Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC 3.1.3.1) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC 3.1.3.1) – Pipeline Review, H2 2016’, provides in depth analysis on Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC 3.1.3.1) targeted pipeline therapeutics.

The report provides comprehensive information on the Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC 3.1.3.1), 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 Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC 3.1.3.1) 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 Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC 3.1.3.1)

The report reviews Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC 3.1.3.1) 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 Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC 3.1.3.1) targeted therapeutics and enlists all their major and minor projects

The report assesses Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC 3.1.3.1) 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 Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC 3.1.3.1) 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 Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC 3.1.3.1)

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 Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC 3.1.3.1) 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

Alexion Pharmaceuticals Inc

Am-Pharma B.V.

Cilian AG

Synthetic Biologics, Inc.

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

Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC

3.1.3.1) Overview 6

Therapeutics Development 7

Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC

3.1.3.1) - Products under Development by Stage of Development 7

Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC

3.1.3.1) - Products under Development by Therapy Area 8

Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC

3.1.3.1) - Products under Development by Indication 9

Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC

3.1.3.1) - Pipeline Products Glance 10

Late Stage Products 10

Early Stage Products 11

Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC

3.1.3.1) - Products under Development by Companies 12

Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC

3.1.3.1) - Products under Development by Universities/Institutes 14

Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC

3.1.3.1) - Therapeutics Assessment 16

Assessment by Monotherapy/Combination Products 16

Assessment by Mechanism of Action 17

Assessment by Route of Administration 19

Assessment by Molecule Type 21

Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC

3.1.3.1) - Companies Involved in Therapeutics Development 23

Alexion Pharmaceuticals Inc 23

Am-Pharma B.V. 24

Cilian AG 25

Synthetic Biologics, Inc. 26

Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC

3.1.3.1) - Drug Profiles 27

asfotase alfa - Drug Profile 27

Product Description 27

Mechanism Of Action 27

R&D Progress 27

Recombinant Alkaline Phosphatase Replacement for Sepsis - Drug Profile 32

Product Description 32

Mechanism Of Action 32

R&D Progress 32

Recombinant Human Alkaline Phosphatase Replacement for Acute Renal Failure, Hypophosphatasia, Sepsis and Ulcerative Colitis - Drug Profile 33

Product Description 33

Mechanism Of Action 33

R&D Progress 33

SBI-425 - Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

SYN-020 - Drug Profile 37

Product Description 37

Mechanism Of Action 37

R&D Progress 37

Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC

3.1.3.1) - Dormant Projects 38

Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC

3.1.3.1) - Featured News & Press Releases 39

Sep 22, 2016: Alexion statement: NICE 2nd ECD for Strensiq (asfotase alfa) 39

May 10, 2016: AM-Pharma publishes safety and pharmacokinetic data from Phase I recAP trial 39

Apr 26, 2016: AM-Pharma receives FDA fast track designation for recAP in Acute Kidney Injury 40

Apr 04, 2016: Data Presented at ENDO 2016 Show Sustained Improvements in Survival Rates, Bone Healing, Respiratory Support and Physical Function in Children with Hypophosphatasia (HPP) Receiving Long-Term Treatment with Strensiq (asfotase alfa) 40

Jan 15, 2016: Researchers to Present New Data at ENDO 2016 Advancing the Understanding of Strensiq (asfotase alfa) in Infants, Children and Adult Patients with Hypophosphatasia (HPP) 43

Dec 03, 2015: Benefits of new drug to treat rare inherited bone disorder too uncertain to justify its high cost says NICE in draft guidance 44

Oct 23, 2015: FDA Approves Strensiq (asfotase alfa) for Treatment of Patients with Perinatal-, Infantile- and Juvenile-Onset Hypophosphatasia 45

Oct 12, 2015: Significant Improvements in Skeletal Mineralization and Physical Function Observed in Children with Hypophosphatasia Treated With Strensiq (asfotase alfa) Sustained for at least Five Years 46

Sep 16, 2015: Alexion Announces Presentations at 2015 American Society for Bone and Mineral Research Annual Meeting, Including New Data on Strensiq in Children with Hypophosphatasia Treated for Five Years 48

Sep 01, 2015: European Commission Grants Marketing Authorization for Strensiq for the Treatment of Patients with Pediatric-Onset Hypophosphatasia 49

Aug 17, 2015: Health Canada Approves Strensiq (asfotase alfa), the First Therapy for Patients with Hypophosphatasia (HPP), an Ultra-rare, Life-threatening Disease 50

Jul 06, 2015: Strensiq Receives Marketing Approval in Japan for Treatment of Patients with Hypophosphatasia 52

Jun 26, 2015: Alexion Receives CHMP Positive Opinions for Strensiq in the European Union 53

Jun 09, 2015: AM-Pharma receives FDA and EMA orphan drug designation to treat hypophosphatasia 54

Mar 07, 2015: New Data from First Natural History Study in Juveniles with Hypophosphatasia Showing Substantial Disease Burden, Including Musculoskeletal Abnormalities and Growth Deficiencies, Presented in Late-Breaking Oral Session at ENDO 2015 54

Appendix 59

Methodology 59

Coverage 59

Secondary Research 59

Primary Research 59

Expert Panel Validation 59

Contact Us 59

Disclaimer 60

List of Tables

List of Tables

Number of Products under Development for, H2 2016 7

Number of Products under Development by Therapy Area, H2 2016 8

Number of Products under Development by Indication, H2 2016 9

Comparative Analysis by Late Stage Development, H2 2016 10

Comparative Analysis by Early Stage Products, H2 2016 11

Number of Products under Development by Companies, H2 2016 12

Products under Development by Companies, H2 2016 13

Number of Products under Investigation by Universities/Institutes, H2 2016 14

Products under Investigation by Universities/Institutes, H2 2016 15

Assessment by Monotherapy/Combination Products, H2 2016 16

Number of Products by Stage and Mechanism of Action, H2 2016 18

Number of Products by Stage and Route of Administration, H2 2016 20

Number of Products by Stage and Molecule Type, H2 2016 22

Pipeline by Alexion Pharmaceuticals Inc, H2 2016 23

Pipeline by Am-Pharma B.V., H2 2016 24

Pipeline by Cilian AG, H2 2016 25

Pipeline by Synthetic Biologics, Inc., H2 2016 26

Dormant Projects, H2 2016 38

List of Figures

List of Figures

Number of Products under Development for, H2 2016 7

Number of Products under Development by Therapy Area, H2 2016 8

Number of Products under Development by Indication, H2 2016 9

Comparative Analysis by Early Stage Products, H2 2016 11

Assessment by Monotherapy/Combination Products, H2 2016 16

Number of Products by Mechanism of Actions, H2 2016 17

Number of Products by Stage and Mechanism of Actions, H2 2016 17

Number of Products by Routes of Administration, H2 2016 19

Number of Products by Stage and Routes of Administration, H2 2016 19

Number of Products by Molecule Types, H2 2016 21

Number of Products by Stage and Molecule Type, H2 2016 21

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