ライセンシング戦略：今日の医薬品ライセンシング動向

Abstract

Introduction

With Pharma struggling to maintain its pipelines and portfolios with products developed in-house, companies are increasingly turning to licensing. However, the search for late-stage developmental products is becoming tougher and more expensive, and companies are now looking towards licensing earlier-stage compounds.

Scope of this report

• Overview of drivers and resistors of licensing deals, with recommendations and case study analysis of how companies can optimize the licensing process
• Examination of how to successfully navigate the licensing process, with analysis of how companies are looking to modernize their licensing strategies
• Analysis of key product deals during 2005-06, analyzing trends for in-licensing, co-development, out-licensing and marketing & promotion deals
• Assessment of drug discovery deals and technology deals, made by the top 20 pharmaceutical companies during 2005-06

Research and analysis highlights

The constant demand for late-stage product candidates has led to spiraling deal costs. Therefore companies are now looking to in-license earlier-stage compounds, demonstrated by the recent resurgence in preclinical and Phase I licensing deals made by the top 20 pharmaceutical companies.

Companies facing patent expiries of key revenue drivers between 2006-12 have in-licensed products to counteract the ensuing sales erosion. However, this tactic is not expected produce a positive growth in the short term for all companies, although it will at least offset part of their revenue deficit.

During 2005-06, Novartis was the leading dealmaker, followed by Bayer-Schering, Roche, and J&J, with the top six companies responsible for 50% of all deals made by the leading 20 companies.

Key reasons to read this report

• Understand the opportunities and threats companies face when licensing their products, and the resultant strategies some companies are employing
• Identify suitable Pharma to target when considering licensing partners for your technologies and products
• Benchmark the success of your licensing strategy in order to improve future deal making success

Table of Contents

• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the report
    • Interviewed licensing executives
    • Chapter summary
  • Definitions
  • Key findings
• CHAPTER 2 DRIVERS AND RESISTORS OF LICENSING
  • Both Pharma and Biotech face the same challenges
  • Drivers and resistors of licensing facing Pharma and Biotechs today
    • Drivers for the licensee
      • In-licensing compensates for declining internal R&D
      • To maintain and build upon a company' s pipeline and portfolio, selective in-licensing is frequently employed
    • Resistors for the licensee
      • In-licensed products offer a lower ROI than those developed in-house
      • Competition for products drives up costs of licensing deals, so Pharma turn to licensing at an early-stage of development
    • Drivers for the licensor
      • Generating cash
      • Sharing the risk
      • Accessing external resources and capabilities
    • Resistors for the licensor
      • Loss of control
• CHAPTER 3 HOW TO SUCCESSFULLY NAVIGATE THE LICENSING PROCESS
  • The key to successful licensing
    • The licensing strategy
    • Identifying an opportunity
      • In-licensing - evaluating needs and identifying potential candidates
      • Out-licensing - overcoming limitations
      • Partners of choice
    • Licensing evaluations
    • Signing the deal and managing the alliance
      • Alliance management structure
    • Novel twists on licensing strategies - case study analysis
      • Debiopharm - the consummate licensor
      • Versant Ventures joins in with Lilly' s Chorus
      • Pharma looks outside its traditional portfolios
  • Deal values
    • Deal structures
      • Upfront payments
      • Milestone payments
      • R&D costs
      • Royalties
      • Deal structure for marketed products
• CHAPTER 4 PRODUCT LICENSING DEALS AND TRENDS
  • Introduction
  • Large Pharma turn to in-licensing to compensate for flagging internal R&D pipelines
    • Reliance on licensing deals
      • Eisai forecast to experience the largest increase in dependency on in-licensed products
      • Merck & Co. set to shift its dependence from in-house to in-licensed products by 2012
      • Boehringer Ingelheim set to decrease its reliance on externally sourced products
      • Sanofi-Aventis expected to focus on in-licensing in the future
      • In-licensing used to offset deficiencies in internal pipelines and portfolios
    • Deals continue to rise through 2005-06
    • Deals for drugs in clinical development predominate
    • In-licensing forms the majority of clinical stage drug deals
      • Licensing and co-development deals are most frequently for compounds in preclinical and Phase I development
      • Continued rise in the number of preclinical and clinical out-licensing deals by big Pharma, but deals for marketed drugs fall sharply
      • Marketing, promotion and distribution deals most commonly associated with marketed products
    • Leading dealmakers
      • Japanese companies raise their deal-making profile
    • Leading in-licensor companies
      • AstraZeneca in-licenses to strengthen its neuroscience portfolio
      • Novartis carried out the greatest number of Phase I and equal highest number of Phase III deals
    • Leading co-developers
      • Novartis and Bayer-Schering performed the largest number of co-development deals
      • Roche continues to strengthen key therapy areas through co-development
      • Few companies entered into co-development deals for drugs in Phase III or above
      • More co-development between large Pharma and large Pharma/Biotech expected in the future
    • Companies continue to enter deals for anti-infective and oncology products
      • Resurgence in deals for oncology drug candidates
      • Continued rise in anti-infective and CNS drug deals
    • Small molecules remain the target of choice for licensing deals, but it will be the biologics driving market growth
    • Leading out-licensors
      • Bayer Schering AG out-license products
      • BMS enters out-licensing agreements to share risk and costs
      • Roche performed the highest number of marketed drug deals
      • Sanofi-Aventis transfers Exubera global rights to Pfizer
      • Big Pharma predicted to increase out-licensing deals in the future
    • Marketing, promotion and distribution deals
      • Top companies predominantly enter marketing and promotion deals as partners
      • Abbott uses marketing agreements to bolster its position in the respiratory market
      • Chugai enhances its position in the cardiovascular market through marketing and promotion deals
      • CNS and anti-infective therapies are the most popular targets for marketing and promotion deals
• CHAPTER 5 TECHNOLOGY LICENSING DEALS AND TRENDS
  • Introduction
    • The importance of technology deals
    • Drug discovery deals take a dive
    • Leading technology dealmakers
      • Merck & Co. remains the dominant drug discovery dealmaker
    • Biologic technologies overtake small molecules in terms of drug discovery deals
      • Therapeutic antibodies and recombinant proteins are the key biologic technologies targeted in drug discovery deals
    • Types of drug discovery deal
      • Assays and arrays
      • Bioinformatics
      • Biopharmaceutical discovery and development
• CHAPTER 6 BIBLIOGRAPHY
  • Datamonitor reports
  • Websites
  • Publications and online articles
  • Glossary of terms
  • List of Tables
    • Table 1: Top 20 pharmaceutical companies, 2005-06
    • Table 2: A complementary strategy - strengths that Pharma and Biotechs bring to a licensing deal
    • Table 3: Ophthalmology licensing deals, 2005-06
    • Table 4: Current treatments for AMD, 2006
    • Table 5: Proportion of upfront payment in terms of total deal costs increases with drug development, 2005-06
    • Table 6: Upfront and milestone payments made by GSK, 2005-06
    • Table 7: Royalty rates for in-licensed compounds
    • Table 8: Top 20 pharmaceutical companies forecast to grow by only an average of 2.6% CAGR, 2006-12
    • Table 9: Product deals made by Japanese headquartered companies during 2005-06
    • Table 10: Key anti-infective drug in-licensing and co-development deals, 2005-06
    • Table 11: Small molecules remain the focus of in-licensing and co-development deals during 2005-06
    • Table 12: Drug discovery and delivery deals made by the top 20 pharmaceutical companies, 2000-06
    • Table 13: Leading companies licensing biopharmaceutical discovery and development technologies, 2005-06
  • List of Figures
    • Figure 1: The key drivers and resistors facing licensees and licensors in today' s pharmaceutical industry
    • Figure 2: Factors responsible for declining revenues
    • Figure 3: The number of in-licensing deals rose rapidly in 2005-06 following gradual growth over previous years
    • Figure 4: Factors determining a licensee' s profits
    • Figure 5: In-licensed products offer a lower ROI than those developed in-house
    • Figure 6: The rising cost of in-licensing, 2000-05
    • Figure 7: Resurgence in the in-licensing of preclinical compounds, 2005-06
    • Figure 8: The pros and cons of in-licensing at different stages of drug development
    • Figure 9: Factors leading to partnership breakdown during licensing deals
    • Figure 10: Overview of the pharmaceutical licensing process
    • Figure 11: Key elements that need to be considered when developing a company' s licensing strategy
    • Figure 12: Key factors to be evaluated when identifying a suitable in-licensing opportunity
    • Figure 13: Merck & Co.' s ' Submit your discovery' licensing opportunity profile template
    • Figure 14: Factors which can tip the balance in favor of initiating or delaying the out-licensing decision for a licensor
    • Figure 15: Partner' s of choice must satisfy several hard and soft factors
    • Figure 16: Novartis' s strategic alliance process
    • Figure 17: Poor deal management can have major detrimental effects on the alliance performance
    • Figure 18: Debiopharm' s business model
    • Figure 19: Licensing agreement between Lilly' s Chorus and Versant Ventures
    • Figure 20: Weighing up upfront payments
    • Figure 21: Mean upfront payments for licensing and co-development deals made by the top 20 Pharma, 2005-06
    • Figure 22: Total and mean upfront payments by licensor, 2005-06
    • Figure 23: Mean milestone payments for licensing and co-development deals made by the top 20 Pharma, 2005-06
    • Figure 24: Total and mean milestone payments by licensor, 2005-06
    • Figure 25: Externally developed drugs will not be sufficient to offset revenue losses from in-house products for GSK, 2006-12
    • Figure 26: Top 20 pharmaceutical companies forecast to grow by only an average of 2.6% CAGR, 2006-2012
    • Figure 27: Companies increasing their in-licensing dependence during 2006-12
    • Figure 28: Companies decreasing their in-licensing dependence during 2006-12
    • Figure 29: In-licensed products are not expected to offset revenue decline from in-house products for Eisai, 2006-12
    • Figure 30: Externally sourced products help drive Merck & Co.' s sales growth during 2006-12
    • Figure 31: Boehringer Ingelheim set to decrease its reliance on externally sourced products during 2005-06
    • Figure 32: Summary of how product sourcing is forecast to effect company sales by 2012
    • Figure 33: In-licensing deals in 2005-06 versus 2000-04
    • Figure 34: In-licensing deals are the most frequent type of deal carried out by the top 20 pharmaceutical companies, 2005-06
    • Figure 35: Deals per stage of drug development, 2005-06
    • Figure 36: Development stage of product' s licensed, by type of deal, during 2005-06
    • Figure 37: Licensing and co-development deals are most frequently made for compounds in preclinical and Phase I development, 2005-06
    • Figure 38: Resurgence in the in-licensing of preclinical compounds, 2005-06
    • Figure 39: Continued rise in the number of preclinical and clinical out-licensing deals, but deals for marketed drugs fall sharply, 2000-06
    • Figure 40: Definition of source and partner companies
    • Figure 41: Novartis was the leading dealmaker during 2005-06
    • Figure 42: Novartis and AstraZeneca were the top in-licensors during 2005-06
    • Figure 43: Number of in-licensing deals versus sales growth, 2005-06
    • Figure 44: Novartis and Bayer-Schering were the top co-developers during 2005-06
    • Figure 45: The ratio of deals per therapy area has changed little between 2000-04 and 2005-06
    • Figure 46: The number of oncology and anti-infective in-licensing and co-development deals grew strongly during 2005-06
    • Figure 47: Novartis entered into the greatest number of small molecule in-licensing and co-development deals, 2005-06
    • Figure 48: Significant increases in deal numbers were made across all biologic categories during 2005-06
    • Figure 49: Bayer-Schering and BMS were the top out-licensors during 2005-06
    • Figure 50: Out-licensing deal territories, 2005-06
    • Figure 51: Novartis was the leading company to enter marketing, promotion and distribution deals during 2005-06
    • Figure 52: Marketing and promotion deals by therapy area, 2005-06
    • Figure 53: The drug development process, including stages where drug delivery technologies can be applied
    • Figure 54: Drug discovery and technology deals made by the top 20 pharmaceutical companies, 2000-06
    • Figure 55: Merck & Co. and Novartis performed the most technology deals during 2005-06
    • Figure 56: Biologic technologies overtake small molecules in terms of drug discovery deals, 2000-06
    • Figure 57: Therapeutic antibodies and recombinant proteins were the key biologics targeted in drug discovery deals, 2005-06
    • Figure 58: Drug discovery technologies, 2005-06