Summary
Global Markets Direct’s, ‘Alkaline Phosphatase (ALKP or Phosphomonoesterase or Glycerophosphatase or Alkaline Phosphohydrolase or EC 3.1.3.1) - Pipeline Review, H1 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.
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.
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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 Ulcerative Colitis, Acute Renal Failure, Sepsis and Hypophosphatasia - 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
Apr 26, 2016: AM-Pharma receives FDA fast track designation for recAP in Acute Kidney Injury 39
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) 39
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) 42
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 43
Oct 23, 2015: FDA Approves Strensiq (asfotase alfa) for Treatment of Patients with Perinatal-, Infantile- and Juvenile-Onset Hypophosphatasia 44
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 45
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 47
Sep 01, 2015: European Commission Grants Marketing Authorization for Strensiq for the Treatment of Patients with Pediatric-Onset Hypophosphatasia 48
Aug 17, 2015: Health Canada Approves Strensiq (asfotase alfa), the First Therapy for Patients with Hypophosphatasia (HPP), an Ultra-rare, Life-threatening Disease 49
Jul 06, 2015: Strensiq Receives Marketing Approval in Japan for Treatment of Patients with Hypophosphatasia 50
Jun 26, 2015: Alexion Receives CHMP Positive Opinions for Strensiq in the European Union 52
Jun 09, 2015: AM-Pharma receives FDA and EMA orphan drug designation to treat hypophosphatasia 53
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 53
Mar 02, 2015: FDA Grants Priority Review for Asfotase Alfa as a Treatment for Patients with Hypophosphatasia 57
Jan 20, 2015: Researchers to Present New Data on Asfotase Alfa in Children with Hypophosphatasia as well as Burden of Disease Data in Adults with HPP at ENDO 2015 Annual Meeting 57
Appendix 59
Methodology 59
Coverage 59
Secondary Research 59
Primary Research 59
Expert Panel Validation 59
Contact Us 59
Disclaimer 60
List of Tables
Number of Products under Development for, H1 2016 7
Number of Products under Development by Therapy Area, H1 2016 8
Number of Products under Development by Indication, H1 2016 9
Comparative Analysis by Late Stage Development, H1 2016 10
Comparative Analysis by Early Stage Products, H1 2016 11
Number of Products under Development by Companies, H1 2016 12
Products under Development by Companies, H1 2016 13
Number of Products under Investigation by Universities/Institutes, H1 2016 14
Products under Investigation by Universities/Institutes, H1 2016 15
Assessment by Monotherapy/Combination Products, H1 2016 16
Number of Products by Stage and Mechanism of Action, H1 2016 18
Number of Products by Stage and Route of Administration, H1 2016 20
Number of Products by Stage and Molecule Type, H1 2016 22
Pipeline by Alexion Pharmaceuticals, Inc., H1 2016 23
Pipeline by Am-Pharma B.V., H1 2016 24
Pipeline by Cilian AG, H1 2016 25
Pipeline by Synthetic Biologics, Inc., H1 2016 26
Dormant Projects, H1 2016 38
List of Figures
Number of Products under Development for, H1 2016 7
Number of Products under Development by Therapy Area, H1 2016 8
Number of Products under Development by Top 10 Indication, H1 2016 9
Comparative Analysis by Early Stage Products, H1 2016 11
Assessment by Monotherapy/Combination Products, H1 2016 16
Number of Products by Mechanism of Actions, H1 2016 17
Number of Products by Stage and Mechanism of Actions, H1 2016 17
Number of Products by Routes of Administration, H1 2016 19
Number of Products by Stage and Routes of Administration, H1 2016 19
Number of Products by Molecule Types, H1 2016 21
Number of Products by Stage and Molecule Type, H1 2016 21
