Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC 2.7.11.1 or EC 2.7.1.153) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC 2.7.11.1 or EC 2.7.1.153) – Pipeline Review, H2 2016’, provides in depth analysis on Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC 2.7.11.1 or EC 2.7.1.153) targeted pipeline therapeutics.

The report provides comprehensive information on the Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC 2.7.11.1 or EC 2.7.1.153) , 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 Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC 2.7.11.1 or EC 2.7.1.153) 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 Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC 2.7.11.1 or EC 2.7.1.153)

The report reviews Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC 2.7.11.1 or EC 2.7.1.153) 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 Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC 2.7.11.1 or EC 2.7.1.153) targeted therapeutics and enlists all their major and minor projects

The report assesses Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC 2.7.11.1 or EC 2.7.1.153) 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 Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC 2.7.11.1 or EC 2.7.1.153) 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 Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC 2.7.11.1 or EC 2.7.1.153)

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 Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC 2.7.11.1 or EC 2.7.1.153) 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

Bayer AG

Curis, Inc.

Eli Lilly and Company

Genentech, Inc.

GlaxoSmithKline Plc

Hutchison MediPharma Limited

Millennium Pharmaceuticals Inc

Novartis AG

PIQUR Therapeutics AG

Sphaera Pharma Pvt. 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

Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC

2.7.11.1 or EC

2.7.1.153) Overview 9

Therapeutics Development 10

Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC

2.7.11.1 or EC

2.7.1.153) - Products under Development by Stage of Development 10

Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC

2.7.11.1 or EC

2.7.1.153) - Products under Development by Therapy Area 11

Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC

2.7.11.1 or EC

2.7.1.153) - Products under Development by Indication 12

Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC

2.7.11.1 or EC

2.7.1.153) - Pipeline Products Glance 15

Late Stage Products 15

Early Stage Products 16

Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC

2.7.11.1 or EC

2.7.1.153) - Products under Development by Companies 17

Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC

2.7.11.1 or EC

2.7.1.153) - Products under Development by Universities/Institutes 23

Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC

2.7.11.1 or EC

2.7.1.153) - Therapeutics Assessment 25

Assessment by Monotherapy/Combination Products 25

Assessment by Mechanism of Action 26

Assessment by Route of Administration 27

Assessment by Molecule Type 28

Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC

2.7.11.1 or EC

2.7.1.153) - Companies Involved in Therapeutics Development 29

Bayer AG 29

Curis, Inc. 30

Eli Lilly and Company 31

Genentech, Inc. 32

GlaxoSmithKline Plc 33

Hutchison MediPharma Limited 34

Millennium Pharmaceuticals Inc 35

Novartis AG 36

PIQUR Therapeutics AG 38

Sphaera Pharma Pvt. Ltd. 39

Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC

2.7.11.1 or EC

2.7.1.153) - Drug Profiles 40

alpelisib - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

BAY-1082439 - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

buparlisib hydrochloride - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

CUDC-907 - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

HM-032 - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

LY-3023414 - Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

NSC-765844 - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

omipalisib - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

PQR-309 - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

Small Molecule to Inhibit PI3K Alpha for Cancer - Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

Small Molecules to Inhibit Pan PI3K for Ovarian Cancer - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

SPR-965 - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

SRX-2523 - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

TAK-117 - Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

taselisib - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC

2.7.11.1 or EC

2.7.1.153) - Dormant Projects 72

Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC

2.7.11.1 or EC

2.7.1.153) - Discontinued Products 74

Phosphatidylinositol 4,5 Bisphosphate 3 Kinase Catalytic Subunit Alpha Isoform (Phosphatidylinositol 4,5 Bisphosphate 3 Kinase 110 kDa Catalytic Subunit Alpha or Phosphoinositide 3 Kinase Catalytic Alpha Polypeptide or Serine/Threonine Protein Kinase PIK3CA or PIK3CA or EC

2.7.11.1 or EC

2.7.1.153) - Featured News & Press Releases 75

Jun 08, 2016: Curis Announces Oral Presentation of Clinical Data Update from the Phase 1 Study of CUDC-907 at the 21st Congress of the European Hematology Association 75

Jun 02, 2016: Curis Announces Presentations Related to CUDC-907 at 2016 ASCO Annual Meeting 75

Apr 11, 2016: Curis Announces Presentation of Preclinical Data for CUDC-907 at AACR Annual Meeting 75

Apr 04, 2016: Curis Announces Publication of CUDC-907 Phase 1 Clinical Trial Data in Lancet Oncology 76

Jan 11, 2016: Seahorse Bioscience XF Technology Reaches 500th Citation in Cancer Research 76

Dec 06, 2015: Curis Reports Clinical Activity of CUDC-907 in Patients With DLBCL Harboring MYC Oncogene Alterations at the 2015 ASH Annual Meeting 77

Nov 05, 2015: Curis Announces Oral Presentation of Phase 1 Data for CUDC-907 at 2015 ASH Annual Meeting 79

Jun 17, 2015: Eli Lilly and Company Enters Into Strategic Partnership with Sarah Cannon Research Institute to Develop Investigational Oncology Therapy 80

Jun 10, 2015: Curis to Present CUDC-907 Clinical Data at the 20th Congress of the European Hematology Association and the 13th International Congress on Malignant Lymphoma 80

May 31, 2015: Curis Reports CUDC-907 Data From the Ongoing Phase 1 Trial at the 2015 ASCO Annual Meeting 81

May 27, 2015: PIQUR announces positive Phase 1 study results and the start of Phase 2 of PQR309 82

May 20, 2015: Curis Announces Presentations of CUDC-907 Clinical Data at 2015 ASCO Annual Meeting 83

May 10, 2015: New Investigational Drug Targeting Difficult to Treat Breast Cancers to Undergo Pan-European Phase II Clinical Trials 84

Apr 21, 2015: SignalRx Presents at 10th Annual Drug Discovery Chemistry Conference on its Dual Kinase-Epigenetic Inhibitors for Treating Cancer 85

Apr 17, 2015: PIQUR to present posters on its lead compound PQR309 at AACR Annual Meeting 2015 86

Appendix 88

Methodology 88

Coverage 88

Secondary Research 88

Primary Research 88

Expert Panel Validation 88

Contact Us 88

Disclaimer 89

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 13

Comparative Analysis by Late Stage Development, H2 2016 15

Comparative Analysis by Early Stage Products, H2 2016 16

Number of Products under Development by Companies, H2 2016 17

Products under Development by Companies, H2 2016 18

Products under Development by Companies, H2 2016 (Contd..1) 19

Products under Development by Companies, H2 2016 (Contd..2) 20

Products under Development by Companies, H2 2016 (Contd..3) 21

Products under Development by Companies, H2 2016 (Contd..4) 22

Number of Products under Investigation by Universities/Institutes, H2 2016 23

Products under Investigation by Universities/Institutes, H2 2016 24

Assessment by Monotherapy/Combination Products, H2 2016 25

Number of Products by Stage and Mechanism of Action, H2 2016 26

Number of Products by Stage and Route of Administration, H2 2016 27

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

Pipeline by Bayer AG, H2 2016 29

Pipeline by Curis, Inc., H2 2016 30

Pipeline by Eli Lilly and Company, H2 2016 31

Pipeline by Genentech, Inc., H2 2016 32

Pipeline by GlaxoSmithKline Plc, H2 2016 33

Pipeline by Hutchison MediPharma Limited, H2 2016 34

Pipeline by Millennium Pharmaceuticals Inc, H2 2016 35

Pipeline by Novartis AG, H2 2016 36

Pipeline by PIQUR Therapeutics AG, H2 2016 38

Pipeline by Sphaera Pharma Pvt. Ltd., H2 2016 39

Dormant Projects, H2 2016 72

Dormant Projects (Contd..1), H2 2016 73

Discontinued Products, H2 2016 74

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 15

Comparative Analysis by Early Stage Products, H2 2016 16

Assessment by Monotherapy/Combination Products, H2 2016 25

Number of Products by Stage and Mechanism of Actions, H2 2016 26

Number of Products by Stage and Routes of Administration, H2 2016 27

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

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