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Acromegaly - Pipeline Review, H2 2015 Is Released

Press Release   •   Feb 03, 2016 18:00 IST

This report provides comprehensive information on the therapeutic development for Acromegaly, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Acromegaly and special features on late-stage and discontinued projects. Global Markets Directs 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 Directs proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct s team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage.

It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease. Scope - The report provides a snapshot of the global therapeutic landscape of Acromegaly - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Acromegaly and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Acromegaly products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment of monotherapy and combination therapy pipeline projects - Coverage of the Acromegaly pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products Reasons to buy - Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Develop strategic initiatives by understanding the focus areas of leading companies - Identify and understand important and diverse types of therapeutics under development for Acromegaly - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - Devise corrective measures for pipeline projects by understanding Acromegaly 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

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Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Acromegaly Overview 9

Therapeutics Development 10

Pipeline Products for Acromegaly - Overview 10

Pipeline Products for Acromegaly - Comparative Analysis 11

Acromegaly - Therapeutics under Development by Companies 12

Acromegaly - Therapeutics under Investigation by Universities/Institutes 13

Acromegaly - Pipeline Products Glance 14

Late Stage Products 14

Clinical Stage Products 15

Early Stage Products 16

Acromegaly - Products under Development by Companies 17

Acromegaly - Products under Investigation by Universities/Institutes 18

Acromegaly - Companies Involved in Therapeutics Development 19

Aegis Therapeutics, LLC 19

Antisense Therapeutics Limited 20

Chiasma, Inc. 21

Crinetics Pharmaceuticals, Inc. 22

DexTech Medical AB 23

Foresee Pharmaceuticals, LLC 24

Ipsen S.A. 25

Isis Pharmaceuticals, Inc. 26

Italfarmaco S.p.A. 27

Novartis AG 28

Peptron, Inc. 29

Sompharmaceuticals S.A. 30

Strongbridge Biopharma plc 31

Acromegaly - Therapeutics Assessment 32

Assessment by Monotherapy Products 32

Assessment by Target 33

Assessment by Mechanism of Action 35

Assessment by Route of Administration 37

Assessment by Molecule Type 39

Drug Profiles 41

ATL-1103 - Drug Profile 41

Product Description 41

Mechanism of Action 41

R&D Progress 41

BIM-23A758 - Drug Profile 43

Product Description 43

Mechanism of Action 43

R&D Progress 43

COR-005 - Drug Profile 44

Product Description 44

Mechanism of Action 44

R&D Progress 44

FP-002 - Drug Profile 47

Product Description 47

Mechanism of Action 47

R&D Progress 47

G-02113 - Drug Profile 48

Product Description 48

Mechanism of Action 48

R&D Progress 48

ISIS-GHRLRx - Drug Profile 49

Product Description 49

Mechanism of Action 49

R&D Progress 49

ITF-2984 - Drug Profile 50

Product Description 50

Mechanism of Action 50

R&D Progress 50

L-779976 - Drug Profile 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

octreotide acetate - Drug Profile 52

Product Description 52

Mechanism of Action 52

R&D Progress 52

octreotide acetate - Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

octreotide acetate - Drug Profile 55

Product Description 55

Mechanism of Action 55

R&D Progress 55

octreotide acetate long acting - Drug Profile 56

Product Description 56

Mechanism of Action 56

R&D Progress 56

octreotide acetate SR - Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

octreotide SR - Drug Profile 59

Product Description 59

Mechanism of Action 59

R&D Progress 59

pasireotide ER - Drug Profile 60

Product Description 60

Mechanism of Action 60

R&D Progress 60

Small Molecules to Activate Somatostatin Receptor Type 4 for Polycystic Kidney Disease, Acromegaly and Neuroendocrine Tumors - Drug Profile 62

Product Description 62

Mechanism of Action 62

R&D Progress 62

Somadex - Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

SXN-101742 - Drug Profile 64

Product Description 64

Mechanism of Action 64

R&D Progress 64

SXN-101959 - Drug Profile 65

Product Description 65

Mechanism of Action 65

R&D Progress 65

Acromegaly - Recent Pipeline Updates 66

Acromegaly - Dormant Projects 76

Acromegaly - Discontinued Products 77

Acromegaly - Product Development Milestones 78

Featured News & Press Releases 78

Nov 03, 2015: Strongbridge Biopharma Announces Data Presentation at the Society for Endocrinology BES 2015 Conference 78

Sep 09, 2015: ATL1103 Higher Dose Study-Dosing Commenced 78

Aug 17, 2015: Chiasma Announces FDA Acceptance For Filing of New Drug Application for Octreotide Capsules in Acromegaly 79

Aug 10, 2015: ANP Licensing Partner for ATL1103 Cortendo Files Prospectus 80

Jun 15, 2015: Chiasma Submits New Drug Application to U.S. FDA for Octreotide Capsules in Acromegaly 80

Apr 16, 2015: ATL1103 - New European Patent Application Allowance 81

Mar 06, 2015: ATL1103 Phase II Trial Data to be presented at ENDO 2015 81

Mar 05, 2015: ATL1103 Higher Dose Study to Support Phase III to Commence 82

Mar 05, 2015: Chiasma Announces New Data for Investigational Octreotide Capsules 82

Feb 09, 2015: Newly Published Phase III Study Results Show Positive Outcomes for Octreotide Capsules in People with Acromegaly 84

Appendix 86

Methodology 86

Coverage 86

Secondary Research 86

Primary Research 86

Expert Panel Validation 86

Contact Us 86

Disclaimer 87

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