- Product Pipeline Review - H2 2011” provides a detailed overview on the Hemispherx Biopharma, Inc.’s research and development focus. The report includes information on current developmental pipeline, complete with latest updates, and features on discontinued and dormant projects.
This report is built using data and information sourced from Global Industries Direct’s proprietary databases, Hemispherx Biopharma, Inc.’s corporate website, SEC filings, investor presentations and featured press releases, both from Hemispherx Biopharma, Inc. and market -specific third party sources, put together by Global Industries Direct’s team.
Scope of the Research
- Hemispherx Biopharma, Inc. - Brief Hemispherx Biopharma, Inc. overview including business description, key information and facts, and its locations and subsidiaries.
- Review of current pipeline of Hemispherx Biopharma, Inc. human therapeutic division.
- Detailed Analysis of pipeline therapeutics across various therapy areas.
- Coverage of current pipeline molecules in various stages of drug development, including the combination treatment modalities, across the globe.
- Product profiles for late stage and clinical stage products of Hemispherx Biopharma, Inc. with complete description of the product’s developmental history, mechanism of action, therapeutic class, target and major milestones.
- Recent updates of the Hemispherx Biopharma, Inc.’s pipeline in the last quarter.
- Key discontinued and dormant projects.
- Latest news and deals relating to the products.
Why Should You Get This Report?
- Evaluate Hemispherx Biopharma, Inc.’s strategic position with total access to detailed information on its product pipeline.
- Assess the growth potential of Hemispherx Biopharma, Inc. in its therapy areas of focus.
- Identify new drug targets and therapeutic classes in the Hemispherx Biopharma, Inc.’s Research and Development portfolio and develop key strategic initiatives to reinforce pipeline in those areas.
- Exploit in-licensing opportunities by identifying windows of opportunity to fill portfolio gaps.
- Exploit collaboration and partnership opportunities with Hemispherx Biopharma, Inc..
- Avoid Intellectual Property Rights related issues.
- Explore the dormant and discontinued projects of Hemispherx Biopharma, Inc. and identify potential opportunities in those areas.
Global Drug Discovery And Development Industry
Table of Contents
Table of Contents 2
List of Tables 4
List of Figures 5
Hemispherx Biopharma, Inc. Snapshot 6
Hemispherx Biopharma, Inc. Overview 6
Key Information 6
Key Facts 6
Hemispherx Biopharma, Inc. – Research and Development Overview 7
Key Therapeutic Areas 7
Hemispherx Biopharma, Inc. – Pipeline Review 9
Pipeline Products by Stage of Development 9
Pipeline Products – Monotherapy 10
Hemispherx Biopharma, Inc. – Pipeline Products Glance 11
Hemispherx Biopharma, Inc. – Late Stage Pipeline 11
Phase III Products/Combination Treatment Modalities 11
Hemispherx Biopharma, Inc. Clinical Stage Pipeline Products 12
Phase II Products/Combination Treatment Modalities 12
Hemispherx Biopharma, Inc.–Early Stage Pipeline Products 13
Pre-Clinical Products/Combination Treatment Modalities 13
Hemispherx Biopharma, Inc. – Drug Profiles 14
Alferon N Injection 14
Product Description 14
Mechanism of Action 14
R&D Progress 14
Ampligen 15
Product Description 15
Mechanism of Action 15
R&D Progress 15
Hemispherx Biopharma, Inc. – Pipeline Analysis 16
Hemispherx Biopharma, Inc. – Pipeline Products by Therapeutic Class 16
Hemispherx Biopharma, Inc. - Pipeline Products By Target 17
Hemispherx Biopharma, Inc. – Pipeline Products by Route of Administration 18
Hemispherx Biopharma, Inc. – Pipeline Products by Molecule Type 19
Hemispherx Biopharma, Inc. – Recent Pipeline Updates 20
Hemispherx Biopharma, Inc. - Dormant Projects 22
Hemispherx Biopharma, Inc. - Discontinued Pipeline Products 23
Discontinued Pipeline Product Profiles 23
Oragen 23
Hemispherx Biopharma, Inc. – Firms Statement 24
Hemispherx Biopharma, Inc. – Locations And Subsidiaries 25
Head Office 25
Other Locations & Subsidiaries 25
Recent Developments 26
May 31, 2007: Hemispherx Presents Primate Results Of Alferon-LDO In Potential Avian Influenza 26
November 29, 2010: Hemispherx Requests FDA For Extension Of Time For Ampligen NDA Submission 26
January 28, 2010: Stanford University Publishes New Data On Immuno-Potential Of Hemispherx’s Ampligen 27
August 27, 2007: Hemispherx Announces Increase In Revenues from Alferon N Injection HPV Indication Under Armada Specialty Pharmacy Agreement 28
May 26, 2009: Hemispherx Biopharma Announces Possible Brief Delay In Fda Action On Ampligen New Drug Application 29
April 23, 2007: Hemispherx And Armada Health Care Enter Agreement To Launch Alferon N Injection Via Specialty Pharmacy Network 29
November 22, 2010: Hemispherx Announces Publication Of New Data On Ampligen’s Activity In Chronic Fatigue Syndrome In Journal Of Applied Research 30
November 22, 2004: Hemispherx Biopharma Initiates Alferon LDO Clinical Program In Collaboration With Princess March garet Hospital In Hong Kong 30
June 21, 2011: Hemispherx Biopharma’s Ampligen Tested In Combination With Experimental Vaccine For Ovarian Cancer Treatment 31
July 20, 2011: Hemispherx Receives FDA Authorization To Initiate New Clinical Trial Of Intranasal Ampligen 32
July 19, 2011: Hemispherx Biopharma Receives US Patent For Use Of Ampligen As Influenza Virus Vaccine 32
July 19, 2010: Hemispherx Receives Indian Approval For Initiation Of Clinical Study With Alferon N Injection In Hospitalized Flu Patients 33
August 18, 2003: Hemispherx Biopharma Enters Into Sales And March keting Agreement With Engitech For Alferon N 33
March 18, 2004: Hemispherx Biopharma Completes Acquisition For Worldwide Rights To Alferon N 34
March 18, 2004: Hemispherx Biopharma Completes Acquisition For Worldwide Rights To Alferon N 34
August 17, 2011: Hemispherx Biopharma Submits Regulatory Approval For Alferon In Argentina 35
May 17, 2010: Hemispherx Prepares Application To Initiate Phase II Clinical Trials In China With Ampligen 35
May 16, 2005: Hemispherx Biopharma Initiates Clinical Trials Of Alferon LDO For Avian Flu And Other Viral Diseases 36
February 16, 2006: Hemispherx Biopharma Unveils Rresults Of Investigational Immunotherapeutics Alferon In Patients With Avian flu 36
December 14, 2010: Hemispherx Receives FDA Extension For Pending NDA Of Chronic Fatigue Syndrome Treatment 37
June 14, 2004: Hemispherx Biopharma Launches Multiple Sclerosis Salvage Program With Natural Interferons 38
January 14, 2010: Hemispherx Biopharma Addresses Ampligen CFS Preclinical Issues 38
July 12, 2010: Hemispherx Reports Successful Culmination Of Three Year Joint Research Program At Japanese NIID 39
May 12, 2011: Hemispherx Biopharma’s Ampligen Cited At Barcelona Vaccine & Active Immunotherapeutics Forum 2011 40
April 11, 2005: Hemispherx Biopharma’S Investigational Drug Increases Physical Performance In New Chronic Fatigue Syndrome (Cfs) Clinical Study 40
January 09, 2008: Hemispherx Biopharma Addresses FDA Questions On Ampligen NDA 41
September 08, 2010: Hemispherx To Present New Retrovirus Data At First International Workshop On XMRV And Chronic Fatigue Syndrome 42
February 08, 2010: Hemispherx Biopharma Announces Independent University Researchers Report Study Results Of Ampligen Against SARS Virus 43
April 07, 2008: Hemispherx Biopharma Accelerates Ampligen As A Potential Adjuvant For Both Avian Influenza And Hiv Vaccines 43
October 06, 2008: Hemispherx Engages The Sage Group As Its Corporate Partnership Advisor For Ampligen To Treat Chronic Fatigue Syndrome 44
September 06, 2011: Hemispherx Enters Into Strategic Alliance With Armada Health Care For Alferon N Injection 44
April 04, 2011: Hemispherx Presents Encouraging Animal Model Data Of Tumor Vaccine Adjuvant - Ampligen At AACR 44
January 04, 2011: Hemispherx Receives FDA Clearance For Alferon LDO Phase II Study In Influenza 45
September 02, 2009: Hemispherx Biopharma Presents Data On New Comparative Analysis Of Alferon LDO In Pandemic Influenza 46
June 02, 2008: Hemispherx Biopharma Completes Enrollment In Phase Ii Study Of Ampligen As Seasonal Flu Vaccine Enhancer 46
March 02, 2004: Hemispherx Biopharma Initiates Phase II Study Of Alferon LDO In HIV Patients 47
February 02, 2010: Hemispherx Biopharma Receives Favorable Notice Via Its Subcontractor That The FDA Seattle District Accepts Ampligen Manufacturing Response 47
June 01, 2004: Hemispherx Biopharma Receives Approval For West Nile Virus Protocol With Alferon N Treatment 48
Financial Deals Landscape 49
Hemispherx Biopharma, Inc., Deals Summary 49
Hemispherx Biopharma, Inc., Pharmaceuticals & Healthcare, Deal Details 51
Asset Transactions 51
Hemispherx Biopharma Takes Over Rights For DOGS From Vanderbilt University 51
Hemispherx Biopharma Takes Over Royalty Interest From Stem Cell Innovations 52
Partnerships 53
Hemispherx Biopharma Enters Into Co-Development Agreement With Max Neeman 53
Hemispherx Enters Into Agreement With Armada Health Care 54
Hemispherx Biopharma Enters Into Research Agreement with Defence Research and Development Canada 55
Hemispherx Biopharma Signs Research Agreement With National Institute of Infectious Diseases 56
Hemispherx Biopharma Forms Collaboration With Vanderbilt University 57
Licensing Agreements 58
Hemispherx Biopharma Enters Into Licensing And March keting Agreement With GP Pharm For Alferon 58
Hemispherx Biopharma Amends Its Licensing And March keting Agreement With GP Pharm 59
Hemispherx Biopharma Enters Into Licensing And March keting Agreement With GP Pharm 60
Hemispherx Biopharma Enters Into A Licensing Agreement With BIKEN 62
Equity Offering 63
Hemispherx Biopharma Raises US$ 0.29 Mln Through Private Placement 63
Hemispherx Biopharma Raises US$ 3 Mln From Exercise Of Series II Warrants 65
Hemispherx Biopharma Raises US$ 2 Mln From Exercise Of Warrants 66
Hemispherx Biopharma Completes Private Placement Of Common Stock For US$ 16 Mln 67
Hemispherx Biopharma Completes Private Placement Of US$ 15 Mln 69
Hemispherx Biopharma Completes Private Placement Of US$ 7 Mln 71
Hemispherx Biopharma Raises US$ 2.2 Mln Through Exercise Of Warrants 73
Debt Offering 74
Hemispherx Biopharma Completes Private Placement Of 6% Debentures For US$ 4 Mln 74
Appendix 75
Methodology 75
Coverage 75
Secondary Research 75
Primary Research 75
Expert Panel Validation 76
Contact Us 76
Disclaimer 76
List of Tables
Hemispherx Biopharma, Inc. – Pipeline by Therapy Area and Indication, H2 2011 8
Hemispherx Biopharma, Inc. – Pipeline by Stage of Development, H2 2011 9
Hemispherx Biopharma, Inc. – Monotherapy Products in Pipeline, H2 2011 10
Hemispherx Biopharma, Inc. – Phase III, H2 2011 11
Hemispherx Biopharma, Inc. - Phase II, H2 2011 12
Hemispherx Biopharma, Inc. - Pipeline By Therapeutic Class, H2 2011 16
Hemispherx Biopharma, Inc. - Pipeline By Target, H2 2011 17
Hemispherx Biopharma, Inc. – Pipeline By Route of Administration, H2 2011 18
Hemispherx Biopharma, Inc. – Pipeline By Molecule Type, H2 2011 19
Hemispherx Biopharma, Inc. – Recent Pipeline Updates, H2 2011 20
Hemispherx Biopharma, Inc. - Dormant Developmental Projects, 2010 22
Hemispherx Biopharma, Inc. - Discontinued Pipeline Products, 2010 23
Hemispherx Biopharma, Inc., Other Locations 25
Hemispherx Biopharma, Inc., Subsidiaries 25
Hemispherx Biopharma, Inc., Deals Summary 49
Hemispherx Biopharma Takes Over Rights For DOGS From Vanderbilt University 51
Hemispherx Biopharma Takes Over Royalty Interest From Stem Cell Innovations 52
Hemispherx Biopharma Enters Into Co-Development Agreement With Max Neeman 53
Hemispherx Enters Into Agreement With Armada Health Care 54
Hemispherx Biopharma Enters Into Research Agreement with Defence Research and Development Canada 55
Hemispherx Biopharma Signs Research Agreement With National Institute of Infectious Diseases 56
Hemispherx Biopharma Forms Collaboration With Vanderbilt University 57
Hemispherx Biopharma Enters Into Licensing And March keting Agreement With GP Pharm For Alferon 58
Hemispherx Biopharma Amends Its Licensing And March keting Agreement With GP Pharm 59
Hemispherx Biopharma Enters Into Licensing And March keting Agreement With GP Pharm 60
Hemispherx Biopharma Enters Into A Licensing Agreement With BIKEN 62
Hemispherx Biopharma Raises US$ 0.29 Mln Through Private Placement 63
Hemispherx Biopharma Raises US$ 3 Mln From Exercise Of Series II Warrants 65
Hemispherx Biopharma Raises US$ 2 Mln From Exercise Of Warrants 66
Hemispherx Biopharma Completes Private Placement Of Common Stock For US$ 16 Mln 67
Hemispherx Biopharma Completes Private Placement Of US$ 15 Mln 69
Hemispherx Biopharma Completes Private Placement Of US$ 7 Mln 71
Hemispherx Biopharma Raises US$ 2.2 Mln Through Exercise Of Warrants 73
Hemispherx Biopharma Completes Private Placement Of 6% Debentures For US$ 4 Mln 74
List of Figures
Hemispherx Biopharma, Inc. – Pipeline by Therapy Area and Indication, H2 2011 8
Hemispherx Biopharma, Inc. – Pipeline by Stage of Development, H2 2011 9
Hemispherx Biopharma, Inc. – Monotherapy Products in Pipeline, H2 2011 10
Hemispherx Biopharma, Inc. – Pipeline By Therapeutic Class, H2 2011 16
Hemispherx Biopharma, Inc. - Pipeline By Target, H2 2011 17
Hemispherx Biopharma, Inc. – Pipeline By Route of Administration, H2 2011 18
Hemispherx Biopharma, Inc. – Pipeline By Molecule Type, H2 2011 19
