Amylin Pharmaceuticals, Inc. – Product Pipeline Review – H2 2011 by GlobalMarketsDirect

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									          Amylin Pharmaceuticals, Inc. – Product Pipeline
                       Review – H2 2011
                                                                                          Reference Code: GMDHC01757CDB

                                                                                                 Publication Date: NOV 2011




Amylin Pharmaceuticals, Inc. – Product Pipeline Review – H2 2011                            GMDHC01757CDB / Published NOV 2011

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




Ta b le o f Co n te n ts
Table of Contents ..................................................................................................................................................................................................... 2
      List of Tables...................................................................................................................................................................................................... 6
      List of Figures .................................................................................................................................................................................................... 7
Amylin Pharmaceuticals, Inc. Snapshot .................................................................................................................................................................... 8
      Amylin Pharmaceuticals, Inc. Overview .............................................................................................................................................................. 8
      Key Information .................................................................................................................................................................................................. 8
      Key Facts ........................................................................................................................................................................................................... 8
Amylin Pharmaceuticals, Inc. – Research and Development Overview ..................................................................................................................... 9
      Key Therapeutic Areas ....................................................................................................................................................................................... 9
Amylin Pharmaceuticals, Inc. – Pipeline Review ......................................................................................................................................................11
      Pipeline Products by Stage of Development ......................................................................................................................................................11
      Amylin Pharmaceuticals, Inc. – Pipeline Products Glance .................................................................................................................................12
      Amylin Pharmaceuticals, Inc. – Late Stage Pipeline ..........................................................................................................................................12
            Registration Filed Products/Combination Treatment Modalities...................................................................................................................12
            Phase III Products/Combination Treatment Modalities ................................................................................................................................13
      Amylin Pharmaceuticals, Inc. Clinical Stage Pipeline Products ..........................................................................................................................14
            Phase II Products/Combination Treatment Modalities .................................................................................................................................14
            Phase I Products/Combination Treatment Modalities ..................................................................................................................................15
Amylin Pharmaceuticals, Inc. – Drug Profiles...........................................................................................................................................................16
      AC2307 .............................................................................................................................................................................................................16
            Product Description ....................................................................................................................................................................................16
            Mechanism of Action...................................................................................................................................................................................16
            R&D Progress .............................................................................................................................................................................................16
      Byetta + Avandia ...............................................................................................................................................................................................17
            Product Description ....................................................................................................................................................................................17
            Mechanism of Action...................................................................................................................................................................................17
            R&D Progress .............................................................................................................................................................................................17
      Byetta + Lantus .................................................................................................................................................................................................18
            Product Description ....................................................................................................................................................................................18
            Mechanism of Action...................................................................................................................................................................................18
            R&D Progress .............................................................................................................................................................................................18
      Exenatide Nasal ................................................................................................................................................................................................19
            Product Description ....................................................................................................................................................................................19
            Mechanism of Action...................................................................................................................................................................................19
            R&D Progress .............................................................................................................................................................................................19
      Exenatide Suspension.......................................................................................................................................................................................20
            Product Description ....................................................................................................................................................................................20
            Mechanism of Action...................................................................................................................................................................................20
            R&D Progress .............................................................................................................................................................................................20
      Exenatide Transdermal Patch ...........................................................................................................................................................................21
            Product Description ....................................................................................................................................................................................21
            Mechanism of Action...................................................................................................................................................................................21
            R&D Progress .............................................................................................................................................................................................21
      Metreleptin ........................................................................................................................................................................................................22
            Product Description ....................................................................................................................................................................................22
            Mechanism of Action...................................................................................................................................................................................22




Amylin Pharmaceuticals, Inc. – Product Pipeline Review – H2 2011                                                                                            GMDHC01757CDB / Published NOV 2011

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



           R&D Progress .............................................................................................................................................................................................22
     Pramlintide ........................................................................................................................................................................................................23
           Product Description ....................................................................................................................................................................................23
           Mechanism of Action...................................................................................................................................................................................23
           R&D Progress .............................................................................................................................................................................................23
     PYY 3-36 + Pramlintide .....................................................................................................................................................................................24
           Product Description ....................................................................................................................................................................................24
           Mechanism of Action...................................................................................................................................................................................24
           R&D Progress .............................................................................................................................................................................................24
Amylin Pharmaceuticals, Inc. – Pipeline Analysis ....................................................................................................................................................25
     Amylin Pharmaceuticals, Inc. – Pipeline Products by Therapeutic Class ...........................................................................................................25
     Amylin Pharmaceuticals, Inc. - Pipeline Products By Target ..............................................................................................................................26
     Amylin Pharmaceuticals, Inc. – Pipeline Products by Route of Administration ...................................................................................................27
     Amylin Pharmaceuticals, Inc. – Pipeline Products by Molecule Type .................................................................................................................28
Amylin Pharmaceuticals, Inc. – Recent Pipeline Updates .......................................................................................................................................29
Amylin Pharmaceuticals, Inc. - Dormant Projects ....................................................................................................................................................30
Amylin Pharmaceuticals, Inc. - Discontinued Pipeline Products ...............................................................................................................................31
     Discontinued Pipeline Product Profiles ..............................................................................................................................................................31
           AC2307 ......................................................................................................................................................................................................31
           Metreleptin ..................................................................................................................................................................................................31
           Pramlintide + Metreleptin ............................................................................................................................................................................32
Amylin Pharmaceuticals, Inc. – Company Statement ...............................................................................................................................................33
Amylin Pharmaceuticals, Inc. – Locations And Subsidiaries ....................................................................................................................................37
     Head Office .......................................................................................................................................................................................................37
     Other Locations & Subsidiaries .........................................................................................................................................................................37
Recent Developments .............................................................................................................................................................................................38
           Oct 31, 2007: Once-Weekly Exenatide Showed Statistical Improvement in Glucose Control Compared to BYETTA...................................38
           Mar 30, 2004: Amylin Pharmaceuticals Advances Clinical Pipeline In Diabetes and Obesity ......................................................................38
           Jul 29, 2003: Amylin Pharmaceuticals Reports Encouraging Phase II Results From GLP-1 Program In Severe Congestive Heart Failure..39
           Apr 29, 2005: Amylin and Lilly Announce FDA Approval of BYETTA (Exenatide) Injection..........................................................................39
           Jun 28, 2010: Amylin Pharmaceuticals, Inc. And Eli Lilly And Company Declared Results From A Study. ..................................................40
           Jun 28, 2010: Eli Lilly And Company Declared Final Results From A Retrospective Study..........................................................................41
           Aug 27, 2008: Amylin & Lly Provided Additionla Inforamation For Fda Alert For Byetta. ..............................................................................41
           Jun 26, 2010: Amylin And Lilly Announce Clinical Study Results Of BYETTA In Combination With Lantus In Patients With Type 2 Diabetes
           ...................................................................................................................................................................................................................42
           Jun 26, 2010: Amylin And Lilly Announce Study Results Of BYETTA At ADA Annual Meeting...................................................................42
           Jun 26, 2010: Amylin Announces SYMLIN Clinical Data For Treatment Of Type 2 Diabetes .......................................................................43
           Jun 26, 2010: When BYETTA Was Added to Lantus, Type 2 Diabetes Patients With Long-Standing Disease Achieved Glycemic Control. 44
           Jun 26, 2006: Nastech Pharmaceutical Company Inc. Enters Into Development And License Agreement With Amylin Pharmaceuticals ....45
           Jan 25, 1999: Amylin Pharmaceuticals Announces Additional Data From Long-Term Pramlintide Studies..................................................45
           Jun 24, 2011: Amylin, Eli Lilly And Alkermes Announce Additional Results From Phase II Study Of Exenatide...........................................46
           Jun 24, 2011: Analysis Finds BYETTA Associated With Lower Likelihood Of Heart Failure Compared With Other Diabetes Therapies ......47
           Jun 24, 2011: Analysis Provides New Insights Into Use Of Amylin's SYMLIN In Patients With Type 1 Diabetes Using Insulin Pumps ........48
           Jun 24, 2011: Retrospective Analysis Finds BYETTA Associated With Lower Likelihood Of Heart Failure Compared With Other Diabetes
           Therapies....................................................................................................................................................................................................49
           Jun 24, 2007: Study Results showed the Comparison between Insulin and BYETTA in Blood Glucose Control. ........................................50
           Jun 23, 2007: BYETTA Associated with Reductions in Cardiovascular Risk Factors in People with Type 2 Diabetes, When Treated for
           Three and Half Years. .................................................................................................................................................................................50
           Feb 23, 2010: Amylin And Takeda To Advance Development Of Pramlintide/Metreleptin Combination Treatment For Obesity ..................51




Amylin Pharmaceuticals, Inc. – Product Pipeline Review – H2 2011                                                                                             GMDHC01757CDB / Published NOV 2011

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



           Dec 22, 2010: Amylin And Lilly Seek Expanded Use Of BYETTA Along With Basal Insulin ........................................................................52
           Oct 22, 2007: On Amylin's Byetta FDA issued alert due to cause of pancreatitis. ........................................................................................52
           Nov 21, 2008: BYETTA (exenatide) Approved for Treatment of Type 2 Diabetes by European Commission ..............................................53
           Aug 20, 2008: Amylin Pharmaceuticals Diabetes Drug Byetta the Focused California Lawsuit....................................................................54
           Oct 19, 2011: Lilly And Amylin Announce FDA Approval Of BYETTA For Use With Insulin Glargine...........................................................54
           Aug 18, 2008: FDA reported deaths with Byetta diabetes drug. ..................................................................................................................55
           Nov 17, 2010: Amylin And Eli Lilly Report Study Results Of BYETTA Compared To Other Diabetes Medications In Type 2 Diabetes
           Patients ......................................................................................................................................................................................................56
           Mar 16, 2011: Amylin And Takeda Voluntarily Suspend Clinical Activities In Obesity Trial ..........................................................................57
           Dec 15, 2009: Amylin Pharmaceuticals, Eli Lilly And Alkermes, Inc Announces Positive Clinical Trial Study Results Of BYETTA ...............57
           Dec 15, 2009: Exenatide Provided Superior Glucose Control Compared to BYETTA..................................................................................58
           Nov 15, 2007: Pramlintide And Leptin Combination Treatment Demonstrates 12.7 Percent Weight Loss In 24-Week Clinical Obesity Study
           ...................................................................................................................................................................................................................58
           Apr 15, 2011: Amylin To Present Data Showing Investigational Metreleptin Treatment Led To Long-Term Improvements In Diabetes And
           Lipid Control In Patients With Lipodystrophy ...............................................................................................................................................59
           Apr 15, 2011: Lilly Announces BYDUREON Recommended For Approval In Europe..................................................................................60
           Nov 10, 2009: Fda Added Warning To Byetta Labeling About Renal Failure. ..............................................................................................61
           Jul 10, 2007: Scottish Medicines Consortium Accepted Byetta - First in a New Class of Medicines- incretin mimetics, used for the
           Treatment of Type 2 Diabetes - Before Patients Start Insulin Therapy . ......................................................................................................62
           Jun 10, 2006: BYETTA Shown to Reduce Blood Glucose Levels When Added to Patients Using a TZD ....................................................62
           Jun 10, 2005: Long-Term Data on BYETTA Show Sustained Improvements in Glucose Control and Progressive Weight Reduction in
           People with Type 2 Diabetes ......................................................................................................................................................................63
           Jun 10, 2005: Study Shows BYETTA Improves Blood Sugar Levels as Effectively as Insulin Glargine .......................................................63
           May 10, 2011: JDRF And Amylin Partner To Investigate Co-Formulating Two Hormones For Treatment Of Type 1 Diabetes ....................64
           Sep 09, 2008: First Reported Head-to-Head Study Showed BYETTA (exenatide) Injection Provided Greater Reduction in Post-Meal
           Glucose Levels Than Januvia (sitagliptin) in Patients With Type 2 Diabetes ...............................................................................................65
           Sep 09, 2008: Head-to-Head Study Showed BYETTA(exenatide) Injection Provided Greater Reduction in Post-Meal Glucose Levels Than
           Januvia(sitagliptin) in Type 2 Diabetes Patients. .........................................................................................................................................65
           Jul 09, 2009: Amylin Pharmaceuticals Announces Positive Results From Dose-Ranging Clinical Study Of Pramlintide/Metreleptin
           Combination Treatment For Obesity ...........................................................................................................................................................66
           Feb 09, 2006: Amylin Pharmaceuticals Announcess Positive Results From Phase II Gose-Ranging Study Of Pramlintide .........................67
           Feb 09, 2006: Pramlintide Obesity Study Results Positive ..........................................................................................................................68
           Dec 08, 2008: Amylin And Lilly Update on FDA Review of Monothearpy BYETTA(exenatide) Injection. ....................................................69
           Jun 07, 2008: Monotherapy BYETTA (exenatide) Injection Study Results Presented at ADA 2008 Showed Adults with Type 2 Diabetes
           Experienced Improved Glycemic Control and Weight Loss ...................................
								
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