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

Published by: Decision Resources

Published: Sep. 10, 2009 - 49 Pages

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?

SPECTRUM Pharmaceutical Industry Dynamics 10-3

Biopharma Quarter 2Q09

Press Date: September 10, 2009 Decision Resources

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

Abstract

• 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?

• 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.

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