Generex Biotechnology Corporation – Product Pipeline Review – H2 2011 by GlobalMarketsDirect

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									            Generex Biotechnology Corporation – Product
                     Pipeline Review – H2 2011
                                                                                          Reference Code: GMDHC01368CDB

                                                                                                 Publication Date: SEP 2011




Generex Biotechnology Corporation – Product Pipeline Review – H2 2011                       GMDHC01368CDB / Published SEP 2011

© Global Markets Direct. This report is a licensed product and is not to be photocopied                                 Page(1)
Generex Biotechnology Corporation – Product Pipeline Review




Ta b le o f Co n te n ts
Table of Contents                                                                                                                    2
List of Tables                                                                                                                       5
List of Figures                                                                                                                      5
Generex Biotechnology Corporation Snapshot                                                                                           6
    Generex Biotechnology Corporation Overview                                                                                       6
    Key Information                                                                                                                  6
    Key Facts                                                                                                                        6
Generex Biotechnology Corporation – Research and Development Overview                                                                7
    Key Therapeutic Areas                                                                                                            7
Generex Biotechnology Corporation – Pipeline Review                                                                                  9
    Pipeline Products by Stage of Development                                                                                        9
    Pipeline Products – Monotherapy                                                                                                 10
Generex Biotechnology Corporation – Pipeline Products Glance                                                                        11
    Generex Biotechnology Corporation Clinical Stage Pipeline Products                                                              11
         Phase I Products/Combination Treatment Modalities                                                                          11
Generex Biotechnology Corporation – Drug Profiles                                                                                   12
    AE-H Vaccine                                                                                                                    12
         Product Description                                                                                                        12
         Mechanism of Action                                                                                                        12
         R&D Progress                                                                                                               12
    AE-IG Vaccine                                                                                                                   13
         Product Description                                                                                                        13
         Mechanism of Action                                                                                                        13
         R&D Progress                                                                                                               13
Generex Biotechnology Corporation – Pipeline Analysis                                                                               14
    Generex Biotechnology Corporation – Pipeline Products by Therapeutic Class                                                      14
    Generex Biotechnology Corporation - Pipeline Products By Target                                                                 15
    Generex Biotechnology Corporation – Pipeline Products by Route of Administration                                                16
    Generex Biotechnology Corporation – Pipeline Products by Molecule Type                                                          17
Generex Biotechnology Corporation – Recent Pipeline Updates                                                                         18
Generex Biotechnology Corporation – Company Statement                                                                               19
Generex Biotechnology Corporation – Locations And Subsidiaries                                                                      23
    Head Office                                                                                                                     23
    Other Locations & Subsidiaries                                                                                                  23
Recent Developments                                                                                                                 24
         Mar 30, 2010: Generex Announces Expansion Plan For FDA Expanded Access Treatment IND Program For Generex Oral-lyn          24
         Jun 29, 2009: Generex Sees Favorable Results From MetControl(tm) Chewing Gum Bio-equivalency Study Leading to Glob         24
         Jul 28, 2010: Generex Reports Positive Update On Pivotal Phase III Trial Of Generex Oral-Lyn                               25
         Apr 28, 2005: Generex Biotechnology Begins Testing New Vaccine AE37 For Breast Cancer Patients                             25
         Apr 28, 2005: Generex Biotechnology Begins Testing New Vaccine For Breast Cancer Patients                                  26
         Apr 27, 2010: Generex Announces Updated Phase I Results From Novel Immunotherapeutic Vaccine Presented At The Euro         27
         May 26, 2010: Generex Biotechnology To Participate In American Society Of Clinical Oncology Annual Meeting In Chic         28
         May 26, 2008: Genere Biotechnology Announces That It Has Produced MetControl, the Company's Proprietary Metformin          29
         Jan 25, 2011: Generex To Increase Patient Enrollment In Phase II Breast Cancer Vaccine Study                               29
         Jan 25, 2006: Generex Biotechnology Announces Interim Results Of Clinical Breast Cancer Trials                             30
         Feb 23, 2011: Generex Announces New Treatment IND Site For FDA Expanded Access Treatment IND Program for Generex Oral-lyn 31




Generex Biotechnology Corporation – Product Pipeline Review – H2 2011                                   GMDHC01368CDB / Published SEP 2011

©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                            Page(2)
Generex Biotechnology Corporation – Product Pipeline Review



         Sep 22, 2010: Generex Presents Abstract On Generex Oral-Lyn At EASD Annual Meeting                                                       31
         Jan 19, 2010: Generex Makes Podium Presentation Of Vaccine Technology Platform With Cancer & Influenza Updates At PepTalk 201031
         Aug 18, 2011: Generex Subsidiary Antigen Express Provides Update On Phase II Breast Cancer Immunotherapy Program                         32
         May 18, 2010: Generex Announces Publication Of Immunotherapeutic Cancer Vaccine Results In Patients With Prostate Cancer                 33
         Oct 16, 2008: Generex Announces Enrollment Of Initial Subjects In Metformin Gum Trial                                                    33
         Jun 16, 2011: Generex Provides Update On Generex Oral-lyn Clinical And Regulatory Program                                                34
         Dec 14, 2009: Generex Announces Phase II Study Interim Results Of AE37 For The Treatment Of Breast Cancer                                35
         Dec 14, 2006: Clinical Trial Results From Cancer Vaccine Being Developed By Generex Biotechnology Subsidiary To Be Presented At
         San Antonio Breast Cancer Symposium                                                                                             35
         Sep 14, 2010: Generex Signs Distribution Agreement For Generex Oral-lyn In Chile                                                         36
         Dec 13, 2010: Generex Announces Publication Of New Positive Generex Oral-lyn Data In Peer-Reviewed Journal                               36
         Jul 13, 2010: Generex Oncology Granted US Patent For AE37 Peptide Vaccine                                                                37
         May 12, 2008: Generex Biotechnology Corp. (GNBT) Develops Chewing Gum Product for Type 2 D                                               37
         Mar 12, 2010: Generex's Oral-Lyn Receives Positive Responses From Independent Physicians And Nurse Practitioners                         38
         Mar 12, 2008: Generex Biotechnology Announces That Its Protocol For Metcontrol, The Company's Proprietary Metformin Chewing Gum
         Product                                                                                                                        39
         Jan 12, 2009: Generex Biotechnology Announces Publication Of Novel Immunotherapeutic Cancer Vaccine Studies                              39
         Jul 11, 2011: Generex Announces Publication Of Studies Conducted Using Antigen Express Proprietary li-Key Technology                     39
         May 10, 2010: Generex Biotechnology Enrolls Over 400 Subjects In Phase III Generex Oral-lyn Trial                                        40
         Aug 08, 2006: Generex Biotechnology Announces Expansion Of Antigen Express Cancer Trials To Include Prostate Cancer Patients             41
         Jul 08, 2011: Generex Provides Preliminary Results Of Generex Oral-lyn Clinical Trials In Patients With Type 1 Diabetes And Patients With
         Impaired Glucose Tolerance                                                                                                            42
         Apr 07, 2011: Generex Announces Oral-lyn Data Presentations At Two International Scientific Symposia                                     43
         Dec 06, 2010: Generex Presents New Positive AE37 Phase II Breast Cancer Vaccine Data At Annual San Antonio Breast Cancer
         Symposium                                                                                                                                44
         Jun 03, 2008: Generex Biotechnology Phase I Trial Results For Novel Immunotherapy Vaccine In Breast Cancer Patient                       44
         Mar 03, 2009: Generex Biotechnology Announces Treatment Of First Patient With Its Novel Immunotherapeutic Vaccine                        45
         Feb 03, 2011: Antigen Express Receives New Patent For AE37 Immunotherapeutic Cancer Vaccine                                              46
         Dec 02, 2008: Generex Announces Positive Results Of Metformin Chewing Gum Trial                                                          46
         Feb 01, 2007: Generex Biotechnology To Initiate Phase II Clinical Trials In Breast Cancer Patients In Collaboration With United States
         Military’s Cancer Institute                                                                                                              47
Financial Deals Landscape                                                                                                                         48
    Generex Biotechnology Corporation, Deals Volume Summary, 2004 to YTD 2011                                                                     48
    Generex Biotechnology Corporation, Deals Summary By Region, 2004 to YTD 2011                                                                  49
    Generex Biotechnology Corporation, Deals Summary, 2004 to YTD 2011                                                                            50
    Generex Biotechnology Corporation Detailed Deal Summary                                                                                       52
         Acquisition                                                                                                                              52
         EnBW Acquires Offshore Ostsee Wind And Eos Offshore                                                                                      52
         WPD Acquires Stake In Independent Power                                                                                                  54
         Equity Offering                                                                                                                          55
         Generex Completes Registered Direct Offering Of $12 Million                                                                              55
         Generex Biotechnology Completes Registered Direct Offering For $5.65 Million                                                             57
         Generex Biotechnology Completes Registered Direct Offering Of $10 Million                                                                59
         Generex Biotechnology Completes Registered Direct Offering For $5 Million                                                                61
         Generex Biotechnology Completes Private Placement Of $7 Million                                                                          63
         Generex Biotechnology Completes Private Placement Of Warrants For $6 Million                                                             65
         Generex Completes Private Placement Of $2 Million                                                                                        67
         Generex Biotechnology Completes Private Placement Warrants For $11 Million                                                               69
         Generex Biotechnology Completes Private Placement Of Warrants For $6 Million                                                             71
         Generex Biotechnology Completes Private Placement Of $3 Million                                                                          73



Generex Biotechnology Corporation – Product Pipeline Review – H2 2011                                     GMDHC01368CDB / Published SEP 2011

©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                                           Page(3)
Generex Biotechnology Corporation – Product Pipeline Review



         Generex Biotechnology Completes Private Placement Of $2 Million                                                           74
         Generex Biotechnology Completes Private Placement Of $2 Million                                                           75
         Debt Offering                                                                                                             76
         Generex Completes Private Placement Of 8% Secured Convertible Notes For $21 Million                                       76
         Generex Completes Private Placement Of 6% Debentures For $4 Million                                                       77
         Generex Completes Private Placement Of 6% Debentures for $4 Million                                                       78
         Generex Completes Private Placement Of 6% Debentures For $3.5 Million                                                     79
         Generex Completes Private Placement Of 6% Secured Convertible Debentures For $2 Million                                   80
         Generex Completes Private Placement Of 6% Secured Convertible Debentures For $2 Million                                   82
         Generex Biotechnology Enters Into An Angreement With Sanofi-Aventis Deutschland                                           84
         Generex Biotechnology Enters Into An Agreement With Pevion Biotech                                                        85
         Generex Biotechnology Enters Into Collaboration With Mayo Clinic                      
								
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