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

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Amylin Pharmaceuticals, Inc. – Product Pipeline Review – H2 2011 Summary Global Market Direct’s pharmaceuticals report, “Amylin Pharmaceuticals, Inc. - Product Pipeline Review - H2 2011” provides data on the Amylin Pharmaceuticals, Inc.’s research and development focus. The report includes information on current developmental pipeline, complete with latest updates, and features on discontinued and dormant projects. This report is built using data and information sourced from Global Markets Direct’s proprietary databases, Amylin Pharmaceuticals, Inc.’s corporate website, SEC filings, investor presentations and featured press releases, both from Amylin Pharmaceuticals, Inc. and industry-specific third party sources, put together by Global Markets Direct’s team. Scope - Amylin Pharmaceuticals, Inc. - Brief Amylin Pharmaceuticals, Inc. overview including business description, key information and facts, and its locations and subsidiaries. - Review of current pipeline of Amylin Pharmaceuticals, Inc. human therapeutic division. - Overview of pipeline therapeutics across various therapy areas. - Coverage of current pipeline molecules in various stages of drug development, including the combination treatment modalities, across the globe. - Product profiles for late stage and clinical stage products of Amylin Pharmaceuticals, Inc. with complete description of the product’s developmental history, mechanism of action, therapeutic class, target and major milestones. - Recent updates of the Amylin Pharmaceuticals, Inc.’s pipeline in the last quarter. - Key discontinued and dormant projects. - Latest news and deals relating to the products. Reasons to buy - Evaluate Amylin Pharmaceuticals, Inc.’s strategic position with total access to detailed information on its product pipeline. - Assess the growth potential of Amylin Pharmaceuticals, Inc. in its therapy areas of focus. - Identify new drug targets and therapeutic classes in the Amylin Pharmac

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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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