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Intranasal Drug Delivery

Published by: Global Industry Analysts

Published: May. 1, 2008 - 219 Pages


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-à-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(R) Receives FDA Approval for Refrigerated Formulation

Nastech Regains Rights for PTH1-34 Nasal Spray

NASONEX(R) 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)

III. COMPETITIVE LANDSCAPE

Total Companies Profiled: 78 (including Divisions/Subsidiaries - 92)

Region/Country Players

The United States 54

Canada 2

Japan 3

Europe 28

France 3

Germany 6

The United Kingdom 13

Rest of Europe 6

Asia-Pacific (Excluding Japan) 2

Middle East 3


Abstract

This report analyzes the US market for Intranasal Drug Delivery in US$ Million. The product is analyzed by the following Therapeutic Areas: Allergic Infections, Analgesics, Osteoporosis, and Vaccinations. Annual forecasts are provided for the period of 2000 through 2015. The report profiles 78 companies including many key and niche players such as Aegis Therapeutics LLC, Alza Corporation, AptarGroup, Inc., Archimedes Pharma, AstraZeneca Plc, MedImmune, Inc., Bayer Consumer Care, Bespak Plc, GlaxoSmithKline Plc, Intranasal Therapeutics, Inc., Javelin Pharmaceuticals, Inc., Kurve Technology, Inc., Nastech Pharmaceutical Company, Inc., Novartis AG, OptiNose AS, Pfizer, Inc., Rexam Plc, Schering-Plough Corporation, Sanofi-Aventis S.A., and Unigene Laboratories, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

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