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New Strategies  for Successful Licensing Acquisitions Peter McFarland, PharmD Postdoctoral Fellow, Clinical Development Forest Labs, Inc. / St. John’s University
Session Panel  ,[object Object],[object Object],[object Object]
What do each of these products have in common? ,[object Object],[object Object],[object Object],[object Object],[object Object]
They’ve all been licensed! ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Licensing Overview  ,[object Object],[object Object],[object Object]
Session Objectives  ,[object Object],[object Object],[object Object],Identifying  Opportunities Scientific Assessment Deal Finalization
Identifying Licensing Opportunities  Aaron Pelta, MBA Senior Manager, Corporate Development Cubist Pharmaceuticals
Identifying License Opportunities ,[object Object],[object Object]
What Are You Looking For? ,[object Object],[object Object],[object Object]
Strategy to Tactics ,[object Object],of acute care drugs development and commercialization for the treatment of unmet medical needs Stage of Development Treatment Setting Indication hospital based programs through products not “me too”
Quantify Opportunity Targets ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],More Detail
Examples ,[object Object],[object Object],1. http://www.gene.com/gene/about/corporate/, accessed May 8, 2008 2. http://www.salix.com/about/index.aspx, accessed May 8, 2008
Environment ,[object Object],[object Object],[object Object],[object Object],1. Thomson Pharma® database accessed May 6, 2008
How Do You Find It? ,[object Object],Sniff Test Preliminary Evaluation Full Diligence Deal Close
Where Do You Find It? Quality Your Network Banks Finders Management Venture Capital Conferences Publications Databases Academia Unsolicited
Challenges ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
One Winning Approach Most Attractive (Most Likely) No Value No Value Accurate Inaccurate Consensus Non-Consensus No Value
Identifying Opportunities Scientific Assessment Identifying  Opportunities Scientific Assessment Deal Finalization
Strategies for Conducting New Product Scientific Assessment (Due Diligence) Yavuz S. Silay, MD,CCRP Associate Director of Clinical Science, Clinical and Medical Affairs KV Pharmaceutical, Ther-Rx and Ethex Corporations
Pharmaceutical Licensing Trends and the Role of Science ,[object Object],[object Object]
Overview of the Licensing Process Out-licensing   In-licensing   Source: MedTRACK, Sept ’07. Datamonitor   Identification of the company’s limitations, and what is required to overcome these Identification of what products can be licensed and to who Performing  evaluations  Identification of gaps in the portfolio; Assessment of what it can offer as a partner? Evaluation of needs and identification of potential candidates Signing confidentiality agreements, drawing-up term sheets,  due diligence  Licensing Strategy  Identifying Opportunity  Licensing Evaluations  Finalizing the Deal and  Alliance Management
What therapeutic areas are more popular? Recent trends? CNS  15% Other  12% Infections  15% Cardiovascular  12% AIID  10% Cancer  7% Women’s Health  7% Digestive System  5% Multiple  4% Respiratory  5% Blood  4% Metabolic/Endocrinology  4% Marketing and Promotion Deals by therapy area, 2005-06 Source: MedTRACK, Sept ’07, Datamonitor
Due Diligence for Evaluating  In-Licensing Opportunities ,[object Object],[object Object],[object Object]
Due Diligence ,[object Object],[object Object],[object Object],[object Object]
Team Effort and Timing  are Crucial ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Avoiding Pitfalls ,[object Object],[object Object],[object Object]
Current and New Sources of Scientifically Valid Deals ,[object Object]
A BALANCED APPROACH: NEITHER SCIENCE NOR BUSINESS CAN BE SACRIFICED FOR THE OTHER OR THE RESULTS WILL BE DISSAPOINTING ,[object Object],[object Object]
ASK THE APPARENT QUESTION PROACTIVELY: ARE THERE ANY EXPERTS TO REVIEW THE DATA AND ARE THERE ENOUGH DATA TO BE REVIEWED BY THE EXPERTS? ,[object Object],[object Object]
Attitude and Knowledge Matters ,[object Object],[object Object]
Why do licensing deals fail? ,[object Object],[object Object],[object Object]
Factors leading to partnership breakdown during licensing deals
Key Elements
Key Factors
The Tools of Science and Current Data Channels ,[object Object],[object Object],[object Object],[object Object]
The Tools of Science and Current Data Channels ,[object Object],[object Object],[object Object],[object Object]
Scientific Assessment Deal Finalization Identifying  Opportunities Scientific Assessment Deal Finalization
Alliance Management & Finalizing the Deal Raj Riswadkar Sr. Director Business Enterprise Development K V Pharmaceutical
Why Alliances ? ,[object Object],[object Object],[object Object],[object Object],[object Object]
Alliance Management – 80% Art ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Typical Alliance Menu HIGH Deals more likely to close HIGH “ Alliance Complexity/Cost Matrix” (Easy to Exotic)** LOW Costs to Close (Licensee) LOW Contract manufacturing to reduce costs ,[object Object],[object Object],[object Object],Eg - Difficult to make Generics (control release, steriles, injectables) Geographical, scale, scope expansion – Adding partner for selling Product X ,[object Object],[object Object],[object Object],[object Object],- In-license of unique product or technology - Joint contribution of unique product or technology Degree Of Complexity ** -  not MECE
Alliance Success ,[object Object],[object Object],[object Object],[object Object],[object Object]
Alliance – Geographical, Scale, Scope Expansion ,[object Object],[object Object],[object Object],[object Object],[object Object],Alliance  Pros and Cons ,[object Object],Implications For right fit partners, closure risks are typically low.  Closure risks increase with competition for the product Typical Risk to Closure - Santarus co-promotion of Zegerid (PPI) with TAP - Vernalis UK’s out-license of Frovatriptan for Migraine in the US to Endo Pharmaceuticals Examples Expanding product penetration geographically, adding customers or for expanded indications Type of Alliance
Alliance – Reducing Costs ,[object Object],[object Object],[object Object],[object Object],[object Object],Alliance  Pros and Cons ,[object Object],[object Object],Implications Deal structure simpler hence closing is not difficult. Agreeing to commercial terms takes the most time Typical Risk to Closure ,[object Object],[object Object],Examples Low cost manufacturing of already launched products Type of Alliance
Alliance – Development & Supply of Product ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Alliance  Pros and Cons ,[object Object],[object Object],Implications Challenges in verifying the R&D capabilities and ‘cGMPness’ of the partner and then agreeing to commercial terms  Typical Risk to Closure In-licensing/supply of generic pharmaceuticals from Asian companies by generic companies like Teva, Akorn and Mylan  Examples Research & Development and supply of products with or without a technology exchange Type of Alliance
Alliance – In-licensing Unique Products/technologies ,[object Object],[object Object],[object Object],[object Object],[object Object],Alliance  Pros and Cons ,[object Object],[object Object],Implications Deal complexity and multiple buyers pose closing challenge High level of due diligence and risk aversion Typical Risk to Closure ,[object Object],[object Object],Examples In-licensing of a unique product and/or technology, or Both sides contribute assets - Joint venture (JV) Type of Alliance
Alliance Management – 80% Art ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Finalizing the deal – How? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Tactics for Finalizing the deal ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Finalizing the Deal: Differentiate Yourself  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Identifying  Opportunities Scientific Assessment Deal Finalization Successful License Acquisition
Question? Answer!
Key References  ,[object Object]

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Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - DIA Presentation 2008

  • 1. New Strategies for Successful Licensing Acquisitions Peter McFarland, PharmD Postdoctoral Fellow, Clinical Development Forest Labs, Inc. / St. John’s University
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7. Identifying Licensing Opportunities Aaron Pelta, MBA Senior Manager, Corporate Development Cubist Pharmaceuticals
  • 8.
  • 9.
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.
  • 15. Where Do You Find It? Quality Your Network Banks Finders Management Venture Capital Conferences Publications Databases Academia Unsolicited
  • 16.
  • 17. One Winning Approach Most Attractive (Most Likely) No Value No Value Accurate Inaccurate Consensus Non-Consensus No Value
  • 18. Identifying Opportunities Scientific Assessment Identifying Opportunities Scientific Assessment Deal Finalization
  • 19. Strategies for Conducting New Product Scientific Assessment (Due Diligence) Yavuz S. Silay, MD,CCRP Associate Director of Clinical Science, Clinical and Medical Affairs KV Pharmaceutical, Ther-Rx and Ethex Corporations
  • 20.
  • 21. Overview of the Licensing Process Out-licensing In-licensing Source: MedTRACK, Sept ’07. Datamonitor Identification of the company’s limitations, and what is required to overcome these Identification of what products can be licensed and to who Performing evaluations Identification of gaps in the portfolio; Assessment of what it can offer as a partner? Evaluation of needs and identification of potential candidates Signing confidentiality agreements, drawing-up term sheets, due diligence Licensing Strategy Identifying Opportunity Licensing Evaluations Finalizing the Deal and Alliance Management
  • 22. What therapeutic areas are more popular? Recent trends? CNS 15% Other 12% Infections 15% Cardiovascular 12% AIID 10% Cancer 7% Women’s Health 7% Digestive System 5% Multiple 4% Respiratory 5% Blood 4% Metabolic/Endocrinology 4% Marketing and Promotion Deals by therapy area, 2005-06 Source: MedTRACK, Sept ’07, Datamonitor
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31.
  • 32. Factors leading to partnership breakdown during licensing deals
  • 35.
  • 36.
  • 37. Scientific Assessment Deal Finalization Identifying Opportunities Scientific Assessment Deal Finalization
  • 38. Alliance Management & Finalizing the Deal Raj Riswadkar Sr. Director Business Enterprise Development K V Pharmaceutical
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  • 51. Identifying Opportunities Scientific Assessment Deal Finalization Successful License Acquisition
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Hinweis der Redaktion

  1. I’d like to welcome everyone the session. This session is entitled “New Strategies for Successful Licensing Acquisitions.” Please take a moment to silence an electronic devices you may be carrying and to get yourselves situated. Also, if you’ve just realized that you’ve ventured into the wrong room, please use this time to exit the room if need be….(2mintues). Excellent! Well it looks like most everyone who is attending the session has had a chance to settle in, so I’d like to get started. Again, I would like to welcome everyone and thank you for attending the session today. . . I’m glade you all could make it. My name is Peter McFarland. I am a PharmD Fellow at Forest Labs, Inc. and St. John’s University. I’ve been with a fellow in Clinical Development with Forest for about one year now, and one of the most intriguing aspects that I’ve noticed about the company is that they license all of their products from other companies. Now being able to see and experience this type of R&D first hand has been a great introduction into the aspects of product in-licensing, but what it has really done is sparked my interest into finding out more about the strategies that go into product licensing…. and how do we get the right products at the right time, that fit our corporate strategy? (NEXT SLIDE)