Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC 2.7.11.22 or EC 2.7.11.23) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC 2.7.11.22 or EC 2.7.11.23) – Pipeline Review, H2 2016’, provides in depth analysis on Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC 2.7.11.22 or EC 2.7.11.23) targeted pipeline therapeutics.

The report provides comprehensive information on the Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC 2.7.11.22 or EC 2.7.11.23), 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 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC 2.7.11.22 or EC 2.7.11.23) 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 Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC 2.7.11.22 or EC 2.7.11.23)

The report reviews Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC 2.7.11.22 or EC 2.7.11.23) 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 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC 2.7.11.22 or EC 2.7.11.23) targeted therapeutics and enlists all their major and minor projects

The report assesses Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC 2.7.11.22 or EC 2.7.11.23) 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 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC 2.7.11.22 or EC 2.7.11.23) 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 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC 2.7.11.22 or EC 2.7.11.23)

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 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC 2.7.11.22 or EC 2.7.11.23) 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

Astex Pharmaceuticals, Inc.

AstraZeneca Plc

Bayer AG

Cyclacel Pharmaceuticals, Inc.

Eli Lilly and Company

Jyant Technologies, Inc.

Presage Biosciences, Inc.

Selvita S.A.

Tolero Pharmaceuticals, Inc.

Tragara Pharmaceuticals, Inc.

Vichem Chemie Research Ltd.

ViroStatics srl

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 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC

2.7.11.22 or EC

2.7.11.23) Overview 9

Therapeutics Development 10

Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC

2.7.11.22 or EC

2.7.11.23) - Products under Development by Stage of Development 10

Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC

2.7.11.22 or EC

2.7.11.23) - Products under Development by Therapy Area 11

Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC

2.7.11.22 or EC

2.7.11.23) - Products under Development by Indication 12

Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC

2.7.11.22 or EC

2.7.11.23) - Pipeline Products Glance 14

Late Stage Products 14

Early Stage Products 15

Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC

2.7.11.22 or EC

2.7.11.23) - Products under Development by Companies 16

Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC

2.7.11.22 or EC

2.7.11.23) - Products under Development by Universities/Institutes 20

Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC

2.7.11.22 or EC

2.7.11.23) - Therapeutics Assessment 22

Assessment by Monotherapy/Combination Products 22

Assessment by Mechanism of Action 23

Assessment by Route of Administration 24

Assessment by Molecule Type 26

Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC

2.7.11.22 or EC

2.7.11.23) - Companies Involved in Therapeutics Development 27

Astex Pharmaceuticals, Inc. 27

AstraZeneca Plc 28

Bayer AG 29

Cyclacel Pharmaceuticals, Inc. 30

Eli Lilly and Company 31

Jyant Technologies, Inc. 32

Presage Biosciences, Inc. 33

Selvita S.A. 34

Tolero Pharmaceuticals, Inc. 35

Tragara Pharmaceuticals, Inc. 36

Vichem Chemie Research Ltd. 37

ViroStatics srl 38

Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC

2.7.11.22 or EC

2.7.11.23) - Drug Profiles 39

alvocidib hydrochloride - Drug Profile 39

Product Description 39

Mechanism Of Action 39

R&D Progress 39

alvocidib hydrochloride - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

AT-7519 - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

AZ-5576 - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

BAY-1112054 - Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

CCT-68127 - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

CYC-065 - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

FIT-039 - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

LY-2857785 - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

sapacitabine + seliciclib - Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

SEL-120 - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

seliciclib - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

Small Molecule to Inhibit CDK4, CDK6 and CDK9 for EBV Infections - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

Small Molecule to Inhibit CDK4, CDK6 and CDK9 for HPV Associated Cancers - Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

Small Molecule to Inhibit CDK4, CDK6 and CDK9 for HSV Infections - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

Small Molecule to Inhibit CDK4, CDK6 and CDK9 for Oncology - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

Small Molecule to Inhibit CDK9 for Multiple Myeloma - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

Small Molecule to Inhibit Cyclin Dependent Kinase 9 for Oncology - Drug Profile 67

Product Description 67

Mechanism Of Action 67

R&D Progress 67

Small Molecules to Inhibit CDK9 for HIV-1 Infection - Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

Small Molecules to Inhibit CDK9 for Inflammatory Pain and Rheumatoid Arthritis - Drug Profile 69

Product Description 69

Mechanism Of Action 69

R&D Progress 69

TG-02 - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

TP-1287 - Drug Profile 73

Product Description 73

Mechanism Of Action 73

R&D Progress 73

voruciclib - Drug Profile 74

Product Description 74

Mechanism Of Action 74

R&D Progress 74

Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC

2.7.11.22 or EC

2.7.11.23) - Dormant Projects 76

Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC

2.7.11.22 or EC

2.7.11.23) - Discontinued Products 78

Cyclin Dependent Kinase 9 (Tat Associated Kinase Complex Catalytic Subunit or C 2K or Cell Division Cycle 2 Like Protein Kinase 4 or Cell Division Protein Kinase 9 or Serine/Threonine Protein Kinase PITALR or CDK9 or EC

2.7.11.22 or EC

2.7.11.23) - Featured News & Press Releases 79

Jun 13, 2016: Tolero Pharmaceuticals Presents Nonclinical Data Demonstrating Alvocidib Provides Drug Combination Strategies Due to the Targeting of MCL-1 79

Jun 06, 2016: Tolero Pharmaceuticals To Present Update On Alvocidib Program At 2016 EHA Congress 79

Jun 06, 2016: Cyclacel Reports Updated Data From Its DNA Damage Response Program on Seliciclib and Sapacitabine Combination in Patients With Solid Tumors at ASCO 80

Jun 06, 2016: Tolero Pharmaceuticals To Present Update On TP-1287 Program At 2016 EHA Congress 82

Jun 03, 2016: Presage Biosciences Appoints David Johnson to Board of Directors 82

May 19, 2016: Cyclacel’s Seliciclib-Sapacitabine Abstract Selected for Oral Presentation at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting 83

Apr 20, 2016: Tolero Pharmaceuticals Presents Nonclinical Data Demonstrating Alvocidib Provides Multiple Drug Combination Strategies Due to the Targeting of MCL-1 83

Apr 19, 2016: Presage Biosciences Presents Data Demonstrating Tumor Growth Inhibition by Voruciclib and Proteasome Inhibitors Superior to Single Agents in Model of Triple Negative Breast Cancer 84

Apr 18, 2016: Cyclacel’s Second-Generation CDK2/9 Inhibitor, CYC065, is an Effective Inducer of Cell Death in B-cell Lymphoma and Synergizes With Bcl-2 or BET Inhibitors 85

Apr 12, 2016: Tolero Pharmaceuticals to Present Update on Alvocidib at the AACR Annual Meeting 2016 86

Dec 14, 2015: Molecular Basis for Development of Cyclacel’s CYC065 CDK2/9 Inhibitor in Triple-Negative Breast Cancer Presented at San Antonio Breast Cancer Symposium 87

Dec 08, 2015: Tolero Pharmaceuticals Announces Mechanistic Data Describing the Activity of Alvocidib within a Time-sequential Regimen 87

Dec 07, 2015: Tolero Pharmaceuticals Presents Preclinical Data Demonstrating Synergistic Activity with a Combination of Alvocidib and Azacytidine 88

Nov 23, 2015: CYC065, Cyclacel's Novel CDK2/9 Inhibitor, Prolongs Survival in MYCN-Addicted Neuroblastoma Models 89

Nov 12, 2015: Tolero Pharmaceuticals Presents Positive Clinical and Preclinical Data on alvocidib at the 57th ASH Annual Meeting and Exposition 90

Appendix 91

Methodology 91

Coverage 91

Secondary Research 91

Primary Research 91

Expert Panel Validation 91

Contact Us 91

Disclaimer 92

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

Number of Products under Investigation by Universities/Institutes, H2 2016 20

Products under Investigation by Universities/Institutes, H2 2016 21

Assessment by Monotherapy/Combination Products, H2 2016 22

Number of Products by Stage and Mechanism of Action, H2 2016 23

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

Number of Products by Stage and Molecule Type, H2 2016 26

Pipeline by Astex Pharmaceuticals, Inc., H2 2016 27

Pipeline by AstraZeneca Plc, H2 2016 28

Pipeline by Bayer AG, H2 2016 29

Pipeline by Cyclacel Pharmaceuticals, Inc., H2 2016 30

Pipeline by Eli Lilly and Company, H2 2016 31

Pipeline by Jyant Technologies, Inc., H2 2016 32

Pipeline by Presage Biosciences, Inc., H2 2016 33

Pipeline by Selvita S.A., H2 2016 34

Pipeline by Tolero Pharmaceuticals, Inc., H2 2016 35

Pipeline by Tragara Pharmaceuticals, Inc., H2 2016 36

Pipeline by Vichem Chemie Research Ltd., H2 2016 37

Pipeline by ViroStatics srl, H2 2016 38

Dormant Projects, H2 2016 76

Dormant Projects (Contd..1), H2 2016 77

Discontinued Products, H2 2016 78

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 Early Stage Products, H2 2016 15

Assessment by Monotherapy/Combination Products, H2 2016 22

Number of Products by Stage and Mechanism of Actions, H2 2016 23

Number of Products by Routes of Administration, H2 2016 24

Number of Products by Stage and Routes of Administration, H2 2016 24

Number of Products by Stage and Molecule Type, H2 2016 26

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