Summary
Global Markets Direct’s, ‘Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) - Pipeline Review, H1 2016’, provides in depth analysis on Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) targeted pipeline therapeutics.
The report provides comprehensive information on the Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22), 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 Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) 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 Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22)
- The report reviews Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) 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 Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) targeted therapeutics and enlists all their major and minor projects
- The report assesses Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) 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 Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) 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 Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22)
- 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 Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) 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
Amicus Therapeutics, Inc.
greenovation Biotech GmbH
iBio, Inc.
ISU ABXIS Co.,Ltd.
JCR Pharmaceuticals Co., Ltd.
Pharming Group N.V.
Protalix BioTherapeutics, Inc.
Shire Plc
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Table of Contents
Table of Contents 2
List of Tables 5
List of Figures 5
Introduction 6
Global Markets Direct Report Coverage 6
Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) Overview 7
Therapeutics Development 8
Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) - Products under Development by Stage of Development 8
Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) - Products under Development by Therapy Area 9
Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) - Products under Development by Indication 10
Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) - Pipeline Products Glance 11
Late Stage Products 11
Early Stage Products 12
Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) - Products under Development by Companies 13
Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) - Therapeutics Assessment 15
Assessment by Monotherapy/Combination Products 15
Assessment by Mechanism of Action 16
Assessment by Route of Administration 17
Assessment by Molecule Type 19
Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) - Companies Involved in Therapeutics Development 21
Amicus Therapeutics, Inc. 21
greenovation Biotech GmbH 22
iBio, Inc. 23
ISU ABXIS Co.,Ltd. 24
JCR Pharmaceuticals Co., Ltd. 25
Pharming Group N.V. 26
Protalix BioTherapeutics, Inc. 27
Shire Plc 28
Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) - Drug Profiles 29
agalsidase alfa - Drug Profile 29
Product Description 29
Mechanism Of Action 29
R&D Progress 29
agalsidase alfa - Drug Profile 31
Product Description 31
Mechanism Of Action 31
R&D Progress 31
agalsidase alfa - Drug Profile 32
Product Description 32
Mechanism Of Action 32
R&D Progress 32
agalsidase beta biosimilar - Drug Profile 33
Product Description 33
Mechanism Of Action 33
R&D Progress 33
AVR-02 - Drug Profile 34
Product Description 34
Mechanism Of Action 34
R&D Progress 34
Enzyme Replacement Therapy + migalastat hydrochloride Biobetter - Drug Profile 35
Product Description 35
Mechanism Of Action 35
R&D Progress 35
migalastat hydrochloride - Drug Profile 36
Product Description 36
Mechanism Of Action 36
R&D Progress 36
MOSS-AGAL - Drug Profile 43
Product Description 43
Mechanism Of Action 43
R&D Progress 43
PRX-102 - Drug Profile 45
Product Description 45
Mechanism Of Action 45
R&D Progress 45
Recombinant Alpha-Galactosidase A Replacement for Fabry’s Disease - Drug Profile 48
Product Description 48
Mechanism Of Action 48
R&D Progress 48
Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) - Dormant Projects 49
Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) - Discontinued Products 50
Alpha-Galactosidase A (Alpha-D-Galactosidase A or Alpha-D-Galactoside Galactohydrolase or Melibiase or EC 3.2.1.22) - Featured News & Press Releases 51
Apr 01, 2016: Amicus Therapeutics Receives Positive CHMP Opinion for Approval of Migalastat in Patients with Fabry Disease in European Union 51
Apr 01, 2016: First oral treatment for Fabry disease recommended for approval in the EU 52
Mar 22, 2016: Amicus Therapeutics Announces Expanded Access Program for Migalastat 53
Mar 03, 2016: Protalix BioTherapeutics Presents Positive Six and Twelve Month Interim Clinical Data on PRX-102 for the Treatment of Fabry Disease at the 12th Annual WORLDSymposium 2016 53
Mar 01, 2016: Amicus Therapeutics Highlights New Phase 3 Fabry Data at WORLDSymposium 2016 55
Feb 22, 2016: Protalix BioTherapeutics to Participate in the SunTrust Robinson Humphrey Orphan Drug Day and the 12th Annual WORLDSymposium 2016 56
Feb 10, 2016: Amicus Therapeutics Announces Presentations on Migalastat at 12th Annual WORLDSymposium 2016 56
Jan 11, 2016: Amicus Therapeutics Provides Update On Migalastat for Fabry Disease 57
Nov 16, 2015: Protalix BioTherapeutics to Conduct Phase III Clinical Trial for PRX-102 for the Treatment of Fabry Disease Following a Successful End-of-Phase II Meeting With FDA 58
Oct 19, 2015: Protalix BioTherapeutics Reports Positive Long Term Data on PRX-102 for Fabry Disease 59
Oct 02, 2015: Amicus Therapeutics Provides U.S. Regulatory Update for Migalastat Monotherapy 60
Sep 15, 2015: Amicus Therapeutics Plans to Submit New Drug Application for Migalastat for Fabry Disease Following Positive Pre-NDA Meeting With FDA 60
Sep 14, 2015: Greenovation receives BfArM approval to start phase I clinical trial for moss-aGal, the world´s first moss-produced drug candidate 61
Sep 09, 2015: Protalix BioTherapeutics Reports Positive Phase I/II Interim Clinical Data on the 1mg/kg Cohort of PRX-102 for Fabry Disease 62
Aug 27, 2015: Fabry enzyme replacement therapy (ERT) based on mannose-mediated cellular uptake shows encouraging preclinical results that allow start of early clinical trials 63
Appendix 64
Methodology 64
Coverage 64
Secondary Research 64
Primary Research 64
Expert Panel Validation 64
Contact Us 64
Disclaimer 65
List of Tables
Number of Products under Development for, H1 2016 8
Number of Products under Development by Therapy Area, H1 2016 9
Number of Products under Development by Indication, H1 2016 10
Comparative Analysis by Late Stage Development, H1 2016 11
Comparative Analysis by Early Stage Products, H1 2016 12
Number of Products under Development by Companies, H1 2016 13
Products under Development by Companies, H1 2016 14
Assessment by Monotherapy/Combination Products, H1 2016 15
Number of Products by Stage and Mechanism of Action, H1 2016 16
Number of Products by Stage and Route of Administration, H1 2016 18
Number of Products by Stage and Molecule Type, H1 2016 20
Pipeline by Amicus Therapeutics, Inc., H1 2016 21
Pipeline by greenovation Biotech GmbH, H1 2016 22
Pipeline by iBio, Inc., H1 2016 23
Pipeline by ISU ABXIS Co.,Ltd., H1 2016 24
Pipeline by JCR Pharmaceuticals Co., Ltd., H1 2016 25
Pipeline by Pharming Group N.V., H1 2016 26
Pipeline by Protalix BioTherapeutics, Inc., H1 2016 27
Pipeline by Shire Plc, H1 2016 28
Dormant Projects, H1 2016 49
Discontinued Products, H1 2016 50
List of Figures
Number of Products under Development for, H1 2016 8
Comparative Analysis by Late Stage Development, H1 2016 11
Comparative Analysis by Early Stage Products, H1 2016 12
Assessment by Monotherapy/Combination Products, H1 2016 15
Number of Products by Stage and Mechanism of Actions, H1 2016 16
Number of Products by Routes of Administration, H1 2016 17
Number of Products by Stage and Routes of Administration, H1 2016 17
Number of Products by Molecule Types, H1 2016 19
Number of Products by Stage and Molecule Type, H1 2016 19
