Exocrine Pancreatic Insufficiency – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Exocrine Pancreatic Insufficiency – Pipeline Review, H2 2016’, provides an overview of the Exocrine Pancreatic Insufficiency pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Exocrine Pancreatic Insufficiency, complete with analysis by stage of development, drug target, 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 therapeutic development for Exocrine Pancreatic Insufficiency 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 of Exocrine Pancreatic Insufficiency

The report reviews pipeline therapeutics for Exocrine Pancreatic Insufficiency 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 Exocrine Pancreatic Insufficiency therapeutics and enlists all their major and minor projects

The report assesses Exocrine Pancreatic Insufficiency therapeutics based on drug target, 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 related to pipeline therapeutics for Exocrine Pancreatic Insufficiency

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 important and diverse types of therapeutics under development for Exocrine Pancreatic Insufficiency

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 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

Companies mentioned

Adare Pharmaceuticals Inc

Anthera Pharmaceuticals Inc

Cilian AG

Laboratoires Mayoly Spindler SAS

Nordmark Arzneimittel GmbH & Co KG

Table of Contents

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

Exocrine Pancreatic Insufficiency - Therapeutics under Development by Companies 8

Exocrine Pancreatic Insufficiency - Pipeline Products Glance 9

Late Stage Products 9

Clinical Stage Products 10

Early Stage Products 11

Exocrine Pancreatic Insufficiency - Products under Development by Companies 12

Exocrine Pancreatic Insufficiency - Companies Involved in Therapeutics Development 13

Adare Pharmaceuticals Inc 13

Anthera Pharmaceuticals Inc 14

Cilian AG 15

Laboratoires Mayoly Spindler SAS 16

Nordmark Arzneimittel GmbH & Co KG 17

Exocrine Pancreatic Insufficiency - Therapeutics Assessment 18

Assessment by Monotherapy Products 18

Assessment by Target 19

Assessment by Mechanism of Action 21

Assessment by Route of Administration 23

Assessment by Molecule Type 24

Drug Profiles 26

burlulipase - Drug Profile 26

Product Description 26

Mechanism Of Action 26

R&D Progress 26

Cilase - Drug Profile 27

Product Description 27

Mechanism Of Action 27

R&D Progress 27

liprotamase - Drug Profile 28

Product Description 28

Mechanism Of Action 28

R&D Progress 28

MS-1819 - Drug Profile 31

Product Description 31

Mechanism Of Action 31

R&D Progress 31

pancrelipase DR - Drug Profile 33

Product Description 33

Mechanism Of Action 33

R&D Progress 33

Exocrine Pancreatic Insufficiency - Dormant Projects 35

Exocrine Pancreatic Insufficiency - Discontinued Products 36

Exocrine Pancreatic Insufficiency - Product Development Milestones 37

Featured News & Press Releases 37

Nov 17, 2016: AzurRx BioPharma and Mayoly-Spindler Announce Initiation of Phase II Clinical Trial of MS1819-SD for Exocrine Pancreatic Insufficiency in Chronic Pancreatitis Patients 37

Jun 28, 2016: Anthera Provides Clinical Program Update for Sollpura 37

Apr 29, 2016: Allergan Receives CHMP Positive Opinion For ENZEPI (Pancrelipase) For Patients With Exocrine Pancreatic Insufficiency (EPI) 38

Mar 19, 2015: Anthera Announces $3 Million Research Award from Cystic Fibrosis Foundation Therapeutics for Development of Sollpura - a Novel Enzyme Therapy 39

Nov 20, 2014: Anthera and Patheon Sign Manufacturing Agreement for Liprotamase Phase III Registration Trial 39

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 40

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 41

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 43

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

Oct 21, 2010: Eurand Presents Data On ZENPEP Without Proton Pump Inhibitors Or H2 Receptor Antagonists For Treatment Of Pancreatic Insufficiency 44

Appendix 46

Methodology 46

Coverage 46

Secondary Research 46

Primary Research 46

Expert Panel Validation 46

Contact Us 46

Disclaimer 47

List of Tables

List of Tables

Number of Products under Development for Exocrine Pancreatic Insufficiency, H2 2016 7

Number of Products under Development by Companies, H2 2016 8

Comparative Analysis by Late Stage Development, H2 2016 9

Comparative Analysis by Clinical Stage Development, H2 2016 10

Comparative Analysis by Early Stage Development, H2 2016 11

Products under Development by Companies, H2 2016 12

Exocrine Pancreatic Insufficiency – Pipeline by Adare Pharmaceuticals Inc, H2 2016 13

Exocrine Pancreatic Insufficiency – Pipeline by Anthera Pharmaceuticals Inc, H2 2016 14

Exocrine Pancreatic Insufficiency – Pipeline by Cilian AG, H2 2016 15

Exocrine Pancreatic Insufficiency – Pipeline by Laboratoires Mayoly Spindler SAS, H2 2016 16

Exocrine Pancreatic Insufficiency – Pipeline by Nordmark Arzneimittel GmbH & Co KG, H2 2016 17

Assessment by Monotherapy Products, H2 2016 18

Number of Products by Stage and Target, H2 2016 20

Number of Products by Stage and Mechanism of Action, H2 2016 22

Number of Products by Stage and Route of Administration, H2 2016 23

Number of Products by Stage and Molecule Type, H2 2016 25

Exocrine Pancreatic Insufficiency – Dormant Projects, H2 2016 35

Exocrine Pancreatic Insufficiency – Discontinued Products, H2 2016 36

List of Figures

List of Figures

Number of Products under Development for Exocrine Pancreatic Insufficiency, H2 2016 7

Number of Products under Development by Companies, H2 2016 8

Comparative Analysis by Late Stage Development, H2 2016 9

Assessment by Monotherapy Products, H2 2016 18

Number of Products by Targets, H2 2016 19

Number of Products by Stage and Targets, H2 2016 19

Number of Products by Mechanism of Actions, H2 2016 21

Number of Products by Stage and Mechanism of Actions, H2 2016 21

Number of Products by Stage and Routes of Administration, H2 2016 23

Number of Products by Molecule Types, H2 2016 24

Number of Products by Stage and Molecule Types, H2 2016 24

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