Intranasal Drug Delivery

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

• Study Reliability and Reporting Limitations
• Disclaimers
• Data Interpretation & Reporting Level
• Quantitative Techniques & Analytics
• Product Definitions And Scope of Study

II. A US MARKET REPORT

1. Industry Overview

• Drug Delivery: A Quick Primer
• The Nose: An Attractive Avenue to Cross the Blood Brain Barrier
• Self-Administration of Drugs Brings Intranasal Drug Delivery Into the Spotlight
• Research & Technology Opens Up New Therapeutic Areas for Nasal Drug Delivery
• Recent Product Developments in the US Intranasal Drug Delivery Market (2007)
• Table 1: The US Nasal Drug Delivery Market: Sales Of Top Six Nasal Formulations for The Year 2005 (In US$ Million) (includes corresponding Graph/Chart)
• R&D: Critical to the Commercialization of Intranasal Drug Delivery
• Tight Junction Biology: A Key Speed Breaker in Commercialization
• RNA Interference (RNAi): A Tool To Manipulate Tight Junctions
• Why Is Nasal Drug Delivery the Theme of All Drug Delivery Research Projects?
• Nasal Drug Delivery Devices & Equipments
• Preservative Free Systems (P.F.S.)
• Traditional Vs Advanced Intranasal Drug Delivery Devices
• Pitfalls Of Traditional Delivery Devices
• The Promise of New Advanced Delivery Devices
• Bi-Directional Nasal Drug Delivery: A Technology With a Huge Potential
• Benefits of Bi-Directional Delivery Authenticated Through Research Studies
• Market for Nasal Spray Devices in the US
• GSK Wields the Leadership Scepter in the US Intranasal Drugs Market
• The Batting Order
• Table 2: US Market for Intranasal Drug Delivery (2004-2006): Percentage Market Share Breakdown of Leading Players - GlaxoSmithKline, Schering-Plough, AstraZeneca, Sanofi-Aventis, and Others (includes corresponding Graph/Chart)

2. Market Dynamics

• Innovation in Drug Delivery: A Talisman For Success
• Controlled Release Technology Is the Buzz Word
• Target-Specific Delivery Devices: Of Critical Value
• Safety and Cost: Primary Growth Drivers
• Preservatives Losing Sheen in Nasal Spray Formulations
• Multi-Dose Containers Evolve to Offer Resistance Against Microbial Contamination
• Bioavailability: An Important Facet of Intranasal Drug Delivery
• Chemical Modification
• Transient Modification & Limited Enzymatic Activity
• Bioavailability of Large Molecules
• Bio-Adhesive Polymers: Useful in Increasing Drug Absorption
• Mixed Opinions on Efficiency of Calcitonin Nasal Spray
• Nasal Preparations Gaining Foothold in Cough and Allergic Categories
• Patent Expiries Impact Market Opportunities

3. Technology Overview

• Intranasal Drug Delivery: A Descriptive Exposition
• Nasal Physiology
• Challenges Involved In Formulating Nasal Drugs
• The Importance of Bioadhesion
• Challenges Involved In Designing Devices
• Overview on the Traditional Drug Administration Routes, Molecular Weight Capabilities, and Dosage Range
• Intranasal Drugs - Prescription (Rx) and Over-the- Counter (OTC)
• Differences Between Systemic Delivery and Local Effects
• Nasal Powders Vs Sprays
• Nasal Drug Delivery Devices
• Types of Drug Delivery Devices
• Droppers
• Sprays
• Aerosol Containers/Inhalers
• Pumps
• Nasal Aspirator
• Intranasal Drug Delivery Vis-a-vis Other Delivery Techniques
• Table 3: US Market for Intranasal Drugs: Percentage share of Topical and Systemic Drugs by value for the Years 2006 and 2012
• Limitations of Intranasal Drug Delivery
• Allergy
• Definition
• Symptoms
• Allergic Rhinitis
• Nasal Allergies
• Table 4: US Market for Nasal Sprays, Drops and Inhalers: Top 10 Brands Ranked by Dollar Sales Through Drug Stores for the Year Ended January 2008 (In US $ Million) (includes corresponding Graph/Chart)
• Table 5: US Market for Nasal Sprays, Drops and Inhalers: Top 10 Brands Ranked by Unit Sales Through Drug Stores for the Year Ended January 2008 (In Thousand Units) (includes corresponding Graph/Chart)
• Table 6: US Market for Nasal Sprays: Top Five Nasal Sprays for Cough, Cold, Sinus and Allergy Ranked by Dollar Retail Sales for the Year Ended January 2008 (In US $ Million) (includes corresponding Graph/Chart)

4. Nasal Drugs: An Overview

• Nasal Drugs For Allergies
• Corticosteroid Nasal Sprays
• Flonase
• Patanase
• Beconase
• Other Nasal Corticosteroid Drugs
• Antihistamine Nasal Sprays
• Astelin Nasal Spray
• Otrivin Nasal Spray
• Livostin Nasal Spray
• Other Nasal Antihistamine Drugs
• Other Brands of Allergy Relievers
• Nasal Drugs for Postmenopausal Osteoporosis
• Calcitonin-Salmon Nasal Spray
• Miacalcin Nasal Spray
• Fortical® Nasal Spray
• Intranasal Pain Management Drugs
• Stadol Nasal Spray
• Rylomine
• Imitrex
• Migranal
• Zolmitriptan Nasal Spray
• Intranasal Analgesics For Treating Migraine
• Select Intranasal Pain Management Products in Development
• Intranasal Vaccination
• Process of Intranasal Immunization
• Market Drivers
• "LAIV" Nasal Spray Flu Vaccine
• FluMist® Vaccine From MedImmune
• Intranasal Drugs for Sexual Dysfunction
• Table 7: US Market for Intranasal Drugs: Projected Revenues for Intranasal Sexual Dysfunction Drugs for the Years 2010 through 2012 in US$ Million (includes corresponding Graph/Chart)
• Nasal Spray for Treating Vitamin B12 Deficiency
• Nasal Spray for Aiding Smoking Cessation
• Intranasal Drugs In the Pipeline

5. Research & Development

• Nastech Enrolls 551 Patients for Phase 2 Trials of PYY3-36 Nasal Spray
• Archimedes Pharma Commences Phase III Trials for NasalFent®
• Archimedes Presents New Clinical Data on NasalFent®
• LigoCyte Commences Clinical Trials for Intranasal Norovirus Vaccine
• Javelin Pharmaceuticals Reveals Phase 2 Study Results for PMI-100/150
• Javelin Pharmaceuticals Commences Phase III Studies for PMI-150
• Nastech Commences Phase 2 Trials for Insulin Nasal Spray
• ACAAI Reveals Results for Trials of Nasacort® AQ Nasal Spray in Children
• TGAR01H from Fabre Kramer
• Aegis Therapeutics Completes First Human Clinical Study on Intravail®
• Nastech Pharmaceutical Presents Clinical Test Results on Parathyroid Hormone
• Zolmitriptan Promises Relief for Cluster Headaches
• CAIV-T: More Effective than Injectable Influenza Vaccines
• Intranasal Therapeutics Conducts Study on Midazolam
• Nastech Announces Phase I Results of Insulin Nasal Spray
• Archimedes Completes Phase II Trials of NASALFENT
• Intranasal Corticosteroid Proven Effective for Treating Allergic Rhinitis
• Aegis Files DMF for Intravail
• Nasal Sprays: A New-Generation Treatment for Gynecological Problems
• Aegis Therapeutics Conducts Feasibility Study on Drug Delivery Technology
• GelVac Powder Delivery System Completes Phase I Clinical Trial
• DelSite Files DMF with the FDA
• OptiNose Develops Intranasal Delivery System for Osteoporosis
• Nastech Initiates Dose Ranging Study of PYY(3-36)
• Valois Develops New Nasal Dispensing System
• Rigel Pharmaceuticals to Initiate R112 Phase II Clinical Trial
• MedPointe Pharmaceuticals Demonstrates ACT1 Study Results on ASTELIN®
• Bentley Pharmaceuticals Demonstrates Clinical Trial Results of its Intra Nasal Insulin Spray

6. Recent Technological Developments

• New-Generation Technologies and Devices
• ViaNase from Kurve Technology
• A New Product from OptiNose
• Nastech' s "Tight Junction Biology" Research Program
• ChiSys™ Nasal Delivery Technology from Archimedes

7. Product Innovations/Introductions

• Aegis Therapeutics Develops ProTek™
• Heel Launches Luffeel® in the US
• Palatin Technologies to Develop Bremelanotide
• Archimedes to Introduce Intranasal Formulation of Human Growth Hormone
• Sinofresh Launches SinoFresh™ Nasal & Sinus Care
• PARI Respiratory Launches Nasal Drug Delivery Program
• OptiNose to Develop New Range of Intranasal Products
• OptiNose and Cambridge Consultants to Develop Advanced Nasal Delivery Device
• Kurve Technology Develops ViaNase ID™
• Upsher-Smith Introduces Fortical® Nasal Spray
• Schering-Plough Launches New Formulation of NASONEX®
• AstraZeneca Unveils Rhinocort Aqua in the US

8. Recent Industry Activity

• Zelos Therapeutics Collaborates with Aegis Therapeutics
• ImmuneRegen BioSciences Partners with LRRI
• Avamys™ Nasal Spray Receives Approval in Europe
• PMI-150 Receives Canadian Patent
• USFDA Approves FluMist® for Young Children
• USFDA Approves Veramyst Nasal Spray for Individuals Aged Two Years and Above
• Kurve Technology Inks Agreement with Schering-Plough
• MedImmune Clarifies FDA Observations
• FluMist® Receives FDA Approval for Refrigerated Formulation
• Nastech Regains Rights for PTH1-34 Nasal Spray
• NASONEX® Receives Ease-of-Use Commendation from Arthritis Foundation
• Aegis Therapeutics Establishes Cedar Therapeutics Inc.
• EMEA Provides Encouraging Feedback for Avamys™ Nasal Spray
• Kurve Technologies Introduces Blog on Nasal Drug Delivery
• Accentia Extends Agreement with Mayo Foundation
• Nastech Signs Development and License Agreement with Amylin
• MedImmune' s FluMist Plant Gets FDA Approval
• ShinNippon Subsidiaries Sign Licensing Agreement with Tokai Pharmaceuticals
• MeadWestvaco Acquires Saint-Gobain Calmar
• Merck Terminates PYY3-36 Partnership with Nastech
• Inspire Signs Licensing Agreement with Boehringer Ingelheim
• P&G Partners with Nastech to Develop PTH(1-34)
• Unigene Laboratories Signs Distribution Agreement with Tzamal Bio Pharma
• GlaxoSmithKline Seeks Marketing Approval for Fluticasone Furoate in the US and Europe
• Kurve Technology Relocates Corporate Headquarters
• Kurve Inks an Agreement with DARA BioSciences
• Kurve Enters into a Development Agreement with Schering-Plough
• Altana Submits NDS for Approval of Ciclesonide Nasal Spray in Canada
• Altana Pharma AG Receives FDA Approval for Pediatric Use of Omnaris
• Intranasal Therapeutics Inc. Receives Financial Funding
• FDA Completes Pre-Approval Inspections at Nastech' s Washington Facility
• Kos Signs Exclusive License Agreement with SkyePharma
• Bentley Signs Agreement with Biocon
• MedImmune Files New Drug Application with the FDA
• Intranasal Therapeutics Files Patent Application for Synthetic THC
• Ionix Pharmaceuticals in Collaboration with Reckitt Benckiser for Drug Development
• University of Kentucky Receives Patent for new Intranasal Device
• Intranasal Technology Extends Collaboration with Aegis Therapeutics
• Accentia Biopharmaceuticals Signs License Agreement with Collegium Pharmaceuticals
• Aegis Therapeutics Extends License Agreement with Intranasal Technologies
• Bentley Pharmaceuticals Signs Agreement with Dong Sung Pharmaceuticals
• Unigene Gets FDA Approval for Fortical Calcitonin- Salmon Nasal Spray
• OptiNose Signs Collaborative Agreement with MedPharm
• West Pharmaceutical Divests Drug Delivery Business to Archimedes Pharma
• Nastech Pharmaceutical Receives FDA Approval for Nascobal Nasal Spray
• Par and Nastech Sign Licensing Agreement
• Aegis Therapeutics Signs Licensing Agreement with University of Alabama
• ITI Receives a Patent for Sedation Inducing Nasal Drug
• Inyx Bags Order from Australian OTC Drug Company

9. Focus on Select Global Players

• Aegis Therapeutics LLC (USA)
• Alza Corporation (USA)
• AptarGroup, Inc. (USA)
• Archimedes Pharma Limited. (UK)
• AstraZeneca Plc (UK)
• MedImmune, Inc. (USA)
• Bayer Consumer Care (USA)
• Bespak Plc (UK)
• GlaxoSmithKline Plc (UK)
• Intranasal Therapeutics, Inc. (USA)
• Javelin Pharmaceuticals, Inc (USA)
• Kurve Technology, Inc. (USA)
• Nastech Pharmaceutical Company, Inc. (USA)
• Novartis AG (Switzerland)
• OptiNose AS (Norway)
• Pfizer, Inc. (USA)
• Rexam Plc (UK)
• Schering-Plough Corporation (USA)
• Sanofi-Aventis S.A. (France)
• Unigene Laboratories, Inc. (USA)

10. Market Analytics

• Table 8: US Recent Past, Current & Future Analysis for Intranasal Drug Delivery by Therapeutic Area - Allergic Infections, Analgesics, Osteoporosis, and Vaccinations Markets Independently Analyzed by Annual Sales Figures in US$ Million for Years 2000 through 2010
• Table 9: US Long-term Projections for Intranasal Drug Delivery by Therapeutic Area - Allergic Infections, Analgesics, Osteoporosis, and Vaccinations Markets Independently Analyzed by Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)
• Table 10: US 10-Year Perspective for Intranasal Drug Delivery by Therapeutic Area -Percentage Breakdown of Values Sales for Allergic Infections, Analgesics, Osteoporosis, and Vaccinations for Years 2003, 2008 & 2012 (includes corresponding Graph/Chart)

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