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Exocrine Pancreatic Insufficiency-Pipeline Review, H1 2015

Exocrine Pancreatic Insufficiency-Pipeline Review, H1 2015


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Executive Summary

Exocrine Pancreatic Insufficiency-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Exocrine Pancreatic Insufficiency-Pipeline Review, H1 2015', provides an overview of the Exocrine Pancreatic Insufficiency's therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Exocrine Pancreatic Insufficiency, 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 Exocrine Pancreatic Insufficiency and special features on late-stage 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, 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 Exocrine Pancreatic Insufficiency

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 Exocrine Pancreatic Insufficiency and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Exocrine Pancreatic Insufficiency 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 Exocrine Pancreatic Insufficiency 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 Exocrine Pancreatic Insufficiency

Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

Devise corrective measures for pipeline projects by understanding Exocrine Pancreatic Insufficiency 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

Table of Contents

Table of Contents 2

List of Tables 4

List of Figures 4

Introduction 5

Global Markets Direct Report Coverage 5

Exocrine Pancreatic Insufficiency Overview 6

Therapeutics Development 7

Pipeline Products for Exocrine Pancreatic Insufficiency-Overview 7

Pipeline Products for Exocrine Pancreatic Insufficiency-Comparative Analysis 8

Exocrine Pancreatic Insufficiency-Therapeutics under Development by Companies 9

Exocrine Pancreatic Insufficiency-Pipeline Products Glance 10

Late Stage Products 10

Clinical Stage Products 11

Early Stage Products 12

Exocrine Pancreatic Insufficiency-Products under Development by Companies 13

Exocrine Pancreatic Insufficiency-Companies Involved in Therapeutics Development 14

Actavis plc 14

Anthera Pharmaceuticals Inc. 15

Cilian AG 16

Laboratoires Mayoly Spindler S.A.S. 17

Nordmark Arzneimittel GmbH & Co. KG 18

Exocrine Pancreatic Insufficiency-Therapeutics Assessment 19

Assessment by Monotherapy Products 19

Assessment by Target 20

Assessment by Mechanism of Action 22

Assessment by Route of Administration 24

Assessment by Molecule Type 25

Drug Profiles 27

burlulipase-Drug Profile 27

Product Description 27

Mechanism of Action 27

R&D Progress 27

Cilase-Drug Profile 28

Product Description 28

Mechanism of Action 28

R&D Progress 28

Enzyme to Replace Lipase for Exocrine Pancreatic Insufficiency-Drug Profile 30

Product Description 30

Mechanism of Action 30

R&D Progress 30

liprotamase-Drug Profile 31

Product Description 31

Mechanism of Action 31

R&D Progress 31

MS-1819-Drug Profile 33

Product Description 33

Mechanism of Action 33

R&D Progress 33

pancrelipase DR-Drug Profile 35

Product Description 35

Mechanism of Action 35

R&D Progress 35

Exocrine Pancreatic Insufficiency-Recent Pipeline Updates 36

Exocrine Pancreatic Insufficiency-Dormant Projects 38

Exocrine Pancreatic Insufficiency-Discontinued Products 39

Exocrine Pancreatic Insufficiency-Product Development Milestones 40

Featured News & Press Releases 40

Nov 20, 2014: Anthera and Patheon Sign Manufacturing Agreement for Liprotamase Phase III Registration Trial 40

Dec 10, 2012: Aptalis Pharma Announces US Commercial Availability Of Ultresa Delayed-release Capsules 40

Aug 01, 2012: Cilian Receives 1m Grant For Development Of Cilase 41

Mar 01, 2012: Aptalis Pharma Receives FDA Approval For ULTRESA Pancrelipase Delayed Release Capsules 41

Jul 14, 2011: Aptalis Pharma Receives FDA Approval Of 25,000 Lipase-Unit Strength Of ZENPEP 42

Jun 17, 2011: Aptalis Pharma Receives FDA Approval For New Low Strength Of ZENPEP 42

Apr 15, 2011: Lilly Receives Complete Response Letter From FDA For Liprotamase For Treatment Of Exocrine Pancreatic Insufficiency 43

Feb 11, 2011: Axcan Completes Acquisition of Eurand and Commences Subsequent Offering Period 43

Jan 12, 2011: Lilly Announces FDA Panel Recommendation For Liprotamase 44

Jan 12, 2011: Eurand Announces Agreement With Nycomed for ZENPEP in Russia-CIS 44

Appendix 45

Methodology 45

Coverage 45

Secondary Research 45

Primary Research 45

Expert Panel Validation 45

Contact Us 45

Disclaimer 46

List of Tables

Number of Products under Development for Exocrine Pancreatic Insufficiency, H1 2015 7

Number of Products under Development for Exocrine Pancreatic Insufficiency-Comparative Analysis, H1 2015 8

Number of Products under Development by Companies, H1 2015 9

Comparative Analysis by Late Stage Development, H1 2015 10

Comparative Analysis by Clinical Stage Development, H1 2015 11

Comparative Analysis by Early Stage Development, H1 2015 12

Products under Development by Companies, H1 2015 13

Exocrine Pancreatic Insufficiency-Pipeline by Actavis plc, H1 2015 14

Exocrine Pancreatic Insufficiency-Pipeline by Anthera Pharmaceuticals Inc., H1 2015 15

Exocrine Pancreatic Insufficiency-Pipeline by Cilian AG, H1 2015 16

Exocrine Pancreatic Insufficiency-Pipeline by Laboratoires Mayoly Spindler S.A.S., H1 2015 17

Exocrine Pancreatic Insufficiency-Pipeline by Nordmark Arzneimittel GmbH & Co. KG, H1 2015 18

Assessment by Monotherapy Products, H1 2015 19

Number of Products by Stage and Target, H1 2015 21

Number of Products by Stage and Mechanism of Action, H1 2015 23

Number of Products by Stage and Route of Administration, H1 2015 24

Number of Products by Stage and Molecule Type, H1 2015 26

Exocrine Pancreatic Insufficiency Therapeutics-Recent Pipeline Updates, H1 2015 36

Exocrine Pancreatic Insufficiency-Dormant Projects, H1 2015 38

Exocrine Pancreatic Insufficiency-Discontinued Products, H1 2015 39

List of Figures

Number of Products under Development for Exocrine Pancreatic Insufficiency, H1 2015 7

Number of Products under Development for Exocrine Pancreatic Insufficiency-Comparative Analysis, H1 2015 8

Number of Products under Development by Companies, H1 2015 9

Comparative Analysis by Clinical Stage Development, H1 2015 11

Assessment by Monotherapy Products, H1 2015 19

Number of Products by Top 10 Targets, H1 2015 20

Number of Products by Stage and Top 10 Targets, H1 2015 21

Number of Products by Top 10 Mechanism of Actions, H1 2015 22

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 23

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 24

Number of Products by Top 10 Molecule Types, H1 2015 25

Number of Products by Stage and Top 10 Molecule Types, H1 2015 26

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Actavis plc

Anthera Pharmaceuticals Inc.

Cilian AG

Laboratoires Mayoly Spindler S.A.S.

Nordmark Arzneimittel GmbH & Co. KG

Exocrine Pancreatic Insufficiency Therapeutic Products under Development, Key Players in Exocrine Pancreatic Insufficiency Therapeutics, Exocrine Pancreatic Insufficiency Pipeline Overview, Exocrine Pancreatic Insufficiency Pipeline, Exocrine Pancreatic Insufficiency Pipeline Assessment


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