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

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ISTA Pharmaceuticals, Inc. – Product Pipeline Review – H2 2011

Summary

Global Market Direct’s pharmaceuticals report, “ISTA Pharmaceuticals, Inc. - Product Pipeline Review - H2 2011” provides data on the ISTA 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, ISTA Pharmaceuticals, Inc.’s corporate website, SEC filings, investor presentations and featured press releases, both from ISTA Pharmaceuticals, Inc. and industry-specific third party sources, put together by Global Markets Direct’s team.

Scope

- ISTA Pharmaceuticals, Inc. - Brief ISTA Pharmaceuticals, Inc. overview including business description, key information and facts, and its locations and subsidiaries.
- Review of current pipeline of ISTA 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 ISTA Pharmaceuticals, Inc. with complete description of the product’s developmental history, mechanism of action, therapeutic class, target and major milestones.
- Recent updates of the ISTA 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 ISTA Pharmaceuticals, Inc.’s strategic position with total access to detailed information on its product pipeline.
- Assess the growth potential of ISTA Pharmaceuticals, Inc. in its therapy areas of focus.
- Identify new drug targets and therapeutic classes in the ISTA Pharmaceuticals, Inc.’s R&D portf

More Info
									 ISTA Pharmaceuticals, Inc. – Product Pipeline Review
                     – H2 2011
                                                                                          Reference Code: GMDHC01774CDB

                                                                                                 Publication Date: NOV 2011




ISTA Pharmaceuticals, Inc. – Product Pipeline Review – H2 2011                              GMDHC01774CDB / Published NOV 2011

© Global Markets Direct. This report is a licensed product and is not to be photocopied                                 Page(1)
ISTA 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
ISTA Pharmaceuticals, Inc. Snapshot....................................................................................................................................................................... 8
      ISTA Pharmaceuticals, Inc. Overview................................................................................................................................................................. 8
      Key Information .................................................................................................................................................................................................. 8
      Key Facts ........................................................................................................................................................................................................... 8
ISTA Pharmaceuticals, Inc. – Research and Development Overview ....................................................................................................................... 9
      Key Therapeutic Areas ....................................................................................................................................................................................... 9
ISTA Pharmaceuticals, Inc. – Pipeline Review.........................................................................................................................................................11
      Pipeline Products by Stage of Development ......................................................................................................................................................11
      Pipeline Products – Monotherapy .....................................................................................................................................................................12
ISTA Pharmaceuticals, Inc. – Pipeline Products Glance ..........................................................................................................................................13
      ISTA Pharmaceuticals, Inc. – Late Stage Pipeline .............................................................................................................................................13
            Phase III Products/Combination Treatment Modalities ................................................................................................................................13
      ISTA Pharmaceuticals, Inc. Clinical Stage Pipeline Products ............................................................................................................................14
            Phase II Products/Combination Treatment Modalities .................................................................................................................................14
            Phase I Products/Combination Treatment Modalities ..................................................................................................................................15
      ISTA Pharmaceuticals, Inc.–Early Stage Pipeline Products ...............................................................................................................................16
            Pre-Clinical Products/Combination Treatment Modalities ............................................................................................................................16
ISTA Pharmaceuticals, Inc. – Drug Profiles .............................................................................................................................................................17
      Bepotastine Nasal Combination ........................................................................................................................................................................17
            Product Description ....................................................................................................................................................................................17
            Mechanism of Action...................................................................................................................................................................................17
            R&D Progress .............................................................................................................................................................................................17
      Bepotastine Nasal Spray ...................................................................................................................................................................................18
            Product Description ....................................................................................................................................................................................18
            Mechanism of Action...................................................................................................................................................................................18
            R&D Progress .............................................................................................................................................................................................18
      Bromfenac Adjunct ............................................................................................................................................................................................19
            Product Description ....................................................................................................................................................................................19
            Mechanism of Action...................................................................................................................................................................................19
            R&D Progress .............................................................................................................................................................................................19
      Ecabet ..............................................................................................................................................................................................................20
            Product Description ....................................................................................................................................................................................20
            Mechanism of Action...................................................................................................................................................................................20
            R&D Progress .............................................................................................................................................................................................20
      Iganidipine ........................................................................................................................................................................................................21
            Product Description ....................................................................................................................................................................................21
            Mechanism of Action...................................................................................................................................................................................21
            R&D Progress .............................................................................................................................................................................................21
      Latanoprost .......................................................................................................................................................................................................22
            Product Description ....................................................................................................................................................................................22
            Mechanism of Action...................................................................................................................................................................................22
            R&D Progress .............................................................................................................................................................................................22
      Low-Concentration Bromday .............................................................................................................................................................................23




ISTA Pharmaceuticals, Inc. – Product Pipeline Review – H2 2011                                                                                              GMDHC01774CDB / Published NOV 2011

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



           Product Description ....................................................................................................................................................................................23
           Mechanism of Action...................................................................................................................................................................................23
           R&D Progress .............................................................................................................................................................................................23
     Remura .............................................................................................................................................................................................................24
           Product Description ....................................................................................................................................................................................24
           Mechanism of Action...................................................................................................................................................................................24
           R&D Progress .............................................................................................................................................................................................24
     Strong Steroids .................................................................................................................................................................................................25
           Product Description ....................................................................................................................................................................................25
           Mechanism of Action...................................................................................................................................................................................25
           R&D Progress .............................................................................................................................................................................................25
     T-Pred ...............................................................................................................................................................................................................26
           Product Description ....................................................................................................................................................................................26
           Mechanism of Action...................................................................................................................................................................................26
           R&D Progress .............................................................................................................................................................................................26
ISTA Pharmaceuticals, Inc. – Pipeline Analysis .......................................................................................................................................................28
     ISTA Pharmaceuticals, Inc. – Pipeline Products by Therapeutic Class ..............................................................................................................28
     ISTA Pharmaceuticals, Inc. - Pipeline Products By Target ................................................................................................................................30
     ISTA Pharmaceuticals, Inc. – Pipeline Products by Route of Administration ......................................................................................................32
     ISTA Pharmaceuticals, Inc. – Pipeline Products by Molecule Type ...................................................................................................................33
ISTA Pharmaceuticals, Inc. – Recent Pipeline Updates ..........................................................................................................................................34
ISTA Pharmaceuticals, Inc. – Company Statement..................................................................................................................................................36
ISTA Pharmaceuticals, Inc. – Locations And Subsidiaries .......................................................................................................................................38
     Head Office .......................................................................................................................................................................................................38
Recent Developments .............................................................................................................................................................................................39
           May 31, 2007: ISTA Pharmaceuticals Announces Positive Preliminary Results From Ecabet Sodium Phase IIb Study...............................39
           May 30, 2006: ISTA Pharmaceuticals Is Initiating Phase III Clinical Trials of a New Once-Daily Formulation of Xibrom for the Treatment of
           Ocular Pain and Inflammation Following Cataract Surgery..........................................................................................................................40
           Jan 30, 2006: ISTA Pharmaceuticals Receives FDA Approval for Expanded Indication of Xibrom to Treat Pain Following Cataract Surgery.
           ...................................................................................................................................................................................................................40
           Jan 30, 2004: ISTA Pharmaceuticals Announces Vitrase Phase III Data Presented at Hawaiian Eye Meeting ............................................40
           Jul 29, 2004: ISTA Pharmaceuticals Launches Istalol in the United States. ................................................................................................41
           Oct 28, 2004: FDA Grants ISTA Pharmaceuticals' Vitrase Five-Year Market Exclusivity .............................................................................41
           Sep 28, 2004: ISTA Pharmaceuticals and Allergan Announce New Vitrase Agreement ..............................................................................41
           Jul 28, 2011: ISTA Pharmaceuticals Reports Results From First of Two Trials In REMURA Phase III Clinical Program For Dry Eye Disease
           ...................................................................................................................................................................................................................42
           Jul 28, 2003: ISTA Pharmaceuticals Announces FDA Approvable Letter for ISTALOL................................................................................43
           Apr 28, 2011: ISTA Pharmaceuticals Reports Positive Topline Results From Phase II Trial Of Bepotastine Besilate Nasal Spray ..............44
           Mar 28, 2005: ISTA Pharmaceuticals Receives FDA Approval for Xibrom for the Treatment of Ocular Inflammation Following Cataract
           Surgery; - Xibrom will be ISTA's Third Product Launched in the U.S. Market - ............................................................................................45
           Jan 28, 2003: FDA Advisory Committee to Consider ISTA Pharmaceuticals' Vitrase on March 17, 2003 ....................................................46
           Sep 27, 2010: ISTA Announces Results From REMURA Phase II Study At International Conference On Tear Film And Ocular Surface ...46
           Sep 27, 2002: ISTA Pharmaceuticals Announces Submission of New Drug Application For ISTALOL, a Unique Formulation of Timolol ....47
           May 27, 2011: Mitsubishi Announces Launch Of Anti-Allergy Agent, Bepotastine Besilate In China And Indonesia. ..................................48
           Oct 26, 2004: ISTA Pharmaceuticals' Istalol Receives 'BT' Rating From FDA, Disallowing Generic Substitution at Pharmacies .................48
           Sep 26, 2007: ISTA Acquires Exclusive North American Rights To Bepotastine .........................................................................................48
           Aug 26, 2009: ISTA says daily Xibrom eye drops met goal in study ............................................................................................................49
           Jul 26, 2004: FDA Accepts ISTA Pharmaceuticals' New Drug Application for Xibrom .................................................................................49
           Aug 25, 2009: STA Pharmaceuticals Announces Positive Preliminary Phase 3 Clinical Results to Support sNDA Filing for Once-Daily
           Xibrom 0.09% .............................................................................................................................................................................................50



ISTA Pharmaceuticals, Inc. – Product Pipeline Review – H2 2011                                                                                               GMDHC01774CDB / Published NOV 2011

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



         May 25, 2004: ISTA Pharmaceuticals Announces Submission of Xibrom NDA to the FDA. ........................................................................50
         Jan 23, 2009: Announcement Of Positive Results For Phase IIb Study Of Ecabet Sodium. ........................................................................50
         Sep 22, 2003: ISTA Pharmaceuticals Presents Vitrase Phase III Data Analysis at Retina Society Annual Meeting .....................................51
         Mar 22, 2011: ISTA Pharmaceuticals Highlights BEPREVE Clinical Data At 2011 American Academy of Allergy, Asthma and Immunology
         Annual Meeting ...........................................................................................................................................................................................52
         Dec 21, 2007: ISTA Pharmaceuticals Submits New Drug Application for Xibrom QD (once-daily)..............................................................53
         Dec 21, 2007: ISTA Pharmaceuticals Submits New Drug Application for Xibrom QD (once-daily)...............................................................53
         Dec 21, 2007: ISTA Pharmaceuticals Submits New Drug Application for Xibrom QD (once-daily)...............................................................53
         Sep 21, 2004: FDA Grants ISTA Pharmaceuticals' Vitrase Three-Year Market Exclusivity ..........................................................................53
         Aug 21, 2003: ISTA Pharmaceuticals Presented Vitrase Phase III Data At American Society of Retina Specialists Meeting .......................54
         Mar 21, 2005: ISTA Pharmaceuticals Files IND For Phase IIb Trial Of Ecabet Sodium ...............................................................................54
         Feb 21, 2006: ISTA Pharmaceuticals Announces Positive Preliminary Results From Phase IIb Trial Of Ecabet Sodium For The Treatment
         Of Dry Eye Syndrome .................................................................................................................................................................................55
         Dec 20, 2001: ISTA Pharmaceuticals Announces Partnership With Otsuka Pharmaceutical Co., Ltd. for Vitrase ........................................56
         Oct 20, 2005: ISTA Pharmaceuticals Announces Phase III Data Demonstrating that a Single Intravitreous Injection of Vitrase Results in
         Improved Visual Acuity. ..............................................................................................................................................................................56
         Aug 20, 2003: FDA Grants Priority Review for ISTA Pharmaceuticals' Vitrase NDA....................................................................................57
         Jun 19, 2006: ISTA Pharmaceuticals Expands Product Pipeline With Two Licensing Agreements For Exclusive North American Rights To
         Investigational Glaucoma Treatments .........................................................................................................................................................57
         Jun 19, 2006: ISTA Pharmaceuticals Expands Product Pipeline With Two Licensing Agreements For Exclusive North American Rights To
         Investigational Glaucoma Treatments .........................................................................................................................................................58
         Dec 18, 2003: ISTA Pharmaceuticals Announces Achievement of Phase III Patient Enrollment Goal for Xibrom ........................................58
         Dec 17, 2009: ISTA Pharmaceuticals Submits New Drug Application Of XiDay For The Treatment Of Ocular Inflammation With The FDA 59
         Dec 17, 2002: ISTA Pharmaceuticals Announces FDA Acceptance of Vitrase NDA....................................................................................59
         Nov 17, 2010: ISTA Pharmaceuticals Granted Three-Year Market Exclusivity for BROMDAY ....................................................................60
         Nov 17, 2010: ISTA Pharmaceuticals Receives Three-Year Market Exclusivity For BROMDAY .................................................................60
         Oct 17, 2005: STA Pharmaceuticals' Xibrom Receives Award for Best New Branded Pharmaceutical Introduction in 2005. ......................61
         Oct 16, 2010: ISTA Receives FDA Approval For BROMDAY ......................................................................................................................61
         Sep 16, 2010: ISTA Pharmaceuticals Initiates Phase III Clinical Program For REMURA In Dry Eye Disease..............................................62
         Dec 14, 2010: ISTA Begins Phase II Study Of Bepotastine Besilate Nasal Spray In Allergic Rhinitis ..........................................................62
         Jul 14, 2010: ISTA Initiates Clinical Development Of Bepotastine Besilate Nasal Spray For Treatment Of Symptoms Associated With
         Seasonal Allergic Rhinitis............................................................................................................................................................................63
         Jul
								
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