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Optimizing Licensing Strategies for the 21st Century Creating Win

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Optimizing Licensing Strategies for the 21st Century: Creating Win-
Win Pharmaceutical and Biotech Licensing Deals

Description:    With in-house R&D productivity failing and healthcare cost-containment policy driving the need for
                differentiation in new product flow, establishing effective alliance networks to secure innovation is
                critical for pharma. Meanwhile, increasing development costs and risk are forcing small research-
                focused companies to maximize the returns from their research through effective alliances.

                Optimizing Licensing Strategies for the 21st Century: Creating Win-Win Pharmaceutical and Biotech
                Licensing Deals provides recommendation-based analysis for both in- and out-licensers seeking to
                optimize portfolio management through effective alliance network. Through enhanced
                understanding of the licensing environment for both early- and late-stage deals, companies can
                assess the performance of deal building blocks, review the way they interact, analyze the forces
                that cause alliance failure and develop winning strategies to revive their pipeline development.

                Reasons to buy

                - Understand the drivers of effective VAP management and assess the implications for your
                licensing strategies
                - Examine the drivers behind your potential partner's licensing decisions and use this to guide win-
                win deal development
                - Evaluate the implications of late- and early-stage licensing strategies on the risk/return profile of
                your portfolio

                "...VAP management must facilitate information flow throughout the organization to provide
                guidance on the formation of corporate strategy..."

                Key findings and highlights

                - In a business environment in which profit is being squeezed, efficient resource allocation should
                be a primary objective. Effective vertical alliance portfolio (VAP) management enables the
                distribution of resources across deals and programs so that the overall value of the portfolio is
                maximized.
                - Throughout an early-stage licensing agreement, the licensor and the licensee form a powerful
                dipole. Using this structural form helps the licensing manager or potential partner understand the
                dynamic and interactive nature of the licensing partnership. This co-interaction is continuous and
                follows the evolution of the two partners' business models.
                - Instead of diversifying development efforts with multiple late-stage trials in different indications,
                partners should identify the most lucrative option and focus on succeeding there. Hence, significant
                market research and strong competitive intelligence are needed to help the partners decide which
                market will be targeted first and how.

                "...The opportunity to acquire critical tacit knowledge during an early-stage licensing deal can help
                the licensee to redefine its in-house supply chain structure and its R&D investing policies..."



Contents:       EXECUTIVE SUMMARY

                ALLIANCE PORTFOLIO MANAGEMENT

                Introduction: strategic alliances – 'what's the big deal?'

                The integration of pharmaceutical portfolio management
                - How value is accumulated or lost in the pharmaceutical portfolio

                The critical role of vertical alliance portfolio management
                - The drivers of allliance portfolio management
- Alliance portfolio management and corporate strategy

The direction of your alliance portfolio management
- Manage an integrated franchise oriented framework
- Identifying successful deals
- Know when to enter or exit

EARLY LICENSING STRATEGIES

Key recommendations for early-stage licensing
- For the licensor
- For the licensee

The structure of our strategic analysis

Drivers for early-stage licensing
- R&D productivity crisis affects early-stage pipeline
- The value chain of early-stage licensing
- Early-stage licensing as a business development tool

Key drivers and resistors for early licensees and licensors
- Innovation-oriented drivers for the licensee
- Innovation-oriented drivers for the licensor
- Innovation-oriented resistors for the licensee
- Innovation-oriented resistors for the licensor
- Business development-oriented drivers for the licensee
- Business development-oriented drivers for the licensor
- Business development-oriented resistors for the licensee
- Business development-oriented resistors for the licensor

The critical role of the licensee/licensor dipole

- What is the dipole?
- The dipole's key characteristics

Optimizing strategies for early stage licensing

Lifecycle-oriented early-stage licensing strategies
- The rules of attraction: know thy partner and thyself
- Formation: set up the deal as a microscopic company
- Execution: an option-based process to reach late phase II
- Expansion: the cornerstone of a long term strategic alliance
- Termination/exit: a decision based on risk evaluation

Deal structure oriented strategies
- Dipole-based formations, roles and early stage deal structures

Emerging sector alliances
- Key roles and deal characteristics
- Winning and failing strategies
- Joint ventures: Key roles and deal characteristics

FI/E alliances: the FI licensee's participation is over 60%
- Key players' roles and deal characteristics
- Roche-Kosan: a deal with win-win characteristics and challenges

FI/E alliances: 50/50 joint ventures
- Equity purchase can significantly boost the dipole's course to success
- AstraZeneca-CAT: a new win-win joint venture

LATE-STAGE LICENSING STRATEGIES

The structure of our strategic analysis
The late-stage licensing environment-drivers and resistors
- The creation of blockusters-painful but critical to maintain growth
- Blockbuster patent expiries – the generics are coming
- Late-stage deals-working to address the blockbuster crisis
- Key dipolic formations
- Main strategic paths

The successful deal – IDEC-Genentech create a blockbuster
- Best practices asscoiated with a successful deal
- Attraction-an antibody expert and a bio-oncology player
- First step: boost the deal's horizontal and vertical capabilities
- Second step: set up favorable 'opportunism' tolerance limits
- Third step:set distinctive roles to bring out the best of both partners
- Fourth step: target the most lucrative market first and expand later

Failing strategies: Genta-Aventis – the 'U-turn' deal
- The dipole's U-turn and its dramatic effects
- Attraction-near-term opportunities and thirst for full integration
- Deal formation-great expectations
- Failure and termination-what went wrong and useful lessons

APPENDIX

FIGURES

Figure 1: Portfolio management should integrate and orchestrate wisely all types of deals
and programs and ensure a profitable transformation of innovation to market capitalization
Figure 2: The direction of a company's ILP and OLP deals during the primary asset transformation
process
Figure 3: Early-stage licensing partners should work to advance their partnership's driving elements
while attempt to lower the impact of resisting factors
Figure 4: Mapping the company's assets
Figure 5: The industry's two fundamental asset transformation processes
Figure 6: Alliance portfolio management, corporate strategy and shareholder expectation
Figure 7: The direction of a pharma company's vertical alliance portfolio according to innovation
and business development values (return/risk)
Figure 8: Map and evaluate your global alliance portfolio as a continuously evolving complex and
highly interactive living body.
Figure 9: Strategic analysis of early-stage licensing
Figure 10: The crisis in pharma R&D productivity reflected in NCE approval trends over the past two
decades
Figure 11: Licensing is one of the key strategies that can be used to prevent industrial growth
suppression
Figure 12: The creation of the early-stage drug licensing value chain
Figure 13: Key driving and resisting forces for the licensee and the licensor within the early-stage
vertical licensing deal environment
Figure 14: Early-stage product licensing driving and resisting forces and the licensor/licensee dipole
Figure 15: The multi-dimensional environment and the positions of the key licensing game
participants before and after the onset of the deals
Figure 16: A typical licensee-licensor dipole position before and after the deal (t1, t2)
Figure 17: The equilibrium state for each dipole is determined by the partners' flexibility to move
within the 'opportunism' tolerance limit
Figure 18: The early-stage licensing deal lifecycle Figure 19: Formation and positioning of the early
licensing dipoles according to innovation and business development risk and return
Figure 20: Strategic formation, positioning and evolution of the dipole where the emerging
licensee's R/R participation is higher than 60%
Figure 21: Equilibrium state between two emerging players with equal participation in terms of risk
and return
Figure 22: The structure of our strategic analysis of late-stage licensing
Figure 23: Number of blockbuster patent expiries by company blockbuster portfolio
Figure 24: Positioning of the licensee-licensor dipole within the late-stage environment in terms of
innovation and business development risk and return
            Figure 25: Key dipoles within the late-stage product licensing environment
            Figure 26: The main strategic paths that the dipoles follow within the late-stage business
            development environment
            Figure 27: Equilibrium state between a fully integrated licensee and an emerging licensor, with the
            former participating with more than 60% in terms of risk and return
            Figure 28: Development of Genentech's therapeutic strategy, 2003-2010
            Figure 29: Presentation of the failing 'U-turn' deal and its path within the late-stage vertical
            licensing environment
            Figure 30: Sanofi-Aventis's therapeutic strategy, 2003-2010



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Description: Optimizing Licensing Strategies for the 21st Century Creating Win