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M&A in pharma

Explores the merits of mega-deal in contrast to a more measured portfolio growth strategy

"Among the 23 new pharmaceutical products approved in the first half of 2007, there were 22 small molecule pharmaceutical drugs and one monoclonal antibody."

Pharmaceutical Product Approval Trends 2007: Key market benchmarks and strategic insights presents a detailed analysis of the new pharmaceutical products approved globally.

The 120-page report outlines the key therapeutic markets, significant pharmaceutical entities which were approved, assesses major companies and identifies key trends and opportunities in order to help inform pharmaceutical decision-making, particularly in the areas of corporate planning, portfolio management and market forecasting.

Selected Headline Findings

• The US and Europe accounted for 90% of the 2006 global sales of new medicines launched between 2002 and 2006
• More than 70% of all new pharmaceutical products approved between 2004 and 2006 received an initial approval in the US
• A total of 38 new pharmaceutical products were approved in the US in 2006 and a total of 31 new pharmaceutical products were approved in Europe in the same year.
• The leading companies by number of new drug approvals in the first half of 2007 were GSK with three and Wyeth with two.
• The leading therapy areas for new drug approvals in 2007 were genito-urinary system and sex hormones (ATC code G) and nervous system (ATC code N) with four.
• The leading generic product by number of applicant approvals in 2006 was meloxicam, which was approved for 21 different companies.

KEY FEATURES OF THE REPORT

• Comprehensive overview of the global approval trends with sections on U.S and E.U approval trends.
• Identifies the top 11 products approved in 2006 including Exforge, Prezista, Gardasil, Invega, Acomplia and Chantix.
• Therapy area trends for antineoplastic and immunomodulating agents, alimentary tract and metabolism, nervous system, anti-infectives for systemic use, cardiovascular system, genitourinary system and sex hormones as well as sensory organs.
• Detailed profiles of major companies (AstraZeneca, Eli Lilly, GlaxoSmithKline, Johnson and Johnson, Merck & Co, Novartis, Pfizer, Roche, Sanofi-Aventis Wyeth.)
• Analysis of key company trends for leading companies by current and prospective new product approvals. (GlaxoSmithKline,Wyeth, Novartis, Shire, Cephalon and Roche.)
• 120 pages long, with 66 figures and 40 tables to illustrate the market trends.
• Coverage US, Europe and Japan

USE THIS REPORT TO:
1. Benchmark your portfolio against key market trends and forecasts in order to plan better for success.

2. Identify key areas of pharmaceutical market growth and key opportunities for delivering successful sales growth over the next five years.

3. Support internal planning and decision-making with an external perspective founded on detailed analysis and transparent market forecasts.

REPORT COVERAGE
The report methodology provides a detailed but transparent analysis of key pharmaceutical market trends, including key markets, therapy areas, products and companies. It compares new product approvals in 2006 with data from the previous two years.

All data used in outlining historical trends is clearly sourced within the report and any data limitations or additional assumptions are explicitly detailed within the text of the report. Future market forecasts are projected based on both historical trends and future expectations over market conditions and events. The assumptions used to form the basis of key market forecasts are outlined in detail within the text of the report.

Summary

Chapter 1 - Overview of global pharmaceutical product approvals (NMEs)

Chapter 2 -Drug approval trends in key global markets

Chapter 3 - Key therapeutic markets in relation to drug approvals

Chapter 4 - Market analysis of recently approved products

Chapter 5 - Analysis of drug approvals by major pharmaceutical companies

Chapter 6 - Analysis of drug approval trends

Appendix

LIST OF FIGURES
Figure 1: Global new pharmaceutical product approvals, 2004-2006
Figure 2: Report structure
Figure 3: 2006 global sales for new medicines launched 2002-2006
Figure 4: New product launches per US$ billion of R&D, 2004-2006
Figure 5: Global launch order, 2004-2006
Figure 6: Global launch schedule, 2004-2006
Figure 7: New product brand strategies, 2004-2006
Figure 8: New product marketing strategies, 2004-2006
Figure 9: New US product approval trends, 2004-2006
Figure 10: New US product approvals by approval process, 2004-2006
Figure 11: New US product approvals by orphan drug status, 2004-2006
Figure 12: Average patent life for new US product approvals, 2004-2006
Figure 13: New US product approvals by post-approval patent life, 2004-2006
Figure 14: New US product approvals by market exclusivity, 2004-2006
Figure 15: New US product approvals, 1997-2006
Figure 16: New US product approvals by product category, 1997-2006
Figure 17: New US investigational new drug (IND) approvals, 1997-2006
Figure 18: New US new molecular entity approvals by indication, 2006
Figure 19: New EU product approval trends, 2004-2006
Figure 20: New EU product approvals by orphan drug status, 2004-2006
Figure 21: New EMEA initial-evaluation applications, 2004-2006
Figure 22: New EMEA post-authorization opinions and notifications, 2004-2006
Figure 23: New EMEA initial notices for parallel-distribution, 2004-2006
Figure 24: New EMEA initial-evaluation approvals by therapy area, 2006
Figure 25: Leading product classes by global product approvals, 2004-2006
Figure 26: Product approval trends by therapeutic category, 2004-2006
Figure 27: Leading therapeutic classes by global product approvals, 2004-2006
Figure 28: Leading antineoplastic and immunomodulating agents approval trends, 2004-2006
Figure 29: Leading alimentary tract and metabolism approval trends, 2004-2006
Figure 30: Leading nervous system approval trends, 2004-2006
Figure 31: Leading anti-infectives for systemic use approval trends, 2004-2006
Figure 32: Leading cardiovascular system approval trends, 2004-2006
Figure 33: Leading genito-urinary system and sex hormones approval trends, 2004-2006
Figure 34: Leading sensory organs approval trends, 2004-2006
Figure 35: New global product approval trends by product category, 2004-2006
Figure 36: New US generic approval trends, 2004-2006
Figure 37: New US generic approval trends by formulation, 2004-2006
Figure 38: New US generic approval trends by chemical composition, 2004-2006
Figure 39: Leading products by new US generic approvals, 2006
Figure 40: Brand sales of leading products by new US generic approvals, 2006
Figure 41: Leading companies by new US generic approvals, 2006
Figure 42: Leading companies by global new drug approvals, 2004-2006
Figure 43: New global drug approvals for leading companies, 2004-2006
Figure 44: Impact of new global drug approval trends for leading companies, 2004-2006
Figure 45: New US and EU drug approval trends for leading companies, 2004-2006
Figure 46: Pfizer's new global drug approval trends, 2004-2006
Figure 47: GlaxoSmithKline's new global drug approval trends, 2004-2006
Figure 48: Sanofi-Aventis's new global drug approval trends, 2004-2006
Figure 49: Novartis's new global drug approval trends, 2004-2006
Figure 50: Johnson & Johnson's new global drug approval trends, 2004-2006
Figure 51: Merck's new global drug approval trends, 2004-2006
Figure 52: Roche's new global drug approval trends, 2004-2006
Figure 53: Eli Lilly's new global drug approval trends, 2004-2006
Figure 54: New pharma product approvals and tentative approvals, 2007
Figure 55: Exforge/ Copalia/ Imprida/ Dafiro (amlodipine/ valsartan) global sales forecast, 2007-2011
Figure 56: Prezista (darunavir) global sales forecast, 2007-2011
Figure 57: Sprycel (dasatinib) global sales forecast, 2007-2011
Figure 58: Gardasil/ Silgard (human papillomavirus vaccine) global sales forecast, 2007-2011
Figure 59: Invega (paliperidone) global sales forecast, 2007-2011
Figure 60: Vectibix (panitumumab) global sales forecast, 2007-2011
Figure 61: Lucentis (ranibizumab) global sales forecast, 2007-2011
Figure 62: Acomplia/ Zimulti (rimonabant) global sales forecast, 2007-2011
Figure 63: Januvia/ Xelevia (sitagliptin) global sales forecast, 2007-2011
Figure 64: Sutent (sunitinib) global sales forecast, 2007-2011
Figure 65: Chantix/ Champix (varenicline) global sales forecast, 2007-2011
Figure 66: Key companies by pharma product approvals and tentative approvals, 2007

LIST OF TABLES
Table 1: Leading antineoplastic and immunomodulating agents approvals, 2004-2006
Table 2: Leading alimentary tract and metabolism approvals, 2004-2006
Table 3: Leading nervous system approvals, 2004-2006
Table 4: Leading anti-infectives for systemic use approvals, 2004-2006
Table 5: Leading cardiovascular system approvals, 2004-2006
Table 6: Leading genito-urinary system and sex hormones approvals, 2004-2006
Table 7: Leading sensory organs approvals, 2004-2006
Table 8: New global pharma drug approvals, 2004
Table 9: New global pharma drug approvals, 2005
Table 10: New global pharma drug approvals, 2006
Table 11: New global monoclonal antibody approvals, 2004-2006
Table 12: New global biologic approvals, 2004-2006
Table 13: Exforge/ Copalia/ Imprida/ Dafiro (amlodipine/ valsartan) profile, 2006
Table 14: Prezista (darunavir) profile, 2006
Table 15: Sprycel (dasatinib) profile, 2006
Table 16: Gardasil/ Silgard (human papillomavirus vaccine) profile, 2006
Table 17: Invega (paliperidone) profile, 2006
Table 18: Vectibix (panitumumab) profile, 2006
Table 19: Lucentis (ranibizumab) profile, 2006
Table 20: Acomplia/ Zimulti (rimonabant) profile, 2006
Table 21: Januvia/ Xelevia (sitagliptin) profile, 2006
Table 22: Sutent (sunitinib) profile, 2006
Table 23: Chantix/ Champix (varenicline) profile, 2006
Table 24: Pfizer's new global drug approvals, 2004-2006
Table 25: GlaxoSmithKline's new global drug approvals, 2004-2006
Table 26: Sanofi-Aventis's new global drug approvals, 2004-2006
Table 27: Novartis's new global drug approvals, 2004-2006
Table 28: AstraZeneca's new global drug approvals, 2004-2006
Table 29: Johnson & Johnson's new global drug approvals, 2004-2006
Table 30: Merck's new global drug approvals, 2004-2006
Table 31: Roche's new global drug approvals, 2004-2006
Table 32: Eli Lilly's new global drug approvals, 2004-2006
Table 33: Wyeth's new global drug approvals, 2004-2006
Table 34: New pharma product approvals in US and EU, 2007
Table 35: New pharma product approvable letters in US, 2007
Table 36: New pharma product CHMP opinions in EU, 2007
Table 37: New pharmaceutical product approvals, 2004
Table 38: New pharmaceutical product approvals, 2005
Table 39: New pharmaceutical product approvals, 2006

Steven Seget is Principal at Delphi Pharma, and provides independent strategic consulting services to the pharmaceutical and biotechnology industries.

Delphi Pharma provides strategic, financial and market-based solutions to clients, focusing primarily on the portfolio management and licensing functions.