiation by interfering with RUNX1 and reducing its transcription transactivation-activity.Therapeutics Development 9

Therapeutics Development 10

Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC

2.7.11.22) - Products under Development by Stage of Development 10

Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC

2.7.11.22) - Products under Development by Therapy Area 11

Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC

2.7.11.22) - Products under Development by Indication 12

Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC

2.7.11.22) - Pipeline Products Glance 14

Late Stage Products 14

Early Stage Products 15

Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC

2.7.11.22) - Products under Development by Companies 16

Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC

2.7.11.22) - Products under Development by Universities/Institutes 21

Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC

2.7.11.22) - Therapeutics Assessment 23

Assessment by Monotherapy/Combination Products 23

Assessment by Mechanism of Action 24

Assessment by Route of Administration 25

Assessment by Molecule Type 27

Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC

2.7.11.22) - Companies Involved in Therapeutics Development 29

Beta Pharma Inc 29

Eli Lilly and Company 30

FLX Bio, Inc. 31

G1 Therapeutics Inc 32

Jiangsu Hengrui Medicine Co Ltd 33

Novartis AG 34

Onconova Therapeutics Inc 35

Pfizer Inc 36

Teijin Pharma Ltd 37

ViroStatics srl 38

XuanZhu Pharma Co Ltd 39

Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC

2.7.11.22) - Drug Profiles 40

abemaciclib - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

BPI-1178 - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

FLX-925 - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

G-1T28 - Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

G-1T38 - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

GZ-381 - Drug Profile 51

Product Description 51

Mechanism Of Action 51

R&D Progress 51

MMD-37K - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

ON-123300 - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

palbociclib - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

ribociclib succinate - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

SHR-6390 - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

Small Molecule to Inhibit CDK 4 and 6 for Rheumatoid Arthritis - Drug Profile 71

Product Description 71

Mechanism Of Action 71

R&D Progress 71

Small Molecule to Inhibit CDK4 and CDK6 for Acute Kidney Injury and Breast Cancer - Drug Profile 72

Product Description 72

Mechanism Of Action 72

R&D Progress 72

Small Molecule to Inhibit CDK4 and CDK6 for Breast Cancer - Drug Profile 73

Product Description 73

Mechanism Of Action 73

R&D Progress 73

Small Molecule to Inhibit CDK4, CDK6 and CDK9 for EBV Infections - Drug Profile 74

Product Description 74

Mechanism Of Action 74

R&D Progress 74

Small Molecule to Inhibit CDK4, CDK6 and CDK9 for HPV Associated Cancers and Warts - Drug Profile 75

Product Description 75

Mechanism Of Action 75

R&D Progress 75

Small Molecule to Inhibit CDK4, CDK6 and CDK9 for HSV Infections - Drug Profile 76

Product Description 76

Mechanism Of Action 76

R&D Progress 76

Small Molecule to Inhibit CDK4, CDK6 and CDK9 for Oncology - Drug Profile 77

Product Description 77

Mechanism Of Action 77

R&D Progress 77

Small Molecule to Target Cdk2, Cdk4, Cdk6, Cyclin D1, Cyclin B1, Cdc2, p53 and p16 for Bacterial Infections and Oncology - Drug Profile 78

Product Description 78

Mechanism Of Action 78

R&D Progress 78

Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC

2.7.11.22) - Dormant Projects 79

Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC

2.7.11.22) - Discontinued Products 80

Cyclin Dependent Kinase 6 (Cell Division Protein Kinase 6 or Serine/Threonine Protein Kinase PLSTIRE or CDK6 or EC

2.7.11.22) - Featured News & Press Releases 81

Nov 16, 2016: PALOMA-2 Phase 3 Study Published In The New England Journal Of Medicine Demonstrates Clinical Benefit Of Pfizer’s IBRANCE (palbociclib) In First-Line ER+, HER2- Metastatic Breast Cancer 81

Nov 10, 2016: IBRANCE (palbociclib) Receives Approval in European Union for the Treatment of Women with HR+/HER2- Metastatic Breast Cancer 82

Nov 01, 2016: Astex Achieves Milestone on US FDA Filing of New Drug Application (NDA) for LEE011 (Ribociclib) Plus Letrozole as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer 84

Nov 01, 2016: Novartis LEE011 (ribociclib) granted FDA Priority Review for first-line treatment of HR+/HER2- advanced breast cancer 84

Oct 08, 2016: Novartis breakthrough therapy LEE011 plus letrozole demonstrates superior progression-free survival as first-line treatment for HR+/HER2- advanced breast cancer compared to a standard of care 85

Oct 05, 2016: Lilly Presents New Data on Abemaciclib At ESMO 2016 86

Sep 16, 2016: Pfizer Receives Positive CHMP Opinion For IBRANCE (palbociclib) In Combination With Endocrine Therapy For The Treatment Of HR+/HER2- Metastatic Breast Cancer In Europe 87

Aug 10, 2016: Lilly Provides Update on MONARCH 2 Phase 3 Trial of Abemaciclib 87

Aug 03, 2016: Novartis CDK4/6 inhibitor LEE011 (ribociclib) receives FDA Breakthrough Therapy designation as first-line treatment for HR+/HER2- advanced breast cancer 88

Jul 13, 2016: European breast cancer trial opens in Ireland 89

Jul 06, 2016: Study Tests New Breast Cancer Drug In African American Women 90

Jun 03, 2016: Lilly Announces Results From MONARCH 1 Trial Of Abemaciclib Monotherapy 91

May 31, 2016: Lilly Announces Webcast To Discuss Abemaciclib Data 92

May 23, 2016: Investigational CDK4/6 inhibitor abemaciclib is active against a range of cancer types 92

May 18, 2016: Eli Lilly to Present final phase 2 monotherapy data on CDK 4 and 6 inhibitor abemaciclib in metastatic breast cancer at ASCO 93

Appendix 95

Methodology 95

Coverage 95

Secondary Research 95

Primary Research 95

Expert Panel Validation 95

Contact Us 95

Disclaimer 96

List of Tables

List of Tables

Number of Products under Development for, H2 2016 10

Number of Products under Development by Therapy Area, H2 2016 11

Number of Products under Development by Indication, H2 2016 12

Comparative Analysis by Late Stage Development, H2 2016 14

Comparative Analysis by Early Stage Products, H2 2016 15

Number of Products under Development by Companies, H2 2016 16

Products under Development by Companies, H2 2016 17

Products under Development by Companies, H2 2016 (Contd..1) 18

Products under Development by Companies, H2 2016 (Contd..2) 19

Products under Development by Companies, H2 2016 (Contd..3) 20

Number of Products under Investigation by Universities/Institutes, H2 2016 21

Products under Investigation by Universities/Institutes, H2 2016 22

Assessment by Monotherapy/Combination Products, H2 2016 23

Number of Products by Stage and Mechanism of Action, H2 2016 24

Number of Products by Stage and Route of Administration, H2 2016 26

Number of Products by Stage and Molecule Type, H2 2016 28

Pipeline by Beta Pharma Inc, H2 2016 29

Pipeline by Eli Lilly and Company, H2 2016 30

Pipeline by FLX Bio, Inc., H2 2016 31

Pipeline by G1 Therapeutics Inc, H2 2016 32

Pipeline by Jiangsu Hengrui Medicine Co Ltd, H2 2016 33

Pipeline by Novartis AG, H2 2016 34

Pipeline by Onconova Therapeutics Inc, H2 2016 35

Pipeline by Pfizer Inc, H2 2016 36

Pipeline by Teijin Pharma Ltd, H2 2016 37

Pipeline by ViroStatics srl, H2 2016 38

Pipeline by XuanZhu Pharma Co Ltd, H2 2016 39

Dormant Projects, H2 2016 79

Discontinued Products, H2 2016 80

List of Figures

List of Figures

Number of Products under Development for, H2 2016 10

Number of Products under Development by Therapy Area, H2 2016 11

Number of Products under Development by Top 10 Indication, H2 2016 12

Comparative Analysis by Late Stage Development, H2 2016 14

Comparative Analysis by Early Stage Products, H2 2016 15

Assessment by Monotherapy/Combination Products, H2 2016 23

Number of Products by Stage and Mechanism of Actions, H2 2016 24

Number of Products by Routes of Administration, H2 2016 25

Number of Products by Stage and Routes of Administration, H2 2016 25

Number of Products by Molecule Types, H2 2016 27

Number of Products by Stage and Molecule Type, H2 2016 27

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