Table of Contents
- Chapter 1 - SUMMARY
- Summary Table: GLOBAL ORPHAN DRUGS DEMAND BY VALUE, THROUGH 2011 ($
MILLIONS)
- Summary Figure: GLOBAL ORPHAN DRUGS DEMAND BY VALUE, 2005-2011 ($
MILLIONS)
- Chapter 2 - OVERVIEW
- DEFINITION OF AN ORPHAN DRUG
- HISTORY OF ORPHAN DRUG LEGISLATION
- FIRST LEGISLATION ON ORPHAN DRUGS
- Amendments to the ODA
- Bills Passed in 2002 Increased Funding and Established the Office of
Rare Diseases
- Orphan Drug Legislation-Global Status
- INCENTIVES FOR ORPHAN DRUG DEVELOPMENT
- THE NEED FOR INCENTIVES
- Table 1 NUMBER OF ORPHAN DRUG DESIGNATIONS AND APPROVALS PER YEAR BY
U.S. FDA, 1983-2006
- CONCERNS ABOUT THE ORPHAN DRUG ACT
- COST-EFFECTIVENESS
- MARKET EXCLUSIVITY VERSUS PATENT PROTECTION
- MARKET SIZE AND KEY PLAYERS
- Table 2 TOP 10 COMPANIES IN THE ORPHAN DRUG MARKET AND THEIR MARKET
SHARES (%)
- CHALLENGES FOR EFFECTIVE USAGE OF THE ORPHAN DRUG ACT
- THE ORPHAN DRUG ACT-A BONUS FOR BIOTECH
- PROFITABILITY OF ORPHAN DRUGS
- MARKET EXCLUSIVITY
- NO REGULATORY RESTRICTIONS ON PRICING
- OFF-LABEL USE
- Chapter 3 - WORLDWIDE INDUSTRY STRUCTURE
- GLOBAL AND REGIONAL SALES OF ORPHAN DRUGS
- Table 3 REGIONAL SALES OF ORPHAN DRUGS, THROUGH 2011 ($ MILLIONS)
- Figure 1 REGIONAL SALES AND FORECASTS FOR ORPHAN DRUGS, 2005-2011 ($
MILLIONS)
- CATEGORIES OF ORPHAN DRUG MARKET PLAYERS
- INDUSTRY TRENDS BY SPONSOR TYPES
- ANALYSIS OF ORPHAN DRUG APPROVALS BY SPONSOR CATEGORIES
- Figure 2 ANALYSIS OF ORPHAN DRUG APPROVALS BY SPONSOR TYPES (%)
- ORPHAN DRUG DESIGNATIONS AND APPROVALS BY COMPANIES
- Table 4 COMPANIES WITH MORE THAN 15 ORPHAN DRUG DESIGNATIONS, 1983-2006
- Table 5 COMPANIES WITH MORE THAN FIVE ORPHAN DRUG APPROVALS, 1983-2006
- ORPHAN DRUG REVENUES BY SPONSOR TYPES
- BIG PHARMA VERSUS BIOTECH COMPANIES
- Table 6 SALES OF LEADING ORPHAN DRUGS-BIG PHARMA VERSUS BIOTECH
COMPANIES, 2006
- Table 6 (CONTINUED)
- Table 6 (CONTINUED)
- ORPHAN DRUGS - A STRATEGIC CHOICE BY BIOTECH COMPANIES
- LEADING PLAYERS IN THE GLOBAL ORPHAN DRUG MARKET
- Table 7 LEADING COMPANIES IN THE ORPHAN DRUG MARKET AND THEIR REVENUES
FROM ORPHAN DRUGS
- PARTNERSHIP STRATEGIES IN THE ORPHAN DRUG MARKET
- Table 8 ANALYSIS OF PARTNERSHIP STRATEGIES IN THE CASE OF LEADING ORPHAN
DRUGS
- Table 8 (CONTINUED)
- ORPHANS TO BLOCKBUSTERS-KEY GROWTH FACTORS
- MULTIPLE ORPHAN INDICATIONS
- Table 9 BLOCKBUSTER ORPHAN DRUGS WITH APPROVALS FOR MULTIPLE INDICATIONS
- Table 9 (CONTINUED)
- OFF-LABEL USAGES/ APPROVAL FOR NON-ORPHAN INDICATIONS
- LACK OF COMPETITION FROM BIOGENERICS
- Table 10 BIOLOGIC BLOCKBUSTERS AND THEIR MARKET EXCLUSIVITY STATUS, 2006
- Table 10 (CONTINUED)
- SYNTHETIC PHARMACEUTICALS AS BLOCKBUSTERS
- PHARMACOGENOMICS AND ITS POTENTIAL IMPACT ON THE ORPHAN DRUG ACT
- Chapter 4 - PRODUCTS
- ORPHAN DRUGS APPROVED BY THE U.S. FDA (1983-2006)
- ORPHAN DRUG DESIGNATIONS AND APPROVALS SINCE 1983
- Table 11 NUMBER OF ORPHAN DESIGNATIONS AND APPROVALS BY U.S. FDA
1983-2006
- Table 11 (CONTINUED)
- Table 12 DETAILS OF ORPHAN DRUG MARKETING APPROVALS BY U.S. FDA,
1983-2006 (TOTAL NO. OF ORPHAN DRUG APPROVALS EACH YEAR
- Table 12 (CONTINUED)
- PERCENTAGE OF ORPHAN DRUG APPROVALS IN OVERALL DRUG APPROVALS BY THE
U.S. FDA IN THE PAST DECADE
- Table 13 DRUGS AND BIOLOGICS APPROVED BY THE FDA FROM 1990 TO 2006, A
COMPARISON OF PRODUCTS WITH AND WITHOUT ORPHAN DRUG STATUS
- ORPHAN DRUGS WITH SALES EXCEEDING $200 MILLION IN 2006
- Table 14 ORPHAN DRUGS WITH GLOBAL SALES EXCEEDING $200 MILLION, 2006
- Table 14 (CONTINUED)
- DETAILED ANALYSIS OF SUCCESSFULL AND PROMISING ORPHAN DRUGS
- AVONEX
- Additional Approvals Gained
- Marketing Strategies
- Sales of Avonex
- Table 15 GLOBAL SALES OF AVONEX, 2000-2006 ($ MILLIONS)
- BETASERON
- Additional Approvals Gained
- Marketing Strategies
- Sales of Betaseron
- Table 16 GLOBAL SALES OF BETASERON, 2000-2006 ($ MILLIONS)
- BOTOX
- Additional Approvals Gained
- Marketing Strategies
- Sales of Botox
- Table 17 GLOBAL SALES OF BOTOX FOR THERAPEUTIC AND COSMETIC USAGES,
2002-2006 ($ MILLIONS)
- CEREZYME/ CEREDASE
- Additional Approvals and Marketing Strategies
- Sales of Cerezyme
- Table 18 GLOBAL SALES OF CEREZYME, 2000-2006 ($ MILLIONS)
- COPAXONE
- Marketing Strategies
- Sales of Copaxone
- Table 19 GLOBAL SALES OF COPAXONE, 2002-2006 ($ MILLIONS)
- ENBREL
- Additional Indications
- Market Strategies
- Sales of Enbrel
- Table 20 U.S. AND INTERNATIONAL SALES OF ENBREL, 2003-2006 ($ MILLIONS)
- EPOGEN
- Recent Threats to Market Share
- Sales of Epogen
- Table 21 GLOBAL SALES OF EPOGEN, 2000-2006 ($ MILLIONS)
- ERBITUX
- Additional Indications
- Market Strategies and Threats
- Sales of Erbitux
- Table 22 GLOBAL SALES OF ERBITUX, 2004-2006 ($ MILLIONS)
- GLEEVEC
- Approval for Multiple Indications
- Market Strategy
- Sales of Gleevec
- Table 23 GLOBAL SALES OF GLEEVEC, 2001-2006 ($ MILLIONS)
- INTRON A/PEGINTRON
- Market Strategy
- Sales of Intron A/PegIntron
- Table 24 GLOBAL SALES OF INTRON A/PEGINTRON, 2004-2006 ($ MILLIONS)
- Table 25 GLOBAL SALES OF KOGENATE, 2001-2006 ($ MILLIONS)
- Table 26 GLOBAL SALES OF LAMICTAL, 2001-2006 ($ MILLIONS)
- NEUPOGEN/ NEULASTA
- Additional Indications
- Marketing Strategies
- Sales of Neupogen/ Neulasta
- Table 27 GLOBAL SALES OF NEUPOGEN/NEULASTA, 2001-2006 ($ MILLIONS)
- Table 28 GLOBAL SALES OF NOVOSEVEN, 2000-2006 ($ MILLIONS)
- PROGRAF
- Additional Indications
- Future Prospects
- Sales of Prograf
- REMICADE
- Additional Approvals
- Characteristics of Target Market
- Sales of Remicade
- Table 29 GLOBAL SALES OF REMICADE, 2001-2006 ($ MILLIONS)
- RITUXAN
- Additional Indications
- Characteristics of Market
- Sales of Rituxan
- Table 30 GLOBAL SALES OF RITUXAN, 2000-2006 ($ MILLIONS)
- TOPAMAX
- Additional Indications
- Sales of Topamax
- Table 31 GLOBAL SALES OF TOPAMAX, 2001-2006 ($ MILLIONS)
- ZOMETA
- Additional indications
- Market Characteristics
- Sales of Zometa
- Table 32 U.S. AND GLOBAL SALES OF ZOMETA, 2002-2006 ($ MILLIONS)
- ORPHAN VACCINES
- ORPHAN DRUG SALES BY TECHNOLOGY
- ORPHAN BIOLOGICS
- Global Sales and Forecasts of Orphan Biologics
- Table 33 SALES AND FORECASTS OF LEADING BIOLOGIC ORPHAN DRUGS,
WORLDWIDE: THROUGH 2011 ($ MILLIONS)
- Figure 3 FORECASTS OF LEADING BIOLOGICAL ORPHAN DRUG SALES, WORLDWIDE,
2005-2011 ($ MILLIONS)
- SUB-CLASSES OF ORPHAN BIOLOGICS
- Table 34 SALES AND FORECASTS OF LEADING MONOCLONAL ANTIBODY ORPHAN DRUG
SALES, WORLDWIDE, THROUGH 2011 ($ MILLIONS)
- Figure 4 FORECAST OF LEADING MONOCLONAL ANTIBODY ORPHAN DRUG SALES,
WORLDWIDE, 2005-2011 ($ MILLIONS)
- Table 35 GLOBAL SALES AND FORECASTS OF LEADING INTERFERONS/ INTERLEUKINS
WITH ORPHAN DRUG STATUS, WORLDWIDE, THROUGH 2011 ($ MILLIONS)
- Figure 5 GLOBAL SALES AND FORECASTS OF LEADING INTERFERONS/ INTERLEUKINS
WITH ORPHAN STATUS, WORLDWIDE, 2005-2011 ($ MILLIONS)
- Table 36 GLOBAL SALES AND FORECASTS OF LEADING GROWTH HORMONES WITH
ORPHAN DRUG STATUS, WORLDWIDE, THROUGH 2011 ($ MILLIONS)
- Figure 6 GLOBAL SALES AND FORECASTS OF LEADING GROWTH HORMONES WITH
ORPHAN DRUG STATUS, WORLDWIDE, 2005-2011 ($ MILLIONS)
- Table 37 GLOBAL SALES AND FORECASTS OF LEADING PLASMA PRODUCT ORPHAN
DRUG SALES, WORLDWIDE, THROUGH 2011 ($ MILLIONS)
- Figure 7 FORECAST OF LEADING PLASMA PRODUCT ORPHAN DRUG SALES,
WORLDWIDE, 2005-2011 ($ MILLIONS)
- NON-BIOLOGIC ORPHAN DRUGS
- Table 38 GLOBAL SALES AND FORECASTS OF LEADING NON-BIOLOGIC ORPHAN
DRUGS, WORLDWIDE, THROUGH 2011($ MILLIONS)
- Figure 8 GLOBAL SALES AND FORECASTS FOR NON-BIOLOGIC ORPHAN DUGS,
WORLDWIDE, 2005-2011 ($ MILLIONS)
- Chapter 5 - APPLICATIONS
- CANCER
- LEUKEMIAS
- Acute Lymphocytic/ Lymphoblastic Leukemia
- Acute Myelogenous/ Myelocytic Leukemia
- Chronic Lymphocytic Leukemia
- Chronic Myelocytic/ Myelogenous Leukemia
- LYMPHOMAS
- Hodgkin' s Lymphoma
- Non-Hodgkin' s Lymphoma
- MULTIPLE MYELOMA
- SOLID TUMORS
- CANCER-RELATED CONDITIONS
- Table 39 ORPHAN DRUGS APPROVED BY U.S. FDA TO TREAT CANCER AND
CANCER-RELATED CONDITIONS
- Table 39 (CONTINUED)
- Table 39 (CONTINUED)
- Table 39 (CONTINUED)
- Table 39 (CONTINUED)
- Table 39 (CONTINUED)
- Table 39 (CONTINUED)
- SALES OF LEADING ORPHAN PRODUCTS TO TREAT CANCER AND CANCER-RELATED
CONDITIONS
- Table 40 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT CANCER: WORLDWIDE,
THROUGH 2011 ($ MILLIONS)
- Figure 9 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT CANCER AND CANCER
RELATED CONDITIONS, WORLDWIDE, 2005-2011 ($ MILLIONS)
- CARDIOVASCULAR DISEASES AND BLOOD DISORDERS
- ANEMIA
- HYPERCALCEMIA
- HYPERTENSION
- HYPOTENSION
- NEUTROPENIA
- TACHYARRHYTHMIAS/TACHYCARDIA
- THROMBOCYTHEMIA
- THROMBOCYTOPENIA
- ORPHAN DRUGS APPROVED TO TREAT CARDIOVASCULAR DISEASES AND BLOOD
DISORDERS
- Table 41 APPROVED ORPHAN DRUGS TO TREAT CARDIOVASCULAR DISEASES AND
BLOOD DISORDERS
- Table 41 (CONTINUED)
- Table 41 (CONTINUED)
- SALES OF LEADING ORPHAN PRODUCTS TO TREAT CARDIOVASCULAR DISEASES AND
BLOOD DISORDERS: WORLDWIDE, THROUGH 2011
- Table 42 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT CARDIOVASCULAR
DISEASES AND BLOOD DISORDERS, THROUGH 2011 ($ MILLIONS)
- Figure 10 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT CARDIOVASCULAR
DISEASES AND BLOOD DISORDERS, WORLDWIDE, 2005-2011 ($ MILLIONS)
- GASTROINTESTINAL DISEASES
- CHOLELITHIASIS
- ESOPHAGEAL VARICES
- ORPHAN PRODUCTS APPROVED TO TREAT GASTROINTESTINAL DISEASES
- Table 43 APPROVED ORPHAN DRUGS TO TREAT GASTROINTESTINAL DISEASES
- Table 43 (CONTINUED)
- SALES OF LEADING ORPHAN PRODUCTS TO TREAT GASTROINTESTINAL DISEASES
- GENETIC DISEASES AND DISORDERS
- ALPHA-1 PROTEINASE DEFICIENCY
- FABRY DISEASE
- GAUCHER DISEASE
- HEMOPHILIA
- MUCOPOLYSACCHARIDOSIS
- TYROSINEMIA
- ORPHAN PRODUCTS APPROVED TO TREAT GENETIC DISEASES AND DISORDERS
- Table 44 APPROVED ORPHAN DRUGS TO TREAT GENETIC DISEASES AND DISORDERS
- Table 44 (CONTINUED)
- Table 44 (CONTINUED)
- SALES OF LEADING ORPHAN PRODUCTS TO TREAT GENETIC DISEASES AND
DISORDERS
- Table 45 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT GENETIC DISEASES
AND DISORDERS, WORLDWIDE, 2005-2011 ($ MILLIONS)
- Figure 11 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT GENETIC DISEASES
AND DISORDERS, WORLDWIDE, 2005-2011 ($ MILLIONS)
- IMMUNE DISEASES
- COMMON VARIABLE IMMUNODEFICIENCY
- INTERSTITIAL CYSTITIS
- JUVENILE RHEUMATOID ARTHRITIS
- ORGAN TRANSPLANT REJECTION
- ORPHAN PRODUCTS APPROVED TO TREAT IMMUNE AND AUTOIMMUNE DISEASES AND
TRANSPLANT REJECTION
- Table 46 APPROVED ORPHAN DRUGS TO TREAT IMMUNE AND AUTOIMMUNE DISEASES/
TRANSPLANT REJECTION
- SALES OF LEADING ORPHAN PRODUCTS TO TREAT IMMUNE AND AUTOIMMUNE
DISEASES AND TRANSPLANT REJECTION
- Table 47 THE MARKET FOR LEADING ORPHAN DRUGS IN THE IMMUNE DISEASES
SECTOR, WORLDWIDE, THROUGH 2011 ($ MILLIONS)
- Figure 12 THE MARKET FOR LEADING ORPHAN DRUGS IN THE IMMUNE DISEASES
SECTOR, WORLDWIDE, 2005-2011 ($ MILLIONS)
- INFECTIOUS DISEASES
- ACQUIRED IMMUNE DEFICIENCY SYNDROME
- CRYPTOCOCCAL MENINGITIS
- CRYPTOSPORIDIOSIS
- CYTOMEGALOVIRUS RETINITIS
- GIARDIASIS
- HYDATID DISEASE
- KERATOCONJUNCTIVITIS
- LEISHMANIASIS
- LEPROSY
- MALARIA
- NEUROCYSTICERCOSIS
- PNEUMOCYSTIC CARINII PNEUMONIA
- RESPIRATORY SYNCYTIAL VIRUS
- TUBERCULOSIS
- ORPHAN PRODUCTS APPROVED TO TREAT INFECTIOUS DISEASES
- Table 48 APPROVED ORPHAN DRUGS TO TREAT INFECTIOUS DISEASES
- Table 48 (CONTINUED)
- Table 48 (CONTINUED)
- SALES OF LEADING ORPHAN PRODUCTS TO TREAT INFECTIOUS DISEASES
- Table 49 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT INFECTIOUS
DISEASES, WORLDWIDE, THROUGH 2011 ($ MILLIONS)
- Figure 13 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT INFECTIOUS
DISEASES, WORLDWIDE, 2005-2011 ($ MILLIONS)
- INFLAMMATORY DISEASES
- ANKYLOSING SPONDYLITIS
- CROHN' S DISEASE
- ORPHAN PRODUCTS APPROVED TO TREAT INFLAMMATORY DISEASES
- Table 50 APPROVED ORPHAN DRUGS TO TREAT INFLAMMATORY DISEASES
- SALES OF LEADING ORPHAN PRODUCTS TO TREAT INFLAMMATORY DISEASES
- Table 51 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT INFLAMMATORY
DISEASES, WORLDWIDE, THROUGH 2011 ($ MILLIONS)
- Figure 14 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT INFLAMMATORY
DISEASES, WORLDWIDE, 2005-2011 ($ MILLIONS)
- NEUROLOGICAL DISEASES AND DISORDERS
- BLEPHAROSPASM
- DYSTONIA
- LENNOX-GASTAUT SYNDROME
- MULTIPLE SCLEROSIS
- NARCOLEPSY/CATAPLEXY
- STRABISMUS
- ORPHAN PRODUCTS APPROVED TO TREAT NEUROLOGICAL DISEASES AND DISORDERS
- Table 52 APPROVED ORPHAN DRUGS FOR NEUROLOGICAL DISEASES AND DISORDERS
- Table 52 (CONTINUED)
- SALES OF LEADING ORPHAN PRODUCTS TO TREAT NEUROLOGICAL DISEASES AND
DISORDERS
- Table 53 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT NEUROLOGICAL
DISEASES AND DISORDERS, WORLDWIDE, THROUGH 2011 ($ MILLIONS)
- Figure 15 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT NEUROLOGICAL
DISEASES AND DISORDERS, WORLDWIDE, 2005-2011 ($ MILLIONS)
- REPRODUCTIVE DISEASES AND DISORDERS
- AMENORRHEA
- PRECOCIOUS PUBERTY
- IMPAIRED SPERMATOGENESIS
- ORPHAN PRODUCTS APPROVED TO TREAT REPRODUCTIVE DISEASES
- Table 54 APPROVED ORPHAN DRUGS TO TREAT REPRODUCTIVE DISEASES AND
DISORDERS
- SALES OF LEADING ORPHAN PRODUCTS TO TREAT REPRODUCTIVE DISEASES AND
DISORDERS
- Table 55 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT, REPRODUC-TIVE
DISEASES AND DISORDERS, WORLDWIDE, THROUGH 2011 ($ MILLIONS)
- Figure 16 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT REPRODUCTIVE
DISEASES AND DISORDERS, WORLDWIDE, 2005-2011 ($ MILLIONS)
- RESPIRATORY DISEASES
- HYALINE MEMBRANE
- MALIGNANT PLEURAL EFFUSION
- PULMONARY HYPERTENSION
- ORPHAN PRODUCTS APPROVED TO TREAT RESPIRATORY DISEASES
- Table 56 APPROVED ORPHAN DRUGS FOR RESPIRATORY DISEASES
- SALES OF LEADING ORPHAN PRODUCTS TO TREAT RESPIRATORY DISEASES
- OTHER SELECTED RARE DISEASES AND DISORDERS FOR WHICH ORPHAN PRODUCTS ARE
AVAILABLE
- ACROMEGALY
- CHRONIC GRANULOMATOUS DISEASE
- CYSTINOSIS
- HOMOCYSTINURIA
- MASTOCYTOSIS
- PAGET' S DISEASE
- ORPHAN PRODUCTS APPROVED TO TREAT MISCELLANEOUS DISEASES AND DISORDERS
- Table 57 APPROVED ORPHAN DRUGS FOR MISCELLANEOUS INDICATIONS
- Table 57 (CONTINUED)
- Table 57 (CONTINUED)
- Table 57 (CONTINUED)
- SALES OF LEADING ORPHAN PRODUCTS TO TREAT MISCELLANEOUS DISEASES AND
DISORDERS
- Table 58 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT, MISCELLANEOUS
DISEASES AND DISORDERS WORLDWIDE, THROUGH 2011 ($ MILLIONS)
- Figure 17 THE MARKET FOR LEADING ORPHAN DRUGS TO TREAT MISCELLANEOUS
DISEASES AND DISORDERS, WORLDWIDE, 2005-2011 ($ MILLIONS)
- THERAPEUTIC AREAS WITH THE HIGHEST REVENUES FROM ORPHAN DRUGS IN 2006
AND THEIR FUTURE GROWTH PROSPECTS
- Table 59 THE MARKET FOR LEADING ORPHAN DRUGS IN KEY THERAPEUTIC AREAS
WORLDWIDE, THROUGH 2011 ($ MILLIONS)
- Figure 18 LEADING ORPHAN DRUG SALES WORLDWIDE AND FORECASTS BY
THERAPEUTIC AREAS, 2006 AND 2011 (%)
- Chapter 6 - LEGISLATION AND REGULATORY ENVIRONMENT
- LEGISLATION IN THE U.S.
- RARE DISEASES ACT OF 200" AND RARE DISEASES ORPHAN PRODUCT DEVELOPMENT
ACT OF 2002
- INCENTIVES FOR ORPHAN DRUG DEVELOPMENT IN THE U.S.
- Technical and Administrative Assistance with the Identification and
Development of Orphan Products
- Availability of FDA Grants to Cover Clinical trial Expenses
- Exemption from Prescription Drug User Fee Act (PDUFA)-Waiver of
Application Fee
- Tax Credits-50% of the Cost of Clinical Trials Undertaken in the U.S.
- Market Exclusivity for 7 Years Following Market Approval
- IMPACT OF THE ORPHAN DRUG ACT IN THE PHARMA AND BIOTECH INDUSTRIES
- WAYS TO CIRCUMVENT MARKET EXCLUSIVITY
- SOME IMPORTANT PUBLIC AGENCIES INVOLVED IN ORPHAN DRUG REGULATION AND
PROMOTION IN THE U.S.
- Table 60 PUBLIC/NON-PROFIT AGENCIES INVOLVED IN ORPHAN DRUG REGULATION
AND PROMOTION IN THE U.S.
- LEGISLATION-EUROPEAN UNION
- INCENTIVES FOR ORPHAN DRUG DEVELOPMENT IN THE EU
- Free Protocol Assistance
- Access to a Centralized Community Procedure for Marketing
Authorization with a 50% Reduction in the Fee
- 10 Years of Post-approval Market Exclusivity
- MAIN PUBLIC AGENCIES INVOLVED IN ORPHAN DRUG REGULATION AND
PROMOTION IN THE EU
- Table 61 MAIN PUBLIC/NON-PROFIT AGENCIES INVOLVED IN ORPHAN DRUG
REGULATION AND PROMOTION IN THE EU
- AVAILABILITY OF ORPHAN DRUGS IN THE MEMBER STATES OF THE EU
- Table 62 SUMMARY OF NATIONAL MEASURES ON ORPHAN DRUGS IN EU
- Table 62 (CONTINUED)
- Table 62 (CONTINUED)
- Table 62 (CONTINUED)
- LEGISLATION-JAPAN
- LEGISLATION-AUSTRALIA
- LEGISLATION-SINGAPORE
- LEGISLATION-OTHER COUNTRIES/ REGIONS
- LEGISLATION COMPARISON-SUMMARY
- Table 63 COMPARISON OF ORPHAN DRUG LEGISLATION IN THE U.S., EU,
AUSTRALIA AND JAPAN
- Table 63 (CONTINUED)
- CONCERN ABOUT THE HIGH PRICE OF ORPHAN DRUGS
- CALL FOR MODIFICATIONS OF ORPHAN DRUG LEGISLATION
- CORRELATION BETWEEN MARKET EXCLUSIVITY AND THE HIGH PRICE OF ORPHAN
DRUGS
- IMPACT OF BIOGENERICS ON THE ORPHAN DRUGS SECTOR
- FACTORS LEADING TO THE DELAY IN IMPLEMENTING REGULATIONS ON
BIOGENERICS
- Chapter 7 - TECHNOLOGY TRENDS ANALYSIS
- PATENT ANALYSIS
- LEADING ORPHAN DRUGS AND RELATED PATENTS
- Table 64 LEADING ORPHAN DRUGS AND THEIR RELEVANT U.S. PATENTS
- Table 64 (CONTINUED)
- Table 64 (CONTINUED)
- TECHNOLOGY TRENDS ANALYSIS BASED ON ORPHAN DRUG APPROVALS
- Table 65BIOLOGICS IN ORPHAN DRUG APPROVALS, 1983-2006
- Figure 19 ORPHAN DRUG APPROVAL TRENDS, BIOLOGICS VERSUS NON-BIOLOGICS,
1983-2006
- Figure 20 ORPHAN DRUG APPROVALS BY PRODUCT TYPES, 2006 (%)
- CONCLUSIONS OF TECHNICAL TRENDS ANALYSIS
- Chapter 8 - COMPANY PROFILES
- AMGEN, INC.
- BAYER AG
- BIOGEN IDEC, INC.
- CELGENE CORPORATION
- GENENTECH, INC.
- GENZYME CORPORATION
- HOFFMANN-LA ROCHE, INC.
- JOHNSON & JOHNSON
- NOVARTIS INTERNATIONAL AG
- NOVO NOVODISK A/S
- SCHERING-PLOUGH CORPORATION
- SIGMA-TAU PHARMACEUTICALS, INC.
- SWEDISH ORPHAN INTERNATIONAL L AB
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