Bronchiectasis Pipeline Review, H2 2015 Summary Global Markets Directs, Bronchiectasis Pipeline Review, H2 2015, provides an overview of the Bronchiectasiss therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Bronchiectasis, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Bronchiectasis and special features on late-stage and discontinued projects. Global Markets Directs 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 Directs proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Directs team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease. Scope The report provides a snapshot of the global therapeutic landscape of Bronchiectasis The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities The report reviews key players involved in the therapeutics development for Bronchiectasis and enlists all their major and minor projects The report summarizes all the dormant and discontinued pipeline projects A review of the Bronchiectasis products under development by companies and universities/research institutes based on information derived from company and industry-specific sources Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages A detailed assessment of monotherapy and combination therapy pipeline projects Coverage of the Bronchiectasis pipeline on the basis of target, MoA, route of administration and molecule type Latest news and deals relating related to pipeline products Reasons to buy Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage Develop strategic initiatives by understanding the focus areas of leading companies Identify and understand important and diverse types of therapeutics under development for Bronchiectasis Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline Devise corrective measures for pipeline projects by understanding Bronchiectasis 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
Table of Contents Table of Contents 2 List of Tables 5 List of Figures 5 Introduction 6 Global Markets Direct Report Coverage 6 Bronchiectasis Overview 7 Therapeutics Development 8 Pipeline Products for Bronchiectasis – Overview 8 Bronchiectasis – Therapeutics under Development by Companies 9 Bronchiectasis – Pipeline Products Glance 10 Late Stage Products 10 Clinical Stage Products 11 Early Stage Products 12 Bronchiectasis – Products under Development by Companies 13 Bronchiectasis – Companies Involved in Therapeutics Development 14 Alitair Pharmaceuticals, Inc. 14 Bayer AG 15 Grifols, S.A. 16 Kamada Ltd. 17 Nostrum Pharmaceuticals, LLC 18 Pulmatrix, Inc. 19 Recipharm AB 20 Savara Inc. 21 Serendex Pharmaceuticals A/S 22 Therabron Therapeutics, Inc. 23 Vertex Pharmaceuticals Incorporated 24 Bronchiectasis – Therapeutics Assessment 25 Assessment by Monotherapy Products 25 Assessment by Target 26 Assessment by Mechanism of Action 28 Assessment by Route of Administration 30 Assessment by Molecule Type 32 Drug Profiles alpha-1 proteinase inhibitor (human) second generation – Drug Profile 34 Product Description 34 Mechanism of Action 34 R&D Progress 34 ALT-09 – Drug Profile 37 Product Description 37 Mechanism of Action 37 R&D Progress 37 ARD-3150 – Drug Profile 38 Product Description 38 Mechanism of Action 38 R&D Progress 38 BAY-858501 – Drug Profile 40 Product Description 40 Mechanism of Action 40 R&D Progress 40 CG-1011 – Drug Profile 41 Product Description 41 Mechanism of Action 41 R&D Progress 41 ciprofloxacin – Drug Profile 42 Product Description 42 Mechanism of Action 42 R&D Progress 42 dapsone – Drug Profile 45 Product Description 45 Mechanism of Action 45 R&D Progress 45 doxofylline – Drug Profile 46 Product Description 46 Mechanism of Action 46 R&D Progress 46 erdosteine – Drug Profile 47 Product Description 47 Mechanism of Action 47 R&D Progress 47 Leukotriene B4 – Drug Profile 49 Product Description 49 Mechanism of Action 49 R&D Progress 49 levofloxacin – Drug Profile 50 Product Description 50 Mechanism of Action 50 R&D Progress 50 molgramostim – Drug Profile 51 Product Description 51 Mechanism of Action 51 R&D Progress 51 PB-01 – Drug Profile 55 Product Description 55 Mechanism of Action 55 R&D Progress 55 vancomycin hydrochloride – Drug Profile 57 Product Description 57 Mechanism of Action 57 R&D Progress 57 VX-371 – Drug Profile 59 Product Description 59 Mechanism of Action 59 R&D Progress 59 Bronchiectasis – Recent Pipeline Updates 60 Bronchiectasis – Dormant Projects 67 Bronchiectasis – Discontinued Products 68 Bronchiectasis – Product Development Milestones 69 Featured News & Press Releases 69 Oct 13, 2015: Aradigm Completes Enrollment in the Second Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis 69 Sep 22, 2015: Aradigm Completes Enrollment in Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-4) 70 Sep 02, 2015: Pulmatrix Issued New Composition of Matter Patent Covering iSPERSE Technology 70 Aug 09, 2015: Serendex to initiate first phase II clinical trial 71 May 27, 2015: Phase I clinical trial of inhaled molgramostim has commenced 72 May 20, 2015: Novozymes Biopharma enables stable formulation of Serendex Pharmaceuticals inhalable biological drug for treatment of severe pulmonary diseases 72 May 10, 2015: Positive topline data from Serendex phase I clinical trial 73 Feb 27, 2015: Serendex submits phase I application 74 Jan 14, 2015: Aradigm Granted Key Composition of Matter Patents for Pulmaquin in Europe and Australia 74 Nov 24, 2014: FDA Grants QIDP Designation to Bayer’s Ciprofloxacin Dry Powder for Inhalation 75 Appendix 76 Methodology 76 Coverage 76 Secondary Research 76 Primary Research 76 Expert Panel Validation 76 Contact Us 76 Disclaimer 77
List of Tables Number of Products under Development for Bronchiectasis, H2 2015 8 Number of Products under Development by Companies, H2 2015 9 Comparative Analysis by Late Stage Development, H2 2015 10 Comparative Analysis by Clinical Stage Development, H2 2015 11 Comparative Analysis by Early Stage Development, H2 2015 12 Products under Development by Companies, H2 2015 13 Bronchiectasis – Pipeline by Alitair Pharmaceuticals, Inc., H2 2015 14 Bronchiectasis – Pipeline by Bayer AG, H2 2015 15 Bronchiectasis – Pipeline by Grifols, S.A., H2 2015 16 Bronchiectasis – Pipeline by Kamada Ltd., H2 2015 17 Bronchiectasis – Pipeline by Nostrum Pharmaceuticals, LLC, H2 2015 18 Bronchiectasis – Pipeline by Pulmatrix, Inc., H2 2015 19 Bronchiectasis – Pipeline by Recipharm AB, H2 2015 20 Bronchiectasis – Pipeline by Savara Inc., H2 2015 21 Bronchiectasis – Pipeline by Serendex Pharmaceuticals A/S, H2 2015 22 Bronchiectasis – Pipeline by Therabron Therapeutics, Inc., H2 2015 23 Bronchiectasis – Pipeline by Vertex Pharmaceuticals Incorporated, H2 2015 24 Assessment by Monotherapy Products, H2 2015 25 Number of Products by Stage and Target, H2 2015 27 Number of Products by Stage and Mechanism of Action, H2 2015 29 Number of Products by Stage and Route of Administration, H2 2015 31 Number of Products by Stage and Molecule Type, H2 2015 33 Bronchiectasis Therapeutics – Recent Pipeline Updates, H2 2015 60 Bronchiectasis – Dormant Projects, H2 2015 67 Bronchiectasis – Discontinued Products, H2 2015 68
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