Jack Geltosky, Ph'D' Vice President External Science, Technology

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Jack Geltosky, Ph.D.Vice PresidentExternal
Science, Technology LicensingBristol-Myers
Squibb November 6, 2006
How to Pick the Ideal Big Pharma Partner
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Actually you have only one choice..
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Bristol-Myers Squibb !!!
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Questions?
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Key Attributes in Picking the Ideal Partner

• Level One
• History of successful alliances
• Stays the course in tough times (e.g.
  BMS-Imclone)
• Demonstrated ability to develop/commercialize in
  the therapeutic area
• Global capabilities
• Does your product fit their strategic focus?
• Potential product synergies
• No competitive development candidate of their own

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Erbitux Staying the course

• Challenges
• FDA Refusal to File Letter (RTF)
• External pressure to pull out (Media/Analyst)
• Tri-party interactions (BMS, Merck KGaA ImClone)

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Erbitux Focus Commitment

• Belief in the drug clear commitment from senior
  management
• Tri-company cross cultural collaboration
• Close interactions/collaboration with FDA on
  registration path forward

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Erbitux Accomplishments

• First cancer therapy to selectively target the
  Epidermal Growth Factor Receptor (EGFR)
• Approved in refractory metastatic colorectal
  cancer (Feb 2004)
• Used alone or combined with chemotherapy
• On-going studies across multiple tumor types
• HN Approved

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Erbitux Lifecycle Management Plan
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Signs to Look for Once the Process Begins

• Level Two
• A transparent expeditious review process
• Responsive to requests
• Commitment from top management
• Flexible
• Open minded, not dogmatic
• An established Alliance Management group
• Nice people good chemistry amongst the teams
• Ask your friends..

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Further into the Process

• Level Three
• Do they share your vision for the product?
• Capabilities presentations, etc.
• Do they problem solve vs. interrogate/prosecute
  during the due diligence process?
• Flexible on deal terms
• Remember, the best deal may not be the richest
  deal

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Advice in Attracting the Ideal Partner

• Be transparent forthcoming - science trumps all
  else
• Need not preach to us about market-size, etc.
• Please, please one point of entry into the
  company
• And do not be afraid to ask questions about us,
  our processes, etc.

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From Big Pharma Perspective

• First send us a non-confidential background
  document that summarizes
• Lead indication for the drug
• Stage of development
• Studies establishing proof of concept (at least
  in animals)
• Studies establishing likely therapeutic window
  (safety margin)
• Sense of drugs developability (PK/PD,
  solubility, etc.)
• Patent status
• Competitive position
• Type of license being sought

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Advice to Biotech

• Decisions are data driven
• Therefore, transparency and forthrightness are
  critical
• And expect us to be equally so, regarding our
  approval process, etc.
• Please make yourselves available for follow-up
  questions, etc.

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BMS Criteria for Candidate In-Licensing

• Strategic Fit
• Unmet Medical / Scientific /Technical Need
• Scientifically Sound
• Feasibility of Development / Utilization
• Commercial / Business Value

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What We Look for in Compounds

• All stages of development
• Biologicals are ok
• For pre-clinical compounds
• Within 12 months of First in Man
• Proof of concept in validated animal models
• Evidence of potential wide therapeutic window
• ADME work-up
• P450, herg, etc. Benign
• Oral bioavailability
• Drugable pharmaceutical properties
• Back-up program !!!

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What We Look for in Compounds (contd)

• For Clinical Stage Compounds
• Good safety tolerability
• PK/PD supporting 1x/day dosing
• Efficacy

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What We Look for in Companies

• Solid group of experienced scientists
• Been there, done that
• Track record of problem solving
• Solid executive team, including investors
• Signs of stability
• Good financial position
• Track record of other alliances
• Ideal company has a proprietary and useful
  platform with multiple candidates arising from
  it.

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What We Have to Offer

• Obvious clinical, regulatory and
  commercialization skills
• Not so obvious is experience and skill to pick
  optimal development candidates and well thought
  out back-up programs
• Just not the assays, etc, but deep experience in
  this area often unappreciated
• First compound never makes it
• Takes significant resources to back up lead

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Major Pharmaceutical Companies US NME Approvals
January 2002 June 2006
2005 Pharma RD Spend (B)
7.1
5.0
2.5
2.9
4.0
3.7
5.5
4.0
3.3
2.6
4.4
Note Includes compounds designated as
classification 1 (NDA chemical type new
molecular entity) by the FDA. Biologics and
vaccines are included. Includes compounds
Genentech filed in the US (i.e., Avastin,
Tarceva) for which Roche had significant
development participation. Approval for Boniva
credited to both Roche and GSK based on
co-development agreement. Source PhRMA, FDA,
Company Reports
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Partnered Products (Peak Sales) BMS partnering
revenues exceed 50 of 2005 annual sales
Infectious Diseases/ Virology
Neuroscience
Cardiovascular
Metabolism
Oncology
1.4 B
2.8 B
1.6 B
578 M
2 B(Metformin Family)
320 M
5.6B
905 M
267 M
2.0B
413 M
696 M
Total molecule sales IMS 3Q2005 MAT