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									         Alnylam Pharmaceuticals, Inc – Product Pipeline
                      Review – H2 2011
                                                                                          Reference Code: GMDHC01712CDB

                                                                                                 Publication Date: NOV 2011




Alnylam Pharmaceuticals, Inc – Product Pipeline Review – H2 2011                            GMDHC01712CDB / Published NOV 2011

© Global Markets Direct. This report is a licensed product and is not to be photocopied                                 Page(1)
Alnylam Pharmaceuticals, Inc – Product Pipeline Review




Ta b le o f Co n te n ts
Table of Contents ..................................................................................................................................................................................................... 2
      List of Tables...................................................................................................................................................................................................... 7
      List of Figures ...................................................................................................................................................................................................10
Alnylam Pharmaceuticals, Inc Snapshot ..................................................................................................................................................................11
      Alnylam Pharmaceuticals, Inc Overview ............................................................................................................................................................11
      Key Information .................................................................................................................................................................................................11
      Key Facts ..........................................................................................................................................................................................................11
Alnylam Pharmaceuticals, Inc – Research and Development Overview ...................................................................................................................12
      Key Therapeutic Areas ......................................................................................................................................................................................12
Alnylam Pharmaceuticals, Inc – Pipeline Review .....................................................................................................................................................15
      Pipeline Products by Stage of Development ......................................................................................................................................................15
      Alnylam Pharmaceuticals, Inc – Pipeline Products Glance ................................................................................................................................16
      Alnylam Pharmaceuticals, Inc – Late Stage Pipeline .........................................................................................................................................16
            Registration Filed Products/Combination Treatment Modalities...................................................................................................................16
      Alnylam Pharmaceuticals, Inc Clinical Stage Pipeline Products .........................................................................................................................17
            Phase II Products/Combination Treatment Modalities .................................................................................................................................17
            Phase I Products/Combination Treatment Modalities ..................................................................................................................................18
      Alnylam Pharmaceuticals, Inc–Early Stage Pipeline Products ...........................................................................................................................19
            Pre-Clinical Products/Combination Treatment Modalities ............................................................................................................................19
            Discovery Products/Combination Treatment Modalities ..............................................................................................................................20
Alnylam Pharmaceuticals, Inc – Drug Profiles..........................................................................................................................................................21
      Actos + Glimepiride ...........................................................................................................................................................................................21
            Product Description ....................................................................................................................................................................................21
            Mechanism of Action...................................................................................................................................................................................21
            R&D Progress .............................................................................................................................................................................................21
      ALN-HPN ..........................................................................................................................................................................................................22
            Product Description ....................................................................................................................................................................................22
            Mechanism of Action...................................................................................................................................................................................22
            R&D Progress .............................................................................................................................................................................................22
      ALN-HTT...........................................................................................................................................................................................................23
            Product Description ....................................................................................................................................................................................23
            Mechanism of Action...................................................................................................................................................................................23
            R&D Progress .............................................................................................................................................................................................23
      ALN-PCS ..........................................................................................................................................................................................................24
            Product Description ....................................................................................................................................................................................24
            Mechanism of Action...................................................................................................................................................................................24
            R&D Progress .............................................................................................................................................................................................24
      ALN-RSV01 ......................................................................................................................................................................................................25
            Product Description ....................................................................................................................................................................................25
            Mechanism of Action...................................................................................................................................................................................25
            R&D Progress .............................................................................................................................................................................................25
      ALN-TTR01 .......................................................................................................................................................................................................27
            Product Description ....................................................................................................................................................................................27
            Mechanism of Action...................................................................................................................................................................................27
            R&D Progress .............................................................................................................................................................................................27
      ALN-TTR02 .......................................................................................................................................................................................................28




Alnylam Pharmaceuticals, Inc – Product Pipeline Review – H2 2011                                                                                           GMDHC01712CDB / Published NOV 2011

©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                                                                                                               Page(2)
Alnylam Pharmaceuticals, Inc – Product Pipeline Review



           Product Description ....................................................................................................................................................................................28
           Mechanism of Action...................................................................................................................................................................................28
           R&D Progress .............................................................................................................................................................................................28
     ALN-VSP ..........................................................................................................................................................................................................29
           Product Description ....................................................................................................................................................................................29
           Mechanism of Action...................................................................................................................................................................................29
           R&D Progress .............................................................................................................................................................................................29
     Drug For Dystonia .............................................................................................................................................................................................30
           Product Description ....................................................................................................................................................................................30
           Mechanism of Action...................................................................................................................................................................................30
           R&D Progress .............................................................................................................................................................................................30
     Drug For Malaria ...............................................................................................................................................................................................31
           Product Description ....................................................................................................................................................................................31
           Mechanism of Action...................................................................................................................................................................................31
           R&D Progress .............................................................................................................................................................................................31
     JC Virus Programe ............................................................................................................................................................................................32
           Product Description ....................................................................................................................................................................................32
           Mechanism of Action...................................................................................................................................................................................32
           R&D Progress .............................................................................................................................................................................................32
     Pandemic Flu Programme.................................................................................................................................................................................33
           Product Description ....................................................................................................................................................................................33
           Mechanism of Action...................................................................................................................................................................................33
           R&D Progress .............................................................................................................................................................................................33
     Parkinson's disease development Program .......................................................................................................................................................34
           Product Description ....................................................................................................................................................................................34
           Mechanism of Action...................................................................................................................................................................................34
           R&D Progress .............................................................................................................................................................................................34
     RNAi Therapeutic ..............................................................................................................................................................................................35
           Product Description ....................................................................................................................................................................................35
           Mechanism of Action...................................................................................................................................................................................35
           R&D Progress .............................................................................................................................................................................................35
     RNAi Therapeutics Program..............................................................................................................................................................................36
           Product Description ....................................................................................................................................................................................36
           Mechanism of Action...................................................................................................................................................................................36
           R&D Progress .............................................................................................................................................................................................36
Alnylam Pharmaceuticals, Inc – Pipeline Analysis ...................................................................................................................................................37
     Alnylam Pharmaceuticals, Inc – Pipeline Products by Therapeutic Class ..........................................................................................................37
     Alnylam Pharmaceuticals, Inc - Pipeline Products By Target .............................................................................................................................39
     Alnylam Pharmaceuticals, Inc – Pipeline Products by Route of Administration ..................................................................................................41
     Alnylam Pharmaceuticals, Inc – Pipeline Products by Molecule Type ................................................................................................................42
Alnylam Pharmaceuticals, Inc – Recent Pipeline Updates ......................................................................................................................................43
Alnylam Pharmaceuticals, Inc - Dormant Projects ...................................................................................................................................................46
Alnylam Pharmaceuticals, Inc – Company Statement ..............................................................................................................................................47
Alnylam Pharmaceuticals, Inc – Locations And Subsidiaries ...................................................................................................................................50
     Head Office .......................................................................................................................................................................................................50
     Other Locations & Subsidiaries .........................................................................................................................................................................50
Recent Developments .............................................................................................................................................................................................51
           Mar 31, 2011: Alnylam Completes Enrollment In ALN-VSP Phase I Clinical Trial........................................................................................51




Alnylam Pharmaceuticals, Inc – Product Pipeline Review – H2 2011                                                                                         GMDHC01712CDB / Published NOV 2011

©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                                                                                                             Page(3)
Alnylam Pharmaceuticals, Inc – Product Pipeline Review



         Mar 31, 2008: Alnylam Presents Pre-clinical Data from Hypercholesterolemia, Liver Cancer, Ebola, And Progressive Multifocal
         Leukoencephalopathy (PML) Programs At RNAi Keystone Symposium ......................................................................................................51
         Mar 31, 2008: Alnylam Presents Pre-clinical Data From Hypercholesterolemia, Liver Cancer, Ebola, And Progressive Multifocal
         Leukoencephalopathy (PML) Programs At RNAi Keystone Symposium. .....................................................................................................52
         Jul 30, 2007: Alnylam And Medtronic Advance Collaboration On Drug-Device Combinations with RNAi Therapeutics For CNS Diseases .53
         Sep 29, 2010: Alnylam Announces Publication Of Phase IIa Study Results Of ALN-RSV01 In Treatment Of RSV Infection In Lung
         Transplant Patients .....................................................................................................................................................................................54
         Jun 29, 2010: Alnylam Obtains Approval To Initiate Phase I Study With ALN-TTR01 In Patients With TTR-Mediated Amyloidosis .............55
         Jun 28, 2011: Alnylam Presents New Data From ALN-TTR Program At Peripheral Nerve Society Meeting ................................................55
         Apr 27, 2010: Alnylam Publishes Results From Phase II GEMINI Trial With ALN-RSV01 ...........................................................................57
         Sep 26, 2011: Alnylam Initiates Phase I Clinical Study Of ALN-PCS In Hypercholesterolemia ....................................................................57
         Jan 25, 2011: Alnylam Receives Positive Opinion For Orphan Drug Designation From European Medicines Agency For ALN-TTR01 .......58
         Dec 23, 2008: Alnylam Advances RNAi Therapeutics Pipeline And Files Company's First Systemic Delivery IND. .....................................59
         Oct 23, 2006: Alnylam Announces Progress In Pre-Clinical Hypercholesterolemia RNAi Therapeutic And MicroRNA Programs ................60
         May 23, 2006: Alnylam And Collaborators Present Pre-Clinical Data For RNAi Therapeutics For The Treatment Of Respiratory Diseases 61
         May 23, 2006: Alnylam and Collaborators Present Pre-Clinical Data For RNAi Therapeutics For The Treatment Of Respiratory Diseases
         Including Pandemic Influenza .....................................................................................................................................................................62
         Jan 23, 2009: Alnylam Receives Clearance From FDA To Initiate Phase I Study With ALN-VSP For The Treatment Of Liver Cancers. .....63
         Feb 22, 2010: Alnylam Initiates Phase IIb Clinical Trial Of ALN-RSV01 In Adult Lung Transplant Patients Infected with RSV Infection ......64
         Jan 21, 2009: Alnylam And Collaborators At Harvard Medical School Demonstrate In Vivo Silencing Of Key Genes Implicated In The
         Transmission Of Herpes Simplex Virus-2 (HSV-2) ......................................................................................................................................65
         Nov 20, 2008: Alnylam Presents Pre-clinical Data From TTR Amyloidosis Development Program ..............................................................66
         Nov 20, 2008: Alnylam Presents Pre-clinical Data From TTR Amyloidosis Development Program 20th Nov 2008 ......................................67
         Jul 20, 2009: Alnylam And Cubist Reports Complete Data From Phase II Study In Respiratory Syncytial Virus ..........................................68
         Apr 20, 2010: Alnylam And Collaborators Present New Pre-Clinical Data From ALN-TTR01 Program ........................................................68
         Jun 19, 2008: Alnylam And Kyowa Hakko Form Alliance For The Development And Commercialization Of ALN-RSV01 In Asia ................70
         Jun 18, 2009: Alnylam And Collaborators Presents New Pre-Clinical Research Findings On RNAi Therapeutics Targeting PCSK9 ...........71
         May 18, 2011: Alnylam's ALN-VSP Abstract Published By American Society Of Clinical Oncology.............................................................72
         Mar 18, 2005: In Vivo Efficacy Data Presented From Alnylam RSV Program At The American Academy Of Allergy, Asthma And
         Immunology Meeting...................................................................................................................................................................................73
         Sep 15, 2009: Alnylam And Medtronic Presents New Late-Stage Pre-clinical Data On ALN-HTT For The Treatment Of Huntington's
         Disease. .....................................................................................................................................................................................................74
         Aug 15, 2005: Alnylam Receives Grant From Michael J. Fox Foundation For Parkinson's Research To Support The Development Of Novel
         Parkinson's Therapies Using RNAi Technology ..........................................................................................................................................75
         Dec 14, 2005: Alnylam Announces Pandemic Flu As Next Development Program; Obtains Initial Federal Funding to Develop RNAi
         Therapeutics For Pandemic Influenza And Identifies Dowpharma(SM) As Potential Source For Domestic Manufacturing. .........................76
         Dec 13, 2007: Alnylam Reports Phase I Clinical Safety Results With Inhalation Dosing Of ALN-RSV01 .....................................................76
         Aug 12, 2008: Alnylam And Collaborators Publish New Pre-Clinical Research On RNAi-Mediated Silencing Of PCSK9.............................78
         Oct 11, 2006: Alnylam Initiates Phase I Clinical Study Of Inhaled Formulation Of ALN-RSV01 ...................................................................79
         Jul 11, 2011: Alnylam Files Clinical Trial Application For ALN-PCS For Treatment Of Severe Hypercholesterolemia..................................80
         Jan 11, 2008: Nucleonics Initiates Hepatitis B Clinical Trial with Expressed Interfering RNA Therapeutic, NUCB1000 ...............................81
         Nov 10, 2010: Alnylam Presents Additional Interim Phase I Data For ALN-VSP For Treatment Of Liver Cancer.........................................81
         Apr 09, 2008: Alnylam Initiates Phase II Trial Of ALN-RSV01 In Adult Lung Transplant Patients Naturally Infected With Respiratory
         Syncytial Virus (RSV) Infection ...................................................................................................................................................................83
         Feb 09, 2005: Medtronic And Alnylam Pharmaceuticals To Collaborate On Potential Treatments For Major Neurodegenerative Diseases 84
         Sep 08, 2011: Alnylam Expands Alnylam 5x15 RNAi Therapeutic Pipeline With ALN-APC, RNAi Therapeutic Targeting Protein C For
         Treatment Of Hemophilia ............................................................................................................................................................................85
         Jun 08, 2009: Alnylam And Cubist Report Preliminary Data From Phase II Study Of ALN-RSV01 ..............................................................86
         Jul 07, 2010: Alnylam Doses ATTR Patients In Phase I Clinical Study Of ALN-TTR01................................................................................87
         Jun 07, 2010: Alnylam Presents Preliminary Phase I Data At ASCO Meeting For ALN-VSP .......................................................................88
         Nov 06, 2006: Alnylam And Yale University Scientists Demonstrate Therapeutic Silencing Of Disease Target Associated With Acute Lung
         Injury Using RNAi .......................................................................................................................................................................................89




Alnylam Pharmaceuticals, Inc – Product Pipeline Review – H2 2011                                                                                        GMDHC01712CDB / Published NOV 2011

©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                                                                                                            Page(4)
Alnylam Pharmaceuticals, Inc – Product Pipeline Review



           Aug 06, 2008: Tekmira Pharmaceuticals Provides Progress Update On Alnylam's ALN-VSP. ...................................................................90
           Jun 04, 2011: Alnylam Presents Phase I Data For ALN-VSP At American Society Of Clinical Oncology Meeting .......................................91
           Jan 04, 2011: Alnylam Reports Positive Data From ALN-VSP Phase I Liver Cancer Trial ...........................................................................93
           Apr 03, 2009: Alnylam Initiates Phase I Clinical Study of ALN-VSP in Patients with Liver Cancer ...............................................................94
           Nov 02, 2009: Alnylam Presents New Pre-Clinical Data ALN-TTR, RNAi Therapeutic Treatment Transthyretin-Mediated Amyloidosis.....95
           Nov 02, 2009: Alnylam Presents New Pre-Clinical Data ALN-TTR, RNAi Therapeutic Treatment Transthyretin-Mediated Amyloidosis.....96
           Nov 01, 2005: Alnylam Submits IND Application For ALN-RSV01...............................................................................................................97
           Aug 01, 2011: Alnylam Completes Phase I Trial Of ALN-VSP In Liver Cancer ............................................................................................98
Financial Deals Landscape......................................................................................................................................................................................99
     Alnylam Pharmaceuticals, Inc, Deals Summary ................................................................................................................................................99
Alnylam Pharmaceuticals, Inc, Pharmaceuticals & Healthcare, Deal Details ..........................................................................................................105
     Asset Transactions..........................................................................................................................................................................................105
           Alnylam Acquires RNAi Therapeutics Assets From Nucleonics .................................................................................................................105
     Venture Financing ...........................................................................................................................................................................................107
           Regulus Therapeutics Secures $20 Million In Series A Preferred Equity Financing ...................................................................................107
     Partnerships ....................................................................................................................................................................................................109
           Molecular Templates Enters Into Research Collaboration With Alnylam Pharmaceuticals.........................................................................109
           Precision NanoSystems Enters Into Delivery Collaboration With Alnylam .................................................................................................110
           AlCana Extends Co-Development Agreement With UBC And Alnylam .....................................................................................................111
           Alnylam And Medtronic Form Collaboration With CHDI Foundation ..........................................................................................................113
           Alnylam Pharmaceuticals Enters Into Agreement With Tekmira Pharmaceuticals .....................................................................................115
           Novartis Extends Agreement With Alnylam Pharmaceuticals ....................................................................................................................116
           Cubist Pharmaceuticals Enters Into Co-Development Agreement With Alnylam .......................................................................................117
           Alnylam Enters Into Research Agreement With Max Planck Institute ........................................................................................................119
           Novartis Extends Co-Development Agreement With Alnylam Pharmaceuticals .........................................................................................120
           Alnylam Pharmaceuticals And Kyowa Hakko Form Alliance......................................................................................................................121
           Alnylam Pharmaceuticals Forms Joint Venture With Isis Pharmaceuticals ................................................................................................122
           Alnylam Pharmaceuticals Amends Agreement With Medtronic .................................................................................................................123
           Biogen Idec Enters Into Agreement With Alnylam .....................................................................................................................................124
           Tekmira Amends Research Collaboration With Alnylam Pharmaceuticals.................................................................................................125
           Alnylam Pharmaceuticals Amends Its Collaboration Agreement With Merck .............................................................................................126
           Alnylam Pharmaceuticals Enters Into Collaboration Agreement With USAMRIID ......................................................................................128
           Alnylam Pharmaceuticals Enters Into Research Agreement With Inex Pharmaceuticals ...........................................................................129
           Alnylam Enters Into Co-Development Agreement With Novartis ...............................................................................................................130
           Alnylam Enters Into Agreement With Novartis ...........................................................................................................................................131
           Alnylam Pharmaceuticals Enters Into Collaboration With University Of Georgia........................................................................................133
           Alnylam Enters Into Agreement With Cystic Fibrosis Foundation ..............................................................................................................134
           Alnylam Enters Into Agreement With Medtronic ...................................
								
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