This report analyzes the worldwide markets for Prescription Drugs in US$ Billion by the following therapeutic class – Oncologics/ Cancer Drugs, Lipid Regulators, Respiratory Agents, Proton Pump Inhibitors, Antidiabetics, Antipsychotics, Antidepressants, Angiotensin II Antagonists, Anti-Epileptics, Autoimmune Agents, and Others. The report provides separate comprehensive analytics for the US Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual forecasts are provided for each region for the period 2006 through 2015. A five-year historic analysis is also provided for these markets. The report profiles 292 companies including many key and niche players worldwide such as Abbott Laboratories, Allergan, Inc., Amgen, Inc., AstraZeneca, Bayer AG, Bristol-Myers Squibb, Boehringer Ingelheim Group, Dr. Reddy's Laboratories Ltd., Eli Lilly and Company, F. Hoffmann-La Roche Ltd., Genentech, Inc., GlaxoSmithKline Plc, Johnson & Johnson, Inc., Merck & Co. Inc., Merck Serono International S.A., Mylan, Inc., Novartis AG, Pfizer, Inc., Ranbaxy Laboratories Limited, Sanofi-Aventis SA, Sanofi Pasteur, Takeda Pharmaceutical Company Limited, Teva Pharmaceutical Industries Ltd., Watson Pharmaceuticals, Inc., and Wyeth. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.
Pharmaceutical Industry
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Quantitative Techniques & Analytics I-3
Product Definition and Scope of Study I-3
II. EXECUTIVE SUMMARY
1. INDUSTRY OVERVIEW & OUTLOOK II-1
Pharma Industry Hit by Economic Downturn II-1
Table 1: Worldwide Prescription Drugs Sales: 2006-2015
(includes corresponding Graph/Chart) II-1
The Regional Impact II-1
Emerging Markets to Drive Growth II-2
Biotechnology II-2
Biotech Bankruptcies Rife in the Current Economic Downturn II-3
Economic Downturn Takes Toll on R&D II-3
Outsourcing - A Mixed Bag II-4
Generics - The Bright Spot II-6
Table 2: Increasing Share of Generics in the Global
Pharmaceutical Market: 1995-2005 (In %) (includes
corresponding Graph/Chart) II-6
Table 3: Generics Share in Select Markets Worldwide - United
States, Germany, UK, Spain, Japan, Italy, France, Finland,
Denmark, The Netherlands, Norway, and Ireland (includes
corresponding Graph/Chart) II-7
Patent Expiries of Major Drugs: 2009-2012 II-8
Patient Spending II-8
Operational Restructuring II-9
Rising R&D Costs Call for Improved Efficiency II-9
Concerns Over Drug Safety and Side Effects Impede Sales II-9
Policy Issues Threaten Innovation II-10
Regulatory Glitches and High Costs Hinder Biogeneric Growth II-10
Opportunities Outside Drug Development II-11
Going Forward in Forward Integration II-11
Forward Integration into Diagnostics II-11
Opportunities in Healthcare II-11
Down the Distribution Chain II-12
2. LEADING PHARMA COMPANIES AND DRUGS WORLDWIDE II-13
Pfizer Reigns Supreme II-13
Table 4: Leading Global Pharmaceutical Companies Worldwide by
Sales (2008, 2007, and 2006) - Pfizer, GlaxoSmithKline,
Novartis, Sanofi-Aventis, AstraZeneca, Roche, Johnson &
Johnson, Merck & Co., Abbott and Eli Lilly - in US$ Billion
(includes corresponding Graph/Chart) II-13
Leading Prescription Drugs Worldwide - Lipitor Leads the Way II-14
Table 5: Leading Prescription Drugs Worldwide by Sales (2008,
2007, and 2006)- Lipitor, Plavix, Nexium, Seretide, Enbrel,
Seroquel, Zyprexa, Remicade, Singulair and Levonox in US$
Billion (includes corresponding Graph/Chart) II-14
Oncology Tops Therapeutic Classes II-14
Table 6: Leading Therapeutic Classes Worldwide by Sales
(2008, 2007, and 2006)- Oncologics, Lipid Regulators,
Respiratory Agents, Proton Pump Inhibitors, Antidiabetics,
Antipsychotics, Antidepressants, Angiotensin II Antagonists,
Anti-Epileptics, Autoimmune Agents and Others in US$ Billion
(includes corresponding Graph/Chart) II-15
3. THERAPEUTIC DRUG CLASSES II-16
Cholesterol Reducers II-16
Statins Lead the Way II-16
Emerging Leaders II-16
Table 7: Leading Cholesterol Reducing Drugs Worldwide: Sales
for the years 2004 through 2008 for Lipitor, Crestor and
Vytorin (in US$ Billion) (includes corresponding
Graph/Chart) II-16
Lack of Product Differentiation Mars ProspectsII-17
Zocor - The First Statin to Switch to OTC II-17
Patent Expiries of Leading Cholesterol Reducers: 2009 and
Beyond II-17
Oncologics II-17
Oncologics/ Cancer Drugs - Largest Therapeutic Class II-17
High Unmet Needs to Drive Growth II-17
Biologics to Reign Supreme II-18
Leading Drugs II-18
Leading Players II-18
Novel Therapies II-18
Respiratory Drugs II-19
Leading Brands and Players II-19
Table 8: Leading Asthma Drugs Worldwide - Value Sales for
the Years 2004-2008 for Seretide, Singulair, Symbicort and
Pulmicort (in US$ Billion) (includes corresponding
Graph/Chart) II-19
Table 9: Select COPD and Allergic Rhinitis Drugs Worldwide:
Value Sales for the Years 2006-2008 for Spiriva, Nasonex
and Zyrtec (In US$ Billion) (includes corresponding
Graph/Chart) II-20
Patent Expiries of Leading Respiratory Drugs: 2008 and Beyond II-20
Antipsychotics II-20
Leading Schizophrenia Drugs II-21
Side Effects of Antipsychotics - A Major IssueII-21
Patent Expiries II-21
Patent Expiries of Leading Anti-Psychotic Drugs II-22
Zyprexa Continues to Lose Market Share II-22
Risperdal Sales to Plunge, Following its Patent Expiry II-22
Generics - Yet to Make a Mark in Antipsychotics II-22
Increasing Use of Antipsychotics in Children Raises Concerns II-22
Proton Pump Inhibitors II-23
Patent Expiries of Leading Proton Pump Inhibitors: 2008 and
Beyond II-24
Table 10: Leading Proton Pump Inhibitors Worldwide - Value
Sales for the Years 2004 through 2006 (US$ Billion) - Nexium,
Prevacid/Takepron, Protronix/Pantazol and AcipHex/Pariet
(includes corresponding Graph/Chart) II-24
Antidepressants II-24
Patent Expiries of Leading Antidepressant Drugs Worldwide:
2005-2015 II-25
Erythropoietins II-25
Competitive Landscape in the Global Erythropoietin Market II-26
Leading Erythropoietin Drugs II-26
Table 11: Leading Erythropoietin Drugs Worldwide - Annual
Revenues for the Years 2004 through 2007 in US$ Billion for
Aranesp, Procrit/Eprex, Epogen and NeoRecormon (includes
corresponding Graph/Chart) II-26
New and Pipeline Products II-27
Biogenerics Pose Imminent Threat II-27
Anti-Arthritics II-27
Table 12: Leading Anti-arthritic Drugs Worldwide - Value
Sales for Years 2006 through 2008 in US$ Billion - Enbrel,
Remicade, Rituxan and Humira (includes corresponding
Graph/Chart) II-28
Anti-Epileptics II-28
Disease Statistics II-29
Available Drugs II-29
Generics to Take the Lead in Anti-Epileptic Market II-29
Table 13: Leading Anti-Epileptic Drugs Worldwide: Value
Sales for years 2005 through 2007 in US$ Billion for
Topamax, Lamictal, Depakote and Keppra (includes
corresponding Graph/Chart) II-30
Patent Expiries of Leading Anti-Epileptic Drugs II-30
New Launches II-30
Pipeline Drugs Bode Brighter Prospects II-30
Pipeline Drugs in Antiepileptics II-31
Calcium Channel BlockersII-31
Antidiabetics II-31
Table 14: Leading Anti-diabetic Drug Sales Worldwide: Value
Sales for Years 2005 through 2008 in US$ Billion for Actos,
Lantus, Avandia Franchise, Januivia and Byetta (includes
corresponding Graph/Chart) II-32
4. MARKET DYNAMICS II-33
Pharma M&A Activity in 2008 II-33
Aggressive M&A Deals by Japanese Companies II-34
Patent Expiries II-34
Patent Expiries for 2008 and 2007 II-35
New Product Approvals II-35
Table 15: New Drugs Approval from 2003-2008 (includes
corresponding Graph/Chart) II-36
Table 16: Biologics Approvals from 2003-2008 (includes
corresponding Graph/Chart) II-36
Table 17: Development of New Molecular Entities (Biological
and Chemical) by Various Region/Country: Percentage Share
Breakdown for the Periods 1998-2002 & 2003-2007 (includes
corresponding Graph/Chart) II-37
Table 18: Number of Compounds Under Development by
Country/Region: Percentage Breakdown for the year 2007
(includes corresponding Graph/Chart) II-37
New Molecular Entities (NMEs) Approved by FDA in 2008 II-38
New Biological Entities Approved by FDA in 2008 II-38
Research and DevelopmentII-39
Table 19: R&D Investments by Pharmaceutical Sector in US and
Europe: 2004-2007 (includes corresponding Graph/Chart) II-39
Cost Pressures II-39
R&D Productivity Slides Despite Increasing Investments II-39
Aging Population Drives Demand II-40
Table 20: World Demographic Trends: People Over 65 as a
Percentage of Total Population by Geographic Region- US,
Canada, Japan, Europe, Asia-Pacific, and Latin America for
years 2000, 2008, 2010, and 2020 (includes corresponding
Graph/Chart) II-40
5. PRESCRIPTION PHARMACEUTICALS - AN OVERVIEW II-41
Biologics II-41
Evolution Of The Global Pharmaceutical IndustryII-42
Drug Development Process - FDA Perspective II-43
Stages of Drug Development Process II-43
Drug Discovery II-43
Pre-Clinical Testing II-43
Clinical Trials II-43
Phase I Clinical TrialII-44
Phase II Clinical Trial II-44
Phase III Clinical Trial II-44
New Drug Application II-44
FDA Review II-44
Phase IV Clinical Trials II-44
FDA’s Drug Safety Review - The Global Standard II-44
6. SELECT THERAPEUTIC CLASSES II-46
Anti-arthritics II-46
COX-2 Inhibitors II-46
Antipsychotic Drugs II-46
Anti-Ulcerants II-47
Codeine & Combinations II-47
Combination Drugs II-48
Anti-Depressants II-48
Selective Serotonin Reuptake Inhibitors (SSRIs) II-48
Serotonin Noradrenaline Re-Uptake Inhibitors (SNRIs) II-49
Serotonin Modulators (5-HT2 blockers) II-49
Dopamine-norepinephrine Reuptake Inhibitors II-49
Monoamine Oxidase Inhibitors (MAOIs) II-50
Erythropoietin II-50
Proton Pump Inhibitors II-50
Seizure Disorder Drugs II-51
Antihistamines II-52
Calcium Channel BlockersII-53
Cholesterol Reducers II-54
7. MARKETING AND PROMOTIONS II-55
Table 21: Promotional Spending by Major Pharma Companies (2006
and 2007) in US$ Million - Pfizer, GlaxoSmithKline, Merck,
AstraZeneca, Sanofi-Aventis, Novartis, Eli Lilly,
Schering-Plough, Johnson & Johnson, and Bristol Myers Squibb
(includes corresponding Graph/Chart) II-55
Table 22: Promotional Spending through Professional Detailing
by Major Pharma Companies (2006 and 2007) in US$ Million -
Pfizer, GlaxoSmithKline, Merck, AstraZeneca, Novartis,
Sanofi-Aventis, Eli Lilly, Johnson & Johnson, Schering-Plough
and Wyeth (includes corresponding Graph/Chart) II-56
Table 23: Direct-To-Consumer Promotional Spending By Major
Pharma Companies (2006 and 2007) in US$ Million - Pfizer,
GlaxoSmithKline, Merck, Bristol Myers Squibb, Sepracor,
AstraZeneca, Schering-Plough, Sanofi-Aventis, Boehringer
Ingelheim and Eli Lilly (includes corresponding Graph/Chart) II-56
Table 24: E-Promotional Spending by Major Pharma Companies
(2006 and 2007) in US$ Million - Merck, GlaxoSmithKline,
Johnson & Johnson, Pfizer, Shire, Eli Lilly, Schering-Plough,
AstraZeneca and Sanofi- Aventis (includes corresponding
Graph/Chart) II-57
8. RECENT INDUSTRY ACTIVITY II-58
Merck & Co. And Schering-Plough to Merge II-58
Pfizer to Acquire Wyeth II-58
CSL and Talecris Biotherapeutics to Withdraw Merger Agreement II-58
AstraZeneca Partners with Merck to Analyze a New Combination
of Anticancer Regimen II-58
Sun Pharmaceutical Acquires ChattemII-59
Novartis Acquires 25% Stake in Alcon II-59
Takeda Acquires Millenium Pharmaceuticals II-59
Teva Acquires Barr II-60
Invitrogen and Applied Biosystems Merge II-60
Eli Lilly Takes Over ImClone Systems II-60
Daiichi- Sankyo Acquires Controlling Stake in Ranbaxy II-60
Fresenius Acquires APP Pharmaceuticals II-61
TPG Acquires 50% Stake in SIA International II-61
GSK Acquires Sirtris II-61
Shire Aquires Controlling Interest in Jerini II-61
Boehringer Ingelheim to Purchase Actimis Pharmaceuticals II-61
Sanofi Pasteur Acquires Acambis II-62
Sanofi-Aventis Acquires Symbion II-62
Nordic and Avista Acquires ConvaTecII-62
King Pharmaceuticals Acquires Alpharma II-62
Shionogi Acquires ScieleII-63
Ranbaxy Inks Indian Marketing License for GLIADEL® with BioPro II-63
Tibotec Gains EC Approval for PREZISTA®’s Extended Indication II-63
GSK and Neptunus to Set up Joint Venture for Developing Flu
Vaccines II-64
AstraZeneca Obtains TRO for Generic Pulmicort Respules II-64
Solvay Pharmaceuticals Enters Into a License Deal with Depomed II-64
AstraZeneca Enters into an Agreement with Par Pharmaceutical II-65
BioReliance and Provecs Enter into Agreement II-65
Cornerstone BioPharma and Critical Therapeutics Merge to Form
Cornerstone Therapeutics II-65
GSK to Acquire Genelabs II-66
Lpath and Merck Serono Forge Partnership II-66
Allergan and Spectrum Ink Collaboration Deal for Bladder
Cancer Drug II-66
EMD Signs Licensing and Collaboration Deal with
Theratechnologies II-67
Medimetriks Receives License for Prescription Brands from
Perrigo II-67
Forest Partners with Phenomix for Developing Diabetic Drug II-68
GSK Biologicals and AFFiRiS Sign Collaboration Agreement II-68
Sanofi-Aventis Strengthens R&D Operations in the Chinese Market II-68
UCB and Pfizer Establish Cyclofluidic II-69
Valeant Pharmaceuticals Completes Coria Laboratories Acquisition II-69
MedImmune Inks Agreement with Omninvest over Reverse Genetic
Technology II-70
Avidas Secures North American Rights of Crown’s Dermatology
Products II-70
Lilly Acquires Two Compounds for Early-Stage Tuberculosis
Drug Pipeline II-71
Eli Lilly and Deciphera Enter into Collaboration and
Licensing Deal II-71
Roche, GlycArt and Genentech Sign Collaboration Agreement II-72
Cardinal Health Plans to Spin-Off Medical and Clinical
Products Businesses II-72
Sanofi Pasteur Holding Acquires Acambis II-72
Eisai Plans NDA Submission for Insomnia Drug II-73
GlaxoSmithKline Enter into Strategic Alliance with Cellzome II-73
Ablynx and Merck Serono Sign Nanobodies® Agreement II-74
GlaxoSmithKline and Valeant Enter into Collaborative Agreement II-74
Noven Enters Supply and License Agreements with P&G
Pharmaceuticals II-75
Eli Lilly Acquires SGX Pharmaceuticals II-75
SymBio Pharmaceuticals Enters into a License Agreement with
Eisai II-75
Roche Sells Four Pharmaceutical Products to Meda AB II-76
AstraZeneca Joins Hands with Abbott for Co-Promotion of Crestor II-76
Gilead Sciences Inks Atripla®, HIV Drug Distribution Deal
with Merck II-77
Eisai China Enters into Licensing Deal with Health Vision II-77
GSK and Harvard Stem Cell Institute Team Up for Drug Discovery II-78
Teva Acquires Bentley Pharmaceuticals II-78
Roche to Acquire ARIUS Research II-78
GlaxoSmithKline and Actelion Collaborate II-79
GSK Enters into Product Disinvestment Agreement with Aspen II-79
Lupin Forges Marketing Alliance with ASCEND for Suprax® Tablets II-80
Merck Serono Inks Multiple Sclerosis Drug-Development Deal
with Bionomics II-80
European Commission Approves Kuvan® of Merck Serono II-81
GSK Collaborates with Mpex for Developing Anti-Bacterial Drugs II-81
Eli Lilly Announces Development & Licensing Agreement with
TransPharma II-81
Mylan Obtains Exclusive Marketing Rights for Glatiramer from
NATCO II-82
Sepracor Acquires Oryx Pharmaceuticals II-82
Mylan Takes Over Merck’s Outstanding Generics Operations II-83
Gilead Acquires Cicletanine Business from Navitas II-83
King Pharmaceuticals to License Third Opioid Analgesic Product II-84
BioPhausia Acquires Prescription Pharmaceutical Offerings
from AstraZeneca II-84
Ranbaxy Enters into Strategic Product Development Agreement
with Merck II-84
EUSA Pharma Acquires Cytogen Corporation II-85
Dr. Reddy’s Announces Two Major Acquisitions II-85
EUSA Divests Stake in Antibody Research and Oncology Product
to IDD II-85
Sanofi Pasteur Delivers H5N1 Bulk Vaccine Antigen to HHS II-86
Ranbaxy Inks Strategic Business Alliance with Orchid II-86
Pfizer Settles Patent Litigation for Lipitor with Ranbaxy II-87
GSK Enters into Collaboration with Regulus Therapeutics II-87
Janssen to Launch J&J Group’s New Drugs in Japan II-88
Roche Alliance Partner Obtains Approval for Actemra in Japan II-88
Abbott Receives Japanese Approval for Rheumatoid Arthritis
Drug, HUMIRA® II-88
Dr. Reddy’s Completes Acquisition of Jet Generici Srl II-89
Eli Lilly, Transition Therapeutics Announce Licensing and
Partnership Agreement II-89
Dr. Reddy’s and 7TM Sign Drug Discovery Agreement for
Selected Drug Targets II-89
Endo Pharmaceuticals Obtains US Rights for Novartis’
Voltaren® Gel II-90
Pfizer to Take Over Serenex II-90
Sanofi-aventis, Amyris, iOWH Sign Semisynthetic Artemisinin
Development Deal II-91
AstraZeneca Files sNDA for Depressive Disorder Drug, Seroquel
XR™ II-91
Forest, Mylan Amend Bystolic Agreement II-92
Fujifilm to Acquire Stake in Toyama Chemicals II-92
Graceway Takes Over Estrasorb II-92
Ranbaxy Announces De-Merger of New-Drug Discovery Research Unit II-93
AstraZeneca Inks Deal with Nomura Phase4 Ventures to Form
Albireo II-93
Cellegy to Merge with Adamis Pharmaceuticals II-93
Mylan Reaches Accord with Novartis for Femara®’s Generic Product II-93
Dyax Signs Licensing and Development Agreements with Sanofi-
aventis II-94
AstraZeneca Files for EU Approval of Seroquel XR™ II-94
MedImmune Files Biologics License Application for motavizumab
to FDA II-94
Farmavita, Belupo Sign Contract for Strategic Merger II-94
Pfizer Japan Secures Production and Marketing Approval for
Champix® II-95
Eisai Enters into License Agreement with AbbottII-95
Eisai Takes Over MGI Pharma II-96
KV Pharmaceutical to Acquire Rights for Gestiva™ from Hologic II-96
Forest and Novexel Enter into Licensing Agreement II-96
Dr. Reddy’s Enters Settlement Agreement with Novartis for
Exelon® II-97
Taisho and Pfizer Sign Agreement for TS-032 II-97
Crucell Enters into Agreement with Sanofi Pasteur II-97
EMEA Approves Second Biogeneric EPO, Retacrit II-98
Endo Pharmaceuticals Licenses AZ-003 from Alexza II-98
Schering-Plough and Centocor Modify Existing Distribution
Agreement II-98
GSK and Santaris Pharma Collaborate in RNA Antagonists Research II-99
GSK Acquires Reliant Pharmaceuticals II-99
Eisai and Minophagen Ink In-Licensing Agreement for Liver
Disease/ Allergic Disease Agents II-100
Bristol-Myers, Gilead Extend Agreement to Commercialize
ATRIPLA® in Europe II-100
GSK and OncoMed Team Up for Antibody Therapeutics for Cancer
Stem Cell Research II-101
GSK Allies with Galapagos for Antiviral and Antibacterial
Development II-101
Eisai and BioArctic Ink Licensing Deal for BAN2401 II-102
Biogen and Neurimmune Join Hands to Develop Drugs for
Alzheimer's Disease II-102
Sanofi-aventis Institutes GDC, Pharmaceutical Development
Center in India II-103
AstraZeneca Obtains Pediatric Exclusivity for ARIMIDEX® from FDA II-103
Covance to Build High-Tech Drug Development Facility II-103
Schering-Plough Takes Over Organon BioSciences II-104
Takeda Launches Takeda San Francisco for Therapeutic Antibody
Research II-104
GSK to Disinvest Lotronex® II-104
Gilead and LGLS Enter Global License Deal for Fibrotic
Diseases Therapy II-105
Watson Acquires Andrx II-105
EPFL and Merck Serono Enter into Agreement II-106
Acura and King R&D Sign Licensing Agreement for Opioid
Analgesic Products II-106
Eli Lilly Inks License Agreement with Glenmark Pharmaceuticals II-107
Wockhardt Takes Over Morton Grove Pharmaceuticals II-107
GSK Enters into Collaboration with Tolerx for Development of
Novel Therapies II-108
Chugai Pharmaceuticals Obtains Approval for Tarceva in Japan II-108
Eli Lilly Announces Strategic Alliance with MacroGenics II-108
BMS, ImClone, Merck Serono Sign Erbitux® Agreement II-109
Wockhardt to Market Gnosis’ SAMe in India II-110
Alpharma Grants US License for Ketoprofen in Transfersome®
Gel to IDEA II-110
Forest and Daiichi Sankyo Sign Contract to Co-Promote AZOR™ II-110
Synta and GSK Sign Oncology Molecule Development Collaboration II-110
Cyclacel to Take Over ALIGN Pharmaceuticals and ALIGN Holdings II-111
GSK Inks Antiviral and Antibacterial Drug Development Deal
with Anacor II-111
AMRI Enters into Research Collaboration with Cystic Fibrosis
Foundation II-112
Mylan Takes over Merck Generics II-112
Kissei and Eisai Ink Licensing Deal for Glufast® Tablets II-112
AMRI Inaugurates New Research Unit in HyderabadII-113
Eisai Inks Co-Promotion Deal with Salix for COLAZAL® Capsules II-113
Kowa and Teva to Establish Joint Venture Generic Drug Firm in
Japan II-113
Nisshin Seifun Pulls Out of Joint Venture Nisshin Kyorin
Pharmaceutical II-114
Chugai and Teijin Sign Agreement for Co-Development of Anti-
Diabetic Drug II-114
MedImmune Inks Licensing Agreement with Novartis over Reverse
Genetic Technology II-114
EUSA Acquires Assets of Innocoll II-115
Noven Enters Supply and License Agreements with P&G
Pharmaceuticals II-115
Parion and Gilead Ink Deal to Develop Drug Candidates for
Pulmonary Disease II-116
Noven Pharmaceuticals Acquires JDS Pharmaceuticals II-116
HHS Places an Order with GSK for Bulk H5N1 Antigen II-117
Synthon Completes Laboratorios Rider Acquisition II-117
Targacept Forges Partnership with GSK II-118
Dong Wha Signs Alliance with P&G Pharma to Develop Treatment
Molecules for Osteoporosis II-118
Barr and Gedeon Richter Sign Pact over Generic Version of
LAMISIL® II-118
Santarus and Victory Pharma Enter Into Co-Promotion Agreement II-119
AMRI Enters into Collaboration for Research with Achaogen II-119
SCI Collaborates with High Q Foundation for Research on
Huntington’s Disease II-120
MonoSol Rx Signs License Agreement with Strativa Pharmaceuticals II-120
Eli Lilly to Launch Public-Private Partnership for Drug
Research in Tuberculosis II-120
Merck Serono and Bristol-Myers Squibb Ink Latin American
Distribution Deal II-121
Strides Arcolab to Take Over Bio-Fermentation Facility in Italy II-121
Amgen to Take Over Alantos Pharmaceuticals II-121
GlaxoSmithKline Establishes R&D Center in ChinaII-122
Wockhardt Acquires Negma Laboratories II-122
Eisai Inks Exclusive Agreement with Solstice over NeuroBloc® II-122
Ranbaxy to Acquire Be-Tabs Pharmaceuticals II-123
Pfizer Obtains Health Canada Approval for LIPITOR in Reducing
Myocardial Infarction II-123
GSK Allies with Wellcome to Develop Antibacterials for
Hospital-Contracted Infections II-124
Bristol-Myers and Pfizer Ink Development and
Commercialization Agreements II-124
Cytos Biotechnology Grants Novartis with Global License for
NicQb II-125
Swiss Federal Register Adds ACOMPLIA® to Reimbursement List II-125
Wockhardt to Introduce Syrio Pharma’s B-Lift Product Range in
India II-126
Eisai Acquires MorphotexII-126
Ranbaxy Obtains Approval for RAN™ Cefprozil Formulations in
Canada II-126
Roche Partners with Transgene to Focus on Therapeutic Vaccine
Program II-127
Cardinal Health Divests Pharmaceutical Technologies and
Services Segment to Blackstone Group II-127
Roche to Acquire BioVeris Corporation II-128
Eli Lilly Acquires Hypnion II-128
Roche Takes Over THP, Broadens Antibody Research Facility II-128
Oxford BioMedica Enters into Development Deal with Sanofi-
Aventis for TroVax® II-129
Iroko Pharmaceuticals Acquires Rights to Indocin® and
Aldomet® Products II-129
Asahi Kasei Inks Licensing Agreement with Eisai Korea over
Vasodilator Eril® II-129
Merck Obtains EU Approval for JANUVIA™ Type 2 Diabetes Drug II-130
Wockhardt Obtains FDA Approval for a Painkiller in the US II-130
Ortho-McNeil Obtains Pediatric Extension for LEVAQUIN® II-131
GlaxoSmithKline Obtains FDA Approval for Tykerb® II-131
Terapia Ranbaxy Secures Marketing Approvals for 20 New Products II-131
Shionogi to Develop and Market BioCryst's peramivir in Japan II-131
Abbott and Eisai Amend Co-Promotion Agreement over HUMIRA® in
Korea and Taiwan II-132
Salix Acquires US Rights to Merck’s Two Oral Suspension Products II-132
Takeda Expands Collaboration with XOMA in Potential
Therapeutic Antibody Programs II-133
GSK Commences Phase III Clinical Trials of Tykerb®, a Post-
Operative Lapatinib II-133
Roche Grants Glaxo with Exclusive Licensing Rights to its ‘
Orlistat’ Drug II-134
GSK and HGS Commence Phase III Trials of LymphoStat-B® in SLE II-134
GSK and Fabre-Kramer Ink Global Deal for Gepirone ER II-134
Ranbaxy Signs Agreement with Zenotech for Biosimilars’ Global
Launch II-135
Ranbaxy Inks Long-Term R&D Deal with GSK II-135
Amgen Inks Three-year Aranesp Supply Agreement with Fresenius II-136
AstraZeneca to Take Over Arrow Therapeutics II-136
Eli Lilly Acquires ICOS CorporationII-136
Pfizer Plans to Takeover BioRexis II-136
Solvay Inks Licensing Deal with Jazz Pharmaceuticals for LUVOX® II-137
Eisai’s’Pariet®, 10mg Tablets’ Receive Clearance for New
Indication in Japan II-137
Eisai Receives EC Approval for Inovelon® II-137
Pfizer Receives Marketing Authorization for Sutent® in
European Union II-137
GlaxoSmithKline Obtains Approval to Market Wellbutrin XR® in
the Netherlands II-138
Forest Laboratories Acquires US Biopharmaceutical Company,
Cerexa II-138
Mylan Laboratories Acquires 51.5% in Matrix II-139
DUSA Enters into an Agreement with Daewoong Pharmaceutical II-139
Penwest and Endo Amend Existing Contract on Opana® ER
Collaboration II-139
Eli Lilly Licenses Glucokinase Activator Program from OSI
Pharmaceuticals II-140
Graceway Pharmaceuticals Acquires 3M Pharmaceuticals Business II-140
Ranbaxy Obtains FDA Approval for Atenolol Tablets II-140
Gilead Sciences Acquires Myogen II-141
Gilead Sciences Acquires Raylo Chemicals II-141
9. FDA APPROVALS FOR 2009, 2008 AND 2007 II-142
10. A REVIEW OF SELECT PRODUCT INTRODUCTIONS IN THE PHARMA INDUSTRY II-144
Amgen Receives Approval for Nplate® II-144
Takeda Wins FDA Marketing Approval for ULORIC II-144
Novartis and MMV Launch Coartem® Dispersible II-144
Ipsen and Medicis Receives FDA Approval for Dysport II-144
Centocor Receives FDA Approval for Simponi II-145
Wyeth Receives FDA Approval for PRISTIQ™ II-145
GSK Receives FDA Approval for Promacta® II-145
Cephalon Receives FDA Approval for TREANDA II-145
Adolor Receives FDA Approval For Entereg® II-145
Lundbeck Introduces Xenazine* (Tetrabenazine) Tablets II-146
Eisai US Receives FDA Approval for Banzel™ (Rufinamide) II-146
Progenics Receives FDA Approval for RELISTOR II-146
J&J Receives Approval for Anti-HIV Medication ‘Intelence’ II-146
Sandoz Launches Generic Fluoxetine Hydrochloride Capsules in US II-146
Sandoz Introduces Eplerenone Tablets II-147
Wockhardt Introduces Midazolam Injection in the US II-147
Dr. Reddy’s Announces Launch of Gener
