|
Sections |
| Title | Starting Page | Number of Pages |
|---|
| I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS | 1 | 1 |
| STUDY RELIABILITY AND REPORTING LIMITATIONS | 1 | 1 |
| DISCLAIMERS | 2 | 1 |
| DATA INTERPRETATION & REPORTING LEVEL | 2 | 1 |
| Quantitative Techniques & Analytics | 2 | 1 |
| PRODUCT DEFINITIONS AND SCOPE OF STUDY | 3 | 1 |
| INTRANASAL DRUG DELIVERY -A US MARKET REPORT | 4 | 1 |
| INDUSTRY OVERVIEW | 4 | 1 |
| Drug Delivery: A Quick Primer | 4 | 1 |
| The Nose: An Attractive Avenue to Cross the Blood Brain Barrier | 4 | 1 |
| Self-Administration of Drugs Brings Intranasal Drug Delivery Into the Spotlight | 5 | 1 |
| Research & Technology Opens Up New Therapeutic Areas for Nasal Drug Delivery | 5 | 1 |
| Recent Product Developments in the US Intranasal Drug Delivery Market (2007) | 5 | 1 |
| Company Device/Technology | 5 | 1 |
| Drug Name 2005 | 6 | 1 |
| R&D: Critical to the Commercialization of Intranasal Drug Delivery | 6 | 1 |
| Tight Junction Biology: A Key Speed Breaker in Commercialization | 6 | 1 |
| RNA Interference (RNAi): A Tool To Manipulate Tight Junctions | 7 | 1 |
| Why Is Nasal Drug Delivery the Theme of All Drug Delivery Research Projects? | 7 | 1 |
| Nasal Drug Delivery Devices & Equipments | 7 | 1 |
| Preservative Free Systems (P.F.S.) | 7 | 2 |
| Traditional Vs Advanced Intranasal Drug Delivery Devices | 9 | 1 |
| Pitfalls Of Traditional Delivery Devices | 9 | 1 |
| The Promise of New Advanced Delivery Devices | 9 | 1 |
| Bi-Directional Nasal Drug Delivery: A Technology With a Huge Potential | 9 | 1 |
| Benefits of Bi-Directional Delivery Authenticated Through Research Studies | 10 | 1 |
| Market for Nasal Spray Devices in the US | 10 | 1 |
| GSK Wields the Leadership Scepter in the US Intranasal Drugs Market | 11 | 1 |
| The Batting Order | 11 | 1 |
| Company 2004 2005 2006 | 11 | 1 |
| Total 100.00 100.00 100.00 | 11 | 1 |
| MARKET DYNAMICS | 12 | 1 |
| Innovation in Drug Delivery: A Talisman For Success | 12 | 1 |
| Controlled Release Technology Is the Buzz Word | 12 | 1 |
| Target-Specific Delivery Devices: Of Critical Value | 12 | 1 |
| Safety and Cost: Primary Growth Drivers | 12 | 1 |
| Preservatives Losing Sheen in Nasal Spray Formulations | 13 | 1 |
| Multi-Dose Containers Evolve to Offer Resistance Against Microbial Contamination | 13 | 1 |
| Bioavailability: An Important Facet of Intranasal Drug Delivery | 13 | 1 |
| Chemical Modification | 13 | 1 |
| Transient Modification & Limited Enzymatic Activity | 14 | 1 |
| Bioavailability of Large Molecules | 14 | 1 |
| Bio-Adhesive Polymers: Useful in Increasing Drug Absorption | 14 | 1 |
| Mixed Opinions on Efficiency of Calcitonin Nasal Spray | 14 | 1 |
| Nasal Preparations Gaining Foothold in Cough and Allergic Categories | 14 | 1 |
| Patent Expiries Impact Market Opportunities | 15 | 1 |
| TECHNOLOGY OVERVIEW | 16 | 1 |
| Intranasal Drug Delivery: A Descriptive Exposition | 16 | 1 |
| Nasal Physiology | 16 | 1 |
| Challenges Involved In Formulating Nasal Drugs | 17 | 1 |
| The Importance of Bioadhesion | 18 | 1 |
| Challenges Involved In Designing Devices | 18 | 1 |
| Overview on the Traditional Drug Administration Routes, Molecular Weight Capabilities, and Dosage Range | 18 | 1 |
| DrugAdministrationRoute Molecular Weight Capabilities Dosage Range | 18 | 2 |
| Intranasal Drugs-Prescription (Rx) and Over-the-Counter (OTC) | 19 | 1 |
| Differences Between Systemic Delivery and Local Effects | 19 | 1 |
| Systemic Delivery Local Effects | 19 | 1 |
| Nasal Powders Vs Sprays | 19 | 1 |
| Nasal Drug Delivery Devices | 20 | 1 |
| Types of Drug Delivery Devices | 20 | 1 |
| Droppers | 20 | 1 |
| Sprays | 20 | 1 |
| Aerosol Containers/Inhalers | 20 | 1 |
| Pumps | 21 | 1 |
| Nasal Aspirator | 21 | 1 |
| Intranasal Drug Delivery Vis-a-vis Other Delivery Techniques | 21 | 1 |
| Drug Type Percentage Share 2006 2012 | 21 | 1 |
| Total 100.00 100.00 | 21 | 1 |
| Limitations of Intranasal Drug Delivery | 22 | 1 |
| Allergy | 22 | 1 |
| Definition | 22 | 1 |
| Symptoms | 22 | 1 |
| Allergic Rhinitis | 23 | 1 |
| Nasal Allergies | 23 | 1 |
| Brands Dollar Sales | 23 | 1 |
| Brands Unit Sales | 24 | 1 |
| Nasal Spray Dollar Sales | 24 | 1 |
| NASAL DRUGS: AN OVERVIEW | 25 | 1 |
| Nasal Drugs For Allergies | 25 | 1 |
| Corticosteroid Nasal Sprays | 25 | 1 |
| Flonase | 25 | 1 |
| Patanase | 25 | 1 |
| Beconase | 25 | 1 |
| Other Nasal Corticosteroid Drugs | 26 | 1 |
| Antihistamine Nasal Sprays | 26 | 1 |
| Astelin Nasal Spray | 26 | 1 |
| Otrivin Nasal Spray | 26 | 1 |
| Livostin Nasal Spray | 26 | 1 |
| Other Nasal Antihistamine Drugs | 26 | 1 |
| Other Brands of Allergy Relievers | 27 | 1 |
| Nasal Spray Company Active Ingredient Year of Patent Expiry | 27 | 1 |
| Nasal Drugs for Postmenopausal Osteoporosis | 27 | 1 |
| Calcitonin-Salmon Nasal Spray | 27 | 1 |
| Miacalcin Nasal Spray | 27 | 1 |
| Fortical (R) Nasal Spray | 27 | 1 |
| Intranasal Pain Management Drugs | 27 | 1 |
| Stadol Nasal Spray | 28 | 1 |
| Rylomine | 28 | 1 |
| Imitrex | 28 | 1 |
| Migranal | 29 | 1 |
| Zolmitriptan Nasal Spray | 29 | 1 |
| Intranasal Analgesics For Treating Migraine | 29 | 1 |
| Analgesic Company Year of Patent Expiry | 29 | 1 |
| Select Intranasal Pain Management Products in Development | 29 | 1 |
| Company Name of the Product Status | 29 | 1 |
| Intranasal Vaccination | 30 | 1 |
| Process of Intranasal Immunization | 30 | 1 |
| Market Drivers | 31 | 1 |
| "LAIV" Nasal Spray Flu Vaccine | 31 | 1 |
| FluMist (R) Vaccine From MedImmune | 31 | 1 |
| Intranasal Drugs for Sexual Dysfunction | 32 | 1 |
| Year Revenues | 32 | 1 |
| Nasal Spray for Treating Vitamin B12 Deficiency | 33 | 1 |
| Nasal Spray for Aiding Smoking Cessation | 33 | 1 |
| Intranasal Drugs In the Pipeline | 33 | 1 |
| Company Drug Status | 33 | 1 |
| RESEARCH & DEVELOPMENT | 34 | 1 |
| Year 2008 in Review | 34 | 1 |
| Nastech Enrolls 551 Patients for Phase 2 Trials of PYY3-36 Nasal Spray | 34 | 1 |
| Year 2007 in Review | 34 | 1 |
| Archimedes Pharma Commences Phase III Trials for NasalFent (R) | 34 | 1 |
| Archimedes Presents New Clinical Data on NasalFent (R) | 34 | 1 |
| Javelin Pharmaceuticals Reveals Phase 2 Study Results for PMI-100/150 | 34 | 1 |
| Javelin Pharmaceuticals Commences Phase III Studies for PMI-150 | 35 | 1 |
| Nastech Commences Phase 2 Trials for Insulin Nasal Spray | 35 | 1 |
| ACAAI Reveals Results for Trials of Nasacort (R) AQ Nasal Spray in Children | 35 | 1 |
| Year 2006 in Review | 36 | 1 |
| TGAR01H from Fabre Kramer | 36 | 1 |
| Aegis Therapeutics Completes First Human Clinical Study on Intravail (R) | 36 | 1 |
| Nastech Pharmaceutical Presents Clinical Test Results on Parathyroid Hormone | 36 | 1 |
| Zolmitriptan Promises Relief for Cluster Headaches | 36 | 1 |
| CAIV-T: More Effective than Injectable Influenza Vaccines | 37 | 1 |
| Intranasal Therapeutics Conducts Study on Midazolam | 37 | 1 |
| Nastech Announces Phase I Results of Insulin Nasal Spray | 37 | 1 |
| Archimedes Completes Phase II Trials of NASALFENT | 38 | 1 |
| Intranasal Corticosteroid Proven Effective for Treating Allergic Rhinitis | 38 | 1 |
| Year 2005 in Review | 38 | 1 |
| Aegis Files DMF for Intravail | 38 | 1 |
| Nasal Sprays: A New-Generation Treatment for Gynecological Problems | 38 | 1 |
| Aegis Therapeutics Conducts Feasibility Study on Drug Delivery Technology | 39 | 1 |
| GelVac Powder Delivery System Completes Phase I Clinical Trial | 39 | 1 |
| DelSite Files DMF with the FDA | 40 | 1 |
| OptiNose Develops Intranasal Delivery System for Osteoporosis | 40 | 1 |
| Nastech Initiates Dose Ranging Study of PYY (3-36) | 40 | 1 |
| Valois Develops New Nasal Dispensing System | 40 | 1 |
| Rigel Pharmaceuticals to Initiate R112 Phase II Clinical Trial | 41 | 1 |
| MedPointe Pharmaceuticals Demonstrates ACT1 Study Results on ASTELIN (R) | 41 | 1 |
| Year 2004 in Review | 41 | 1 |
| Bentley Pharmaceuticals Demonstrates Clinical Trial Results of its Intra Nasal Insulin Spray | 41 | 1 |
| RECENT TECHNOLOGICAL DEVELOPMENTS | 42 | 1 |
| New-Generation Technologies and Devices | 42 | 1 |
| ViaNase from Kurve Technology | 42 | 1 |
| A New Product from OptiNose | 42 | 1 |
| Nastech's "Tight Junction Biology" Research Program | 43 | 1 |
| ChiSys (TM) Nasal Delivery Technology from Archimedes | 43 | 1 |
| PRODUCT INNOVATIONS/INTRODUCTIONS | 44 | 1 |
| Year 2006 in Review | 44 | 1 |
| Aegis Therapeutics Develops ProTek (TM) | 44 | 1 |
| Heel Launches Luffeel (R) in the US | 44 | 1 |
| Palatin Technologies to Develop Bremelanotide | 44 | 1 |
| Archimedes to Introduce Intranasal Formulation of Human Growth Hormone | 44 | 1 |
| Sinofresh Launches SinoFresh (TM) Nasal & Sinus Care | 44 | 1 |
| PARI Respiratory Launches Nasal Drug Delivery Program | 45 | 1 |
| Year 2005 in Review | 45 | 1 |
| OptiNose to Develop New Range of Intranasal Products | 45 | 1 |
| OptiNose and Cambridge Consultants to Develop Advanced Nasal Delivery Device | 45 | 1 |
| Kurve Technology Develops ViaNase ID (TM) | 45 | 1 |
| Upsher-Smith Introduces Fortical (R) Nasal Spray | 46 | 1 |
| Schering-Plough Launches New Formulation of NASONEX (R) | 46 | 1 |
| Year 2000 in Review | 46 | 1 |
| AstraZeneca Unveils Rhinocort Aqua in the US | 46 | 1 |
| RECENT INDUSTRY ACTIVITY | 47 | 1 |
| Year 2008 in Review | 47 | 1 |
| Zelos Therapeutics Collaborates with Aegis Therapeutics | 47 | 1 |
| ImmuneRegen BioSciences Partners with LRRI | 47 | 1 |
| Avamys (TM) Nasal Spray Receives Approval in Europe | 47 | 1 |
| PMI-150 Receives Canadian Patent | 47 | 1 |
| Year 2007 in Review | 48 | 1 |
| USFDA Approves FluMist (R) for Young Children | 48 | 1 |
| USFDA Approves Veramyst Nasal Spray for Individuals Aged Two Years and Above | 48 | 1 |
| Kurve Technology Inks Agreement with Schering-Plough | 48 | 1 |
| MedImmune Clarifies FDA Observations | 48 | 1 |
| FluMist (R) Receives FDA Approval for Refrigerated Formulation | 48 | 1 |
| Nastech Regains Rights for PTH1-34 Nasal Spray | 48 | 1 |
| NASONEX (R) Receives Ease-of-Use Commendation from Arthritis Foundation | 49 | 1 |
| Aegis Therapeutics Establishes Cedar Therapeutics Inc. | 49 | 1 |
| EMEA Provides Encouraging Feedback for Avamys (TM) Nasal Spray | 49 | 1 |
| Kurve Technologies Introduces Blog on Nasal Drug Delivery | 49 | 1 |
| Year 2006 in Review | 49 | 1 |
| Accentia Extends Agreement with Mayo Foundation | 49 | 1 |
| Nastech Signs Development and License Agreement with Amylin | 50 | 1 |
| MedImmune's FluMist Plant Gets FDA Approval | 50 | 1 |
| ShinNippon Subsidiaries Sign Licensing Agreement with Tokai Pharmaceuticals | 50 | 1 |
| MeadWestvaco Acquires Saint-Gobain Calmar | 50 | 1 |
| Merck Terminates PYY3-36 Partnership with Nastech | 50 | 1 |
| Inspire Signs Licensing Agreement with Boehringer Ingelheim | 51 | 1 |
| P&G Partners with Nastech to Develop PTH (1-34) | 51 | 1 |
| Unigene Laboratories Signs Distribution Agreement with Tzamal Bio Pharma | 52 | 1 |
| GlaxoSmithKline Seeks Marketing Approval for Fluticasone Furoate in the US and Europe | 52 | 1 |
| Kurve Technology Relocates Corporate Headquarters | 52 | 1 |
| Kurve Inks an Agreement with DARA BioSciences | 52 | 1 |
| Kurve Enters into a Development Agreement with Schering-Plough | 52 | 1 |
| Altana Submits NDS for Approval of Ciclesonide Nasal Spray in Canada | 52 | 1 |
| Altana Pharma AG Receives FDA Approval for Pediatric Use of Omnaris | 53 | 1 |
| Intranasal Therapeutics Inc. Receives Financial Funding | 53 | 1 |
| FDA Completes Pre-Approval Inspections at Nastech's Washington Facility | 53 | 1 |
| Kos Signs Exclusive License Agreement with SkyePharma | 53 | 1 |
| Year 2005 in Review | 53 | 1 |
| Bentley Signs Agreement with Biocon | 53 | 1 |
| MedImmune Files New Drug Application with the FDA | 54 | 1 |
| Intranasal Therapeutics Files Patent Application for Synthetic THC | 54 | 1 |
| Ionix Pharmaceuticals in Collaboration with Reckitt Benckiser for Drug Development | 54 | 1 |
| University of Kentucky Receives Patent for new Intranasal Device | 54 | 1 |
| Intranasal Technology Extends Collaboration with Aegis Therapeutics | 55 | 1 |
| Accentia Biopharmaceuticals Signs License Agreement with Collegium Pharmaceuticals | 55 | 1 |
| Aegis Therapeutics Extends License Agreement with Intranasal Technologies | 55 | 1 |
| Bentley Pharmaceuticals Signs Agreement with Dong Sung Pharmaceuticals | 55 | 1 |
| Unigene Gets FDA Approval for Fortical Calcitonin-Salmon Nasal Spray | 56 | 1 |
| OptiNose Signs Collaborative Agreement with MedPharm | 56 | 1 |
| West Pharmaceutical Divests Drug Delivery Business to Archimedes Pharma | 56 | 1 |
| Nastech Pharmaceutical Receives FDA Approval for Nascobal Nasal Spray | 56 | 1 |
| Year 2004 in Review | 56 | 1 |
| Par and Nastech Sign Licensing Agreement | 56 | 1 |
| Aegis Therapeutics Signs Licensing Agreement With University of Alabama | 57 | 1 |
| Year 2003 in Review | 57 | 1 |
| ITI Receives a Patent for Sedation Inducing Nasal Drug | 57 | 1 |
| Inyx Bags Order from Australian OTC Drug Company | 57 | 1 |
| FOCUS ON SELECT GLOBAL PLAYERS | 58 | 1 |
| Aegis Therapeutics LLC (USA) | 58 | 1 |
| Alza Corporation (USA) | 58 | 1 |
| AptarGroup, Inc. (USA) | 58 | 1 |
| Archimedes Pharma Limited. (UK) | 59 | 1 |
| AstraZeneca Plc (UK) | 59 | 1 |
| MedImmune, Inc. (USA) | 59 | 1 |
| Bayer Consumer Care (USA) | 60 | 1 |
| Bespak Plc (UK) | 60 | 1 |
| GlaxoSmithKline Plc (UK) | 60 | 1 |
| Intranasal Therapeutics, Inc. (USA) | 61 | 1 |
| Javelin Pharmaceuticals, Inc (USA) | 61 | 1 |
| Kurve Technology, Inc. (USA) | 61 | 1 |
| Nastech Pharmaceutical Company, Inc. (USA) | 61 | 1 |
| Novartis AG (Switzerland) | 62 | 1 |
| OptiNose AS (Norway) | 62 | 1 |
| Pfizer, Inc. (USA) | 62 | 1 |
| Rexam Plc (UK) | 63 | 1 |
| Schering-Plough Corporation (USA) | 63 | 1 |
| Sanofi-Aventis S.A. (France) | 63 | 1 |
| Unigene Laboratories, Inc. (USA) | 63 | 1 |
| MARKET ANALYTICS | 64 | 1 |
| Long-term Projections | 64 | 1 |
