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

Published by: Decision Resources

Published: Jun. 4, 2009 - 47 Pages


Table of Contents


Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction

Events Perspective

On the Competitive Front: Biotech Balances Bankruptcies, Bailouts—and, Soon, Boons

On the Economic Front: Healthcare Features of the Stimulus Package

Comparative Effectiveness Research

NIH Funding

Other

On the Approvals Front: FDA’s First “Pharm” Animal Drug Approval

Deals Perspective

Mergers & Acquisitions

Notable Product-Related Deals

Therapy-Area Deals—Focus on Oncology

Biologics Continue to Be a Dealmaking Focus

Biosimilars

Stem Cells

Other Notable Biologics Activity

Pharmacogenomics/Biomarkers/Diagnostics

Technology Deals

Generics Perspective: Today’s Economy Presents the Industry with Opportunities and Challenges

Actavis and Ratiopharm for Sale

Layoffs at Ratiopharm, Teva, and Pliva

Teva and Momenta Aim to Make History with U.S. Biosimilar Approvals

Obama Paves the Way for a Biosimilars Mechanism

Strategy Perspective

Return of the Mega-Consolidation

Healthcare Policy: Inside Looking Out or Outside Looking In?

GlaxoSmithKline in the Developing World: The Price Is Right?

Expert Commentary

Biotech Investment Trends: The Quest for Capital

Tables

1. National Institutes of Health Challenge Grant Areas and Sample Topics

2. Select Transgenic Animal Drug Development Programs

3. Top Company Dealmaking Activity, Q1 2009

4. Top 20 Pharmaceutical Companies, by 2008 Pharmaceutical Sales, Pre- and Post-Mega-Mergers

5. Select Therapy-Area Deals, Q1 2009

6. Select Biologics-Related Deals, Q1 2009

7. Select Oncology Pharmacogenomics/Biomarker/Diagnostics-Related Deals, Q1 2009

8. Record of the European Medicine Association’s MAA Procedures

9. Decision Resources Analyst Opinion: Perspectives on Teva’s G-CSF Biosimilars Initiative in the United States

10. Summary of U.S. Biosimilars Legislation

Figures

1. Biotech Quarterly Initial Public Offerings and Venture Capital Investments, 2002-2008

2. First-Quarter 2009 U.S. Drug Approval Tallies and Highlights

3. Number of First-Quarter Deals, 2006-2009

4. Pharma and Biotech Deals Valued at More Than $100 Million in the First Quarter of Each Year, 2006-2009

5. Three Deals, More Than $150 Billion Spent: Pfi zer/Wyeth, Roche/Genentech, and Merck & Co./ Schering-Plough, Q1 2009

6. Select Mergers & Acquisitions Valued at More Than $100 Million, Q1 2009

7. Select Pharma and Biotech Product-Related Deals Valued at More Than $2 Million, Q1 2009

8. Percentage of Deals by Therapeutic Area, Q1 2009

9. Percentage of Deals by Technology Type, Q1 2009

10. Select Financial Results for Teva, 2007 and 2008

11. Corporate Evolution of Pfi zer

12. Dates of Patent Expiry for Pfi zer’s Blockbuster Drugs

13. Dates of Patent Expiry for Wyeth’s Leading Drugs

14. Dates of Patent Expiry for Merck and Schering-Plough’s Leading Drugs

Abstract

Introduction

No Bear Stearns, no Lehman Brothers, no Chrysler, no humiliating hat-in-hand audiences with Congress. The biopharma industry has not seen one of its leaders tumble in the way that the financial and automotive industries have. Certainly, though, many smaller players are succumbing in the international economic meltdown; major players are making moves that are critical to their survival; and the possibility of a federal bailout of the biotech industry has been raised. Clearly, the state of the economy is hastening change in the industry, which will confront a narrowed playing field, greater cost-consciousness, and opportunities to innovate in terms of technologies and business models.

Get the Answers You Need to Shape Your Strategy
  • The first quarter brought the return of the mega-merger. What do these mammoth deals signal for the Big Pharma/Big Biotech participants? What do they say about the industry in general?
  • Healthcare reform debates continue in the United States. What is the state of the coalition exploring change? What does the financial stimulus package mean for healthcare?
  • Small biotechs are suffering given the current economic condition. What is the outlook for this sector? How has the investment environment been affected? Where are the opportunities?
  • Many companies are targeting biosimilar development, recognizing that payers will embrace these alternatives. How is U.S. regulatory guidance shaping up? What companies are pursuing biosimilar approvals? What is the outlook for Teva, which has announced that it will pursue a biosimilar BLA?
Scope
  • Events: guidance and approvals involving transgenic animals; biotech industry financial and investment trends, challenges, opportunities, and outlook; U.S. stimulus package funding in the healthcare arena.
  • Dealmaking: deal volume, deal type, deal value, deal focus, most active companies, therapeutic area focus, biologics focus.
  • Generics: Actavis and Ratiopharm up for sale; layoffs announced at key generics companies; the push for biosimilars.
  • Strategy: return of the mega-merger; pending healthcare reform in the United States; Big Pharma’s philanthropic ventures in developing countries.
  • Expert commentary: “Biotech Investment Trends: The Quest for Capital,” by Decision Resources senior analyst Barbara M. Bolten, M.S., M.B.A.


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