TABLE 9 SOME PRESCRIPTION DRUGS USED TO TREAT BENIGN SKIN GROWTHS TABLE 9 (CONTINUED) BULLOUS DISORDERS OR BLISTERING DISEASES...

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1 CHAPTER ONE: INTRODUCTION... 1 STUDY GOALS AND OBJECTIVES... 1 REASONS FOR DOING THIS STUDY... 1 INTENDED AUDIENCE... 1 SCOPE OF REPORT... 1 METHODOLOGY... 2 INFORMATION SOURCES... 2 ABOUT THE AUTHOR... 2 RELATED BCC RESEARCH REPORTS... 2 BCC ONLINE SERVICES... 3 DISCLAIMER... 3 CHAPTER TWO: SUMMARY... 4 SUMMARY TABLE GLOBAL DERMATOLOGICAL THERAPEUTICS REVENUE FORECAST BY MARKET SEGMENT, THROUGH 2013 ($ BILLIONS)... 5 SUMMARY FIGURE GLOBAL DERMATOLOGICAL THERAPEUTICS REVENUE FORECAST BY MARKET SEGMENT, 2008 AND 2013 (%)... 6 CHAPTER THREE: OVERVIEW... 7 HUMAN SKIN... 7 TABLE 1 FUNCTIONS OF THE SKIN... 7 TABLE 1 (CONTINUED)... 8 SKIN DISORDERS... 9 TABLE 2 DISORDERS OF THE SKIN... 9 TABLE 2 (CONTINUED) TABLE 2 (CONTINUED) TABLE 2 (CONTINUED) ACNE TABLE 3 TYPES OF ACNE ROSACEA TABLE 4 TYPES OF ROSACEA TABLE 5 DRUGS AND THEIR ACTION AGAINST ACNE AND ROSACEA BACTERIAL INFECTIONS OF THE SKIN TABLE 6 TYPES OF BACTERIAL INFECTIONS OF THE SKIN TABLE 6 (CONTINUED) TABLE 6 (CONTINUED) TABLE 7 SOME PRESCRIPTION DRUGS PRESCRIBED TO TREAT BACTERIAL SKIN INFECTIONS TABLE 7 (CONTINUED) TABLE 7 (CONTINUED) BENIGN SKIN GROWTHS OR TUMORS TABLE 8 TYPES OF BENIGN SKIN GROWTHS OR TUMORS TABLE 8 (CONTINUED)... 20

2 TABLE 9 SOME PRESCRIPTION DRUGS USED TO TREAT BENIGN SKIN GROWTHS TABLE 9 (CONTINUED) BULLOUS DISORDERS OR BLISTERING DISEASES TABLE 10 TYPES OF BULLOUS DISORDERS TABLE 10 (CONTINUED) TABLE 11 SOME PRESCRIPTION DRUGS USED TO TREAT BULLOUS SKIN DISORDERS TABLE 11 (CONTINUED) SKIN CANCERS TABLE 12 TYPES OF SKIN CANCERS TABLE 12 (CONTINUED) Types of Melanoma Lentigo Maligna Melanoma Superficial Spreading Melanoma Nodular Melanoma Acral-Lentiginous Melanoma TABLE 13 SKIN CANCER INCIDENCE IN THE U.S TABLE 14 SOME PRESCRIPTION DRUGS USED TO TREAT CUTANEOUS CARCINOMAS CORNIFICATION DISORDERS Calluses and Corns TABLE 15 TYPES OF CALLUSES AND CORNS Ichthyosis or Dry Skin TABLE 16 TYPES OF ICHTHYOSIS TABLE 16 (CONTINUED) Keratosis Pilaris TABLE 17 TYPES OF KERATOSIS PILARIS Sebaceous Cysts Dermatitis TABLE 18 TYPES OF DERMATITIS TABLE 18 (CONTINUED) TABLE 19 SOME DRUGS PRESCRIBED FOR DERMATITIS Fungal Infections of the Skin TABLE 20 TYPES OF FUNGAL INFECTIONS OF THE SKIN TABLE 20 (CONTINUED) TABLE 21 SOME DRUGS PRESCRIBED TO TREAT FUNGAL INFECTIONS OF THE SKIN TABLE 21 (CONTINUED) HYPERSENSITIVITY AND INFLAMMATORY DISORDERS Acute Febrile Neutrophilic Dermatosis (Sweet s Syndrome) Drug Eruptions and Reactions TABLE 22 TYPES OF DRUG REACTIONS AND TYPICAL CAUSATIVE AGENTS... 35

3 TABLE 22 (CONTINUED) Erythema Multiforme TABLE 23 TYPES OF ERYTHEMA MULTIFORME Erythema Nodosum Granuloma Annulare Panniculitis Pyoderma Gangrenosum Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Bed Sore Pityriasis Rosea TABLE 24 SOME DRUGS PRESCRIBED TO TREAT HYPERSENSITIVITY AND INFLAMMATORY DISORDERS TABLE 24 (CONTINUED) PARASITIC INFECTIONS OF THE SKIN TABLE 25 TYPES OF PARASITIC INFECTION OF THE SKIN TABLE 25 (CONTINUED) TABLE 26 SOME DRUGS PRESCRIBED TO TREAT PARASITIC INFECTIONS OF THE SKIN PSORIASIS AND SCALING DISEASES TABLE 27 TYPES OF PSORIASIS AND SCALING DISEASES Psoriasis Treatment PIGMENTATION DISORDERS TABLE 28 TYPES OF PIGMENTATION DISORDERS Birthmarks Poison Ivy TABLE 29 SOME PRESCRIPTION DRUGS FOR PIGMENTATION DISORDERS REACTIONS TO SUNLIGHT Aging Actinic Keratoses Skin Cancers Photosensitivity TABLE 30 TYPES OF PHOTOSENSITIVITY Sunburn SWEATING DISORDERS TABLE 31 TYPES OF SWEATING DISORDERS VIRAL SKIN DISEASES TABLE 32 TYPES OF VIRAL SKIN DISEASES TABLE 32 (CONTINUED) TABLE 33 SOME DRUGS PRESCRIBED TO TREAT VIRAL DISEASES OF THE SKIN TABLE 33 (CONTINUED) COMMON DIAGNOSTIC TESTS FOR SKIN DISORDERS DERMOSCOPY... 50

4 PATCH TESTING SKIN BIOPSY CULTURE PHOTOTESTS MORBIDITY/PREVALENCE TABLE 34 SKIN DISORDER MORBIDITY IN THE U.S. BY AGE AND CAUSE (THOUSANDS) THERAPEUTIC PROCEDURES FOR THE SKIN CANCER SURGERY Excisional Biopsy to Remove Skin Cancer Curettage and Electrocautery Mohs Micrographic Surgery (MMS) Wide Local Excision Skin Grafting Lymph Node Removal CHEMICAL PEELS CRYOTHERAPY/CRYOSURGERY Ice Packs Cold Gel Packs Ice Immersion Ice Massage Vapocoolant Sprays RADIOTHERAPY CHEMOTHERAPY Chemotherapy Creams Chemotherapy into a Vein LASER SURGERY TABLE 35 SKIN CONDITIONS REQUIRING ONLY LASER SURGERY TABLE 35 (CONTINUED) TABLE 35 (CONTINUED) Carbon Dioxide Laser YAG Laser Pulsed Dye Laser or Argon Laser Excimer Laser TABLE 36 ADVANTAGES AND DISADVANTAGES OF EXCIMER LASER PHOTODYNAMIC THERAPY TABLE 37 VARIOUS CANCERS TREATABLE BY PDT Application in Dermatology TABLE 38 VARIOUS SKIN DISORDERS TREATABLE BY PDT Goeckerman Treatment PUVA Ultraviolet B Phototherapy Broadband Narrowband... 68

5 TABLE 39 ADVANTAGES AND DISADVANTAGES OF UVB THERAPY SCLEROTHERAPY CHAPTER FOUR: PRESCRIPTION DERMATOLOGICAL DRUGS SYSTEMIC DRUGS ACITRETIN CLINDAMYCIN ERYTHROMYCIN CYCLOSPORINE TABLE 40 ADVANTAGES AND DISADVANTAGES OF CYCLOSPORINE METHOTREXATE TABLE 41 ADVANTAGES AND DISADVANTAGES OF METHOTREXATE THALIDOMIDE SYSTEMIC ANTIBACTERIAL AGENTS Antileprotic Drugs (Including Dapsone) Antimalarial Drugs (Including Hydroxychloroquine) SYSTEMIC ANTIFUNGAL AGENTS SYSTEMIC ANTIHISTAMINES SYSTEMIC ANTIPARASITIC AGENTS SYSTEMIC ANTIPRURITIC AGENTS SYSTEMIC ANTIVIRAL AGENTS SYSTEMIC CORTICOSTEROIDS SYSTEMIC INTERFERONS SYSTEMIC RETINOID OTHER SYSTEMIC DRUGS Thioguanine Hydroxyurea Mycophenolate Mofetil Sulfasalazine BIOLOGICAL THERAPIES (BIOLOGICS) Colchicine CYTOTOXIC AND IMMUNOSUPPRESSIVE DRUGS Retinoids Hormones and Anti-Androgens Hormones and (Continued) TOPICAL TREATMENTS ACICLOVIR TOPICAL RETINOIDS ANTHRALIN TABLE 42 ADVANTAGES AND DISADVANTAGES OF ANTHRALIN COAL TAR TABLE 43 ADVANTAGES AND DISADVANTAGES OF COAL TAR CORTICOSTEROIDS TABLE 44 ADVANTAGES AND DISADVANTAGES OF CORTICOSTEROIDS91 TABLE 45 TOPICAL CORTICOSTEROIDS,

6 TABLE 45 (CONTINUED) TABLE 45 (CONTINUED) RETINOID: TAZAROTENE TABLE 46 ADVANTAGES AND DISADVANTAGES OF TAZAROTENE VITAMIN D3: CALCIPOTRIENE TABLE 47 ADVANTAGES AND DISADVANTAGES OF CALCIPOTRIOL CAPSAICIN TOPICAL MEDICATIONS IN CLINICAL TRIALS MOISTURIZERS AND SCALE REMOVERS TABLE 48 DRUG TREATMENTS FOR SKIN DISEASE INTRODUCED IN TABLE 48 (CONTINUED) TABLE 48 (CONTINUED) TABLE 48 (CONTINUED) TABLE 48 (CONTINUED) TABLE 48 (CONTINUED) CHAPTER FIVE: TECHNOLOGY REVIEW EMERGING TECHNOLOGIES IN DERMATOLOGY DNA MICROARRAY TECHNOLOGY IN DERMATOLOGY ADVANCES IN THE TREATMENT OF VARICOSE VEINS EMERGING TREATMENT OF ATOPIC DERMATITIS EMERGING DRUGS FOR ICHTHYOSIS PROGRESS IN THE MANAGEMENT OF ACNE PLASMA SKIN REGENERATION TECHNOLOGY TABLE 49 NEW TECHNOLOGIES IN DERMATOLOGY TABLE 49 (CONTINUED) PERMEATION ENHANCEMENT TECHNOLOGIES Drug Permeation Enhancement via Buccal Route Thiomatrix: Permeation Enhancement Merrion s Technology: Gastrointestinal Permeation Enhancement Technology (GIPET) FIGURE 1 GASTROINTESTINAL PERMEATION ENHANCEMENT TECHNOLOGY Transdermal Protein Delivery or Measurement Using Low- Frequency Sonophoresis RADIOTHERAPY External Radiotherapy Conformal Radiotherapy Intensity Modulated Radiotherapy Internal Radiotherapy Radioactive Implants Radioactive Liquids Radioactive (Continued) PLASMA SKIN REGENERATION

7 Plasma Skin (Continued) Plasma Skin (Continued) CHAPTER SIX: PATENT ANALYSIS PATENT ISSUE TRENDS IN UNITED STATES FIGURE 2 U.S. PATENT TRENDS, TABLE 50 NUMBER OF U.S. PATENTS ISSUED, 2003 TO JULY 31, TABLE 51 COMPANIES AND NUMBER OF U.S. PATENTS FILED BY THEM, 2003 TO JULY 31, TABLE 52 RECENT DERMATOLOGY U.S. PATENTS TABLE 52 (CONTINUED) TABLE 52 (CONTINUED) TABLE 52 (CONTINUED) PATENT ISSUE TRENDS IN EUROPE TABLE 53 EUROPEAN DERMATOLOGICAL PATENTS, 2003 JULY TABLE 54 RECENT PATENTS ISSUED BY THE EPO TABLE 54 (CONTINUED) CHAPTER SEVEN: INDUSTRY PARTICIPANT PROFILES MANUFACTURERS OF DERMATOLOGICAL DRUGS AGI DERMATICS ALLERGAN, INC AMGEN, INC ANACOR PHARMACEUTICALS ANIKA THERAPEUTICS, INC ASTELLAS US, LLC CHESTER VALLEY PHARMACEUTICALS, INC CORIA LABORATORIES, LTD CORIA LABORATORIES, LTD DERMIK LABORATORIES, INC DUSA PHARMACEUTICALS, INC EISAI, INC FERNDALE LABORATORIES, INC GALDERMA LABORATORIES GENENTECH, INC ISOLAGEN, INC LEO PHARMA A/S MEDICIS PHARMACEUTICAL CORP MEDIMETRIKS PHARMACEUTICALS, INC MERZ PHARMA UK, LTD NEOSIL, INC NYCOMED U.S., INC OBAGI MEDICAL PRODUCTS, INC ONSET THERAPEUTICS ORTHONEUTROGENA

8 PIERRE FABRE PHARMACEUTICALS, INC PRIME PHARMACEUTICALS CORP QLT, INC QUINNOVA PHARMACEUTICALS SCHERING-PLOUGH CORP SINCLAIR PHARMACEUTICALS SKINMEDICA, INC STIEFEL LABORATORIES, INC SUMMERS LABORATORIES, INC SYNTOPIX GROUP, PLC TRIAX PHARMACEUTICALS, LLC VALEANT PHARMACEUTICALS INTERNATIONAL VALEO PHARMA, INC WARNER CHILCOTT, LTD XOMA, LTD NON-COMMERCIAL ORGANIZATIONS AFRICAN ASSOCIATION OF DERMATOLOGY AMERICAN ACADEMY OF DERMATOLOGY (AAD) AMERICAN BEHCET S DISEASE ASSOC., INC AMERICAN CELIAC SOCIETY AMERICAN HEMOCHROMATOSIS SOCIETY, INC AMERICAN LUPUS SOCIETY AMERICAN SKIN ASSOCIATION, INC AMERICAN SOCIAL HEALTH ASSOC ARTHRITIS FOUNDATION ASIAN DERMATOLOGICAL ASSOCIATION ASSOCIATION OF PROFESSORS OF DERMATOLOGY ATAXIA-TELANGIECTASIA CHILDREN S PROJECT BASAL CELL CARCINOMA NEVUS SYNDROME/GORLIN SYNDROME BAY AREA LUPUS FOUNDATION BLOOM S SYNDROME REGISTRY BRITISH ASSOCIATION OF DERMATOLOGISTS CELIAC DISEASE FOUNDATION CELIAC SPRUE ASSOCIATION/USA CICATRICIAL ALOPECIA RESEARCH FOUNDATION COALITION OF SKIN DISEASES CORNELIA DE LANGE SYNDROME FOUNDATION, INC CUTANEOUS LYMPHOMA FOUNDATION DERMATOLOGY FOUNDATION DERMATOLOGY NURSES ASSOCIATION (DNA) DERMATOPATHOLOGY FOUNDATION DYSAUTONOMIA FOUNDATION, INC DYSTROPHIC EPIDERMOLYSIS BULLOSA

9 THE ECTODERMAL DYSPLASIA SOCIETY EHLERS DANLOS NATIONAL FOUNDATION (EDNF) EHLERS-DANLOS SYNDROME FOUNDATION EUROPEAN ACADEMY FOR DERMATOLOGY AND VENEREOLOGY EADV Administrative Office THE EUROPEAN DERMATOLOGY FORUM EUROPEAN SOCIETY FOR DERMATOLOGICAL RESEARCH EUROPEAN UNION OF MEDICAL SPECIALISTS FOUNDATION FOR ICHTHYOSIS AND RELATED SKIN TYPES (F.I.R.S.T.) GLUTEN INTOLERANCE GROUP (DERMATITIS HERPETIFORMIS) HEMOCHROMATOSIS RESEARCH FOUNDATION HIDRADENITIS SUPPURATIVA FOUNDATION, INC HISTIOCYTOSIS ASSOCIATION OF AMERICA INFLAMMATORY SKIN DISEASE INSTITUTE (ISDI) INTERNATIONAL FOUNDATION FOR DERMATOLOGY THE INTERNATIONAL LEAGUE OF DERMATOLOGICAL SOCIETIES OFFICE INTERNATIONAL PEMPHIGUS PEMPHIGOID FOUNDATION THE INTERNATIONAL SOCIETY OF DERMATOPATHOLOGY KLIPPEL-TRENAUNAY SUPPORT GROUP LUPUS FOUNDATION OF AMERICA, INC LYMPHOMA RESEARCH FOUNDATION LYMPHOMATOID PAPULOSIS CENTRAL REGISTRY MARFAN ASSOC. U.K THE MELANOMA RESEARCH FOUNDATION MUSCULAR DYSTROPHY ASSOC MYOSITIS ASSOCIATION OF AMERICA (MAA) NATIONAL ALOPECIA AREATA FOUNDATION (NAAF) NATIONAL ATAXIA FOUNDATION NATIONAL ECZEMA ASSOCIATION (NEA) NATIONAL ECZEMA ASSOCIATION FOR SCIENCE AND EDUCATION NATIONAL ECZEMA SOCIETY NATIONAL EPIDERMOLYSIS BULLOSA REGISTRY NATIONAL FOUNDATION FOR ECTODERMAL DYSPLASIAS NATIONAL FOUNDATION FOR VITILIGO AND PIGMENT DISORDERS NATIONAL INCONITENTIA PIGMENTI FOUNDATION NATIONAL MEDICAL ASSOC NATIONAL NEUROFIBROMATOSIS FOUNDATION

10 NATIONAL ORGANIZATION FOR ALBINISM AND HYPOPIGMENTATION (NOAH) NATIONAL ORGANIZATION FOR RARE DISORDERS (NORD) THE NATIONAL PEMPHIGUS FOUNDATION NATIONAL PSORIASIS FOUNDATION NATIONAL REGISTRY FOR ICHTHYOSIS AND RELATED DISORDERS NATIONAL VITILIGO FOUNDATION NEVOID BASAL CELL CARCINOMA SYNDROME SUPPORT NETWORK PACHYONYCHIA CONGENITA PROJECT THE PSORIASIS ASSOC SCLERODERMA FEDERATION, INC SCLERODERMA FOUNDATION SCLERODERMA RESEARCH FOUNDATION THE SCLERODERMA SOCIETY SOCIETY FOR INVESTIGATIVE DERMATOLOGY (SID) SOCIETY FOR PEDIATRIC DERMATOLOGY (SPD) THE STURGE-WEBER FOUNDATION THE VITILIGO SOCIETY, U.K VITILIGO SUPPORT INTERNATIONAL VZV RESEARCH FOUNDATION XERODERMA PIGMENTOSUM SOCIETY TABLE 55 DERMATOLOGICAL ASSOCIATIONS TABLE 55 (CONTINUED) STRATEGIC ALLIANCES IN THE DERMATOLOGY MARKET MERGERS & ACQUISITIONS TABLE 56 SIGNIFICANT MERGERS AND ACQUISITIONS ( ) TABLE 56 (CONTINUED) TABLE 56 (CONTINUED) VENTURE CAPITAL DEALS CHAPTER EIGHT: REGULATORY PREVIEW DRUG REGULATION IN THE UNITED STATES LICENSES FOR MEDICAL DEVICES DRUG REGULATION IN THE UNITED KINGDOM LICENSES FOR DRUGS DRUG AND EQUIPMENT APPROVAL IN EUROPE LICENSES FOR MEDICAL EQUIPMENT REIMBURSEMENT FOR DERMATOLOGICAL TREATMENT REIMBURSEMENT IN THE UNITED STATES REIMBURSEMENT IN EUROPE Reimbursement in Europe (Continued) CHAPTER NINE: MARKET METRICS

11 MARKET TRENDS BIG PHARMA S FOCUS ON BLOCKBUSTER DRUGS ENABLES SPECIALTY FOCUS BY SMALL AND MEDIUM-SIZED FIRMS174 COSMETIC/AESTHETIC DERMATOLOGY FACES DOWNTURN 174 CHANGES IN REIMBURSEMENT AND OTHER LEGISLATION ARE CREATING UNCERTAINTY Managed Care Issues Medical Liability Physician Quality Reporting Initiative (PQRI) Dermatologic Surgery Cosmetic Procedure Tax INCREASED USE OF GENERICS IN PRESCRIPTION DERMATOLOGY DIFFICULTIES IN DETERMINATION OF BIOAVAILABILITY OF TOPICAL DRUGS PHYSICIAN SHORTAGE AND PARAMEDIC INFLUX IN DERMATOLOGY CERTIFICATION EXAM FOR NURSE PRACTITIONERS IN DERMATOLOGY NOW AVAILABLE USE OF PROCEDURE-THERAPY AND SPECIFIC DRUGS IN DERMATOLOGY POLLUTION CONTRIBUTES TO RISE IN ATOPIC DERMATITIS179 MANUFACTURERS OF TNF-BLOCKER DRUGS ORDERED TO HIGHLIGHT RISK OF FUNGAL INFECTIONS HIGHER CO-PAYS FOR BIOLOGICS IMPACTS PRESCRIPTIONS181 U.S. DERMATOLOGICAL MARKET TABLE 57 LEADING DRUGS PRESCRIBED BY OFFICE-BASED DERMATOLOGISTS ALL INDICATIONS, 2008 (THOUSANDS) PRESCRIPTION DATA FOR ACNE Prescription Data for Acne (Continued) FIGURE 3 PRESCRIBING OF ORAL ANTIBIOTICS FOR THE INTITIAL TREATMENT OF ACNE: CURRENT AND IN 1 YEAR (N=75) FIGURE 4 PRESCRIBING OF TOPICAL ANTIBIOTICS/RETINOIDS FOR ACNE: CURRENT AND IN 1 YEAR (N=75) TABLE 58 U.S. DERMATOLOGICAL THERAPEUTICS MARKET: REVENUE FORECAST BY MARKET SEGMENT, THROUGH 2013 ($ BILLIONS) FIGURE 5 SHARE OF SEGMENTS IN U.S. PRESCRIPTION DERMATOLOGY MARKET, 2008 AND 2013 (%) FIGURE 5 (CONTINUED) FIGURE 6 LEADING PRESCRIPTION DRUG REVENUES IN GLOBAL DERMATOLOGY MARKET, 2008 ($ MILLIONS) FIGURE 6 (CONTINUED) ENBREL

12 FIGURE 7 ENBREL SALES IN GLOBAL DERMATOLOGY MARKET BY GEOGRAPHY, 2008 (%, TOTAL REVENUE = $ 3,230 MILLION) BOTOX FIGURE 8 BOTOX SALES IN THE GLOBAL DERMATOLOGY MARKET BY GEOGRAPHY, 2008 (%, TOTAL REVENUE = $ 1,200 MILLION FIGURE 8 (CONTINUED) LOCERYL FIGURE 9 LOCERYL SALES IN GLOBAL DERMATOLOGY MARKET BY GEOGRAPHY, 2008 (%, TOTAL = $350 MILLION FIGURE 10 GLOBAL DERMATOLOGICAL PRESCRIPTION MARKET BY REGIONAL SHARE FUTURE OUTLOOK, 2011 (%) TABLE 59 MARKET SHARE OF PRESCRIPTION DRUG MANUFACTURERS, ($ MILLIONS) GLOBAL DERMATOLOGICAL THERAPEUTICS MARKET FIGURE 11 GLOBAL DERMATOLOGICAL MARKET BY REGIONAL SHARE, 2008 (%) TABLE 60 GLOBAL DERMATOLOGICAL THERAPEUTICS REVENUE FORECAST BY MARKET SEGMENT, THROUGH FIGURE 12 GLOBAL PRESCRIPTION DERMATOLOGY MARKET SHARE BY SEGMENT, 2008 (%) FIGURE 12 (CONTINUED) GLOBAL DERMATOLOGICAL (CONTINUED) GLOBAL DERMATOLOGICAL (CONTINUED)