Stakeholder Opinions: Commercial strategies in cardiovascular and metabolic diseases successful market positioning at company and brand level becomes paramount

Published by: Datamonitor

Published: Apr. 1, 2009 - 157 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the cardiovascular analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor Key insights

Related reports

CHAPTER 2 MARKET POSITIONING

Market targeting

Multiple brand applications across a therapy area

Sanofi-Aventis

Novartis

Defined therapy area

Novo Nordisk

Niche indications

Staggered launch and indication expansion

Orphan indications

Drug support

Patient and physician support

Diagnostics

Involvement in the generics industry

No involvement

Marketing of generic versions of own brands

Full generics portfolio with branded development

Specialized generics

Launch position

First to market

Januvia (sitagliptin)

Mevacor (lovastatin)

Best-in-class

Norvasc (amlodipine)

Effient (prasugrel)

Me-too

Diovan (valsartan)

Niche in primary care

Bystolic (nebivolol)

Entry in genetic indication before expansion into primary care

Mipomersen

CHAPTER 3 DRUG DEVELOPMENT STRATEGIES

Regulatory approval

Cardiovascular endpoints

Regulatory authority divergence

FDA prescription drug user fee deadline

Risk Evaluation and Mitigation Strategy

Portfolio focus

Non-insulin antidiabetics

Therapy replacement

Market entrants

Pipeline sourcing

In-house development

Novo Nordisk

Abbott

Licensing and co-development

Big Pharma - Big Pharma

Big Pharma - small originator

Outsourcing discovery

Company purchase

Mega-merger

Technology and pipeline acquisition

Small add-on

Development strategies

Expertise and intellectual property

Probiodrug

Sirtris

Drug repositioning

CombinatoRx

Pfizer

Spin-outs

Speedel

Esperion

Biotech

Exit

CHAPTER 4 PRE- AND POST-LAUNCH STRATEGIES

Defensive strategies

Intellectual property

Patenting strategies

Patent extensions

Marketing exclusivity

Pediatric extensions

Competition obstruction

Market positioning

Primary indication

Clinical viability

Commercial viability

Differentiation

Clinical efficacy

Side-effect profile

Method of delivery

Pricing and reimbursement

Dangers of differentiation

Indication expansion

Related indications

Heart failure

Diabetic populations

Market expansion

AstraZeneca, Crestor and JUPITER

Lifecycle management

Derivatives

Plavix

Lipitor

Reformulations

Tricor

Long-acting beta blockers

Byetta LAR

Long-acting oral antidiabetics

Fixed dose combinations

Franchise development

Franchise expansion

Co-ordinated drug differentiation

GALAXY program

CHAPTER 5 PRE- AND POST-PATENT EXPIRY STRATEGIES

Revenue maximization

Last marketing push

Beta blockers

Calcium channel blockers

Price manipulation

Zocor

Norvasc

Own-brand generics

Greenstone and amlodipine

Rx-to-OTC switching

Xenical and Alli

Mevacor

Generic entry

Paragraph IV abbreviated new drug application

Generic simvastatin

Authorized generics

At-risk generic launch

Lotrel

Market expansion

US

Italy

France

Generic quality

CHAPTER 6 PHARMACEUTICAL COMPANY 'ETHICS'

Clinical development

Clinical trial design to maximize perceived efficacy

Tekturna

Effient

Suppression of negative clinical data

Vytorin

Influencing the roster of the FDA Advisory Committee

Effient

Independent publication of safety concerns

Dr Steve Nissen and Avandia

Exerting pressure on critics

GlaxoSmithKline and Avandia

Influencing physicians

Commercial practices

Dose availability restriction

Pfizer and sildenafil

Anti-trust practices

Abbott

Co-development partnership

Pfizer and Nektar

BIBLIOGRAPHY

General References

Datamonitor Reports

APPENDIX

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the cardiovascular analysis team

Disclaimer

List of Tables

Table 1: Sanofi-Aventis's cardiovascular and metabolic branded products, 1960s-2009

Table 2: Novartis's hypertension brands, 1978-2009

Table 3: Novartis's hypertension development pipeline, 2009

Table 4: Novartis's cardiovascular and metabolic branded products (excluding hypertension)

Table 5: Novo Nordisk's insulin portfolio, 1987-2009

Table 6: US approvals for Avastin, 2004-2009

Table 7: Indications in development for oral antithrombotics, 2009

Table 8: Comparison of lead molecules in the dipeptidyl peptidase-IV inhibitor class, 2009

Table 9: Comparison of leading molecules in the statin class, 2000

Table 10: Efficacy comparison of calcium channel antagonists

Table 11: Clinical efficacy of angiotensin receptor blockers

Table 12: US-approved angiotensin receptor blocker indications, 2009

Table 13: Efficacy comparison of leading US beta blockers

Table 14: Regulatory divergence for cardiovascular agents in Europe and the US

Table 15: New drug applications and missed fee deadlines

Table 16: GlaxoSmithKline's non-insulin antidiabetic development pipeline, 2002-08

Table 17: Takeda's non-insulin antidiabetic development pipeline, 2002-08

Table 18: Merck & Co's non-insulin antidiabetic development pipeline, 2002-08

Table 19: Novartis's non-insulin antidiabetic development pipeline, 2002-08

Table 20: Januvia (sitagliptin) development timescale, 2001-06

Table 21: Galvus (vildagliptin) development timescale, 1996-2008

Table 22: Abbott's cardiovascular and metabolic marketed products and late-stage development candidates, 2009

Table 23: Portfolio complementarities between Sanofi-Synthelabo and Aventis

Table 24: Filed Orange Book patents for Lipitor (atorvastatin; Pfizer), 2009

Table 25: Head-to-head statin trials for Crestor (rosuvastatin)

Table 26: Head-to-head statin trials for Vytorin (ezetimibe + simvastatin)

Table 27: Clinical efficacy and side-effect profiles of common oral non-insulin antidiabetics

Table 28: Relative success of late-stage pipeline direct thrombin inhibitors in the seven major markets

Table 29: Insurance reimbursement levels of angiotensin receptor blockers in selected California insurance plans

Table 30: History of Tricor lifecycle management, 1998-2005

Table 31: AstraZeneca's GALAXY clinical trial program for Crestor

Table 32: Indexed volume (Standard Units) and value ($m) sales of beta blockers in the US, 2004-06

Table 33: Indexed volume (Standard Units) and value ($m) calcium channel blockers in the US, 2004-06

List of Figures

Figure 1: Pros and cons of targeted marketing strategies in the cardiovascular arena

Figure 2: Involvement in the generics industry by some leading pharmaceutical companies, 2009

Figure 3: Clinical evidence frequently benefits follow-on therapies

Figure 4: Indexed revenues of the Januvia franchise in diabetes in the US ($), 2006-08

Figure 5: Dipeptidyl peptidase-IV inhibitor forecast revenues in the seven major markets, 2007-2017

Figure 6: Indexed volume sales (standard units) of statins in the US, 1999-2001

Figure 7: Division of the US calcium channel antagonist market, 1999

Figure 8: Forecast impact of Effient on clopidogrel units sold (SU) in the 5EU

Figure 9: US angiotensin receptor blocker market split by units sold (SU), 2007

Figure 10: Forecast Bystolic revenues in the US, 2007-2017

Figure 11: Development timeline for Januvia and Galvus, 1995-2008

Figure 12: Drug repositioning as a means to streamline development

Figure 13: Data exclusivity mechanism for pharmaceutical products in the European Union, 2004

Figure 14: Revenue forecasts for the leading direct thrombin inhibitors, 2007-2017

Figure 15: Lipitor market penetration in Germany and the UK, 2007

Figure 16: Angiotensin receptor blocker US market share ($), 2007

Figure 17: Vytorin revenues in the US, 2007-08

Figure 18: Plavix revenues in the US, 2005-08

Figure 19: Toprol-XL revenues in the US, 2007-08

Figure 20: Coreg franchise revenues in the US, 2007-08

Figure 21: Forecast revenues for Byetta and Byetta LAR in the seven major markets, 2007-2017

Figure 22: US revenue distribution between the free agent and fixed dose combinations in angiotensin receptor blockers, 2007

Figure 23: Impact of thiazolidinedione FDCs in the US and 5EU, 2007

Figure 24: Impact of potential link with myocardial infarction on the Avandia franchise revenues in the US, 2007-08

Figure 25: Impact of potential link with myocardial infarction on the Avandia franchise revenues in the 5EU, 2007-08

Figure 26: Revenues of Novo Nordisk's insulin analogs in the seven major markets, 2007

Figure 27: Pricing of simvastatin in the US, 2005-Q2 08

Figure 28: Simvastatin market share in the US, Q1-Q3 2006

Figure 29: Pricing of amlodipine in the US, 2006-Q2 2008

Figure 30: Amlodipine market share in the US, 2006-Q2 2008

Figure 31: Indexed volume (Standard Units) sales of amlodipine in the US, 2005-Q2 2007

Figure 32: Indexed Rx and OTC revenues of orlistat in the US, 2007-Q2 2008

Figure 33: Indexed volume (Standard Units) sales of simvastatin in the US, 2005-Q2 2008

Figure 34: Impact of Teva's US at-risk launch of benazepril + amlodipine, 2007- Q2 2008

Figure 35: Expansion of the US simvastatin market following patent expiry, Q1 2005-Q2 2008

Figure 36: Reversal of the decline of the US pravastatin market following patent expiry, Q3 2003-Q1 2008

Figure 37: Expansion of the simvastatin market in Italy following patent expiry, Q1 2005-Q2 2008

Figure 38: Expansion of the simvastatin market in France following patent expiry, Q3 2004-Q2 2008

Abstract

• Analysis of company and brand marketing positioning
• Analysis of methods employed to bolster R&D pipelines
• Analysis of the methods used to achieve brand differentiation and revenue maximization.

• Understand key company positioning strategies
• Identify optimal R&D strategies
• Identify effective methods for restricting the impact of generics following patent expiry

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