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Table of Contents for The Clinical Trials Business



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INTRODUCTION

 XXII

STUDY GOALS AND OBJECTIVES

XXII

REASONS FOR DOING THE STUDY

XXII

CONTRIBUTION OF THE STUDY AND FOR WHOM

XXIII

METHODOLOGY

XXIII

ANALYST CREDENTIALS

XXIII

SCOPE AND FORMAT

XXIII

INFORMATION SOURCES

XXIII

RELATED BCC REPORTS

XXIV

BCC ONLINE SERVICES

XXIV

DISCLAIMER

XXV

SUMMARY

 XXVI

Summary Table 1:
U.S. FORECAST OF SPONSORED CLINICAL TRIALS MARKET, THROUGH 2011

XXVII

Summary Figure:
U.S. SPONSORED CLINICAL TRIALS MARKET, 2003-2011 ($ BILLIONS)

XXVIII

Summary Table 2:
U.S. MARKET FORECAST OF CLINICAL TRIAL FUNDING SOURCES, THROUGH 2011 ($ BILLIONS)

XXVIII

CLINICAL TRIALS OVERVIEW

 1

TYPES OF CLINICAL TRIALS

1

CLINICAL TRIAL PHASES

1

WHO SPONSORS CLINICAL TRIALS?

1

Figure 1 DRUG DEVELOPMENT TIMELINE

2

Table 1 PHASES OF THE CLINICAL TRIAL

2

PHASE I

3

PHASE II

3

PHASE III

4

PHASE IV/POST-MARKETING TRIALS

4

FACTORS AFFECTING STUDY SIZE

4

PHYSICIAN AND PATIENT RECRUITMENT

5

U.S. GOVERNMENT REGULATIONS

6

PHARMACEUTICALS AND BIOLOGICS

6

Table 2 U.S. LAWS AFFECTING DRUG APPROVAL TIMES

6

ADDITIONAL U.S. LAWS AFFECTING CLINICAL TRIALS

6

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA)

6

BEST PHARMACEUTICALS FOR CHILDREN ACT (BPCA), 2002

7

Table 3 ACTIVE MOIETIES FOR WHICH THE FDA HAS REQUESTED STUDIES

8

FOOD AND DRUG ADMINISTRATION (FDA)

8

BACKGROUND

8

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)

9

CBER AND BIOTERRORISM

10

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

10

CDER AND BIOTERRORISM

10

CRITICAL PATH INITIATIVE (CPI)

10

MEDICAL DEVICES

11

CENTER FOR DEVICES AND RADIOLOGIC HEALTH (CDRH)

11

ARTICLES SUBJECT TO MEDICAL DEVICE AMENDMENTS

11

CLASSIFICATION OF DEVICES (GENERAL SECTION 513)

12

CLASS I - GENERAL CONTROLS

12

CLASS II - SPECIAL CONTROLS

12

CLASS III

12

Table 4 ORIGINAL PMA SUBMISSIONS

13

EXPEDITED REVIEW

13

Figure 2 NEW DRUG DEVELOPMENT

13

Table 5 NEW DRUG APPLICATIONS (NDA & BLA) AND AVERAGE APPROVAL TIMES, 2003-2005

14

EXPEDITED DEVELOPMENT AND REVIEW

14

Table 6 INDICATIONS GIVEN PRIORITY REVIEW BY SEGMENT OF FDA

15

SUBPART E

15

ACCELERATED APPROVAL (SUBPART H)

15

PRIORITY REVIEW

15

FAST TRACK

16

Table 7 NEW DRUG APPLICATION APPROVALS

16

PEDIATRICS

16

U.S. LITIGATION AND CLINICAL TRIALS

17

Table 8 INSURANCE COMPANIES OFFERING CLINICAL TRIAL LIABILITY INSURANCE

18

INVESTIGATIONAL REVIEW BOARD (IRB)

18

EUROPEAN REGULATIONS

19

EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS (EMEA)

19

HISTORY

19

QUICK FACTS ABOUT THE EMEA ARE AS FOLLOWS

19

Table 9 EMEA MEMBER COUNTRIES AND REPRESENTATIVES

20

APPROVAL PROCEDURES

20

THE REGULATION OF DRUG DEVELOPMENT IN JAPAN

21

INTERNATIONAL CONFERENCE OF HARMONIZATION (ICH)

21

INTERNATIONAL CONFERENCE OF …(CONTINUED)

22

INDUSTRY

 23

WHO FUNDS CLINICAL TRIALS?

23

Table 10 U.S. MARKET FORECAST FOR DIRECT SPENDING CLINICAL TRIALS BY ORGANIZATION TYPE, THROUGH 2011 ($ BILLIONS)

24

Figure 3 MAJOR FUNDING SOURCES FOR CLINICAL TRIALS, 2005-2011 ($MILLIONS)

25

Table 11 U.S. CLINICAL TRIALS BY ORGANIZATION TYPE AND PHASE, 2005 (NUMBER OF CLINICAL TRIALS RECRUITING SUBJECTS)

26

Figure 4 NUMBER OF CLINICAL TRIALS BY MAJOR SPONSORS, 2005 (NUMBER OF CLINICAL TRIALS)

26

BIOTECH/ PHARMACEUTICAL COMPANIES

27

Table 12 U.S. MARKET FORECAST OF REGISTERED CLINICAL TRIALS SPONSORED BY INDUSTRY BY PHASE, THROUGH 2011 (UNITS)

27

Figure 5 U.S. MARKET FORECAST OF CLINICAL TRIALS SPONSORED BY INDUSTRY, 2005-2011 (UNITS)

27

Table 13 U.S. MARKET FORECAST FOR R&D SPENDING BY PHARMA MEMBER COMPANIES AND MAJOR U.S. BIOPHARMACEUTICAL COMPANIES, THROUGH 2011 ($ BILLIONS)

28

NATIONAL INSTITUTES OF HEALTH AND OTHER FEDERAL AGENCIES OF THE FEDERAL GOVERNMENT

28

Table 14 U.S. MARKET FORECAST FOR REGISTERED CLINICAL TRIALS SPONSORED BY THE FEDERAL GOVERNMENT, THROUGH 2011

29

Figure 6 CLINICAL TRIALS SPONSORED BY THE FEDERAL GOVERNMENT BY PHASE, 2005-2011 (NUMBERS RECRUITING SUBJECTS)

29

PRIVATE ORGANIZATIONS, UNIVERSITIES AND SPECIALTY GROUPS

29

Table 15 U.S. MARKET FORECAST FOR NUMBERS OF REGISTERED CLINICAL TRIALS SPONSORED BY UNIVERSITIES OR OTHER ORGANIZATIONS, THROUGH 2011 (UNITS)

30

Figure 7 NUMBERS OF CLINICAL TRIALS SPONSORED BY UNIVERSITIES OR OTHER ORGANIZATIONS, 2005-2011 (NUMBER OF CLINICAL TRIALS)

31

WHO CONDUCTS CLINICAL TRIALS?

31

CONTRACT RESEARCH ORGANIZATIONS (CROS)

32

BIOTECHNOLOGY VS. PHARMACEUTICAL

33

CLINICAL TRIAL RESEARCH THERAPEUTIC AREAS

33

Table 16 U.S. MARKET FORECAST OF PHRMA MEMBER R&D FUNDING BY THERAPEUTIC CATEGORY*, THROUGH 2011 ($ BILLION)

34

Figure 8 PHRMA MEMBER R&D FUNDING BY THERAPEUTIC CATEGORY, 2006 (PERCENT SHARE)

34

Figure 8 (CONTINUED)

35

Figure 9 PHRMA MEMBER R&D FUNDING BY THERAPEUTIC CATEGORY, 2011 (PERCENT SHARE)

35

Figure 9 (CONTINUED)

36

Table 17 BEST-SELLING PHARMACEUTICAL DRUGS WORLDWIDE, 2005 ($ BILLION)

36

Table 18 BEST-SELLING PHARMACEUTICAL DRUGS IN THE UNITED STATES, 2005 ($ BILLION)

37

Table 19 FASTEST SELLING PHARMACEUTICAL DRUGS IN THE UNITED STATES, 2005 ($ MILLION)

37

TRENDS IN CLINICAL TRIALS

38

ELECTRONIC DATA CAPTURE (EDC)

38

Table 20 NUMBER OF CLINICAL RESEARCH TRIALS BY AREA, THROUGH 2011

38

TECHNOLOGIES

38

Table 21 NUMBER OF CLINICAL TRIALS USING NEW TECHNOLOGIES, THROUGH 2011

39

Table 22 NEW TECHNOLOGIES AND PROJECTED EFFECT ON CLINICAL TRIALS

40

ANTISENSE

40

APOPTOSIS

41

BIOCHIPS/ MICROARRAYS

41

BIOINFORMATICS

41

BIOPROCESSORS

41

CELLS AND CELL SIGNALING

42

CELL THERAPY (I.E., STEM CELLS, TISSUE REPAIR)

43

CHEMICAL GENOMICS

43

CYTOMICS

43

ELECTRONIC DATA CAPTURE AND E-SUBMISSION

43

GENE THERAPY

43

GENOMICS

44

NOVEL DRUG DELIVERY SYSTEMS

44

PROTEOMICS

44

THERANOSTICS

45

TRANSGENICS

45

NANOTECHNOLOGY

45

NATURAL SOURCES

46

FACTORS INFLUENCING DRUG DEVELOPMENT

46

Figure 10 FACTORS INFLUENCING DRUG DEVELOPMENT

46

EPIDEMIOLOGICAL TRENDS

47

LEGISLATION

47

NEW TECHNOLOGIES

47

BIOTERRORISM

48

CLINICAL TRIAL COSTS

48

FACTORS INLFLUENCING CLINICAL TRIAL COSTS

48

FACTORS INCREASING CLINICAL TRIAL COSTS

48

FACTORS INCREASING CLINICAL … (CONTINUED)

49

FACTORS INCREASING CLINICAL TRIAL COSTS

50

FACTORS DECREASING CLINICAL TRIAL COSTS

50

RECENT AND FUTURE TRENDS IN CLINICAL TRIAL PROCESSES

50

RESEARCH AND DEVELOPMENT BUDGETS

51

Table 23 SELECTED BIOTECHNOLOGY COMPANIES, R&D COSTS, CLINICAL TRIAL COSTS, AND PERCENTAGE OF R&D SPENT ON CLINICAL TRIALS, 2005 ($MILLIONS)

51

RESEARCH AND DEVELOPMENT … (CONTINUED)

52

Table 24 PROJECTED COSTS FOR SELECTED U.S.-BASED BIOTECHNOLOGY COMPANIES, 2006 AND 2011 ($ MILLION)

53

Table 25 SELECTED PHARMACEUTICAL COMPANIES, R&D COSTS, CLINICAL TRIAL COSTS, AND PERCENTAGE OF R&D TO NET SALES, 2005 ($ BILLION)

54

Table 26 PROJECTED COSTS FOR SELECTED U.S. BASED PHARMACEUTICAL COMPANIES, 2006 ($ BILLION)

55

PRODUCT PIPELINE

55

BIOLOGICS

55

Table 27 SELECTED BIOLOGICS

56

OUTSOURCING AND CONTRACT RESEARCH ORGANIZATIONS

56

GLOBALIZATION

57

TIME-TO-MARKET PRESSURES

57

TECHNOLOGY CHANGES WILL INCREASE DEMAND FOR CRO SERVICES

58

NEGATIVE PRESSURES ON THE CRO INDUSTRY

58

DRUGS BY SYSTEM

58

CARDIOVASCULAR

58

Table 28 SELECTED CARDIOVASCULAR THERAPEUTICS IN DEVELOPMENT, 2005

59

Table 29 AVERAGE COST OF CLINICAL DEVELOPMENT FOR CARDIOVASCULAR DRUGS PER TRIAL IN THE U.S. BY PHASE, THROUGH 2011 ($ MILLION)

60

CENTRAL NERVOUS SYSTEM

60

Table 30 AVERAGE COST OF CLINICAL DEVELOPMENT FOR CENTRAL NERVOUS SYSTEM DRUGS PER TRIAL IN THE U.S. BY PHASE, THROUGH 2011 ($MILLIONS)

60

Table 31 SELECTED CENTRAL NERVOUS SYSTEM THERAPEUTICS IN DEVELOPMENT, 2005-2006

61

GASTROINTESTINAL DISEASE

62

Table 32 SELECTED GASTROINTESTINAL THERAPEUTICS IN DEVELOPMENT, 2005-2006

62

INFECTION

62

Table 33 SELECTED ANTI-INFECTIVES IN DEVELOPMENT, 2005

63

Table 34 U.S. FORECAST FOR THE AVERAGE COST OF CLINICAL DEVELOPMENT OF ANTI-INFECTIVE DRUGS PER TRIAL BY PHASE, THROUGH 2011 ($ MILLION)

64

INFLAMMATION

64

Table 35 SELECTED ANTI-INFLAMMATORY THERAPEUTICS IN DEVELOPMENT, 2005

65

CANCER

65

CANCER VACCINES

66

Table 36 PHASE III AND IV ANTI-CANCER PIPELINE

66

ORTHOPEDICS

67

Table 37 PHASE III AND IV MUSCULOSKELETAL THERAPEUTICS PIPELINE

67

RESPIRATORY

67

Table 38 SELECTED RESPIRATORY/PULMONARY THERAPEUTICS IN DEVELOPMENT, 2005

67

DEVICES

68

BIOMEMS

68

STENTS

68

IMPLANTS

68

Table 39 RECENT MAJOR DEVICE APPROVALS

69

U.S. PATENT ANALYSIS

 70

INTRODUCTION

70

GENERAL TRENDS

70

Figure 11 NEW MOLECULAR ENTITY (NME) APPLICATIONS, 1995-2004

70

TRENDS IN SELECT THERAPEUTIC AREAS

71

Figure 12 NOTABLE PATENTS IN FOUR MAJOR THERAPEUTIC AREAS, 2005 (%)

71

CONCLUSIONS OF ANALYSIS

71

CLINICAL TRIAL MARKETS

 72

CONTRACT RESEARCH ORGANIZATIONS (CROS)

72

ISSUES DRIVING THE CRO BUSINESS

72

FINANCIAL

73

ORGANIZATION

73

EFFICIENCY

73

OUTSOURCING CLINICAL TRIALS TO FOREIGN COUNTRIES

73

Table 40 NUMBER OF LISTED CLINICAL TRIALS WITH A TREATMENT ARM ACTIVELY RECRUITING SUBJECTS LOCATED IN TARGETED OUTSOURCING COUNTRIES, FEBRUARY 2006

74

Table 40 (CONTINUED)

75

Figure 13 NUMBERS OF CLINICAL TRIALS LISTED WITH THE NIH WITH A TREATMENT ARM IN SPECIFIC COUNTRIES, 2006

75

Table 41 AVERAGE COST PER PATIENT FOR TRIALS IN THE U.S., CANADA, AND WESTERN EUROPE FOR ALL THERAPEUTIC AREAS, THROUGH 2011 ($)

76

ADVANTAGES

76

Table 42 AVERAGE COST PER PATIENT FOR TRIALS IN REDUCED COST COUNTRIES, THROUGH 2011*

77

EFFICIENCY

77

DISADVANTAGES

77

SOCIOPOLITICAL ISSUES

78

BRAZIL

78

PATENT PROTECTION

78

PHARMACEUTICAL AND CLINICAL TRIAL REGISTRATION

78

CLINICAL TRIALS

78

Table 43 BRAZILIAN DOMESTIC PHARMACEUTICAL COMPANIES

79

CHINA

79

PATENT PROTECTION

79

PHARMACEUTICAL AND CLINICAL TRIAL REGISTRATION

79

CLINICAL TRIALS

79

LEADING CHINESE PHARMACEUTICAL COMPANIES

79

INDIA

80

ADVANTAGES

80

DISADVANTAGES

80

KEY POINTS FOR DOING CLINICAL STUDIES IN INDIA

80

Table 44 INDIAN DOMESTIC PHARMACEUTICAL PRODUCERS

81

Table 45 TOP FIVE BIOTECHNOLOGY COMPANIES IN INDIA

82

ROMANIA

82

PATENT PROTECTION

82

RUSSIA

82

PATENT PROTECTION

83

Table 46 LEADING RUSSIAN PHARMACEUTICAL COMPANIES

83

MERGERS AND ACQUISITIONS

83

Table 47 MERGERS AND ACQUISITIONS

84

COMPANY PROFILES

 85

BIOTECHNOLOGY COMPANIES

85

Table 48 REVENUES AND R&D EXPENDITURES FOR SELECTED BIOTECHNOLOGY COMPANIES, WITH PERCENT CHANGE, 2004 AND 2005 ($ MILLIONS)

85

ACAMBIS

85

Table 49 ACAMBIS PRODUCT PIPELINE

86

AMGEN

86

Table 50 AMGEN PRODUCT PIPELINE

87

ARRAY BIOPHARMA

87

Table 51 ARRAY BIOPHARMA PRODUCT PIPELINE

88

ARQULE, INC.

88

Table 52 ARQULE PRODUCT PIPELINE

89

AVANIR

89

Table 53 AVANIR PRODUCT PIPELINE

89

BIOGEN IDEC INC.

90

Table 54 BIOGEN PRODUCT PIPELINE

90

Table 54 (CONTINUED)

91

BOSTON LIFE SCIENCES, INC.

91

Table 55 BOSTON LIFE SCIENCES PRODUCT PIPELINE

91

CELGENE

92

Table 56 CELGENE PRODUCT PIPELINE

92

Table 56 (CONTINUED)

93

CELL THERAPEUTICS, INC. (CTI)

93

Table 57 CTI PRODUCT PIPELINE

94

CEPHALON INC.

94

Table 58 CEPHALON PRODUCT PIPELINE

95

CHIRON

95

Table 59 CHIRON PRODUCT PIPELINE

96

CORGENTECH

96

Table 60 CORGENTECH PRODUCT PIPELINE

97

CORIXA CORP.

97

Table 61 CORIXA PRODUCT PIPELINE

98

CURAGEN CORP.

98

Table 62 CURAGEN PRODUCT PIPELINE

99

CYTOKINETICS, INC.

99

Table 63 CYTOKINETICS PRODUCT PIPELINE

100

DENDREON CORP.

100

Table 64 DENDREON PRODUCT PIPELINE

101

DYNAVAX TECHNOLOGIES

101

Table 65 DYNAVAX TECHNOLOGIES' PRODUCT PIPELINE

102

ELAN CORPORATION, PLC

103

Table 66 ELAN PRODUCT PIPELINE

103

ENZON PHARMACEUTICALS, INC.

103

Table 67 ENZON PRODUCT PIPELINE

104

EXACT SCIENCES CORP.

104

GENENTECH

105

Table 68 GENENTECH PRODUCT PIPELINE

105

GENZYME

106

Table 69 GENZYME PRODUCT PIPELINE

106

Table 69 (CONTINUED)

107

GILEAD SCIENCES, INC

107

Table 70 GILEAD SCIENCES PRODUCT PIPELINE

108

GTC BIOTHERAPEUTICS, INC.

108

Table 71 GTC BIOTHERAPEUTICS PRODUCT PIPELINE

109

GTX INC.

109

Table 72 GTX PRODUCT PIPELINE

110

HUMAN GENOME SCIENCES INC.

110

Table 73 HUMAN GENOME SYSTEMS PRODUCT PIPELINE

111

IDERA PHARMACEUTICALS (HYBRIDON, INC.)

111

Table 74 IDERA PRODUCT PIPELINE

112

ICOS CORP.

112

Table 75 ICOS PRODUCT PIPELINE

113

IMMUNOGEN, INC.

113

Table 76 IMMUNOGEN PRODUCT PIPELINE

114

IMCLONE SYSTEMS INC.

115

Table 77 IMCLONE SYSTEMS PRODUCT PIPELINE

115

IMMUNOGEN, INC.

116

Table 78 IMMUNOGEN PRODUCT PIPELINE

116

IMMUNE RESPONSE CORP.

117

Table 79 IMMUNE RESPONSE PRODUCT PIPELINE

117

LA JOLLA PHARMACEUTICAL CO.

117

LORUS THERAPEUTICS, INC.

118

Table 80 LORUS PRODUCT PIPELINE

118

MAXIM PHARMACEUTICALS/EPICEPT CORP.

119

Table 81 MAXIM PRODUCT PIPELINE

119

MAXYGEN, INC.

120

Table 82 MAXYGEN PRODUCT PIPELINE

120

MEDIMMUNE

120

Table 83 MEDIMMUNE PRODUCT PIPELINE

121

MILLENNIUM PHARMACEUTICALS, INC.

122

Table 84 MILLENIUM PRODUCT PIPELINE

122

Table 84 (CONTINUED)

123

MGI PHARMA, INC.

123

Table 85 MGI PHARMA PRODUCT PIPELINE

124

MYRIAD GENETICS, INC.

124

Table 86 MYRIAD PRODUCT PIPELINE

125

NPS PHARMACEUTICALS, INC.

125

Table 87 NPS PHARMACEUTICALS PRODUCT PIPELINE

126

PRAECIS PHARMACEUTICALS, INC.

126

Table 88 PRAECIS PRODUCT PIPELINE

127

REPLIGEN

127

Table 89 REPLIGEN PRODUCT PIPELINE

127

SANGAMO BIOSCIENCES, INC.

128

Table 90 SANGAMO BIOSCIENCES PRODUCT PIPELINE

128

SEATTLE GENETICS, INC.

128

Table 91 SEATTLE GENETICS PRODUCT PIPELINE

129

SERONO

129

Table 92 SERONO PRODUCT PIPELINE

130

TRIMERIS, INC.

131

VALENTIS, INC.

131

Table 93 VALENTIS PRODUCT PIPELINE

132

VERTEX

132

Table 94 VERTEX PRODUCT PIPELINE

133

VICAL INC.

133

Table 95 VICAL PRODUCT PIPELINE

134

XECHEM INTERNATIONAL INC.

134

XOMA

135

Table 96 XOMA PRODUCT PIPELINE

135

PHARMACEUTICAL COMPANIES

136

Table 97 REVENUES AND R&D EXPENDITURES FOR SELECTED PHARMACEUTICAL COMPANIES, WITH PERCENT CHANGE, 2004 AND 2005 ($BILLIONS)

136

ABBOTT LABORATORIES

136

Table 98 ABBOTT PRODUCT PIPELINE

137

ADVANCIS PHARMACEUTICAL CORP.

137

Table 99 ADVANCIS PHARMACEUTICALS PRODUCT PIPELINE

138

ALLERGAN, INC.

138

Table 100 ALLERGAN PRODUCT PIPELINE

139

ASTRAZENECA

140

Table 101 ASTRAZENECA PRODUCT PIPELINE

140

Table 101 (CONTINUED)

141

Table 101 (CONTINUED)

142

BAXTER INTERNATIONAL, INC.

143

BRADLEY PHARMACEUTICALS, INC.

143

BRISTOL-MYERS SQUIBB

143

Table 102 BRISTOL-MYERS SQUIBB PRODUCT PIPELINE

144

CORTEX PHARMACEUTICALS

145

Table 103 CORTEX PHARMACEUTICALS PRODUCT PIPELINE

145

DUSA PHARMACEUTICALS, INC.

145

Table 104 DUSA PRODUCT PIPELINE

146

ENDO PHARMACEUTICALS

146

Table 105 ENDO PHARMACEUTICALS PRODUCT PIPELINE

147

ELI LILLY

147

Table 106 ELI LILLY PRODUCT PIPELINE

148

GLAXOSMITHKLINE

148

Table 107 GLAXOSMITHKLINE PRODUCT PIPELINE

149

Table 107 (CONTINUED)

150

Table 107 (CONTINUED)

151

Table 107 (CONTINUED)

152

HI-TECH PHARMACAL, INC.

153

IDENIX PHARMACEUTICALS, INC.

153

Table 108 IDENIX PRODUCT PIPELINE

153

INOTEK PHARMACEUTICALS

154

Table 109 INOTEK PRODUCT PIPELINE

154

JOHNSON & JOHNSON

154

Table 110 JOHNSON & JOHNSON PRODUCT PIPELINE

155

MERCK

155

Table 111 MERCK PRODUCT PIPELINE

156

Table 111 (CONTINUED)

157

NOVARTIS

157

NOVEN PHARMACEUTICALS, INC.

158

Table 112 NOVEN PRODUCT PIPELINE

158

PFIZER

159

PHARMION CORP,

159