Pharmaceutical Licensing Overview

Product Code DAT18705
Publication Date March 2010
Publisher Datamonitor
Product Type Report
Pages 114
ISBN Number not applicable

Pharmaceutical Licensing Overview

Big Pharma continues to restructure its internal R&D departments as part of widespread cost-cutting measures to help reduce the impact of the impending 2011 patent cliff. To fill pipeline voids with new products, companies continue to make acquisitions and form partnerships with small pharma, biotech companies and academia, although the relationships between each are becoming increasingly dynamic.

Scope

  • Overview of Big Pharma's current and anticipated future reliance on externally sourced products
  • Overview of drivers and resistors of licensing deals and an assessment of key trends and factors that will shape the future make-up of licensing
  • Analysis of key product deals during 2008-09, analyzing trends for in-licensing, out-licensing and manufacturing/supply arrangements
  • Assessment of drug discovery and technology deals made by the top 10 pharmaceutical companies during 2008-09

Highlights

  • The number of in-licensing deals in 2009 increased by 12% over 2008, confirming that Big Pharma is actively seeking acquisitions and licensing agreements as a more cost-effective means of gaining access to novel products than carrying out extensive in-house R&D.
  • Although deals for drugs at the earliest stages of development accounted for almost 60% of all product in-licensing deals analyzed, Big Pharma greatly increased its focus on Phase II and III products in 2009 as it looks to offset the 2011 patent cliff by incorporating more advanced-stage products into its pipelines to enhance short/mid-term growth.
  • GlaxoSmithKline was by far the most active Big Pharma player. While many of its Big Pharma peers have participated in large M&A deals over the past 2 years, GlaxoSmithKline has thus far preferred to focus on incorporating externally acquired products into its pipeline.

Reasons to Purchase

  • Appreciate the drivers and resistors companies face when licensing products, and the resultant strategies some companies are employing
  • Identify suitable pharma partners to target when considering out-licensing your technologies and products
  • Understand the direction the constantly evolving pharmaceutical licensing landscape is moving in order to identify the best strategies to succeed

Contents

  • 1. about This Report
    • Chapter structure
  • Executive Summary
    • Licensing trends overview
    • Evolving trends in the licensing landscape
    • Product licensing deals and trends
    • Technology licensing deals and trends
    • Bibliography
    • Contributing experts
    • Related reports
    • Upcoming related reports
  • 2. Executive Summary
    • Strategic scoping and focus
    • Key findings
    • Key dEFInitions
    • Deal dEFInitions
    • Company classifications
    • Explanation of launch/core/expiry analysis
    • Table of Contents
  • 3. Licensing Trends Overview
    • Key findings
    • Big Pharma trends
    • Big Pharma's reliance on externally sourced products drives sales growth
    • Big Pharma's sourcing of external products is set to grow
    • AstraZeneca to become more reliant on in-licensed products as internal products face generic competition
    • Abbott's recent M&A activity will reduce reliance on in-licensed products
    • Pfizer's acquisition of Wyeth will see it more reliant on sales from in-licensed products
    • Licensing deal trends
    • Annual change in deal activity
    • Big Pharma increases number of in-licensing deals during 2009
    • Cash-rich Big Pharma capitalized on economic situation through second half of 2009
    • Deals by subject
    • The majority of Big Pharma's licensing activity focuses on deals for drug candidates
    • Deals by company
    • GlaxoSmithKline was the most active Big Pharma player
    • GlaxoSmithKline raised its level of in-licensing activity in the second half of 2009
    • Eli Lilly to focus on internal R&D capabilities rather than externally-sourced products
  • 4. Evolving Trends in The Licensing Landscape
    • Key findings
  • Introduction
    • Both Pharma and Biotech face the same core challenges
    • Drivers and resistors of licensing
    • Big Pharma's internal R&D crisis drives licensing quest
    • Poor returns from Pharma's internal R&D the confounding issue
    • Widespread cost-saving measures and essential refocusing central to Big Pharma's streamlined R&D
    • Biopharma's needs to collaborate are manifold
    • Big Pharma's cash and expertise is essential to advance Biopharma's pipeline candidates
    • Alliances allow companies to share the cost and inherent risks of drug development
    • Accessing external resources and capabilities
    • Future outlook for licensing deals
    • Big Pharma evolution
    • Partnership agreements become more intricate as licensees look to share development risk
    • How far can Big Pharma take its cost-cutting strategies?
    • Big Pharma's near-term focus
    • Late-and mid-stage deal activity set to increase as Pharma looks to offset the patent cliff
    • Deals with academia to multiply and become more complex
    • Pharma will turn increasingly to universities for early-stage innovation
    • Closer collaboration will reduce academic caution
    • Niche indications and orphan drugs are attractive licensing propositions
    • Smaller patient populations offset by attractive economic incentives
    • GlaxoSmithKline and Pfizer show greater concentration on orphan drugs
    • Push towards personalized medicine will shape technology deals
    • Strategic licensing options available for Pharma in growing diagnostics market
    • Big Pharma out-licensing to increase as internal R&D focus is realigned
    • Big Pharma divestitures could represent opportunities for smaller companies
    • Early-stage deal structure changes highlight Big Pharma's aversion to shouldering risk
    • Smaller upfront fees and additional milestone payments replace large opening values for riskier early-stage products
    • Option-based deals - a low-cost method of securing rights to potentially innovative early-stage products
    • Big Pharma's specialist external arms represent an alternative way to invest in and incorporate innovation
    • Big Pharma venture and option funds provide another route to team up with biotechs
    • GlaxoSmithKline's Centre of Excellence for External Drug Discovery focuses on option-based deals
    • Focus on emerging markets will increase
    • Regional rights sought to fuel push into emerging markets
    • Asia to become a key source of innovation in years to come
  • 5. Product Licensing Deals and Trends
    • Key findings
    • Pharmaceutical licensing trends
    • in-licensing trends
    • Deals by primary goal
    • Research and discovery and product license deals most popular deal types for Big Pharma
    • Deals by therapy area
    • Infectious diseases is the most common therapy area for Big Pharma's product in-licensing deals
    • Influenza vaccine developments head anti-infective in-licensing deals
    • Central nervous system deals focus on the emergence of biologic treatments for Alzheimer's disease and pain
    • GlaxoSmithKline and Sanofi-Aventis up their focus on in-licensing oncology candidates in 2009
    • Deals by stage of development
    • Research/discovery stage products represent more than a third of all product in-licensing deals made by Big Pharma
    • Big Pharma moves its attention to in-licensing products at more advanced stages of development
    • Full license agreements form the majority of clinical stage product in-licensing deals
    • Marketing, promotion and distribution deals most commonly associated with marketed products
    • Deals by value - upfront fee paid
    • A premium upfront fee is standard for drug candidates that have reached Phase III development
    • Deals for central nervous system drugs commanded the highest upfront fees during 2008-09
    • Deals by drug type
    • Small molecules remain the main target of in-licensing deals amid increasing focus on biologics
    • Pfizer leads the way in stem cell therapy deals as Big Pharma generally refrains from mass investment
    • Deals by leading dealmakers
    • GlaxoSmithKline leads the field in terms of product in-licensing deals
    • Abbott and Roche restrict product licensing deals as attention turns to mega-merger activity
    • Eli Lilly, Sanofi-Aventis and Roche focus on securing the full licensing rights to a product
    • Johnson & Johnson ties up the greatest proportion of research and discovery deals
    • All Big Pharma companies in-license products across a range of therapy areas
    • Roche and Eli Lilly's in-licensing deals focus on small molecules with biologic candidates largely acquired through M&A activity
    • GlaxoSmithKline focuses on acquiring vaccines while Sanofi-Aventis leads the way in monoclonal antibody deals
    • Deals by source company type
    • The smallest pharma/biotech companies are the source of most in-licensed products
    • Vast majority of deals with mid-sized and fellow Big Pharma companies are for marketing rights
    • Deals by region
    • 2009 saw a significant increase in product in-licensing deals for specific regions
    • Asia expected to become a key source of innovation in years to come
    • out-licensing trends
    • Deals by primary goal and region
    • More than half of Big Pharma's product out-licensing deals are for marketing/promotion/distribution purposes
    • Leading dealmaker trends
    • GlaxoSmithKline and Pfizer more than double product out-licensing activity in 2009
    • Marketed products accounted for over half of all out-licensed products
    • Novartis largely out-licensed commercially-ready products for co-promotional reasons
    • GlaxoSmithKline divests US rights for Wellbutrin XL to Biovail for $510m
    • out-licensing agreements for clinical-stage products
    • Innovative risk-mitigation deal struck by Eli Lilly for Alzheimer's disease candidates
    • Pfizer out-licenses products following R&D prioritization
    • Manufacturing and supply deals
    • Deals by leading dealmakers
    • Sanofi-Aventis signed the most manufacturing/supply product agreements
    • Eli Lilly extends previous alliance with Amylin to include supply of a once-weekly diabetes product
    • Leading source companies
    • Lonza emerges as a key partner for Big Pharma's outsourced manufacturing
  • 6. Technology Licensing Deals and Trends
    • Key findings
    • Technology licensing trends
    • Trends in technology deals
    • Focus of technology
    • The majority of deals are for drug discovery and diagnostic technologies
    • Diagnostic technology deals
    • Drive towards personalized medicine results in numerous deals for diagnostics
    • Biomarkers seen as a tool to enhance clinical development
    • Deals to identify companion biomarkers for cancer subtypes facilitates move towards targeted therapies
    • Drug discovery technologies
    • An array of technologies are available to increase drug discovery productivity
    • Sanofi-Aventis gains access to a number of biopharmaceutical discovery/development platforms
    • Assay/screening is high on GlaxoSmithKline's agenda
    • Bioinformatics software designed to improve internal efficiencies of drug development
    • Drug delivery technologies
    • Novel delivery optimization technologies focus on improving delivery of biologic drugs
    • Drug production technologies
    • Big Pharma seeks high-yielding and more cost-effective biologic production processes
    • Medical device technology
    • Johnson & Johnson's specialist subsidiaries license catheter and stent device technologies for cardiovascular diseases
    • Leading technology dealmakers
    • Johnson & Johnson signed the most technology licensing deals with its specialist subsidiaries featuring heavily
    • Abbott focused on diagnostic technology deals supporting its market-leader status in the field
    • Sanofi-Aventis sought drug discovery technologies to help identify its next generation of revenue drivers
  • 7. Bibliography
    • Company press releases
    • Other web-based articles
    • Other sources
    • Datamonitor reports
  • Appendix
    • Company classification
    • Contributing experts
    • About Datamonitor
    • About Datamonitor Healthcare
    • About the Healthcare Strategic Analysis team
    • Geographic specific reports:
    • Global issue reports:
    • Datamonitor consulting
    • Disclaimer
  • List of Tables
    • Table 1: Big Pharma's influenza vaccine in-licensing deals, 2008-09
    • Table 2: Big Pharma's central nervous system biologics in-licensing deals, 2008-09
    • Table 3: Sanofi-Aventis's oncology product in-licensing deals, 2009
    • Table 4: Leading central nervous system product in-licensing deals by upfront fee and value, 2008-09
    • Table 5: All 235 product in-licensing deals performed by the top 10 pharma companies by type, 2008-09
    • Table 6: Big Pharma's South and Central American product in-licensing deals, 2008-09
    • Table 7: Big Pharma's clinical-stage drug out-licensing deals, 2008-09
    • Table 8: Select diagnostic technology licensing deals made by the top 10 pharma companies, 2008-09
    • Table 9: Top 150 pharmaceutical companies in terms of 2008 sales
  • List of Figures
    • Figure 1: The PharmaVitae Explorer
    • Figure 2: Sales forecast dynamics of the top 10 pharma companies, 2009-2014
    • Figure 3: Top 10 pharma companies' reliance on externally sourced products, 2002-2014
    • Figure 4: AstraZeneca's prescription pharmaceutical sales by source ($m), 2009-2014
    • Figure 5: Abbott's pre-Solvay acquisition prescription pharmaceutical sales by source ($m), 2009-2014
    • Figure 6: Pfizer, Wyeth, and combined Pfizer-Wyeth reliance on externally sourced products, 2002-2014
    • Figure 7: Licensing deals performed by the top 10 pharma companies, 2008-09
    • Figure 8: Licensing deals performed by the top 10 pharma companies by quarter, 2008-09
    • Figure 9: Subject of licensing deals performed by the top 10 pharma companies, 2008-09
    • Figure 10: in-licensing deals performed by the top 10 pharma companies by category, 2008-09
    • Figure 11: in-licensing deals performed by the top 10 pharma companies by quarter, 2008-09
    • Figure 12: The key drivers and resistors facing licensees and licensors in today's pharmaceutical industry
    • Figure 13: The growing cost of drug discovery and allocation of R&D investment by function (%), 1975-2008
    • Figure 14: Stage of development at signing for all 235 in-licensing product deals performed by the top 10 pharma companies, 2008-09
    • Figure 15: Primary goal of all 235 product in-licensing deals performed by the top 10 pharma companies, 2008-09
    • Figure 16: Therapy area focus for all 235 product in-licensing deals by the top 10 pharma companies, 2008-09
    • Figure 17: Therapy area focus for all 235 product in-licensing deals by the top 10 pharma companies, 2008 versus 2009
    • Figure 18: Big Pharma's oncology product in-licensing deals, 2008-09
    • Figure 19: Product in-licensing deals by stage of development at signing by the top 10 pharma companies, 2008-09
    • Figure 20: Comparison of product in-licensing deals by stage of development at signing by the top 10 pharma companies, 2008-09
    • Figure 21: Product in-licensing by stage of development at signing and primary goal by the top 10 pharma companies, 2008-09
    • Figure 22: Mean upfront fee value ($m) by stage of development at signing for all in-licensing product deals performed by the top 10 pharma companies, 2008-09
    • Figure 23: All 235 product in-licensing deals performed by the top 10 pharma companies by type, 2008-09
    • Figure 24: All 235 product in-licensing deals performed by the top 10 pharma companies by type and quarter, 2008-09
    • Figure 25: Product in-licensing deals performed by the top 10 pharma companies, 2008-09
    • Figure 26: Primary goal of all 235 product in-licensing deals performed by the top 10 pharma companies, 2008-09
    • Figure 27: Stage of development of all 235product in-licensing deals performed by the top 10 pharma companies, 2008-09
    • Figure 28: Therapy area of all 235 product in-licensing deals performed by the top 10 pharma companies, 2008-09
    • Figure 29: Product type of all 235 product in-licensing deals performed by the top 10 pharma companies, 2008-09
    • Figure 30: Biologic product in-licensing deals performed by the top 10 pharma companies by type, 2008-09
    • Figure 31: Source company of all 235 product in-licensing deals performed by the top 10 pharma companies, 2008-09
    • Figure 32: Source company and primary goal of all 235 product in-licensing deals performed by the top 10 pharma companies, 2008-09
    • Figure 33: Product in-licensing deals performed by the top 10 pharma companies by region, 2008-09
    • Figure 34: Primary goal of all 94 product out-licensing deals performed by the top 10 pharma companies, 2008-09
    • Figure 35: Product out-licensing deals performed by the top 10 pharma companies, 2008-09
    • Figure 36: All 94 product out-licensing deals performed by the top 10 pharma companies by stage of development, 2008-09
    • Figure 37: Novartis's key ex-US out-licensing regional co-promotion deals, 2008-09
    • Figure 38: All 17 manufacturing and supply licensing deals performed by the top 10 pharma companies, 2008-09
    • Figure 39: Application of different technology types across the drug development process
    • Figure 40: Focus of all 133 technology licensing deals performed by the top 10 pharma companies, 2008-09
    • Figure 41: Breakdown of drug discovery technology licensing deals performed by the top 10 pharma companies, 2008-09
    • Figure 42: The role of drug delivery technologies in a drug's lifecycle
    • Figure 43: Focus of all 133 technology licensing deals performed by the top 10 pharma companies, 2008-09