Alpha Galactosidase A (Alpha D-Galactosidase A or Alpha D Galactoside Galactohydrolase or Melibiase or Agalsidase or GLA or EC 3.2.1.22) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Alpha Galactosidase A (Alpha D-Galactosidase A or Alpha D Galactoside Galactohydrolase or Melibiase or Agalsidase or GLA or EC 3.2.1.22) – Pipeline Review, H2 2016’, provides in depth analysis on Alpha Galactosidase A (Alpha D-Galactosidase A or Alpha D Galactoside Galactohydrolase or Melibiase or Agalsidase or GLA 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 Agalsidase or GLA 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 Agalsidase or GLA 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.

Updated report will be delivered in 48 hours of order confirmation.

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 Agalsidase or GLA or EC 3.2.1.22)

The report reviews Alpha Galactosidase A (Alpha D-Galactosidase A or Alpha D Galactoside Galactohydrolase or Melibiase or Agalsidase or GLA 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 Agalsidase or GLA 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 Agalsidase or GLA 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 Agalsidase or GLA 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 Agalsidase or GLA 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 Agalsidase or GLA 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

JCR Pharmaceuticals Co., Ltd.

Pharming Group N.V.

Protalix BioTherapeutics, Inc.

Shire Plc

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 4

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 Agalsidase or GLA 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 Agalsidase or GLA 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 Agalsidase or GLA 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 Agalsidase or GLA 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 Agalsidase or GLA 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 Agalsidase or GLA 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 Agalsidase or GLA 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 Agalsidase or GLA or EC

3.2.1.22) - Companies Involved in Therapeutics Development 21

Amicus Therapeutics, Inc. 21

greenovation Biotech GmbH 22

JCR Pharmaceuticals Co., Ltd. 23

Pharming Group N.V. 24

Protalix BioTherapeutics, Inc. 25

Shire Plc 26

Alpha Galactosidase A (Alpha D-Galactosidase A or Alpha D Galactoside Galactohydrolase or Melibiase or Agalsidase or GLA or EC

3.2.1.22) - Drug Profiles 27

agalsidase alfa - Drug Profile 27

Product Description 27

Mechanism Of Action 27

R&D Progress 27

agalsidase alfa - Drug Profile 29

Product Description 29

Mechanism Of Action 29

R&D Progress 29

AVR-02 - Drug Profile 30

Product Description 30

Mechanism Of Action 30

R&D Progress 30

Enzyme Replacement Therapy + migalastat hydrochloride Biobetter - Drug Profile 31

Product Description 31

Mechanism Of Action 31

R&D Progress 31

migalastat hydrochloride - Drug Profile 32

Product Description 32

Mechanism Of Action 32

R&D Progress 32

MOSS-AGAL - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

pegunigalsidase alfa - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

Recombinant Alpha-Galactosidase A Replacement for Fabry’s Disease - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

Alpha Galactosidase A (Alpha D-Galactosidase A or Alpha D Galactoside Galactohydrolase or Melibiase or Agalsidase or GLA or EC

3.2.1.22) - Dormant Projects 47

Alpha Galactosidase A (Alpha D-Galactosidase A or Alpha D Galactoside Galactohydrolase or Melibiase or Agalsidase or GLA or EC

3.2.1.22) - Discontinued Products 48

Alpha Galactosidase A (Alpha D-Galactosidase A or Alpha D Galactoside Galactohydrolase or Melibiase or Agalsidase or GLA or EC

3.2.1.22) - Featured News & Press Releases 49

Sep 07, 2016: Protalix BioTherapeutics Announces Presentation of Results from the Phase I/II Clinical Trial of PRX-102 for the Treatment of Fabry Disease at the Society for the Study of Inborn Errors of Metabolism 49

Aug 31, 2016: Amicus Therapeutics to Highlight Fabry Disease Program at Society for the Study of Inborn Errors of Metabolism Annual Symposium 49

Aug 10, 2016: New England Journal of Medicine Publishes Pivotal Phase 3 FACETS Study of Migalastat for Patients with Fabry Disease 50

Aug 10, 2016: Protalix BioTherapeutics Announces Additional Positive Data from its Phase I/II Clinical Trial for PRX-102 for the Treatment of Fabry Disease 50

Aug 03, 2016: Amicus Therapeutics to Submit Japanese New Drug Application for Migalastat for Fabry Disease in 1H17 52

Aug 02, 2016: Almac Group’s Integrated Development to Commercialisation Services Support Amicus Therapeutics’ First Commercial Orphan Drug Product 53

Jun 06, 2016: Protalix BioTherapeutics Initiates PRX-102 Global Phase III Clinical Trial of Fabry Disease to Support United States and European Filings 53

May 31, 2016: Amicus Therapeutics Announces European Commission Approval for Galafold (Migalastat) in Patients with Fabry Disease in European Union 54

Apr 01, 2016: Amicus Therapeutics Receives Positive CHMP Opinion for Approval of Migalastat in Patients with Fabry Disease in European Union 56

Apr 01, 2016: First oral treatment for Fabry disease recommended for approval in the EU 57

Mar 22, 2016: Amicus Therapeutics Announces Expanded Access Program for Migalastat 58

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 58

Mar 01, 2016: Amicus Therapeutics Highlights New Phase 3 Fabry Data at WORLDSymposium 2016 60

Feb 22, 2016: Protalix BioTherapeutics to Participate in the SunTrust Robinson Humphrey Orphan Drug Day and the 12th Annual WORLDSymposium 2016 61

Feb 10, 2016: Amicus Therapeutics Announces Presentations on Migalastat at 12th Annual WORLDSymposium 2016 61

Appendix 63

Methodology 63

Coverage 63

Secondary Research 63

Primary Research 63

Expert Panel Validation 63

Contact Us 63

Disclaimer 64

List of Tables

List of Tables

Number of Products under Development for, H2 2016 8

Number of Products under Development by Therapy Area, H2 2016 9

Number of Products under Development by Indication, H2 2016 10

Comparative Analysis by Late Stage Development, H2 2016 11

Comparative Analysis by Early Stage Products, H2 2016 12

Number of Products under Development by Companies, H2 2016 13

Products under Development by Companies, H2 2016 14

Assessment by Monotherapy/Combination Products, H2 2016 15

Number of Products by Stage and Mechanism of Action, H2 2016 16

Number of Products by Stage and Route of Administration, H2 2016 18

Number of Products by Stage and Molecule Type, H2 2016 20

Pipeline by Amicus Therapeutics, Inc., H2 2016 21

Pipeline by greenovation Biotech GmbH, H2 2016 22

Pipeline by JCR Pharmaceuticals Co., Ltd., H2 2016 23

Pipeline by Pharming Group N.V., H2 2016 24

Pipeline by Protalix BioTherapeutics, Inc., H2 2016 25

Pipeline by Shire Plc, H2 2016 26

Dormant Projects, H2 2016 47

Discontinued Products, H2 2016 48

List of Figures

List of Figures

Number of Products under Development for, H2 2016 8

Comparative Analysis by Early Stage Products, H2 2016 12

Assessment by Monotherapy/Combination Products, H2 2016 15

Number of Products by Stage and Mechanism of Action, H2 2016 16

Number of Products by Routes of Administration, H2 2016 17

Number of Products by Stage and Routes of Administration, H2 2016 17

Number of Products by Molecule Types, H2 2016 19

Number of Products by Stage and Molecule Type, H2 2016 19

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