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									       Novo Nordisk A/S – Product Pipeline Review – H2
                            2011
                                                                                          Reference Code: GMDHC01678CDB

                                                                                                 Publication Date: NOV 2011




Novo Nordisk A/S – Product Pipeline Review – H2 2011                                        GMDHC01678CDB / Published NOV 2011

© Global Markets Direct. This report is a licensed product and is not to be photocopied                                 Page(1)
Novo Nordisk A/S – Product Pipeline Review




Ta b le o f Co n te n ts
Table of Contents ..................................................................................................................................................................................................... 2
      List of Tables.....................................................................................................................................................................................................10
      List of Figures ...................................................................................................................................................................................................13
Novo Nordisk A/S Snapshot ....................................................................................................................................................................................14
      Novo Nordisk A/S Overview ..............................................................................................................................................................................14
      Key Information .................................................................................................................................................................................................14
      Key Facts ..........................................................................................................................................................................................................14
Novo Nordisk A/S – Research and Development Overview .....................................................................................................................................15
      Key Therapeutic Areas ......................................................................................................................................................................................15
Novo Nordisk A/S – Pipeline Review .......................................................................................................................................................................18
      Pipeline Products by Stage of Development ......................................................................................................................................................18
      Novo Nordisk A/S – Pipeline Products Glance ..................................................................................................................................................19
      Novo Nordisk A/S – Late Stage Pipeline ...........................................................................................................................................................19
            Registration Filed Products/Combination Treatment Modalities...................................................................................................................19
            Phase III Products/Combination Treatment Modalities ................................................................................................................................20
      Novo Nordisk A/S Clinical Stage Pipeline Products ...........................................................................................................................................21
            Phase II Products/Combination Treatment Modalities .................................................................................................................................21
            Phase I Products/Combination Treatment Modalities ..................................................................................................................................22
      Novo Nordisk A/S–Early Stage Pipeline Products .............................................................................................................................................23
            Pre-Clinical Products/Combination Treatment Modalities ............................................................................................................................23
Novo Nordisk A/S – Drug Profiles ............................................................................................................................................................................24
      Degludec...........................................................................................................................................................................................................24
            Product Description ....................................................................................................................................................................................24
            Mechanism of Action...................................................................................................................................................................................24
            R&D Progress .............................................................................................................................................................................................24
      Degludecplus ....................................................................................................................................................................................................25
            Product Description ....................................................................................................................................................................................25
            Mechanism of Action...................................................................................................................................................................................25
            R&D Progress .............................................................................................................................................................................................25
      Haemostatic agent ............................................................................................................................................................................................26
            Product Description ....................................................................................................................................................................................26
            Mechanism of Action...................................................................................................................................................................................26
            R&D Progress .............................................................................................................................................................................................26
      IDegLira ............................................................................................................................................................................................................27
            Product Description ....................................................................................................................................................................................27
            Mechanism of Action...................................................................................................................................................................................27
            R&D Progress .............................................................................................................................................................................................27
      Insulin Degludec + Liraglutide ...........................................................................................................................................................................28
            Product Description ....................................................................................................................................................................................28
            Mechanism of Action...................................................................................................................................................................................28
            R&D Progress .............................................................................................................................................................................................28
      IPH 24...............................................................................................................................................................................................................29
            Product Description ....................................................................................................................................................................................29
            Mechanism of Action...................................................................................................................................................................................29
            R&D Progress .............................................................................................................................................................................................29
      Levemir + Novolog ............................................................................................................................................................................................30




Novo Nordisk A/S – Product Pipeline Review – H2 2011                                                                                                        GMDHC01678CDB / Published NOV 2011

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Novo Nordisk A/S – Product Pipeline Review



          Product Description ....................................................................................................................................................................................30
          Mechanism of Action...................................................................................................................................................................................30
          R&D Progress .............................................................................................................................................................................................30
    Levemir + Victoza + Metformin ..........................................................................................................................................................................31
          Product Description ....................................................................................................................................................................................31
          Mechanism of Action...................................................................................................................................................................................31
          R&D Progress .............................................................................................................................................................................................31
    NN1218.............................................................................................................................................................................................................33
          Product Description ....................................................................................................................................................................................33
          Mechanism of Action...................................................................................................................................................................................33
          R&D Progress .............................................................................................................................................................................................33
    NN1250 + Insulin Aspart ...................................................................................................................................................................................34
          Product Description ....................................................................................................................................................................................34
          Mechanism of Action...................................................................................................................................................................................34
          R&D Progress .............................................................................................................................................................................................34
    NN1731.............................................................................................................................................................................................................35
          Product Description ....................................................................................................................................................................................35
          Mechanism of Action...................................................................................................................................................................................35
          R&D Progress .............................................................................................................................................................................................35
    NN1810.............................................................................................................................................................................................................36
          Product Description ....................................................................................................................................................................................36
          Mechanism of Action...................................................................................................................................................................................36
          R&D Progress .............................................................................................................................................................................................36
    NN1953.............................................................................................................................................................................................................37
          Product Description ....................................................................................................................................................................................37
          Mechanism of Action...................................................................................................................................................................................37
          R&D Progress .............................................................................................................................................................................................37
    NN7008.............................................................................................................................................................................................................38
          Product Description ....................................................................................................................................................................................38
          Mechanism of Action...................................................................................................................................................................................38
          R&D Progress .............................................................................................................................................................................................38
    NN7088.............................................................................................................................................................................................................39
          Product Description ....................................................................................................................................................................................39
          Mechanism of Action...................................................................................................................................................................................39
          R&D Progress .............................................................................................................................................................................................39
    NN7128.............................................................................................................................................................................................................40
          Product Description ....................................................................................................................................................................................40
          Mechanism of Action...................................................................................................................................................................................40
          R&D Progress .............................................................................................................................................................................................40
    NN7129.............................................................................................................................................................................................................41
          Product Description ....................................................................................................................................................................................41
          Mechanism of Action...................................................................................................................................................................................41
          R&D Progress .............................................................................................................................................................................................41
    NN7415.............................................................................................................................................................................................................42
          Product Description ....................................................................................................................................................................................42
          Mechanism of Action...................................................................................................................................................................................42
          R&D Progress .............................................................................................................................................................................................42
    NN7999.............................................................................................................................................................................................................43




Novo Nordisk A/S – Product Pipeline Review – H2 2011                                                                                                    GMDHC01678CDB / Published NOV 2011

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Novo Nordisk A/S – Product Pipeline Review



          Product Description ....................................................................................................................................................................................43
          Mechanism of Action...................................................................................................................................................................................43
          R&D Progress .............................................................................................................................................................................................43
    NN8209.............................................................................................................................................................................................................44
          Product Description ....................................................................................................................................................................................44
          Mechanism of Action...................................................................................................................................................................................44
          R&D Progress .............................................................................................................................................................................................44
    NN8226.............................................................................................................................................................................................................45
          Product Description ....................................................................................................................................................................................45
          Mechanism of Action...................................................................................................................................................................................45
          R&D Progress .............................................................................................................................................................................................45
    NN8555.............................................................................................................................................................................................................46
          Product Description ....................................................................................................................................................................................46
          Mechanism of Action...................................................................................................................................................................................46
          R&D Progress .............................................................................................................................................................................................46
    NN8765.............................................................................................................................................................................................................47
          Product Description ....................................................................................................................................................................................47
          Mechanism of Action...................................................................................................................................................................................47
          R&D Progress .............................................................................................................................................................................................47
    NN8828.............................................................................................................................................................................................................49
          Product Description ....................................................................................................................................................................................49
          Mechanism of Action...................................................................................................................................................................................49
          R&D Progress .............................................................................................................................................................................................49
    NN9535.............................................................................................................................................................................................................50
          Product Description ....................................................................................................................................................................................50
          Mechanism of Action...................................................................................................................................................................................50
          R&D Progress .............................................................................................................................................................................................50
    NN9924.............................................................................................................................................................................................................51
          Product Description ....................................................................................................................................................................................51
          Mechanism of Action...................................................................................................................................................................................51
          R&D Progress .............................................................................................................................................................................................51
    NNC 0113-0987 ................................................................................................................................................................................................53
          Product Description ....................................................................................................................................................................................53
          Mechanism of Action...................................................................................................................................................................................53
          R&D Progress .............................................................................................................................................................................................53
    NNC 0123-0000-0338 .......................................................................................................................................................................................54
          Product Description ....................................................................................................................................................................................54
          Mechanism of Action...................................................................................................................................................................................54
          R&D Progress .............................................................................................................................................................................................54
    NNC-0156-0000-0009 .......................................................................................................................................................................................55
          Product Description ....................................................................................................................................................................................55
          Mechanism of Action...................................................................................................................................................................................55
          R&D Progress .............................................................................................................................................................................................55
    rFXIII .................................................................................................................................................................................................................56
          Product Description ....................................................................................................................................................................................56
          Mechanism of Action...................................................................................................................................................................................56
          R&D Progress .............................................................................................................................................................................................56
    Victoza ..............................................................................................................................................................................................................58




Novo Nordisk A/S – Product Pipeline Review – H2 2011                                                                                                        GMDHC01678CDB / Published NOV 2011

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Novo Nordisk A/S – Product Pipeline Review



           Product Description ....................................................................................................................................................................................58
           Mechanism of Action...................................................................................................................................................................................58
           R&D Progress .............................................................................................................................................................................................58
Novo Nordisk A/S – Pipeline Analysis......................................................................................................................................................................60
     Novo Nordisk A/S – Pipeline Products by Therapeutic Class.............................................................................................................................60
     Novo Nordisk A/S - Pipeline Products By Target ...............................................................................................................................................62
     Novo Nordisk A/S – Pipeline Products by Route of Administration ....................................................................................................................64
     Novo Nordisk A/S – Pipeline Products by Molecule Type ..................................................................................................................................65
Novo Nordisk A/S – Recent Pipeline Updates.........................................................................................................................................................66
Novo Nordisk A/S - Dormant Projects ......................................................................................................................................................................72
Novo Nordisk A/S - Discontinued Pipeline Products ................................................................................................................................................73
     Discontinued Pipeline Product Profiles ..............................................................................................................................................................73
           NN7720 ......................................................................................................................................................................................................73
           Long-acting growth hormone ......................................................................................................................................................................73
           NN028 ........................................................................................................................................................................................................74
           NN1952 ......................................................................................................................................................................................................74
           NN1998 ......................................................................................................................................................................................................74
           NN1998 + Metformin + Glimepiride .............................................................................................................................................................74
           NN414 ........................................................................................................................................................................................................75
           NN8209 ......................................................................................................................................................................................................75
           NN8226 ......................................................................................................................................................................................................75
           NN9112 ......................................................................................................................................................................................................75
           NN9161 ......................................................................................................................................................................................................76
           NN9925 ......................................................................................................................................................................................................76
           Rosiglitazone + Metformin + Glimepiride .....................................................................................................................................................76
Novo Nordisk A/S – Company Statement ................................................................................................................................................................77
Novo Nordisk A/S – Locations And Subsidiaries ......................................................................................................................................................78
     Head Office .......................................................................................................................................................................................................78
     Other Locations & Subsidiaries .........................................................................................................................................................................78
Recent Developments .............................................................................................................................................................................................81
           Jul 31, 2000: Vagifem, World's First Vaginal Estrogen Tablet, Relieves Symptoms of Vaginal Dryness and Painful Sexual Intercourse. ....81
           Mar 31, 2010: Study Shows Switching To Once-Daily Victoza From Exenatide Further Improves Blood Sugar Control In Patients With Type
           2 Diabetes ..................................................................................................................................................................................................81
           Dec 30, 2009: Novo Nordisk Expects Formal Feedback On Liraglutide From USFDA.................................................................................82
           Sep 30, 2002: Novo Nordisk's new insulin analog formulation with disposable prefilled doser is available in the United States. ...............82
           May 30, 2003: Novo Nordisk disputes Pfizer’s attempted termination of US hormone replacement therapy agreement ..............................83
           Apr 29, 2010: Novo Nordisk Initiates Phase I Trial With Oral GLP1 Analogue Using Merrion's GIPET Technology .....................................83
           Apr 29, 2010: Novo Nordisk Starts Phase I Trial With Oral GLP1 Analogue Using Merrion Pharmaceutical’s GIPET Technology ...............84
           Feb 29, 1996: Novo Nordisk receives approval of NovoSeven for the treatment of haemophilia patients with inhibitors ..............................84
           Jul 28, 1998: Novo Nordisk Submits New Drug Application for Recombinant Velosulin BR .........................................................................85
           Jun 28, 2010: Novo Nordisk Announces Clinical Trial Results Of NovoLog For Treatment Of Type 2 Diabetes Patients .............................85
           Jun 28, 2010: Novo Nordisk Announces Clinical Trial Results Of NovoLog For Treatment Of Type 2 Diabetes Patients .............................86
           Mar 28, 2006: Novo Nordisk launches Levemir in the United States ...........................................................................................................87
           Feb 28, 2011: Innate Pharma Receives Milestone Payment For IPH 2201 Licensed To Novo Nordisk .......................................................87
           Jan 28, 1998: Schering-Plough and Novo Nordisk Announce Copromotion Agreement For PRANDIN and Diabetes Care Products ..........87
           Jun 27, 2011: Novo Nordisk's Degludec Reduces Hypoglycaemia And Improves Long-Term Control In Patients With Type 1 And Type 2
           Diabetes .....................................................................................................................................................................................................88
           Jan 27, 2005: Study evaluates Long-term Efficacy and Safety of NovoLog Mix 70/30 in Type 2 Diabetes as Compared to Biphasic Human
           Insulin 30. ...................................................................................................................................................................................................89




Novo Nordisk A/S – Product Pipeline Review – H2 2011                                                                                                       GMDHC01678CDB / Published NOV 2011

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Novo Nordisk A/S – Product Pipeline Review



         Jan 27, 2005: The Study Showed NovoLog Mix 70/30 Improved Blood Glucose Control Better Than Insulin Glargine. ..............................89
         Dec 26, 2001: First and Only Insulin Analog Approved for Pump Therapy; New Indication for NovoLog (insulin aspart [rDNA origin]
         injection) Offers Additional Treatment Option for Insulin Users....................................................................................................................90
         Sep 26, 2011: Novo Nordisk Files For Regulatory Approval Of Ultralong-Acting Insulin Degludec In Europe ..............................................90
         Sep 26, 2011: Novo Nordisk Files For Regulatory Approval Of Ultralong-Acting Insulin DegludecPlus In Europe .......................................91
         Jun 26, 2010: Novo Nordisk Presents Phase II Study Data Of Insulin Degludec At 70th Annual Scientific Sessions Of ADA ......................91
         Mar 26, 1999: US Food and Drug Administration approves NovoSeven for treatment of haemophilia patients with inhibitors .....................92
         Feb 26, 2007: Phase 3 stroke trial shows that NovoSeven reduces bleeding in the brain, but does not improve long-term clinical outcomes
         ...................................................................................................................................................................................................................92
         Jan 26, 2010: Novo Nordisk receives US approval for Victoza (liraglutide) for the treatment of type 2 diabetes ..........................................93
         Jan 26, 2010: Novo Nordisk's Victoza Receives USFDA Approval For The Treatment Of Type 2 Diabetes ................................................93
         Jul 25, 2003: Type 2 Diabetes Therapy With Insulin (Novolin Human Insulin (rDNA Origin)) Plus Metformin Provides Equivalent Blood
         Glucose Control But Costs Two-Thirds Less Than Therapy With Three Oral Anti-Diabetic Agents, Study Shows; Novolin Plus Metformin
         Treatment Also Associated With Fewer Treatment Failures And Fewer Dropouts Due to Adverse Events. .................................................94
         Jun 25, 2011: Novo Nordisk's New Study Data Shows Benefits Of Adding Levemir Insulin Therapy To Victoza .........................................94
         Jun 25, 2001: Study shows oral antidiabetic drug repaglinide has unique mechanism of action ..................................................................95
         Sep 24, 2009: Paladin Receives Canadian Approval For GlucaGen For Treatment Of Severe Hypoglycemia In Diabetes Patients ............96
         Aug 24, 2007: Public statement on Ultratard (Insulin human (rDNA)) - withdrawal of the marketing authorisation in the European Union ...96
         Jun 24, 2008: Novo Nordisk receives approval in the US for PrandiMet ......................................................................................................97
         Jun 24, 1996: US Food and Drug Administration Approved GlucaGen ........................................................................................................97
         Dec 23, 1997: US Food and Drug Administration (FDA) Approves Prandinn , New Oral Treatment for Type 2 Diabetes.............................97
         Sep 23, 2011: CHMP Adopts Positive Opinion On Use Of Novo Nordisk's Levemir In Children With Type 1 Diabetes Aged Two To Five
         Years ..........................................................................................................................................................................................................98
         Aug 23, 2010: Novo Nordisk And Upsher-Smith Sign Exclusive Agreement To Market Vagifem 10mcg .....................................................98
         May 23, 2008: Novo Nordisk files for regulatory approval of liraglutide in both the US and Europe. ............................................................99
         Apr 23, 2010: The Lancet Publishes New Data Demonstrating Superior Efficacy Of Victoza Compared To Januvia In Treatment Of Type 2
         Diabetes .....................................................................................................................................................................................................99
         Apr 23, 2009: Novo Nordisk receives positive opinion on Victoza (liraglutide) from the European regulatory authorities ...........................100
         Mar 23, 2011: New Clinical Trial Data Supports Use Of Levemir In Children Aged Two To Five Years, Novo Nordisk Says .....................101
         Feb 23, 2011: Novo Nordisk Submits First Recombinant Treatment For Factor XIII Deficiency For US Regulatory Approval ....................101
         Dec 22, 2010: Novo Nordisk Reports Phase IIIa Study Results Of Degludec In Type 1 And Type 2 Diabetes ...........................................102
         Oct 22, 2008: G2 Therapies And Novo Nordisk Announce The Start Of Cinical Trials Of The Anti-C5aR Antibody In Chronic Inflammatory
         Diseases ...................................................................................................................................................................................................103
         Oct 22, 2002: Prandin approved for new indication combination therapy with insulin sensitisers ...............................................................104
         Jun 22, 2010: Novo Nordisk Re-Initiates Phase III Development Of Liraglutide For Obesity......................................................................104
         Jun 22, 2004: New breakthrough for NovoSeven ......................................................................................................................................104
         Mar 22, 2005: A Haemostatic Drug (rFVIIa) Currently Licensed For The Treatment Of Haemophilia Patients Could Soon Change The Way
         Critical Bleeding In Blunt Trauma Is Managed ..........................................................................................................................................105
         Sep 21, 2010: Novo Nordisk Presents Clinical Pharmacology Data For Degludec ....................................................................................106
         Jul 21, 2003: Novo Nordisk assumes US marketing of Activella and Vagifem immediately .......................................................................107
         Jul 21, 2003: Novo Nordisk Assumes US Marketing of Activella and Vagifem Immediately .......................................................................107
         Jan 21, 2011: Dainippon Obtains Manufacturing And Marketing Approval For SUREPOST ......................................................................108
         Nov 20, 2003: Study Showed Three-Fourths of Patients With Diabetes Prefered NovoLog Mix 70/30 FlexPen Prefilled Disposable Insulin
         Pen Over Vial and Syringe. .......................................................................................................................................................................108
         Oct 20, 2005: FDA Approves Levemir (Insulin Detemir [rDNA Origin] Injection) for Treatment of Diabetes in Children .............................108
         Sep 20, 2010: New Data Show Patient Satisfaction Is Significantly Higher With Novo Nordisk's Injectable Victoza Than Oral Januvia In
         Type 2 Diabetes........................................................................................................................................................................................109
         Jul 20, 1999: Recombinant Version of Novo Nordisk Velosulin BR Approved for Use in Diabetes Treatment. ...........................................110
         May 20, 2010: Vagifem 10 mcg to Replace Vagifem 25 mcg Formulation for Atrophic Vaginitis. ..............................................................110
         Jan 20, 2011: Novo Nordisk appealing patent ruling .................................................................................................................................111
         Jan 20, 2010: Novo Nordisk receives approval for Victoza in Japan..........................................................................................................111
         Jan 20, 2010: Novo Nordisk Receives Approval For Victoza In Japan ......................................................................................................111



Novo Nordisk A/S – Product Pipeline Review – H2 2011                                                                                                       GMDHC01678CDB / Published NOV 2011

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Novo Nordisk A/S – Product Pipeline Review



         Jan 20, 2007: FDA Approves NovoLog Category Change for Use in Pregnant Women with Type 1 Diabetes...........................................112
         Dec 19, 2003: Breakthrough for NovoSeven: new study shows significant reduction in blood transfusion needed in trauma patients .......112
         Nov 19, 2007: Sciele Pharms Enters Into An Exclusive Agreement with Novo Nordisk to Market Prandin and PrandiMet .........................113
         Nov 19, 2007: Sciele Signs Exclusive Agreement with Novo Nordisk to Market Prandin and PrandiMet ...................................................113
         Nov 19, 1998: US Food and Drug Administration approves Activelle, Novo Nordisk's new Hormone Replacement Therapy Product........113
         Nov 19, 1997: Advisory committee recommends approval for Prandin, Novo Nordisk's new oral hypoglycemic agent ..............................114
         Feb 19, 2004: European Commission approves NovoSeven in two new indications .................................................................................114
         Jan 19, 2011: Novo Nordisk intends to appeal adverse ruling in Prandin (Repaglinide) patent case .........................................................115
         Oct 18, 
								
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