Evolving Trends in Biopharmaceutical Licensing: Deal assessments, drivers and resistors

Published by: Business Insights

Published: Mar. 1, 2009 - 112 Pages

Table of Contents

Evolving Trends in Biopharmaceutical Licensing Executive Summary

Introduction to biopharmaceutical licensing

Biopharmaceutical deals and trends

Drivers and resistors facing biopharmaceutical licensing

Companies involved in biopharmaceutical licensing

The evolutionary pattern of biopharmaceutical licensing

Chapter 1 Introduction to biopharmaceuticals and licensing

Summary

Introduction

Overview of the biopharmaceutical industry

The Biopharma-Pharma relationship

The licensing process

Meeting the licensing challenge

Biopharma continues to shine

Chapter 2 Biopharmaceutical deals and trends

Summary

Introduction

Biopharmaceutical licensing trends

Number and average value of Biopharma licensing deals

Licensing deal partners

Biopharma’s standing: out-licensing versus in-licensing deals

Licensing deal types

Licensing trends in drug development

The rising costs of early-stage licensing

Mid-stage deal-making: lucrative prospects

Therapeutic focus in Biopharma licensing

Chapter 3 Drivers and resistors of biopharmaceutical licensing

Summary

Introduction

Overview of drivers and resistors in biopharmaceutical licensing

Key drivers

Generating cash

Pharma turns to Biopharma to maintain revenue growth; Biopharma gaining an upper hand

Risk sharing

Access to expertise

Key resistors

Reduced control

Increasing complexity of licensing deals: positive for Biopharma but with a higher risk attached

Stricter regulatory and political environments

Future strategic direction

Chapter 4 Leading companies involved in biopharmaceutical licensing

Summary

Introduction

Who is looking to Biopharma and why?

Two sides of the Pharma coin: GlaxoSmithKline and Roche

GlaxoSmithKline: a Biopharma façade?

Roche: building upon an established presence in Biopharma

The Biopharma/Pharma dynamic

Amgen: the leading Biopharma

Gilead: diversification after market domination

Cephalon: a Biopharma out-licensor

Alnylam: a developer of novel therapeutics based on RNA interference

Chapter 5 The evolutionary pattern of biopharmaceutical licensing

Summary

Introduction

The big deals of 2008: a sign of what is to come?

Who holds the future to ImClone?

The Roche and Genentech saga

Biopharma to Biopharma: Genzyme and Isis

Takeda looks to Biopharma for entry to the US market

Pfizer and Wyeth

Are M&As the new licensing?

Potential arrival of biosimilars: a catalyst for Biopharma M&A

The financial crisis and the future of Biopharma

The promise of emerging markets

Keys to future success

Recommendations and strategies for future Biopharma licensing deals and alliances

Chapter 6 Appendix

MedTRACK data

Index

List of Figures

Figure 1.1: Number of NMEs and BLAs approved by the US FDA

Figure 1.2: Strengths of Biopharma and Pharma

Figure 1.3: Overview of the pharmaceutical licensing process

Figure 1.4: Global sales* of Biopharma vs. Pharma

Figure 2.5: Number and average value of Biopharma licensing deals, 2001-08

Figure 2.6: Number of top 20 Biopharma licensing deals by partner, 2001-08

Figure 2.7: Number of Biopharma in- and out-licensing deals by partner, 2004-08

Figure 2.8: Biopharma licensing by deal type, 2001-08

Figure 2.9: Biopharma out-licensing distribution by clinical stage, 2001-08

Figure 2.10: Early-stage deal models with associated pros & cons

Figure 2.11: Early-stage alliances—number of deals and deal size, 2001-08

Figure 2.12: Trends in technology, Biopharma out-licensing, 2002-07

Figure 2.13: Number of Biopharma out-licensing deals ($100m+ nominal deal value) by clinical stage, 2005-08

Figure 2.14: Therapeutic focus in Biopharma licensing deals, 2005-08

Figure 3.15: Drivers and resistors facing biopharmaceutical licensing

Figure 3.16: Biopharma R&D spend

Figure 3.17: Biopharma funding

Figure 3.18: Progression of Biopharma’s involvement in licensing deals

Figure 3.19: Estimated last patent expiry dates of selected proteins

Figure 3.20: Future strategic directions for Biopharma in meeting current challenges

Figure 4.21: Biopharma’s transition via forward and downward integration

Figure 5.22: Announced number of Biopharma mergers & acquisitions, 2001-08

Figure 5.23: Drug patent expiries in the US, 2008-2012

Figure 5.24: Future licensing and alliance scenarios for Biopharma

List of Tables

Table 4.1: GSK’s licensing and alliance activity, 2008

Table 4.2: GSK’s licensing and alliance activity, 2007

Table 4.3: GSK’s licensing and alliance activity, 2006

Table 4.4: GSK’s licensing and alliance activity, 2005

Table 4.5: Roche’s licensing and alliance activity, 2008

Table 4.6: Roche’s licensing and alliance activity, 2007

Table 4.7: Roche’s licensing and alliance activity, 2006

Table 4.8: Roche’s licensing and alliance activity, 2005

Table 4.9: Amgen’s licensing and alliance activity, 2007-08

Table 4.10: Amgen’s licensing and alliance activity, 2005-06

Table 4.11: Gilead’s licensing and alliance activity, 2005-07

Table 4.12: Cephalon’s licensing and alliance activity, 2005-07

Table 4.13: Alnylam’s licensing and alliance activity, 2005-07

Table 5.14: Sales in 7MM and pharmerging markets ($m), 2003-07

Abstract

Evolving Trends in Biopharmaceutical Licensing: Deal assessments, drivers and resistors

Large Pharma companies have become heavily dependant upon alliances and in-licensing to gain access to technologies/new molecular entities from Biopharma. This reliance has strengthened Biopharma’s bargaining position, and is reflected in negotiation tactics which aim to expand their role beyond product discovery and development towards an active participation in the the future of their products. This is emphasized by the growing complexity of licensing deals, as Biopharma attempts to secure marketing and commercialization rights within partnership deals.

Furthermore, recent increases in internal Biopharma consolidation are an indicator of the ability of well-established Biopharma companies to effectively compete against traditional big Pharma.

‘Evolving Trends in Biopharmaceutical Licensing’ is a report published by Business Insights that provides a detailed analysis of licensing strategies in the biopharmaceutical industry over the 2001-08 period. This report examines the growth of the biopharmaceutical industry, deal-making trend data, drivers and challenges facing biopharmaceutical licensing, and profiles of biopharmaceutical licensing among leading companies. The future prospects of the industry are assessed and the potential impact of political/regulatory factors upon licensing and alliances is identified. This report also investigates the influence of the recent upsurge in M&A activity and provides recommendations on the strategies that can sustain future growth.

Key Findings

• Several top-ranked Biopharma companies have matched the consistent sales growth of major traditional pharma companies. A key component of this success has been the increasing reliance of big Pharma to improve R&D productivity and rejuvenate sales of marketed portfolios through licensing and partnership deals.
• Big Pharma has been acquiring Biopharma companies at an increasing rate, resulting in this becoming the fastest-growing M&A sector in 2008 with deal values up 87%. Intense competition and financial uncertainty has also prompted a surge in biopharma consolidation, with 52 biopharma/biopharma deals in 2007.
• Considerable potential for Biopharma licensing deals still exists, particularly within the OAD class of drugs and non-invasive insulin drug delivery technologies.
• The total deal size of early-stage alliances with biopharma has increased six-fold, with total deal values in 2007 estimated at $18bn. This has been driven by the relatively lower costs of discovery and lead development, despite the higher risk of failure.
• Co-development/co-promotion deals accounted for 30% of licensing deals over 2006-07. Licensing deals will continue to become more complex due to biopharma’s desire to remain involved in their product lifecycle beyond the stages of discovery and development

Use this report to...

• Examine the licensing landscape of the biopharma industry with this report’s analysis of Biopharma and Pharma licensing and alliance activity and an examination of specific approaches utilized by both sectors.
• Discover the drivers and challenges facing Biopharma licensing, understand how Biopharma companies are preparing to exploit new opportunities and assess deal-making trends across clinical trials phases and key therapeutic areas.
• Evaluate the strategies of leading companies involved in biopharmaceutical licensing with this report’s analysis of deal activities amongst leading players and identify the changing dynamics of Biopharma/Pharma partnerships.
• Assess the future prospects of the Biopharma industry and how current market and political/regulatory factors will impact the dynamics of licensing and alliances, as well as potential strategies for sustaining growth.

Explore issues including...

• Biopharmas reduced reliance on Pharma. Biopharma is sustaining its efforts to increase its role outside of product development/discovery to become actively engaged in the future of their products. As such, it is becoming increasingly difficult to differentiate big Pharma from major Biopharma companies.
• Optimizing revenue potential. Biopharma are increasingly targeting high value therapy areas, such as oncology and inflammatory disease, bringing them into direct competition with major Pharma.
• Future competitive strategies. With licensing deals increasing in value and complexity, Biopharma companies are looking to increase their involvement by forming long-term, partnership-based relationships. This active engagement in licensing deals will typically involve the negotiation of equity investment and the co-promotion and co-marketing of a drug that allows Biopharma to generate additional downstream revenues.
• Drug development potential. The emergence of several new Biopharma companies with innovative technology platforms has created immense potential for intra-Biopharma licensing trends to continue developing novel drugs that can successfully differentiate themselves within the marketplace.

Discover...

• How will the increasing competition for attractive Biopharma licensing candidates affect deal terms and values?
• How can Biopharma companies improve their licensing strategies to ensure future growth?
• What have been the major trends in licensing agreements between Biopharma and Pharma over 2001-08?
• Which strategies have Biopharma used to reduce their reliance on Pharma?
• How has the value, volume and competition for Biopharma licensing deals changed over 2001-08?
• What have been the strategies of successful Biopharma and Pharma deal-makers?
• Why are Biopharma and Pharma increasingly adopting M&A strategies instead of entering into licensing agreements?

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