The Nanotech Revolution in Drug Delivery - Cientifica Delivery White Paper.pdf · The Nanotech Revolution in Drug Delivery ... There are 58 case studies on nano- ... and are regarded

The Nanotech Revolution in Drug DeliveryEstablishing a New Paradigm in PharmaceuticalsNanotechnology-enabled drug delivery systems (DDS) over the next five years are forecast to dramatically reshape the way existing drugs are delivered. The growing range of nanotechnology enabled drug delivery methods is poised to change the way new compounds are formulated, and to extend the life cycle of existing compounds.

By 2012 nano-enabled DDS will capture over a 15% share of the market from its current potion of 4%. But that is just the beginning. After 2015, nano-enabled technologies will take the lion’s share of the market, making up nearly 90% of the drug delivery market--a complete transforma-tion of the way DDS are formulated.

Market Drivers:

Clinical Benefits of Nanotechnology in Drug Delivery

The benefits of nanotech-based drug DDS will be dra-matic for both doctors and patients, providing lower drug

toxicity, more specific targeting and reduced cost of treat-ments.

At present many drugs fail clinical trials because the com-pound cannot be delivered to the site where it is needed without having some interaction with the human body on the way. The result can range from triggering a severe im-mune system response to toxic side effects. Getting the ac-tive compound to where it is needed, and effectively deliv-ering it is one of the holy grails in the treatment of diseases ranging from inflammations to cancer.

Unlocking the value of Pharma’s existing com-pounds

The global pharmaceutical industry has been developing compounds for over a century, but many of these never get to market.

The acceptance of new drug formulations is expensive and slow, taking up to 15 years to obtain accreditation of new drug formulas with no guarantee of success. Compounds

The Nanotech Revolution in Drug Delivery

Page 1 ©Cientifica Ltd 2007 www.cientifica.com

“A new value para-digm is taking shape in the drug delivery market.Nanostructured de-livery techniques will shape the future of drug delivery.”

Market Drivers:

Clinical Benefits Unlocking the value of

Pharma’s existing compoundsDemographics

Opportunities:The Creation of New

DDS CompaniesNew Products are Already

on the MarketMarket Growth

Technologies: Nanoparticles Nanocystals Polymer Therapeutics Liposomes

•• What are they?• Availability• Key Players• How are they applied to

drug delivery?

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which are highly effective, such as Taxol for the treatment of cancer, are also toxic to healthy cells, and current deliv-ery methods are unable to target just the diseased cells, leading to side effects.

As a result, drug formulation companies are looking to make use of these already in-use drugs and finding better ways of delivering them to their targets. At present, several hundred billion dollars worth of existing compounds which cannot be delivered properly are sitting in IP vaults unused, and the industry is keen to unlock and exploit this valuable intellectual property.

New drug delivery compounds will also extend the product and patent lifecycles of drugs, allowing the creation of New Chemical Entities (NCE’s) via reformulation of exist-ing and/or orphaned compounds, and subsequent creation of value for shareholders and consumers. Many drugs are poorly soluble, a major problem when the human body is 70% water. In general, poor water solubility correlates with slow dissolution rate, and decreasing the particle size in-creases the surface area, which leads to an increase in dis-solution rate.

Opportunities:

The Creation of New DDS Companies

The global pharmaceutical industry is increasingly relying on outsourcing innovation in every business area, from clinical trials to drug discovery. The result has been a healthy market for acquisitions of companies which have a proven technology, and this has in turn stimulated more and more venture backed start ups in the bio and pharma space.

The development of nano-enabled DDS has followed this pattern, and has not been restricted to the large pharma-ceutical companies. Many new companies have been launched that have developed novel methods for exploiting nanotechnologies in drug delivery, and many more are in incubation.

Nano DDS companies are popping up all around the world, in Europe, the US and across Asia, for example

• Nanocarrier (Japan)• CeramiSphere Pty Ltd (Australia)• Nanovindex Ltd (UK)• Aquanova (Germany)• Insert Therapeutics (USA)• Biophan (USA)• Capsulution (Germany)• Flamel Technologies (France)

However, it seems likely that, as the large pharmaceutical companies explore the wide variety of drugs that may benefit from new nanoparticle-based delivery techniques, there will be some consolidation of methods into a few generally useful ones and opportunities for smaller compa-nies will start to dry up.

New Products are Already Coming through Clinical Trials

Nano-enabled DDS have already hit the market with a number of FDA approved compounds. Initially these have primarily been with the polymer Polyethylene glycol (PEG) in which PEG is conjugated with peptides and proteins but this will soon change and novel nanostructures and nano-particles will begin to take a larger share of the new nano-enabled DDS.

As an example Nucryst is in Phase 2 clinical trials with silver nanoparticles for drug delivery to treat atopic derma-titis, and Accusphere is in Phase 1 clinical trials with a nanoparticle that treats solid tumors while the US FDA approved the first inhalable version of insulin in 2006. The novel alternative to injectable insulin for the treatment of type-1 and type-2 diabetes was developed by Pfizer with Sanofi-Aventis and Nektar Therapeutics, and is marketed as "Exubera".

Market Growth

Unlike other markets in which nanotechnology is merely projected to have an impact, nano-enabled DDS already represents a $3.39 billion market.

But we are just seeing the tip of the iceberg as the technol-ogy shifts from polymer therapeutics through to truly inno-vative approaches enabled by our control of materials on the same scale at which nature works. By 2012 the total market for nanotechnology-enabled drug delivery will rise to $26 billion, representing a compound annual growth rate of 37% over the next five years, and after 2012 things become really interesting, the value of these nano-enabled compounds will sky rocket, reaching $220 billion by 2015.

Beyond just the economics, the use of nanoparticles will transform medical treatment, allowing practitioners to use drugs to target specific areas of the body, without side ef-fects or concerns over toxicity since lower doses could be used, concentrating the effect where needed. The utility of nanoparticles in drug delivery to improve human health and quality of life is potentially enormous.

This White Paper presents four technologies that will change the paradigm of the drug delivery market, includ-ing:



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• Nanoparticles (including inorganic, polymer and solid lipid nanoparticles)

• Nanocrystals• Polymer Therapeutics (including polymer drugs,

polymer drug conjugates, polymer micelles and den-drimers)

• Liposomes

For more detailed information please see “The Nanoparti-cle Drug Delivery Market Report”

Value of Nanotechnology Based DDS 2006-2015

$0

$50,000

$100,000

$150,000

$200,000

$250,000

2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Year

US

$ M

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on

s

Polymer TherapeuticsDendrimersOther NanostructuresNanoparticles

Source: The Nanoparticle Drug Delivery Report

The Nanoparticle Drug Delivery Market Report

• Nanoparticle drug delivery system by therapeutics

• Nanoparticle drug delivery system by technology

• Nanoparticle drug delivery system by delivery method

The report will give Pharma inves-tors a comprehensive understanding on the impact of nanotechnologies on the pharmaceutical market and companies, which include companies that are producing nanomaterials/technologies to enable better drug delivery compounds (drug delivery company) and companies that are using nano-enabled formulations to enhance drug delivery (drug formula-tion company).

The report will provide an in-depth discussion on recent developments of nanoparticle-enabled drug delivery systems (DDS) and future opportuni-ties. It is tailored for investors who plan to invest in the pharmaceutical industry with an eye towards how nanoparticle drug delivery technol-ogy will impact the economics of the pharmaceutical market. The infor-mation includes business summaries, technology core competencies, how nanoparticle adds value for investors in drug delivery companies, comer-cialization strategies, intellectual property and available markets.

There are 58 case studies on nano-particle DDS listed in the report ac-cording to 3 categories:• Delivery Method/Routes of ad-

ministration Oral administration

Transdermal deliveryInjectable deliveryTopical deliveryNasal/pulmonary deliveryImplantable delivery

• TherapeuticsCancer therapyVaccinesAntibodyDNA-based therapy

• TechnologyNanoparticulate encapsulationDendrimer-based targeted thera-

peutics technologyLiposomes nanotechnologyNanotube technologiesNanoparticles coating technologySilica-chitosan nanocompositeNanosome technologyNanosuspension technologyNanocrystal technologyNanoshell technologyPolymer therapeutics

There are totally 58 nanoparticle drug delivery platforms/technolologies stud-ied in the report. There are totally 61 companies refered in the report, which includes 38 drug formulation compa-nies and 23 drug delivery companies. For each company a full profile is pro-vided. USA takes up 70% of the total companies involved in nanoparticle-enhanced drug delivery technology.

Available Applications Of Nanoparticle In Drug Delivery

1. Acromegaly2. Age-related macular degen-eration3. Anesthetic4. Antibodies5. Antiemetic6. Antiinfectives, oncologics, cardiac drugs and others7. Atopic dermatitis 8. B-cell Chronic Lymphocytic/Non-Cancer ther-apy 9. Chronic kidney disease10. Eating disorders11. End stage renal failure Lymphoma/Intrathecal therapy of lymphomatous meningitis12. Febrile neutropenia13. Fungal infections14. Glioblastoma15. Hepatitis A, C16. HIV/AIDS 17. Influenza18. Immunodeficiency syn-drome19. Immunosuppressant20. Kaposi sarcoma21. Hodgkin’s Chronic fatigue immune dysfunction (myalgic encephalomyelitis; ME)22. Lipid regulation23. Menopausal therapy24. Multiple sclerosis25. Rheumatoid arthritis and Crohn’s disease



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Nanoparticles

What are they?

Nanoparticles can be divided into three groups:• Inorganic nanoparticles• Solid lipid nanoparticles• Polymer nanoparticles

Inorganic nanoparticles is the generic term for several nanoparticles including for example metal oxide- and non-oxide ceramics, metals, calcium phosphate, gold, silicate and magnetic nanoparticles. So called “nanoshells” combine various inorganic elements or materials. They typically have a silicon core, which is sealed in an outer metallic cover.

Polymer nanoparticles involve various natural or biocompatible synthetic polymers. They include ra-tionally designed macromolecular drugs, polymer-drug and polymer-protein conjugates, polymeric mi-celles containing covalently bounded drugs, and polyplexes for DNA delivery.

Polymer nanoparticles can be divided into nano-spheres, which build a continuous polymer matrix

and can be referred as “drug sponges” and nanocap-sules, which consist of a polymer layer enclosing a fluid-filled cavity and are mimicking liposomes.

Solid lipid nanoparticles combine the advan-tages but avoiding the disadvantages of other colloi-dal carriers have attracted increasing attention in recent years, and are regarded as an alternative car-rier system to traditional colloidal systems, such as emulsions, liposomes and polymeric microparticles and nanoparticles.

How are they applied to drug delivery?

Nanoparticles are widely used in drug delivery where they can increase drug solubility and, additionally, can lead to controlled release and/or drug targeting. They are used in anti-cancer treatment, gene-delivery, asthma inhalers, hormone delivery through the skin, drug delivery through the eye and in oral and vaccine delivery systems. A lot of companies employ nanoparticles in anti-cancer treatment.



Availability: In February 2005, the first nanoparticu-late drug delivery product, Abraxane for the treatment of breast cancer was launched by Abraxis Oncology, a division of American Pharmaceutical Partners, Inc.

Key Players: American Pharmaceutical Partners (USA)CritiTech (USA)Novax Inc (USA)RTP Pharma (USA)Sheffield PharmaceuticalsNanosphereEiffel TechnologiesBiosante PharmaceuticalsAdvectus Life Sciences (USA)Copernicus Therapeutics (USA)TH

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NanocrystalsWhat are they?

Increasing the active surface area is the key to many applications of nanotechnologies, from improving automotive and industrial catalysts to improving the uptake of poorly soluble drugs in the human body. Nanocrystals are ground in special mills and the result-ing drugs can be applied intravenously as nanosuspen-sions or bronchially through an inhaler. This small size enhances the surface/volume-ratio and bioavailability of almost insoluble pharmaceuticals.

How are they applied to drug delivery?

For poorly water-soluble drug compounds, grinding them into nanoscale crystals increases the surface area of the compounds, which leads to an increase in disso-lution rate.

In one of the best known cases, Elan Pharmaceuticals’ NanoCrystal® technology, particles are small particles of drug substance, typically less than 1000 nanometers (nm) in diameter, which are produced by milling the

drug substance using a proprietary, wet-milling tech-nique. The resulting particles of the drug are stabilized against agglomeration by surface adsorption of selected GRAS (Generally Regarded As Safe) stabilizers.

The result is an aqueous dispersion of the drug sub-stance that behaves like a solution, which can be proc-essed into finished dosage forms for all routes of ad-ministration. The size of the particles allows for safe and effective passage through capillaries.

NanoCrystal technology represents both an enabling technology for evaluating new chemical entities that exhibit poor water solubility and also a valuable tool for optimizing the performance of established drugs. NanoCrystal technology is of particular benefit for drugs with poor solubility in water.

The process is also useful for moderately soluble drugs when a high concentration of drug in a low volume of fluid is desired.



Availability: The first United States approval of a product produced incorporating the NanoCrystal® tech-nology occurred in August 2000.

Key Players: Elan Pharmaceuticals (USA)SkyePharma (UK)

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Polymer Therapeutics

What is it?

Polymer therapeutics differ from particle shaped drug de-livery systems in their dimensions. They are molecular units with diameters of a few nanometres and can be sub-divided into four groups:• Polymer drugs• Polymer drug conjugates• Polymer micelles • Dendrimers

How is it applied to drug delivery?

A drug can be covalently bound to the four groups above. They differ from other drug-delivery systems in which a drug is encapsulated or solubilised and are more akin to new chemical entities since chemical conjugation occurs (i.e the combined polymer and drug behave as a com-pound different from either component).

Early designs for a polymer therapeutic system involved attaching a water-soluble polymer to a drug through a selected linker molecule. Trapping low molecular weight drugs as polymer conjugates not only temporarily inacti-vates the drug, but also restricts their uptake by cells to endocytosis (the process whereby cells absorb material such as proteins from the outside by engulfing it with their cell membrane).

As high molecular weight macromolecules of the drugs are unable to diffuse passively into cells, they are 'engulfed' as membrane-encircled sacs called vesicles, in which intra-cellular enzymes then set to work to release the drug.

This means that the polymer-drug conjugate should be able to circulate longer in the body, potentially without the toxic side-effects associated with many drugs. With the appropriate biodegradable linker, and/or a cell-specific targeting group, it should be possible to deliver the drug direct to the target site.



Availability: The first poly (ethylenglycol) (PEG)ylated proteins were approved by regulatory authorities for routine clinical use in the early 1990s.

Key Players: StarPharma (USA)Enzon (USA)Teva Pharmaceuticals (Israel)

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LiposomesWhat are they? Liposomes are small spheres that have a lipid layer that sur-rounds an active pharmaceutical ingredient. Their basic com-ponents are amphiphilic molecules, which spontaneously form liposomes in aqueous ambiance. Hydrophilic ends of the globular bilayers point to the waterside, hydrophobic ends are oriented bilateral to the centre of the layer.

How are they applied to drug delivery?Because a liposome can encapsulate an aqueous solution with a hydrophobic outer membrane, hydrophilic solutes cannot pass through the lipids. So, lipsomes can carry both hydrophobic molecules (its outer membrane) and hydrophilic molecules (the inner aqueous core).

The liposome delivers its contents to the appropriate site by having its lipid bilayer fuse with bilayers of the cell membrane. By making liposomes in a solution of DNA or drugs (which would normally be unable to diffuse through

the membrane) they can be (indiscriminately) delivered past the lipid bilayer.

Liposomes can also be designed to deliver drugs in other ways. Liposomes that contain low (or high) pH can be constructed such that dissolved aqueous drugs will be charged in solution. As the pH naturally neutralizes within the liposome the drug will also be neutralized, allowing it to freely pass through a membrane.

Another strategy for liposome drug delivery is to target endocytosis events. Liposomes can be made in a particular size range that makes them viable targets for natural macrophage phagocytosis. These liposomes may be di-gested while in the magrophage's phagosome, thus releas-ing its drug. Liposomes can also be decorated with opson-ins and ligands to activate endocytosis in other cell types.



Availability: In 1995, the first liposome-encapsulated form of the anti-cancer drugs doxorubicin and daunrubicin are approved for human use.

Key Players: SkyePharma (UK)Ortho Biotech (USA)Anosys (USA)Azaya Therapeutics (USA)LiPlasome Pharma (USA)

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The Nanoparticle Drug Delivery Market Report ----- Table of Contents

..........................................................TABLE OF EXHIBITS 9

....................................................EXECUTIVE SUMMARY 13

AIM, SCOPE AND ORGANIZATION OF REPORT. 13CIENTIFICA NANOTECHNOLOGY MODEL. 17

Definitions of Nanotechnologies 18Major Assumptions 18

BACKGROUND. 20

..............................MARKET FORECAST & OVERVIEW 21

............................INTRODUCTION TO THE MARKETS 30

NANOPHARMACEUTICALS. 30NANOTECHNOLOGY IN DRUG DELIVERY. 31NANOBIOTECHNOLOGY IN DRUG DELIVERY. 32OTHER APPLICATIONS FOR NANOMATERIALS IN THE MEDICAL AND PHARMACEUTICAL SECTOR 32TRENDS AND NEEDS. 33ROADMAP. 34NANOTECHNOLOGY INFLUENCE IN PHARMACEUTICAL VALUE CHAIN. 35ANALYTICAL TECHNIQUES FOR NANOPARTILE DRUG DE-LIVERY. 39

Properties 39.Production Of Nanoparticles 39

.Measuring Dispersion Of Nanoparticles 40Analysis Of Carrier Systems 41

NANOPARTICLES AS DRUG CARRIERS. 42.What Can Nanoparticles Do In Drug Delivery 42

Overview On The Types Of Nanoparticles In Drug De-.livery 44

The First Nanoparticle Drug Delivery System Reaches The Market 47Present And Future Applications 48

PROJECTED PRODUCT PIPELINE FOR NANOPARTICLE IN DRUG DELIVERY MARKET. 51

Overview Of Nanoparticle Drug Delivery System (DDS) In Various Applications 51Available Applications Of Nanopartcile In Drug Deliv-

.ery 52

DRUG DELIVERY CHALLENGES -- WHY DRUG ...........................DELIVERY & WHY NANOPARTICLES

54

THE NEED FOR BETTER DRUG THERAPY. 54THE NEED FOR DRUG SOLUBILITY. 54THE NEED FOR SITE-SPECIFIC AND ORGAN-SPECIFIC IN FUNCTION. 55

DRIVERS AND OPPORTUNITIES FOR NANOPARTI-.......................................................CLE DRUG DELIVERY

56

THE AIM OF DRUG TARGETING. 56REASONS WHY THE DRUG DELIVERY MARKET IS RAPIDLY EXPANDING. 56MARKET DRIVERS FOR ENHANCED DRUG DELIVERY. 57THE ADVANTAGES OF USING POLYMERIC NANOPARTICLES (PNPS) IN DRUG DELIVERY. 58

EXPANDING GOVERNMENTAL FUNDING DRIVES THE NANOBIOTECHNOLOGY MARKET. 59HOW DRUG COMPANIES ARE REACTING TO THIS EXPAN-SION. 60

......................FUTURE BARRIERS AND CHALLENGES 62

BIG PHARMACEUTICAL COMPANIES RELUCTANT TO IN-VEST IN UNTRIED TECHNOLOGIES. 62LACK OF REGULATORY CASE LAW. 62LONG ADMISSION PROCEDURES INCLUDING FOR EXAMPLE SEVERAL CLINICAL TRIALS. 63A NEED FOR RAPID SCREENING METHODS. 63SCALABILITY OF NANOPARTICLE PRODUCTION. 63AN URGENT NEED FOR ANALYTICAL METHODS. 63A NEED FOR THE INVESTIGATION OF FURTHER NANOPAR-TICLES. 63THE POTENTIAL TOXICITY OF ENGINEERED NANOPARTI-CLES IS AN UNSOLVED ISSUE AND STILL NEEDS TO BE DEALT WITH. 64THE FUTURE OF NANO AND BIO COLLABORATIONS IS PROMISING. 67

NANOPARTICLE ADDED VALUE IN DRUG DELIV-..........................................................................................ERY

69

CASE STUDY -- UNIVERSITY OF MICHIGAN’S NANOPARTICLE-BASED PAIN RELIEF STUDY FOR MILI-TARY BATTLEFIELD USE. 69CASE STUDY -- ACUSPHERE’S HYDROPHOBIC DRUG DE-LIVERY SYSTEM (HDDS™) FOR REFORMULATION OF HY-DROPHOBIC DRUGS. 70CASE STUDY -- IMARX’S HYDROPLEX™ PLATFORM FOR DELIVERING HYDROPHOBIC DRUGS. 72CASE STUDY – ALPHARX’S NANOPARTICLE DRUG DELIV-ERY PLATFORM FOR ANTIBIOTIC DRUGS. 75CASE STUDY – CYTRX’S RNAI NANOPARTICLE DELIVERY TECHNOLOGY FOR RNAI THERAPEUTICS. 76

INVESTING IN NANOPARTCLE-ENABLED DRUG ........................................................DELIVERY INDUSTRY

78

CASE STUDY – NANOTHERAPEUTICS’ COMMERCIALISA-TION STRATEGY. 78

.Business Summary 78.Technology Core Competency 78

.Commercialisation Strategy 78.Available Market 79

CASE STUDY – HOW CAN NANOVINDEX’S NANOPARTICLE HYDROGEL COMPOSITES ADD VALUE FOR DRUG DELIV-ERY INVESTORS. 79


How Nanoparticles Add Value For Investors In Drug .Delivery Company 79

.Comercialization Strategy 80.Available Market 80

CASE STUDY -- KEYSTONE NANO’S MOLECULAR DOTS (MDS) COMMERCIALISATION STRATEGY. 80






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INJECTABLE DELIVERY. 110Case Study -- Biophan Technologies’ Nanomagnetic Guided Drug Delivery 110Case Study -- Nanobiotix’s NanoBiodrugsTM. 114

TOPICAL DELIVERY. 115Case Study -- Starpharma’s VivaGel™ 115Case Study – Nanotherapeutics’ NanoDRY™; Nano-COAT™ and NanoQUAD™ Drug Delivery Systems 116

INHALED/NASAL/PULMONARY DELIVERY. 118Case Study -- Interstitial NanoSystem’s Pulmonary

.Nanoparticle Delivery 119IMPLANTABLE DELIVERY. 119

Case Study -- Biophan Technologies’ Nanomagnetic Drug Delivery: Drug-Eluting Implanted Devices 120Case Study -- NanoBioMagnetics’ Organ-Assisting-

.Device (OAD) Technologies 125

NANOPARTICLE DRUG DELIVERY SYSTEM BY ..................................................................THERAPEUTICS

127

THERAPY. 127CANCER THERAPY. 128

Case Study -- Nanocarrier’s Micellar Nanoparticles .And Key Delivery Systems 130

Case Study -- Abraxis BioScience’s Nanoparticle Al-bumin Bound (nabTM .) Technology Platform 135Case Study -- Abraxis BioScience’s Abraxane® 136Case Study -- Access Pharmaceuticals, Inc.’s Nanopar-

.ticle Aggregate Drug Delivery Technology 137Case Study -- Access Pharmaceuticals’ ProLindac™ 138Case Study -- Advance Nanotechnologies’ Nanoparti-

.cle Composites Drug Delivery System 140Case Study -- BioAlliance Pharma’s Nanoparticle-

.based Transdrug® Drug Delivery Platform 142Case Study -- Cornerstone Pharmaceuticals’ Emulsi-

.phan™ Nanoparticle Tumor Targeting Technology 143Case Study -- Insert Therapeutics’ Nanoparticle Medi-

.ated Drug Delivery System 151Case Study -- Keystone Nano’s Molecular Dots (MDs)

.Drug Delivery Technology 152Case Study -- Magforce Nanotechnologies’ MagFor-ce® Nanoparticles 157Case Study -- Tempo Pharmaceuticals’ Nanocell™

.Technology 158Case Study -- Aphios Corporation’s TaxosomesTM. 159

VACCINES. 160Case Study -- Biosante Pharmaceuticals’ Calcium

.Phosphate Nanoparticles (CAP)-based Technology 160Case Study -- NanoMed's Nanotemplate Engineering

.Technology 163Case Study -- Novavax’s Micellar Nano Particles (MNPs), Novasome® Paucilamellar Vesicles And

.Virus-Like Particle (VLP) Technology 166ANTIBODY. 167

.Case Study -- Ablynx’s Nanobody® Platform 167Case Study – NanoViricides’ Targeted Anti-Viral

.Therapeutics Platform 169DNA BASED THERAPY. 172

Case Study -- Introgen Therapeutics’ Nanoparticle .Drug Delivery Technology Platform 173

Case Study -- Asklêpios BioPharmaceutical Inc.’s Bio-.logical Nano Particles (BNP™) Platform 176

.Intellectual Property 81CASE STUDY – NANOCARRIER’S PROTEINS NANOENCAP-SULATION SEEKING OUT BIG BIOTECH BUSINESS. 81

.Business summary 81.Technology Core Competency 81



CASE STUDY -- NANOBIOMAGNETICS’ BUSINESS MODEL FOR ORGAN-ASSISTING-DEVICE (OAD) TECHNOLOGIES. 86



.Commercialisation Strategy 88.Intellectual Property 89

CASE STUDY – HOW CAN AVIDIMER THERAPEUTICS’ AVIDIMERS PLATFORM TECHNOLOGY ADD VALUE FOR DRUG DELIVERY INVESTORS. 89

.Business Summary 89.Techonology Core Competency 90


.Commercialisation Strategy 92CASE STUDY -- CAPSULUTION’S COMMERCIALISATION STRATEGY FOR LBL-TECHNOLOGY®-BASED DRUG DE-LIVERY SYSTEMS. 92

.Business Summary 92How Nanoparticles Add Value For Investors In Drug

.Delivery Company 92.Commercialisation Strategy 92

CASE STUDY -- ACCESS PHARMACEUTICALS’ PRODUCT PIPELINE FOR COBALAMIN™- MEDIATED DISEASE TAR-GETING. 93


How Nanoparticle Add Value For Investors In Drug .Delivery Company 93

CASE STUDY - AZAYA THERAPEUTICS’ PRODUCT PIPELINE FOR PROTEIN STABILIZED LIPOSOME (PSL™) NANOTECH-NOLOGY. 94


.Commercialisation Strategy 95

NANOPARTICLE DRUG DELIVERY SYSTEM BY DELIVERY METHOD/ROUTES OF ADMINISTRA-

........................................................................................TION 98

DELIVERY METHOD. 98ORAL ADMINISTRATION. 99

Case Study -- Access Pharmaceuticals’ Cobalamin™ - Mediated Disease Targeting 99Case Study – Nanotherapeutics’ Nanoparticle Oral Applications 103Case study – SoluBest’s Solumer™ Technology Plat-form 103

TRANSDERMAL DELIVERY. 106Case Study -- Biophan Technologies’ Transdermal

.Patches By Using Halloysite Nanotubes Technology 106Case Study -- The Interstitial NanoSystems’ Transder-

.mal Nanoparticle Delivery 108



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Case Study -- Baxter BioPharma Solutions’ NANO-.EDGE Dispersion Technology 243

POLYMER THERAPEUTICS. 244Case Study – Labopharm’s Polymeric Nano-Delivery System™ 244Case Study -- Intezyne Technologies’ IVECT™ Drug

.Delivery Platform (DDP) 248Case Study -- Insert Therapeutics’ Nanoparticle Medi-

.ated Drug Delivery System 250

APPENDIX 1: LIST OF NANOPARTICLE DRUG DE-.......................LIVERY PLATFORMS/TECHNOLOGIES

255

APPENDIX 2: NANOPARTICLES IN DRUG DELIV-ERY PRODUCTS ON THE MARKET OR IN CLINI-

..................................................................CAL PHASE 1/2/3 258

APPENDIX 3: OVERVIEW OF NANOPARTICLE AP-.................................PLICATIONS IN DRUG DELIVERY

261

APPENDIX 4: DRUG DELIVERY COMPANY - COM-PANIES WHO PRODUING NANOPARTICLES/TECHNOLOGIES ENABLE BETTER DRUG DELIV-

..............................................................ERY COMPOUNDS 269

APPENDIX 5: DRUG FORMULATION COMPANY - COMPANIES WHO USING NANOPARTICLE-ENABLED FORMULATIONS TO ENHANCE DRUG

.............................................................................DELIVERY 281

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About CientificaTwenty Years Of Nanotech

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Case Study -- Copernicus Therapeutics’ DNA Nano-particles 180Case Study -- Calando Pharmaceuticals’ Targeted Polymeric Nanoparticle Delivery Systems And Sirna

.Design 184Case Study -- Epeius Biotechnologies’ Targeted Deliv-

.ery System (TDS) Technology 188Case Study -- Intradigm’s Nanoparticle-Based Delivery System 190Case Study -- Flamel Technologies’ Medusa® Delivery

.Platform 194Case Study -- Novosom AG’s SMARTICLES® and

.CAGICLES® Technology 198Case Study -- Transgenex Nanobiotech’s SiPlex™

.Technology 200

NANOPARTICLE DRUG DELIVERY SYSTEM BY .....................................................................TECHNOLOGY

202

NANOPARTICULATE ENCAPSULATION. 202Case Study -- Aquanova’s Nanoparticulate Encapsula-

.tion Technology 202Case Study -- Bio Delivery Sciences International’s

.Bioral® Encochleation Drug Delivery Technology 205Case Study -- Capsulution’s LBL-Technology®-based

.Drug Delivery Systems 207Case Study -- Ceramisphere’s Encapsulation Technol-

.ogy 209Case Study – Genesegues’ Targeted Nanocapsule

.Technology 210Case Study – iCeutica’s Encapsulated Organic Nano-

.particles (EON™) Platform 212Case Study – NutraLease’s Nanoencapsulation Tech-

.nology 213THE DENDRIMER-BASED TARGETED THERAPEUTICS TECHNOLOGY. 220

Case Study -- Avidimer Therapeutics’ Avidimers 220Case Study -- Dendritic Nanotechnologies Inc.

.(DNT)’S Priostar™ Dendrimer Nanotechnology 223LIPOSOMES NANOTECHNOLOGY. 226

Case Study -- Azaya Therapeutics’ Protein Stabilized Liposome (PSL) Nanotechnology Platform 228Case Study -- LiPlasome Pharma’s Liposome-based

.Drug Delivery Platform 229NANOTUBE TECHNOLOGIES. 231

Case Study -- Biophan Technologies’ Halloysite Nano-.tube Technologies 231

Case Study -- NanoCyte’s Nanotube Technology-based .Drug Delivery System 232

NANOSHELL TECHNOLOGY. 233Case Study -- Nanospectra Biosciences’ AuroLase™

.Cancer Therapy 233NANOPARTICLES COATING TECHNOLOGY. 235

Case Study -- Cytimmune’s Colloidal Gold .Nanoparticle-Based Delivery Platform 235

SILICA-CHITOSAN NANOCOMPOSITE. 238Case Study -- ISTN’s Silica-Chitosan Nanocomposties For Peptic Ulcer Treatment 238

NANOCRYSTAL TECHNOLOGY. 238.Case Study -- Elan’s NanoCrystal® Technology 238

NANOSOME TECHNOLOGY. 241Case Study -- Molecular Therapeutics’ Nanosome Plat-form 241

NANOSUSPENSION TECHNOLOGY. 243



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Nanotech Revolution in Drug Delivery This new white paper analyses the impact of nanoparticles on the drug delivery market by focusing on five groups of nanoparticles that are projected to capture a majority of the market.www.cientifica.com

THE NANOTECH REVOLUTION IN DRUG DELIVERY

For more details on The Nanoparticle Drug Delivery Market Report contact us at:

Cientifica Ltd7 Devonshire SqCutlers GardensLondon EC2M 4YHUK

Tel +44 (0)207 377 8480Fax +44 (0)207 990 8410

email [email protected] www.cientifica.com

your needs are unique and always tailor our services accord-ingly.

* Market analysis & forecasting * Strategic technology consulting * Competitor benchmarking * Customer / supplier awareness * Risk assessment * Policy and legislative hotspots * Investment and acquisition studies * Product penetration and market positioning * Supplier identification and evaluation



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mailto:[email protected]

mailto:[email protected]





Documents

The Nanotech Revolution in Drug Delivery - Cientifica Delivery White Paper.pdf · The Nanotech Revolution in Drug Delivery ... There are 58 case studies on nano- ... and are regarded