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Licensing Strategies - Examining Today’s Pharmaceutical Licensing Trends

Published by: Datamonitor

Published: Nov. 14, 2007 - 162 Pages


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

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

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

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.

Reasons to Purchase

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

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