US Intranasal Drug Delivery Industry

Mar 16, 2011, 16:37 ET from Reportlinker

NEW YORK, March 16, 2011 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

US Intranasal Drug Delivery Industry -

This report analyzes the US market for Intranasal Drug Delivery in US$ Million by the following Therapeutic Areas: Allergic Infections, Analgesics, Osteoporosis, and Vaccinations. Annual estimates and forecasts are provided for the period 2007 through 2015. Also, a six-year historic analysis is provided for this market. The report profiles 75 companies including many key and niche players such as Aegis Therapeutics LLC, Alza Corporation, AptarGroup, Inc., Archimedes Pharma Limited, AstraZeneca Plc, MedImmune, Inc., Bayer Consumer Care, Bespak Plc, GlaxoSmithKline Plc, Ikano Therapeutics Inc., Javelin Pharmaceuticals, Inc., Kurve Technology, Inc., Marina Biotech, Inc., Merck & Co., Inc., Novartis AG, OptiNose AS, Pfizer, Inc., Rexam Plc, 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.





Study Reliability and Reporting Limitations 1

Disclaimers 2

Data Interpretation & Reporting Level 2

Quantitative Techniques & Analytics 3

Product Definitions and Scope of Study 3


Drug Delivery: A Quick Primer 4

The Nose: An Attractive Avenue to Cross the Blood Brain Barrier 4

Self-Administration of Drugs Brings Intranasal Drug Delivery

Into the Spotlight 5

Research & Technology Opens Up New Therapeutic Areas for

Nasal Drug Delivery 5

Product Developments in the US Intranasal Drug Delivery

Market: 2007 6

R&D: Critical to the Commercialization of Intranasal Drug

Delivery 6

Tight Junction Biology: A Key Speed Breaker in

Commercialization 6

RNA Interference (RNAi): A Tool to Manipulate Tight Junctions 7

Why Is Nasal Drug Delivery the Theme of All Drug Delivery

Research Projects? 7

Nasal Drug Delivery Devices & Equipment 7

Preservative Free Systems (P.F.S.) 7

Traditional Vs. Advanced Intranasal Drug Delivery Devices 9

Pitfalls Of Traditional Delivery Devices 9

The Promise of New Advanced Delivery Devices 9

Bi-Directional Nasal Drug Delivery: A Technology With a Huge

Potential 9

Benefits of Bi-Directional Delivery Authenticated Through

Research Studies 10

Market for Nasal Spray Devices in the US 11

GSK Looses Share to Merck, Following Patent Expiry of Flonase 11

Table 1: US Intra-Nasal Steroid Market for Allergic Rhinitis:

Sales of Leading Nasal Formulations for 2008 (includes

corresponding Graph/Chart) 11

Table 2: The US Nasal Drug Delivery Market for Allergic

Rhinitis: Sales Of Top Four Nasal Steroid Formulations for

The Year 2005 (In US$ Million) (includes corresponding

Graph/Chart) 12


Innovation in Drug Delivery: A Talisman For Success 13

Controlled Release Technology Is the Buzz Word 13

Target-Specific Delivery Devices: Of Critical Value 13

Safety and Cost: Primary Growth Drivers 13

Preservatives Losing Sheen in Nasal Spray Formulations 14

Multi-Dose Containers Evolve to Offer Resistance Against

Microbial Contamination 14

Bioavailability: An Important Facet of Intranasal Drug Delivery 14

Chemical Modification 15

Transient Modification & Limited Enzymatic Activity 15

Bioavailability of Large Molecules 15

Bio-Adhesive Polymers: Useful in Increasing Drug Absorption 15

Mixed Opinions on Efficiency of Calcitonin Nasal Spray 15

Nasal Preparations Gaining Foothold in Cough and Allergic

Categories 16

Patent Expiries Impact Market Opportunities 16


Intranasal Drug Delivery: A Descriptive Exposition 17

Nasal Physiology 17

Challenges Involved In Formulating Nasal Drugs 18

The Importance of Bioadhesion 19

Challenges Involved In Designing Devices 19

Overview of the Traditional Drug Administration Routes,

Molecular Weight Capabilities, and Dosage Range 20

Intranasal Drugs - Prescription (Rx) and Over-the- Counter (OTC) 20

Differences Between Systemic Delivery and Local Effects 20

Nasal Powders Vs Sprays 21

Nasal Drug Delivery Devices 21

Types of Drug Delivery Devices 22

Droppers 22

Sprays 22

Aerosol Containers/Inhalers 22

Pumps 22

Nasal Aspirator 22

Intranasal Drug Delivery Vis-à-vis Other Delivery Techniques 22

Table 3: US Market for Intranasal Drugs: Percentage share of

Topical and Systemic Drugs by value for the Years 2006 and

2015 23

Limitations of Intranasal Drug Delivery 23

Allergy 23

Definition 23

Symptoms 24

Allergic Rhinitis 24

Nasal Allergies 24

Table 4: 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) 25

Table 5: 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) 25

Table 6: 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) 26


Nasal Drugs for Allergies 27

Corticosteroid Nasal Sprays 27

Flonase 27

Patanase 27

Beconase 28

Other Nasal Corticosteroid Drugs 28

Antihistamine Nasal Sprays 28

Astelin Nasal Spray 28

Otrivin Nasal Spray 28

Livostin Nasal Spray 28

Other Nasal Antihistamine Drugs 29

Select Brands of Allergy Relievers 29

Nasal Drugs for Postmenopausal Osteoporosis 29

Calcitonin-Salmon Nasal Spray 29

Miacalcin Nasal Spray 29

Fortical® Nasal Spray 29

Intranasal Pain Management Drugs 30

Stadol Nasal Spray 30

Rylomine 31

Imitrex 31

Migranal 31

Zolmitriptan Nasal Spray 31

Intranasal Analgesics For Treating Migraine 31

Select Intranasal Pain Management Products in Development 32

Intranasal Vaccination 32

Process of Intranasal Immunization 33

Market Drivers 33

"LAIV" Nasal Spray Flu Vaccine 34

FluMist® Vaccine From MedImmune 34

Intranasal Drugs for Sexual Dysfunction 34

Table 7: US Market for Intranasal Sexual Dysfunction Drugs:

Revenues for the Years 2010 through 2012 in US$ Million

(includes corresponding Graph/Chart) 35

Nasal Spray for Treating Vitamin B12 Deficiency 35

Nasal Spray for Aiding Smoking Cessation 35

Intranasal Drugs in Pipeline: 2008 and 2009 36

Other Intranasal Drugs in Pipeline 37


Nastech Enrolls 551 Patients for Phase 2 Trials of PYY3-36

Nasal Spray 38

Archimedes Pharma Commences Phase III Trials for NasalFent® 38

Archimedes Presents New Clinical Data on NasalFent® 38

LigoCyte Commences Clinical Trials for Intranasal Norovirus

Vaccine 38

Javelin Pharmaceuticals Reveals Phase 2 Study Results for PMI

-100/150 39

Javelin Pharmaceuticals Commences Phase III studies for PMI-150 39

Nastech Commences Phase 2 Trials for Insulin Nasal Spray 39

ACAAI Reveals Results for Trials of Nasacort® AQ Nasal Spray

in Children 39

TGAR01H from Fabre Kramer 40

Aegis Therapeutics Completes First Human Clinical Study on

Intravail® 40

Nastech Pharmaceutical Presents Clinical Test Results on

Parathyroid Hormone 40

Zolmitriptan Promises Relief for Cluster Headaches 41

CAIV-T: More Effective than Injectable Influenza Vaccines 41

Intranasal Therapeutics Conducts Study on Midazolam 41

Nastech Announces Phase I Results of Insulin Nasal Spray 42

Archimedes Completes Phase II Trials of NASALFENT 42

Intranasal Corticosteroid Proven Effective for Treating

Allergic Rhinitis 42

Aegis Files DMF for Intravail 43

Nasal Sprays: A New-Generation Treatment for Gynecological

Problems 43

Aegis Therapeutics Conducts Feasibility Study on Drug Delivery

Technology 43

GelVac Powder Delivery System Completes Phase I Clinical Trial 44

OptiNose Develops Intranasal Delivery System for Osteoporosis 44

Nastech Initiates Dose Ranging Study of PYY(3-36) 45

Valois Develops New Nasal Dispensing System 45

Rigel Pharmaceuticals to Initiate R112 Phase II Clinical Trial 45

MedPointe Pharmaceuticals Demonstrates ACT1 Study Results on


Bentley Pharmaceuticals Demonstrates Clinical Trial Results of

its Intra Nasal Insulin Spray 46


New-Generation Technologies and Devices 47

ViaNase from Kurve Technology 47

A New Product from OptiNose 47

Nastech's "Tight Junction Biology" Research Program 48

ChiSys™ Nasal Delivery Technology from Archimedes 48


TheraBiogen to Introduce TheraMax Cold & Flu Nasal Spray 49

Sinus Dynamics™ Unveils NasaTouch™ Nasal Delivery Device 49

3M Drug Delivery Systems Introduces Nasal MDI 49

MeadWestvaco Introduces Preservative-Free Nasal Pumps 49

GlaxoSmithKline Introduces Avamys Nasal Spray 50



Aegis Therapeutics Develops ProTek™ 51

Heel Launches Luffeel® in the US 51

Archimedes to Introduce Intranasal Formulation of Human Growth

Hormone 51

Sinofresh Launches SinoFresh™ Nasal & Sinus Care 51

PARI Respiratory Launches Nasal Drug Delivery Program 52

OptiNose to Develop New Range of Intranasal Products 52

OptiNose and Cambridge Consultants to Develop Advanced Nasal

Delivery Device 52

Kurve Technology Develops ViaNase ID™ 52

Upsher-Smith Introduces Fortical® Nasal Spray 53

Schering-Plough Launches New Formulation of NASONEX® 53

AstraZeneca Unveils Rhinocort Aqua in the US 53


Upsher-Smith Acquires ITI-111 from Ikano Therapeutics 54

Hospira Acquires Javelin Pharmaceuticals 54

Archimedes Pharma Receives Approval for PecFent Nasal Spray 54

Cypress Bioscience Obtains Patent Rights for Carbetocin Therapy 55

MDRNA, Inc. Announces Change of Name 55

Prosonix Inks Product Co-Development and Licensing with Trimel

Biopharma 55

Serenity Pharmaceuticals and Allergan Sign Agreement 56

Ethicon Acquires Acclarent 56

Ikano's Midazolam Obtains Orphan Drug Designation 56

FDA Issues Not-Approvable Letter for Nastech's Generic

Calcitonin-Salmon 56

Trimel BioPharma Acquires Direct Haler 57

Lupin Takes Over AllerNaze™ Rights from Collegium Pharmaceutical 57

Nanotherapeutics Purchases DelSite Assets 57

Schering-Plough Merges with Merck 58

Valois Pharma and Nycomed Launch Spray Pump for Fentanyl 58

Phylogica and Aegis Therapeutics Collaborate 58

Intranasal Therapeutics is Now Ikano Therapeutics 58

FDA Clears Use of New Clone in Calcitonin Production of Unigene 58

Zelos Therapeutics Collaborates with Aegis Therapeutics 59

ImmuneRegen BioSciences Partners with LRRI 59

Avamys™ Nasal Spray Receives Approval in Europe 59

PMI-150 Receives Canadian Patent 59


Javelin Releases Phase III Data of Rylomine Intranasal Morphine 60

FDA Recommends Supplemental Study for Javelin's PMI-150 60

Palatin Re-Acquires Bremelanotide Rights from King Pharma 60

USFDA Approves FluMist® for Young Children 61

USFDA Approves Veramyst Nasal Spray for Individuals Aged Two

Years and Above 61

Kurve Technology Inks Agreement with Schering-Plough 61

MedImmune Clarifies FDA Observations 61

FluMist(R) Receives FDA Approval for Refrigerated Formulation 61

Nastech Regains Rights for PTH1-34 Nasal Spray 61

NASONEX(R) Receives Ease-of-Use Commendation from Arthritis

Foundation 62

Aegis Therapeutics Establishes Cedar Therapeutics Inc. 62

EMEA Provides Encouraging Feedback for Avamys™ Nasal Spray 62

Kurve Technologies Introduces Blog on Nasal Drug Delivery 62

Accentia Extends Agreement with Mayo Foundation 62

Nastech Signs Development and License Agreement with Amylin 63

MedImmune's FluMist Plant Gets FDA Approval 63

ShinNippon Subsidiaries Sign Licensing Agreement with Tokai

Pharmaceuticals 63

MeadWestvaco Acquires Saint-Gobain Calmar 63

Merck Terminates PYY3-36 Partnership with Nastech 64

Inspire Signs Licensing Agreement with Boehringer Ingelheim 64

P&G Partners with Nastech to Develop PTH(1-34) 64

Unigene Laboratories Signs Distribution Agreement with Tzamal

Bio Pharma 65

GlaxoSmithKline Seeks Marketing Approval for Fluticasone

Furoate in the US and Europe 65

Kurve Technology Relocates Corporate Headquarters 65

Kurve Inks an Agreement with DARA BioSciences 65

Kurve Enters into a Development Agreement with Schering-Plough 66

Altana Submits NDS for Approval of Ciclesonide Nasal Spray in

Canada 66

Altana Pharma AG Receives FDA Approval for Pediatric Use of

Omnaris 66

Intranasal Therapeutics Inc. Receives Financial Funding 66

FDA Completes Pre-Approval Inspections at Nastech's Washington

Facility 66

Kos Signs Exclusive License Agreement with SkyePharma 67

Bentley Signs Agreement with Biocon 67

Intranasal Therapeutics Files Patent Application for Synthetic

THC 67

Ionix Pharmaceuticals in Collaboration with Reckitt Benckiser

for Drug Development 67

University of Kentucky Receives Patent for new Intranasal Device 68

Intranasal Technology Extends Collaboration with Aegis

Therapeutics 68

Accentia Biopharmaceuticals Signs License Agreement with

Collegium Pharmaceuticals 68

Aegis Therapeutics Extends License Agreement with Intranasal

Technologies 69

Bentley Pharmaceuticals Signs Agreement with Dong Sung

Pharmaceuticals 69

Unigene Gets FDA Approval for Fortical Calcitonin- Salmon

Nasal Spray 69

OptiNose Signs Collaborative Agreement with MedPharm 69

West Pharmaceutical Divests Drug Delivery Business to

Archimedes Pharma 70

Nastech Pharmaceutical Receives FDA Approval for Nascobal

Nasal Spray 70

Par and Nastech Sign Licensing Agreement 70

Aegis Therapeutics Signs Licensing Agreement with University

of Alabama 70

ITI Receives a Patent for Sedation Inducing Nasal Drug 71

Inyx Bags Order from Australian OTC Drug Company 71


Aegis Therapeutics LLC (USA) 72

Alza Corporation (USA) 72

AptarGroup, Inc. (USA) 72

Archimedes Pharma Limited. (UK) 73

AstraZeneca Plc. (UK) 73

MedImmune, Inc. (USA) 73

Bayer Consumer Care (USA) 74

Bespak Plc. (UK) 74

GlaxoSmithKline Plc (UK) 74

Ikano Therapeutics Inc. (USA) 75

Javelin Pharmaceuticals, Inc. (USA) 75

Kurve Technology, Inc. (USA) 76

Marina Biotech, Inc. (USA) 76

Merck & Co., Inc. (USA) 76

Novartis AG (Switzerland) 77

OptiNose AS (Norway) 77

Pfizer, Inc. (USA) 77

Rexam Plc (UK) 78

Sanofi-Aventis S.A. (France) 78

Unigene Laboratories, Inc. (USA) 78


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 2007 through 2015 (includes corresponding

Graph/Chart) 79

Table 9: US Historic Review 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

2006 (includes corresponding Graph/Chart) 80

Table 10: US 11-Year Perspective for Intranasal Drug Delivery

by Therapeutic Area -Percentage Breakdown of Values Sales for

Allergic Infections, Analgesics, Osteoporosis, and

Vaccinations for Years 2005, 2010 & 2015 (includes

corresponding Graph/Chart) 81


Total Companies Profiled: 75 (including Divisions/Subsidiaries - 90)


Region/Country Players


The United States 53

Canada 2

Japan 3

Europe 27

France 3

Germany 5

The United Kingdom 13

Rest of Europe 6

Asia-Pacific (Excluding Japan) 5


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Nicolas Bombourg



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