Anti-Hypertensive Drugs - Global Strategic Business Report

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-3
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3

II. Executive Summary

1. MARKET AT A GLANCE II-1
Introduction II-1
Hypertension - Prevalence II-1
Market Overview II-1
Current and Future Analysis II-2
ARBs Lead the World Anti-hypertension Drugs Market II-2
Lack of R&D Innovation, Genericization Characterize the Global
Anti-Hypertensive Drugs Market II-3

2. HYPERTENSION: Definition, Concerns, Consequences,
Categorization, Diagnosis, Treatment, Side Effects, and Leading
Drugs II-4
Definition II-4
Blood Pressure II-4
High Blood Pressure II-4
Concerns II-4
Consequences II-5
Hypertension and Diabetic Population II-5
Categorization II-5
Primary and Secondary Hypertension II-5
Acute Hypertension II-5
Diagnosis II-6
Treatment II-6
Lifestyle Modifications II-6
Avoiding Nicotine Products II-6
Avoiding Alcohol II-6
Avoiding Processed Foods II-6
Restricting Sodium II-7
Reducing Weight II-7
Adopting Biofeedback / Relaxation Techniques II-7
Anti-Hypertensive Drugs II-7
Beta Blockers II-7
Types of Beta-blockers II-8
Calcium Channel Blockers II-8
Types of Calcium Channel Blockers II-8
Angiotensin II Receptor Blockers II-8
Types of Angiotensin II Receptor Blockers II-9
ACE Inhibitors II-9
Types of ACE Inhibitors II-9
Diuretics II-10
Types of Diuretics II-10
Other Anti-hypertensive Drugs II-11
Renin Inhibitors II-11
Vasodilators II-11
Types of Vasodilators and Brand Names II-11
Alpha Blockers II-11
Mixed Blockers II-11
Adrenergic Receptor Agonist II-12
Aldosterone Receptor Antagonists II-12
Central Alpha Agonists II-12
Side Effects II-12
Side Effects by Drug Class II-12
Thiazide Diuretics II-12
Beta-blockers II-13
ACE Inhibitors II-13
Peripheral Vasodilators II-13
Side Effects by Drug Name II-13
Side Effects Profile of Select Anti-hypertensive Drugs II-13
Select Leading Anti-hypertensive Drugs: A Review II-15
Benicar/Olmetec II-15
Cleviprex II-15
Cozaar II-15
Diovan/Diovan HCT II-15
Exforge II-16
Norvasc II-16
Tekturna/Rasilez II-16
Tekturna HCT II-16

3. RESEARCH & DEVELOPMENT II-18
Takeda’s TAK-536 Reaches Phase III Clinical Trials in Japan II-18
China Pharma Commences Clinical Trials for Candesartan Generic II-18
Taipei Medical University Reveals Results of New Blood
Pressure Study II-18
Researchers Identify New Genes Affecting Blood Pressure II-18
Italian Study Demonstrates Benefits of Investigational
Amlodipine and Telmisartan Combination Treatment in Blood
Pressure Patients Exposed to Risk of Cardiovascular Events II-19
Gilead Sciences Announces Phase III Darusentan Data II-19
Gilead Sciences Commences Phase II Trial of Cicletanine II-20
New Clinical Data Demonstrates Effectiveness of Rasilez/
Tekturna in Obese Patients with Hypertension in Comparison to
Monotherapy with Diuretic Hydrochlorothiazide II-20
New Study Demonstrates Effectiveness of Exforge® in
Controlling High Blood Pressure in "difficult-to-treat"
Patients than Amlodipine Alone II-20
New Analyses Demonstrates Use of Cleviprex for Controlling
Perioperative Hypertension to Lower the Risk of Heart Attack
and Mortality Following Cardiac Surgery II-20
Surface Logix Announces Encouraging Phase IIa Results of SLx-2101 II-21
Observational Study Demonstrates Telmisartan to Provide
Powerful Blood Pressure Control for Complete 24-hours,
Including the Risky Hours of Early Morning II-21
New Study Demonstrates Tekturna® When Combined with Diovan® to
Have Additional Blood Pressure Lowering Effect II-22
Protherics Develops High Blood Pressure Vaccine II-22

4. PRODUCT INTRODUCTIONS II-23
Takeda Introduces ECARD for Hypertension Treatment II-23
Amneal Pharmaceuticals Introduces Benazepril HCI II-23
Ranbaxy Laboratories to Introduce Daiichi Sankyos Olvance in
India II-23
Gemini Pharmaceuticals Launches Anti-hypertensive Medicine,
Micardis II-23
Shionogi Introduces Fluitran® 1mg II-24
Helvepharm Launches New Anti-hypertensive Drug II-24
Ranbaxy Laboratories Introduces Amlodipine II-24
Nicholas Piramal Launches Hypertension Management Device II-24
GlaxoSmithKline Introduces Ambrisentan II-24
Novartis Introduces Aliskiren II-24
Dainippon Introduces Avapro for Hypertension Treatment II-25
Shionogi Introduces Irbetan for Hypertension Treatment II-25
Pfizer Japan Introduces Sildenafil II-25
Surgipharm Launches Diovan and Co-diovan II-25
King Pharmaceuticals Introduces Altace Tablets II-25
Encysive Pharmaceuticals Introduces Thelin Tablets II-25
Dr Reddys Laboratories Introduces Atocor-R II-26
Wockhardt to Introduce Amlodipine Tablets II-26
GlaxoSmithKline Launches Coreg CR Extended-Release Capsules II-26
Toray and Astellas Introduce Careload LA Tablets II-26
Encysive Introduces Sitaxentan Encysive II-26
GlaxoSmithKline Introduces Carzec II-27
Encysive Pharmaceuticals Introduces Thelin II-27
Ranbaxy Laboratories Introduces Generic Drug Verapamil II-27
Actavis Group Introduces NIFEdipine (XR) Tablets II-27
Apotex Introduces Norvasc Generic II-27
Novartis Introduces Aliskiren II-27
Encysive Introduces Sitaxentan II-28
Pfizer to Release the Generic Version of Norvasc II-28
Mylan Introduces Generic Blood Pressure Medicines II-28

5. RECENT INDUSTRY ACTIVITY II-29
Sanofi-Aventis Takes Over Helvepharm II-29
ARCA Biopharma Merges with Nuvelo II-29
Astellas and Nippon Receive Approval for Micombi®
Antihypertensive Drug II-29
The Medicines Co Announces EU Acceptance of MAA for Cleviprex II-29
Actelion and GeneraMedix Sign Definitive Agreement II-30
AtCor Medical Enters into Contract with Pharmaceutical Company II-30
Ranbaxy Receives FDA Approval for Anti-hypertensive Drug II-30
Sun Pharmaceuticals Receives Approval for Generic Version of
Accupril II-30
Sucampo Pharma Americas Wins Rights to Rescula II-30
Novartis Obtains Approval from Japanese Health Ministry II-31
Novartis Obtains FDA Approval for Exforge HCT II-31
Novartis Obtains Approval for Four New Medicines II-32
Aveva Drug Delivery Obtains Approval for Clonidine TDS II-32
Ranbaxy Receives Approval to Market Anti-Hypertension Drug II-32
Actelion Receives FDA Approval for New Ventavis Formulation II-32
Sinobiopharma Receives Chinese Approval for Perindopril II-32
Pfizer Acquires Encysive Pharmaceuticals II-33
GlaxoSmithKline Acquires Bristol Myers Squibb’s Egyptian Business II-33
Gilead Sciences Acquires Navitas’ Cicletanine Business Assets II-33
Shionogi Acquires Sciele Pharma II-34
Recordati Acquires Yeni Ilac II-34
Kyowa Hakko Merges with Kirin Pharma II-34
Belupo and Farmavita Announce Merger II-35
Daiichi Sankyo India and GlaxoSmithKline Sign Co-Promotion Deal II-35
Sciele Pharma and Addrenex Pharmaceuticals Sign Exclusive
Agreement II-35
Merck Serono Signs Distribution Agreement with Bristol-Myers
Squibb II-35
Forest Laboratories Holdings Amends Agreement with Mylan II-36
Speedel Secures FDA Approval for Tekturna HCT II-36
Lupin Receives FDA Approval for Generic Ramipril Capsules II-36
Daiichi Sankyo Submits Application for Anti-hypertensive Drug
Approval II-36
Mylan Receives FDA Approval for Nisoldipine Extended-Release II-37
Glenmark Wins FDA Approval for Trandolapril II-37
Novartis Obtains FDA Approval for Tekturna HCT II-37
Mylan Receives Tentative Approval for Generic Version of
Benicar HCT II-37
Novartis Secures Swissmedic Approval for Rasilez HCT II-37
Kyowa Secures Japanese Approval for Amlodipine Generic II-37
Aurobindo Pharma Obtains FDA Approval II-38
Actelion Receives EU Approval for Tracleer II-38
The Medicines Company Wins FDA Approval for Cleviprex II-38
Indian Pharmaceuticals Wins Approval for Propranolol
Hydrochloride Tablets II-38
Aurobindo Pharma Secures FDA Approval for Lotensin Generic II-38
Zydus Cadila Obtains FDA Approval for Marketing of Benazepril II-38
Mylan Wins FDA Approval for Mavik’s Generic II-39
Kampala Pharma to Commence Production of High Blood Pressure
Drugs II-39
Merck Extends Licensing Agreement with AstraZeneca II-39
Helpson Receives China FDA Approval to Market Bumetanide Generic II-39
Sciele Pharma Obtains FDA Approval II-39
DAIICHI SANKYO ILAÇ Acquires Anti-hypertensive Drug, Concor II-39
Novartis’ Rasilez HCT Receives European Committee Recommendation II-40
Pfizer Wins Patent Protection Lawsuit for Norvasc in Canada II-40
Forest Labs and Daiichi Sankyo Terminate Azor Co-Promotion
Agreement II-40
Novartis Wins Canadian Approval for Rasilez II-40
Hi-Tech Pharmacal Receives ANDA Approval from FDA II-40
Dr. Reddys Receives FDA Approval for Trandolapril II-41
Quantum Genomics and PCAS Pharma Sign Strategic Agreement II-41
GeneraMedix Wins Approval from FDA for Epoprostenol II-41
Pharmaceutical Holdings Changes Name to URL Pharma II-41
Zydus Cadila Obtains Approval from U.S. FDA for Ramipril Capsules II-42
Zydus Cadila Obtains Approval from U.S. FDA for Four Drugs II-42
KV Pharmaceutical Obtains FDA Approval for Toprol-XL Generic II-42
Ranbaxy Pharmaceuticals and AstraZeneca Sign Agreements II-42
Recordati Completes Mutual Recognition with 28 European Nations II-43
Recordati Obtains Australian Approval for Zan-Extra® II-43
Santen Pharmaceutical Obtains Approval for TAPROS II-43
Santen Obtains Marketing Authorization for TAFLOTAN II-43
Boehringer Ingelheim Wins EU Commission Approval for
MicardisPlus® 80/25 II-44
Daiichi Sankyo Europe Obtains Marketing Approval of SEVIKAR® II-44
Daiichi Sankyo Establishes Subsidiary in Ireland II-44
GlaxoSmithKline Wins EC Marketing Approval for Volibris II-44
NicOx Enters into Alliance with Royal DSM II-45
NicOx Enters into Alliance with Archimica II-45
NicOx Enters into Alliance with Capsugel II-45
Novartis Obtains FDA Approval for Exforge and Diovan HCT II-45
Actelion and Merck Initiate Phase II Program Dosing, Reach
Fourth Milestone II-46
Jupiter Bioscience Acquires Drug Technology II-46
Recordati- Berlin Chemie Expand Licensing Agreement II-46
Meda and Recordati Enter into Agreement for Zaneril® II-46
Glenmark Wins FDA Approval for Coreg II-47
Novartis Secures FDA Approval for Exforge II-47
Caraco Receives ANDA Approval for Norvasc Generic II-47
Mylan and Forest Labs Win FDA Approval to Market Bystolic II-47
Daiichi Sankyo Secures FDA Approval for Azor II-47
Teva Bags Approval to Market Accupril Generic II-48
Meda and Recordati Sign Long-Term Agreement II-48
Ranbaxy Bags Approval to Produce and Market Amlodipine Besylate II-48
Caraco Receives FDA Approval for Atenolol Tablets II-48
Sciele Pharma and Addrenex Enter into Agreement II-49
Novartis Wins Swissmedic Approval for Tekturna II-49
Lupin Bags Approval to Market Prinivil’s Generic Version II-49
Aurobindo Pharma Receives FDA Approval for Accuretic’s
Generic Version II-49
Gilead Sciences Wins FDA Approval for Letairis II-49
Guangdong Luote Signs Agreement with Nippon Chemiphar II-50
Wockhardt Wins FDA Approval to Market Lisinopril II-50
Kaken to Commence Marketing Procylin for Pulmonary
Hypertension Treatment II-50
Encysive Pharma Wins Australian Approval for THELIN® II-50
Ranbaxy Wins Approval to Market Atenolol II-51
Novartis Secures EC Approval for Exforge II-51
Ranbaxy Receives Health Canada Approval for Lisinopril Tablets II-51
Ranbaxy Receives Tentative Approval for Valsartan Tablets II-51
Bristol-Myers and sanofi-aventis Obtain FDA Approval for AVALIDE II-52
Par Pharmaceutical Receives FDA Approval for Propranolol HCl ER II-52
Ranbaxy Receives Approval from FDA for Coreg Generic II-52
KV Pharmaceuticals Obtains FDA Approval for Toprol-XL Generic II-53
Mylan Wins Approval for Propranolol Hydrochloride ER Capsules II-53
Novartis Wins EU Approval for Rasilez II-53
Actavis Group Secures FDA Approval for Carvedilol Tablets II-53
Par Pharmaceuticals Ships ER Metoprolol Succinate Tablets II-53
Biovail Reaches Settlement Agreement with Watson Pharmaceuticals II-54
Lexicon Genetics Announces Name Change II-54

6. FOCUS ON SELECT MAJOR PLAYERS II-55
AstraZeneca PLC (UK) II-55
Bayer AG (Germany) II-55
Biovail Corp. (Canada) II-56
Boehringer Ingelheim GmbH (Germany) II-56
Bristol-Myers Squibb Company (USA) II-56
Daiichi Sankyo Company, Limited (Japan) II-57
Dr. Reddys Laboratories Ltd. (India) II-57
Forest Laboratories, Inc. (USA) II-57
GlaxoSmithKline PLC (UK) II-58
Merck & Co., Inc. (USA) II-58
Mylan, Inc. (USA) II-59
Novartis AG (Switzerland) II-59
Pfizer, Inc. (USA) II-60
Ranbaxy Laboratories Limited (India) II-60
Sanofi-aventis (France) II-61
Solvay Pharmaceuticals SA (Belgium) II-61
Takeda Pharmaceutical Company Limited (Japan) II-61
Teva Pharmaceutical Industries Limited (Israel) II-62
The Medicines Company (USA) II-62

7. GLOBAL MARKET PERSPECTIVE II-64
Table 1: World Recent Past, Current & Future Analysis for
Anti-hypertensive Drugs by Geographic Region - US, Europe and
Rest of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2007 through 2015 (includes
corresponding Graph/Chart) II-64

Table 2: World Historic Review Analysis for Anti-hypertensive
Drugs by Geographic Region - US, Europe and Rest of World
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2001 through 2006 (includes
corresponding Graph/Chart) II-65

Table 3: World 15-Year Perspective for Anti-hypertensive Drugs
by Geographic Region - Percentage Breakdown of Dollar Sales
for the US, Europe and Rest of World Markets for 2003, 2009 &
2015 (includes corresponding Graph/Chart) II-66

III. MARKET

1. UNITED STATES III-1
A.Market Analysis III-1
Hypertension - Prevalence III-1
Table 4: Hypertension Prevalence Among Adults in the US -
Percentage Share Breakdown by Age Group: 2005-2006 (includes
corresponding Graph/Chart) III-1

Table 5: Hypertension Prevalence Among Adults in the US -
Percentage Share Breakdown by Gender: 2005-2006 III-2

Table 6: Hypertension Prevalence Among Adults in the US -
Percentage Share Breakdown by Race/Ethnicity: 2005-2006
(includes corresponding Graph/Chart) III-2

Table 7: Hypertension Treatment Among Hypertensive Adults
in the US - Percentage Share Breakdown by Gender and Age
Group: 2005-2006 (includes corresponding Graph/Chart) III-2

Table 8: Hypertension Treatment Among Hypertensive Adults
in the US - Percentage Share Breakdown by Race/Ethnicity:
2005-2006 (includes corresponding Graph/Chart) III-3

Table 9: Outpatient Department Visit with Hypertension as
Co-morbid Chronic Condition in the US - Percentage Share
Breakdown by Age Group: 2006 (includes corresponding
Graph/Chart) III-3

Table 10: Outpatient Department Visits with Hypertension as
Co-morbid Chronic Condition in the US - Percentage Share
Breakdown by Gender: 2006 III-4
Market Overview III-4
Table 11: US Anti-hypertensive Drugs Market - Sales and
Percentage Share Breakdown by Leading Drugs in US$ Million
Between October 2007 and October 2008 (includes
corresponding Graph/Chart) III-4

Table 12: US Anti-hypertensive Drugs Market - Percentage
Share Breakdown of Leading Class of Drug Based on Total
Prescriptions for 2007 (includes corresponding Graph/Chart) III-5

Table 13: US Anti-hypertensive Drugs Market - Percentage
Share Breakdown of ACE Inhibitors Based on Total
Prescriptions for 2007 (includes corresponding Graph/Chart) III-5

Table 14: US Anti-hypertensive Drugs Market - Percentage
Share Breakdown of Angiotension Receptor Blockers (ARBs)
Based on Total Prescriptions for 2007 (includes
corresponding Graph/Chart) III-6
New Patient Therapy Starts to Witness Slowdown III-6
Table 15: US Anti-hypertensive Drugs Market - Percentage
Share Breakdown of Angiotensin II Receptor Blockers by New
Prescriptions for 2006, 2007 and 2008 (includes
corresponding Graph/Chart) III-6

Table 16: US Anti-hypertensive Drugs Market - Percentage
Share Breakdown of ACE Inhibitors by New Prescriptions for
2006, 2007 and 2008 (includes corresponding Graph/Chart) III-7

Table 17: US Anti-hypertensive Drugs Market - Percentage
Share Breakdown of Calcium Channel Blockers by New
Prescriptions for 2006, 2007 and 2008 (includes
corresponding Graph/Chart) III-8
African Americans At Major Health Risk Due to Hypertension III-8
Research & Development III-9
Product Launches III-10
Strategic Corporate Developments III-12
Select Players III-25
B.Market Analytics III-28
Table 18: US Recent Past, Current & Future Analysis for
Anti-hypertensive Drugs - Annual Sales Figures in US$
Million for Years 2007 through 2015 (includes corresponding
Graph/Chart) III-28

Table 19: US Historic Review Analysis for Anti-hypertensive
Drugs - Annual Sales Figures in US$ Million for Years 2001
through 2006 (includes corresponding Graph/Chart) III-28

2. EUROPE III-29
A.Market Analysis III-29
Hypertension - Prevalence III-29
Non-Invasive Blood Pressure Monitoring on Growth Trajectory III-29
Regional Markets at a Glance III-29
United Kingdom III-29
Hypertension - Prevalence III-29
Hypertension Treatment - Monotherapy and Combination
Therapies III-30
Denmark III-30
Cheaper Alternatives for Hypertension Treatment III-30
Norway III-30
New Branded Drugs Dominate Anti-hypertensive Drugs Market III-30
New Amendments to Medicines Reimbursement III-30
Proposed New Reimbursement Conditions in Norway III-31
Research and Development III-32
Product Launches III-34
Strategic Corporate Developments III-35
Select Players III-40
B.Market Analytics III-44
Table 20: European Recent Past, Current & Future Analysis
for Anti-hypertensive Drugs - Annual Sales Figures in US$
Million for Years 2007 through 2015 (includes corresponding
Graph/Chart) III-44

Table 21: European Historic Review Analysis for
Anti-hypertensive Drugs - Annual Sales Figures in US$
Million for Years 2001 through 2006 (includes corresponding
Graph/Chart) III-44

3. REST OF WORLD III-45
A.Market Analysis III-45
Canada III-45
Table 22: Canadian Anti-hypertensive Drugs Market - Total
Number of Prescriptions in Thousands for 1996 and 2006
(includes corresponding Graph/Chart) III-45
Japan III-46
Australia III-46
Australians to Shell Out More on Anti-Hypertensive Drugs III-46
China III-46
Hypertension - A Major Health Concern in China III-46
Anti-hypertensive Drugs Market III-47
Hypertension Outlook III-47
Competitive Landscape III-48
India III-48
Anti-Hypertensive Drugs Manufacturers III-48
Korea III-48
Anti-hypertensive Drugs Market III-48
Table 23: Korean Anti-hypertensive Drugs Market - Leading
Classes of Drugs by Value Sales in US$ Million for 2007,
2008, and 2009 (Q1) (includes corresponding Graph/Chart) III-49

Table 24: Korean Anti-hypertensive Drugs Market -
Percentage Share Breakdown of Leading Drugs by Outpatient
Prescription Value for 2007, 2008 and 2009 (H1) (includes
corresponding Graph/Chart) III-49
Anti-hypertension Drugs Market - Angiotensin Receptor Blockers III-50
Table 25: Korean Anti-hypertensive Drugs Market -
Percentage Share Breakdown of Leading Angiotension
Receptor Blockers by Prescription Value for 2008 and 2009
(Q1) (includes corresponding Graph/Chart) III-50
Anti-hypertension Drugs Market - Calcium Channel Blockers III-51
Table 26: Korean Anti-hypertensive Drugs Market -
Percentage Share Breakdown of Leading Calcium Channel
Blocker by Prescription Value for 2008 and 2009 (Q1)
(includes corresponding Graph/Chart) III-51
Anti-hypertension Drugs Market - Beta-blockers III-52
Table 27: Korean Anti-hypertensive Drugs Market -
Percentage Share Breakdown of Leading Beta- blockers for
2008 and 2009 (Q1) (includes corresponding Graph/Chart) III-52
Kenya III-53
Anti-hypertensive Drugs Market III-53
Manufacturing Overview III-53
Generics Erode Share of Ethical Drugs III-53
Research and Development III-54
Product Launches III-55
Strategic Corporate Developments III-57
Select Players III-64
B.Market Analytics III-67
Table 28: Rest of World Recent Past, Current & Future
Analysis for Anti-hypertensive Drugs - Annual Sales Figures
in US$ Million for Years 2007 through 2015 (includes
corresponding Graph/Chart) III-67

Table 29: Rest of World Historic Review Analysis for
Anti-hypertensive Drugs - Annual Sales Figures in US$
Million for Years 2001 through 2006 (includes corresponding
Graph/Chart) III-67

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 145 (including Divisions/Subsidiaries - 176)

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Region/Country Players

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The United States 31
Canada 4
Japan 15
Europe 51
France 7
Germany 6
The United Kingdom 8
Italy 3
Spain 3
Rest of Europe 24
Asia-Pacific (Excluding Japan) 65
Latin America 2
Africa 2
Middle East 6

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