Biopharma Quarter: Key Trends and Events of the Second Quarter of 2009

Biopharma Quarter: Key Trends and Events of the Second Quarter of 2009 published by Decision Resources, Inc. in September, 2009. This report consists of 49 Pages and the price starts from US $ 4600.

Introduction

Abstract

“Last quarter, we included Vanda Pharmaceuticals in our list of companies struggling for survival in the midst of the economic downturn. This quarter, we note Vanda' s success, not only because it signals a comeback but also because the company' s resurrection, made possible by the FDA' s approval of the company' s Fanapt brand of iloperidone, is a victory in the move toward personalized medicine. Vanda prevailed in its quest for Fanapt' s approval based on pharmacogenetically stratifi ed research showing the effi cacy of the drug in particular subgroups of patients; companion diagnostics to guide the use of Fanapt might reach the market as well. Personalized medicine is a pending new paradigm for healthcare and one of the trends that companies in the biopharma sector must monitor and consider in formulating their strategies.”- Catherine Cuddihee, M.S., Principal Director.

The first Phase 0 trial results, the first fruits of Japan' s biosimilar pathway, the first straightforward use of the social marketing tool Twitter to advance a drug franchise, the first moves of the EU to regulate third-party mentions of pharmaceuticals, the first encounter with the H1N1 strain of infl uenza. These firsts of the second quarter of 2009 are among the developments that companies in the biopharma sector should consider in the context of their business strategies. This report provides biopharma players with event- and trend-related alerts, explanations, and models to heed.

• Voices call for a healthcare paradigm shift toward personalized medicine. What does the approval of Vanda' s Fanapt teach contenders in this space? What hobbles the paradigm shift?
• Drug development is stymied by a variety of factors. How is the FDA transforming to facilitate R&D? How are scrutiny and regulation of the industry changing in major-market regions? What are the opportunities in niche diseases?
• Novo Nordisk took a big step in the social marketing arena with the launch of a Twitter-based campaign. How is the company using this medium? How does the campaign relate to conventional marketing wisdom? What are the related regulatory issues?
• Pharma industry dealmaking continues at a relatively steady state. What companies are among the big players? What are the notable deals of the second quarter of 2009? How has the H1N1 fl u pandemic infl uenced dealmaking?
• National governments have enacted measures to drive use of generics and biosimilars. What results have been recorded in the United States? In Japan? What effect has this focus had on the fortunes of generics companies?

Scope

• Events Perspective: Phase 0 trials, iloperidone approval, warfarin payment decision, FDA reform, orphan drug funding, DTC advertising, regulation, social marketing, Twitter.
• Deals Perspective: Deals compared with prior time periods; deals by company, therapeutic area, technology; deals focusing on H1N1 and stem cell technologies.
• Generics Perspective: Japanese biosimilars, leading generics companies, generics dealmaking, generics-based healthcare savings.
• Strategy Perspective: Focus on the H1N1 fl u (swine fl u) pandemic.
• Expert commentaries: Implications of Phase 0 clinical trials for oncology, orphan drug development strategies, opportunities for makers of infl uenza diagnostics.

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• Events Perspective
  • On the Personalized Medicine Front: Steps Forward and Back
    • Fanapt Approval
    • Bristol-Myers Squibb' s Coumadin
  • On the Drug Development Front
    • FDA' s Improved Image
    • First Phase 0 Oncology Trial
    • Support for Rare Diseases
  • On the Marketing Front and the Regulatory Front
    • Social Marketing Push
    • Confi dentiality of Prescriber-Identifi able Data
    • Further Restrictions on DTC Advertising
• Deals Perspective
  • H1N1' s Infl uence on Dealmaking in the Second Quarter
  • Notable M&As
  • Notable Product Deals
  • Therapy-Area Deals
  • Technology Deals
  • Focus on Stem Cells
• Generics Perspective: Consistent Growth in a Key Sector
  • First Biosimilar Approval in Japan
  • Leading Generics Companies of 2008
  • Big Pharma Gains a Bigger Footprint in Generics
  • Fallout at Ranbaxy
  • Data Report: Mixed Results for Generics Initiatives
• Strategy Perspective: Focus on the H1N1 Pandemic
  • Swine Flu: Round One
    • A Global Crisis
    • Economic and Public Health Dilemma
    • Epidemiological Background
    • Virus Characteristics
    • Medical Response to Flu
    • Detection
    • Prevention
    • Treatment
  • Swine Flu: Round Two?

Expert Commentaries

• Phase 0 Trials: Implications for Cancer Drug Development
• What Are the Benefi ts of Orphan Drug Status?
• H1N1 Flu Pandemic: Expanding Opportunities for Infl uenza Screening

Tables

• 1. Emerging Diagnostic Profi le Acceptable to 88% of Surveyed Psychiatrists: Genetic Theranostic to Predict Atypical Antipsychotic Effi cacy .
• 2. Orphan Drug Policies in the United States, Europe, and Japan
• 3. Select Findings from Decision Resources' Coverage of Orphan Drug Indications
• 4. Top Company Dealmaking Activity, Q2 2009
• 5. Deals Related to the H1N1 Outbreak, Q2 2009
• 6. Select Deals by Therapeutic Area, Q2 2009
• 7. Collaborations Focused on Stem Cell Technologies, Q2 2009
• 8. Top Ten Infl uenza Vaccines by Revenue, 2008
• 9. Top Five Antivirals for the Treatment of Infl uenza by Revenue, 2008

Figures

• 1. Q2 2009 U.S. Drug Approval Tallies and Highlights
• 2. Number of Q2 Deals, 2006-2009
• 3. Number of Deals Valued at More Than $100 Million in the Second Quarter of Each Year, 2006-2009
• 4. Three Deals, More Than $150 Billion Spent: Pfi zer/Wyeth, Roche/Genentech, and Merck & Co./Schering-Plough, Q1 2009
• 5. Select Mergers and Acquisitions Valued at More Than $50 Million, Q2 2009
• 6. Select Product-Related Deals Valued at More Than $100 Million, Q2 2009
• 7. Percentage of Deals by Therapeutic Area, Q2 2009
• 8. Percentage of Technology-Focused Deals by Technology Type, Q2 2009
• 9. 2008 Revenue of Leading Generics Companies
• 10. Revenue and Profi t for Select Ranbaxy Subsidiaries, 2008
• 11. Growth in the Savings to the U.S. Healthcare System as a Result of Generic Drugs, 2000-2008

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