Market Report Source

Overview

Introduction
With fewer truly novel products entering the market, combined with increasing developmental time and spend, and declining ROI, successful launches have never been more important for pharmaceutical companies. Therefore, to ensure a successful launch, manufacturers must employ a multitude of timely strategies to ensure their product enter the market as soon and as smoothly as possible.

Scope

• Analysis of brand drug launch strategies in the US and five major European markets
• Examination of pit falls manufacturers face following approval, which can frequently delay the launch of a product
• Identification of commercialization strategies employed by manufacturers to increase the market voice of their product prior to and post launch
• Provides case-studies of both the most successful drug launches as well as launch failures during 200206

Highlights
Although the number of NDAs submitted to the FDA continue to rise year on year, the number of new molecular entities is on the decline, reflecting the increased cost of developing novel products With a decrease in R&D productivity in recent years, in order to maximize the return on investment, drugs launched in the US and 5EU markets between 2002 and 2006, have typically been commercialized by a single pharmaceutical company By 2012, average sales per drug per year are predicted to be lower, and manufacturers will have a greater reliance on launch portfolio compensating for revenues loses of marketed products, due to patent expiries

Reasons to Purchase

• Gain insight into launch strategies employed by pharmaceutical manufacturers today
• Understand successful launch strategies and identify how these can best be implemented
• Benchmark the success of product launches in order to improve future launch planning and forecasting

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the report

Key findings

CHAPTER 2 PLANNING FRAMEWORKS – STRUCTURING EARLY PRE-LAUNCH STRATEGY

Planning your launch campaign

Market assessment

Developing your target market

Evaluating the commercial potential of a market

Competitive assessment

Improving diagnoses and building patient awareness is key

Prioritizing pricing and reimbursement

Prioritize P&R in drug development

Setting the price for a new drug

Determine which country to launch in first

Perform brand strengthening throughout the lifecycle to ensure maximum price and high reimbursement

Designing the marketing mix

Positioning is key

Defining the brand essence

CHAPTER 3 REGULATORY ISSUES IMPACTING LATE-STAGE PRE-LAUNCH

The road to regulatory approval

Overview of trends facing launching manufacturers

Regulatory definitions

FDA definitions

EMEA definitions

The number of NDAs submitted is growing in the US and EU

Rise in approval rates in 2006

Rise in submissions and approvals driven by product modifications

Mean approval times by the FDA and EMEA are similar

Clinical trials are taking longer

Pain drugs experience the shortest mean development times

Companies and drug approvals

Faster approval times has not affected drug safety

Balancing faster development with drug safety

Putting a price on approval delays

NDAs and BLAs are most likely to receive ‘priority review’ status

Fast Track approvals

Orphan drugs and niche markets

Advantages of launching an orphan drug

Delays in product approvals in the US

In-licensed drugs in the US experience a higher rate of first-time approvals

Drugs that require input from advisory meetings experience lower first-time approval rates in the US

Large US companies have higher FDA approval success rates than small non-US firms

Product/application deficiencies hamper the approval process

Phase IV studies and post-marketing commitments aid faster approval

Post-marketing commitments are on the increase

The majority of PMCs are unfinished

Regulation of PMCs set to improve

CHAPTER 4 ANALYZING LAUNCH STRATEGIES POST-APPROVAL

Delays to launch following approval

Finalizing pricing and reimbursement delays launches in Europe

Patent infringement prevents Novartis from an early launch of Exforge

Scheduling delays launch of drugs with abuse liability

Drugs are traditionally launched in the US first

Drugs historically approved in the US market prior to the 5EU

The proportion of drugs approved first in the 5EU has remained flat

Between 2002 and 2006 more drugs were launched first in the US market

The proportion of drugs launched first in the 5EU has remained flat

Approval to launch time is fastest in the US, but the 5EU is catching up

US overtakes EU in launching NMEs

Launch timing and market entry

Product launch determines level of long-term success

Case studies: brands which have not followed the traditional uptake curve

Predicting the long-term success of a drug based upon its launch

Drug quality cannot be relied upon alone to drive commercial success

Launch order is not a significant determinant of relative commercial success

Case studies: launch order is not significant

Seasonal factors should be considered at drug launch

ADHD drug manufacturers should be aware of the implications of drug holidays when launching a new product

Entering the market in time for the annual flu season is vital for manufacturers of influenza vaccines

CHAPTER 5 COMMERCIALIZATION AND PROMOTION STRATEGIES

Commercialization

Co-promotion versus co-marketing

Why choose co-promotion?

Why choose co-marketing?

Manufacturers increasingly employ global brand strategies

Different 5EU and US marketers

Lilly’s use of a CSO to maximize the launch of Cymbalta

Co-development and co-marketing enhances Vytorin’s launch and uptake

Promotion

How much should be spent on promotion?

How to prepare your market?

Drugs with novel mechanisms of action

Drugs with similar therapeutic profiles

Launching into a developed market by focusing upon niche subsets of the patient population

Which promotional methods can be employed?

Prioritizing awareness campaigns

Development of a patient education website

Television disease advertising

Patient mailing

Promotional spend at launch

Direct-to-consumer advertising

Changes to DTC advertising in the US

Leading new drugs by DTC spend

Detailing and sampling

eSampling

Celebrex’s detailing and sampling drives uptake in arthritis market

Lunesta’s detailing, sampling and DTC promotion drives uptake

CHAPTER 6 LAUNCH CASE STUDY ANALYSIS

Failure to launch

Pfizer’s terminated indiplon collaboration leads to decline in CNS franchise revenues, 2005-10

Lilly’s Arxxant is no longer expected to gain approval

Most successful launches during 2002-06

Atripla – the future HIV market leader

Lexapro – the most successful CNS drug launched during 2002-06

Vytorin – the first combination pill for hypercholesterolemia

Neulasta – second generation success for Amgen

Key companies in the US market

Pharmaceutical companies set to launch a greater number of new products in the future

Launch portfolios sales forecast to increase

Reliance on sales from launch portfolios expected to increase by 2012

Case study analysis of key company launch portfolios

GSK forecast to have the strongest launch portfolio by 2012

Novartis boasts the largest launch portfolio during 2006-12

J&J’s launch portfolio is dominated by its 2007 launch products

AstraZeneca will rely on line extensions instead of its sparse pipeline to grow sales

Forest’s 2006 sales rely almost entirely on recently launched products

Wyeth’s reliance on launch portfolio sales is expected to increase from 0% to 25% in 2012

Future launch outlook for leading pharmaceutical companies

Pharmaceutical companies forecast to launch a greater number of new products in the future

Launch portfolios sales forecast to increase, but return set to fall

Reliance on sales from launch portfolios forecast to increase by 2012

Key therapy areas 2006-12

The value of branded products from the top 50 global companies is expected to grow to $430 billion by 2012

20% of products launched by 2012 will be for CNS disorders

CHAPTER 7 BIBLIOGRAPHY

Datamonitor reports

Websites

Publications and online articles

Conference literature

Glossary of terms

APPENDIX

IMS vs. company-reported data reconciliation

List of Tables

Table 1: Average daily sales of the top ten highest selling drugs in the US (2006)

Table 2: Single- and multi-cycle approval rates by application type (%) (2002-04)

Table 3: Barriers and solutions to approval by the FDA

Table 4: Factors leading to delays in FDA product approval (2002-04)

Table 5: Comparison of Xolair’s US sales – IMS Midas Sales data versus Genentech’s company reported sales data ($m)

Table 6: No significant difference in commercial success between priority and ‘standard reviewed’ products in the US (2002-06)

Table 7: Number of clinical abstracts presented at conferences in year preceding and following US launch

Table 8: Number of journal articles published in year preceding and following US launch

Table 9: Drivers and resistors of co-promotion

Table 10: Drivers and resistors of co-marketing

Table 11: Brands that do not follow a global (US+EU) brand strategy, launched between 2002 and 2006

Table 12: Leading drugs by DTC spend, launched in the US between 2001 and 2005

Table 13: Leading companies by number of new branded (original or licensed) US product launches (Q2 2002-Q4 2006 and 2006-12)

Table 14: Reliance of leading pharmaceutical companies on their launch portfolios during 2002-06 and 2006-12

Table 15: The CNS market will experience the greatest number of new drug launches, and largest sales by 2012

List of Figures

Figure 1: Planning a product launch framework

Figure 2: Stakeholder input should be utilized at all stages of drug development and launch

Figure 3: Static and dynamic patient flows in the schizophrenia market

Figure 4: Rise of the once-daily ADHD drugs to market leading status in the US, 2001-05

Figure 5: The launch of Requip for restless legs syndrome rejuvenated the brand’s sales, Q1 2004-Q1 2006

Figure 6: Pharmacoeconomic tasks to carry out in each drug development phase

Figure 7: The optimal launch across Europe takes place over three waves

Figure 8: Proportion of drug launch positions for each country (2003-06)

Figure 9: Rebif: promotion focusing upon drug efficacy

Figure 10: Lexapro’s positioning drove it to blockbuster status during its second year on the market, and has maintained Forest’s antidepressant franchise revenues, Q1 2001-Q4 2006

Figure 11: Fosamax once-weekly’s superior profile significantly grew franchise sales (Q1 1999-Q4 2003)

Figure 12: Defining the ‘brand essence’

Figure 13: Despite its second to market position, Levitra’s lack of differentiation has hindered uptake

Figure 14: The US currently is leading the world in terms of pharmaceutical R&D (1997-2005)

Figure 15: US R&D expenditure is on the increase, with biopharmaceutical companies leading the way, 1980-2006

Figure 16: With declining return on investment, successful launches have never been more important for pharmaceutical companies, 1990-2004

Figure 17: Since 2001, the number of NDAs received by the FDA has increased year-on-year

Figure 18: New drug applications received by the EMEA, 2001-06

Figure 19: Approvals and positive opinions in both the US and EU rose in 2006 (2001-06)

Figure 20: The number of new active substances launched on the world market is declining (2001-05)

Figure 21: Similar approval times for products in the US and 5EU (2000-05)

Figure 22: The FDA approved more drugs more quickly than did the EMEA between 2000 and 2005

Figure 23: The lengthening clinical trials since 1999-01 are offsetting the advantage gained by shorter product approvals in the US (1984-2004)

Figure 24: Faster approval rates have not affected drug safety in the US (1980s-2000)

Figure 25: Fastest developing pharmaceutical companies have a one-year and $1 billion advantage (2005)

Figure 26: CDER: Number of approvals of Priority and Standard NDAs, BLAs, NMEs and New BLAs (2000-06)

Figure 27: CDER approval times for Priority and Standard NDAs, BLAs, NMEs and New BLAs (2000-06)

Figure 28: Fast Track determination scheme

Figure 29: Fast Track approvals by indication (1998-2006)

Figure 30: US Fast Track products approved (1998-2006)

Figure 31: Fast Track + Accelerated Review designations lead to the shortest drug development time

Figure 32: EMEA orphan drug designation procedures, 2004-06

Figure 33: Comparison of orphan drug approvals in the US and 5EU (2000-05) (months)

Figure 34: In-licensed drugs experience a higher rate of first-time approvals by the FDA (2002-04)

Figure 35: Drugs that require input from advisory meetings experience lower first-time approval rates (2002-04)

Figure 36: Experienced sponsors gain higher rates of first-time approvals (2002-04)

Figure 37: Larger US-based companies have the highest drug approval rates (2002-04)

Figure 38: Safety issues account for one-third of all problems experienced during the FDA approval process (2002-04)

Figure 39: The EMEA is finalizing ever more procedures in an increasingly shorter time period (2001-06)

Figure 40: Average delay between marketing authorization and effective market access from a sample of products launched between June 2000 and June 2004

Figure 41: US forecast of Novartis’s Exforge, Diovan and Lotrel sales, 2006-11

Figure 42: The majority of drugs were approved in the US first between 2002 and 2006

Figure 43: The proportion of drugs approved first in the 5EU has remained flat, 2002-06

Figure 44: The majority of drugs launch in the US before entry into the 5EU markets (2002-06)

Figure 45: More drugs are being launched in the US earlier, 2002-06

Figure 46: Time from drug approval to launch across the 5EU between Q4 2001 and Q3 2006

Figure 47: Time from drug approval to first 5EU launch between Q4 2001 and Q3 2006

Figure 48: Time from drug approval to launch between Q1 2002 and Q4 2005

Figure 49: Time from drug approval to first US launch between Q4 2001 and Q3 2006

Figure 50: Since 2000, the US has been the world leader in developing novel drug candidates (1986-2005)

Figure 51: US leads the world market in terms of sales for newly launched products, 2005

Figure 52: Uptake trends of drugs launched in the US and 5EU between 2002 and 2006

Figure 53: Mean country drug uptake trends post launch between 2002 and 2006

Figure 54: Wholesaler stocking significantly skewed Inspra’s initial uptake, 2003-06

Figure 55: Avandamet uptake hit by disruption in supply and launch of competitor product, 2002-06

Figure 56: Data collection discrepancy skews Xolair uptake curve, 2003-06

Figure 57: Success at launch is correlated to mid- to long-term success (2002-06)

Figure 58: No significant difference in commercial success between priority and standard reviewed products in the US (2002-06)

Figure 59: Comparison of Q3 commercial success of newest and subsequent product launches for a given disease/condition in the US (2002-06)

Figure 60: Despite its second to market position, Levitra’s lack of differentiation has hindered uptake

Figure 61: Truvada exceeds peak sales of Viread + Emtriva after only 1.5 years on the US market (Q2 2003-Q1 2007

Figure 62: Sales of protease inhibitors launched between 2002 and 2006

Figure 63: Monthly growth and decline of US ADHD drug revenues, 2001-04

Figure 64: US revenues of flu vaccines, 2002-06

Figure 65: Launch of MedImmune’s FluMist and GSK’s Fluarix, 2003-06

Figure 66: Promotional spend of FluMist and Fluarix at launch, Q1 2004-Q4 2006

Figure 67: Stage of licensing for top 50 deals in terms of 2005 revenues

Figure 68: The majority of products launched in the US and 5EU between 2001 and 2005 were marketed by a single company

Figure 69: The majority of brands launched between 2002 and 2006 use the same brand name in the US and 5EU

Figure 70: Number of drugs launched in the US and 5EU by totally different marketers (2001-05)

Figure 71: Key risks and benefits of using contract sales forces

Figure 72: Co-marketing helps Vytorin to become a global blockbuster after only two years (Q1 2002-Q4 2006)

Figure 73: Top 10 US pharmaceutical companies’ promotional spending in 2006

Figure 74: Companies with higher promotional spend in 2006 experienced a higher annual growth rate for 2005-06

Figure 75: Key determinants driving promotional spend

Figure 76: Explanation of Raptiva’s mechanism

Figure 77: Pre-launch marketing had a striking effect on the uptake of psoriasis drugs Q2 2002-Q1 2007)

Figure 78: Example of clear explanation of a complex mechanism for novel biologic therapy in autoimmune disease

Figure 79: Xolair pre-launch campaign

Figure 80: Methods of promoting drugs to patients and physicians in the US

Figure 81: Return on promotional spend for drugs launched in the US during 2004 and 2006 (and subsequently launched in the EU)

Figure 82: DTC expenditure in the US, 1997-2005

Figure 83: Promotional spend for Vytorin, Zocor and Zetia, 2003-05

Figure 84: The optimum sampling strategy combines both traditional and eSampling

Figure 85: Top 10 most heavily DTC advertised drugs in 2000

Figure 86: Pfizer’s Celebrex experienced a much greater return on DTC spend than Merck & Co’s Vioxx (2000)

Figure 87: Sales of leading drugs launched in the US market, Q4 2004-Q4 2005

Figure 88: Fewer pipeline drugs are discontinued as development progresses (1994-2005)

Figure 89: Discontinuation of the indiplon franchise has resulted in a decline in Pfizer’s CNS franchise forecast sales for 2005-10

Figure 90: Discontinuation of Arxxant has resulted in a decline in Lilly’s diabetes franchise forecast sales for 2005-10

Figure 91: Most successful US launches during 2002-06

Figure 92: Atripla yielded half of its constituent branded drug sales within three quarters of launch, Q1 2006-Q1 2007

Figure 93: Strong launch of Lexapro has protected Forest’s antidepressant franchise in the face of generic competition (Q1 2001-Q3 2006)