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    Human Therapeutic Product
    Discovery and Development
    Company
    Montserrat Capdevila
+
    What is the Business Model?

        Discovery of therapeutics products that will treat, cure or
         prevent a particular disease or illness.

        Focus on scientific discovery and innovation to advance the
         practice of medicine.

        Same premise as pharma but using bio-molecular
         techniques.

        Initial IP is usually spin-out from academic or federal
         research. ( or other small biotech companies)
             Licensed
             Or self developed ( rights of to the technology are given back to
              lead scientist)
+
    MedImmune

        1988-89: Founded in by Wayne T. Hockmeyer as Molecular
         Vaccines Inc.
             Technology spin-out from Walter Reed Army Institute of Research (?).
             Main technology: Production of antibodies using DNA recombinant
              technologies.

        1990: Name changed to MedImmune.

        1991: MedImmune completes its initial public offering:
             2,875,000 shares of common stock at $9.25 per resulting in net
              proceeds of $23,987,000 in proceeds to the company.

        1992: David Mott joins Medimmune as VP of Business
         Development. ( Main success point)
+
    Medimmune

        1993: Acquired rights for distribution of CytoGam
         (Cytomegalovirus Immune Globulin Intravenous (human))
         from Connaught Laboratories and becomes the sole
         distributor of the product.

        1995: RespiGam (respiratory syncytial virus immune globulin
         intravenous (Human) (RSV-IGIV). A sterile liquid
         immunoglobulin G containing neutralizing antibody to
         Respiratory Syncytial Virus (RSV). Approved by FDA in 1995.

        1995: MedImmune acquires exclusive worldwide rights to
         human papillomavirus technology developed at the
         University of Rochester.
+
    Medimmune

        1997: Medimmune forms with GlaxoSmithKline (formerly
         SmithKline Beecham) a worldwide human papillomavirus
         vaccine alliance.

        1998: Receive FDA approval for Synagis
             A monoclonal antibody produced by recombinant DNA
              technology used in the prevention of Respiratory Syncytial Virus
              ( RSV) infections.
             Medimmune has three products in the market.

        2000: David Mott becomes CEO
+
    Medimmune

        2003: FDA approves FluMist® (Influenza Virus Vaccine Live,
         Intranasal), the first influenza vaccine delivered as a nasal
         mist available in the United States for healthy people.

        2004: MedImmune has 4 products on the market
             Synagis is their biggest seller ( $1.06 billion in revenue in 2005)

        2007: AstraZeneca acquires MedImmune drug development
         pipeline for $15.2 billion.

        2008: David Mott leaves MedImmune and Becomes a General
         Partner in NEA.
+
    MedImmune: Strengths & Weaknesses

        Weaknesses:
             Unproven CEO (????)
             First four products failed


        Strengths:
             Good management team: David Mott
             Founder did not wear so many hats
             Clear technology focus
             Very good at raising capital
             Excellent project management
+
    Panacea

        Founded in 1999 by a father and a son.
             Hossein A. Ghanbari, PhD
              Chairman, CEO & Chief Scientific Officer

        Diagnostics and Therapeutics

        Focused on targeting Cancer and CNS disorders.

        2000: Series A financing

        2002: Named Maryland Incubator Company of the Year

        2002: Series B financing $3 Million

        2002: Panacea Pharmaceuticals, Inc. and MedImmune Sign Collaboration and License
         Agreement to Discover, Develop, and Commercialize Cancer Therapeutics.
             Exclusive, worldwide agreement covers development of drugs using Panacea's HAAH
              Oncology Technology
+
    Panacea

        2003:Signs License Agreement with Massachusetts General
         Hospital/Harvard University for SF-25 Oncology Program

        2004:Collaboration with Walter Reed Army Institute of
         Research for Pre-Clinical Studies on Drug Candidates for
         Stroke and Other Neurodegenerative Conditions.

        2005: Raises $7 Million in Series C Round of Financing

        2006: New President & Chief Operating Officer ( Stephen
         Keith MD). Raises $8.9 Million in Series D Round of Financing.

        2008: Panacea Pharmaceuticals Announces Issuance of a U.S.
         Patent Covering Anti-HAAH Antibodies
+
    Panacea

        2009:
             COO & President resigns
             Company is cash deficient
             Sued for unpaid wages by former employees
             In 10 years they have 3 products: All in pre-clinical!
             Survival seems bleak
             Ghanbari is in denial
+
    Panacea: Strengths & Weaknesses

        Weaknesses:
             Inefficient Management Team: Founder was too involved, too
              many hats
             Technology focus was to broad
             Too many collaborations, no results
             Not good at raising capital
             All in-house technologies in pre-clinical for 10 yrs…questionable
              project management.

        Strengths:
             Rapid initial growth
             Good at forging collaborations
+
    Main Challenges For This Model

        Securing IP
             Important to have IP patented and “legally” licensed .
             Monitoring to avoid infringements

        Identifying your niche in the market
             Choosing the right market and avoiding being too broad

        Securing your capital
             Capital requirements are high:
                Seed: 1-5 million
                Venture Capitals will demand high amount of equity to offset high risk.


        Turning your company from science to a business.
             Key Success Factor: Let a scientists do the science and a CEO do the business.
+
    Summing-up

        Average Cost of a therapeutic: $800-1 billion

        40-60% of your pipeline will fail i.e. FDA approval

        Very long regulatory process 9-12 yrs…and counting…

        Why Invest in bio-therapeutics?
             Pharma’s patents are running out. New Business Opportunities.
             Average yearly revenue from a blockbuster therapeutic:
              $700million - $12 billion per year
             David Mott made $150 million from Medimmune-AstraZeneca
              acquisition….if you are smart, you cash out.
+
    Any questions???

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The Business Of Science

  • 1. + Human Therapeutic Product Discovery and Development Company Montserrat Capdevila
  • 2. + What is the Business Model?   Discovery of therapeutics products that will treat, cure or prevent a particular disease or illness.   Focus on scientific discovery and innovation to advance the practice of medicine.   Same premise as pharma but using bio-molecular techniques.   Initial IP is usually spin-out from academic or federal research. ( or other small biotech companies)   Licensed   Or self developed ( rights of to the technology are given back to lead scientist)
  • 3. + MedImmune   1988-89: Founded in by Wayne T. Hockmeyer as Molecular Vaccines Inc.   Technology spin-out from Walter Reed Army Institute of Research (?).   Main technology: Production of antibodies using DNA recombinant technologies.   1990: Name changed to MedImmune.   1991: MedImmune completes its initial public offering:   2,875,000 shares of common stock at $9.25 per resulting in net proceeds of $23,987,000 in proceeds to the company.   1992: David Mott joins Medimmune as VP of Business Development. ( Main success point)
  • 4. + Medimmune   1993: Acquired rights for distribution of CytoGam (Cytomegalovirus Immune Globulin Intravenous (human)) from Connaught Laboratories and becomes the sole distributor of the product.   1995: RespiGam (respiratory syncytial virus immune globulin intravenous (Human) (RSV-IGIV). A sterile liquid immunoglobulin G containing neutralizing antibody to Respiratory Syncytial Virus (RSV). Approved by FDA in 1995.   1995: MedImmune acquires exclusive worldwide rights to human papillomavirus technology developed at the University of Rochester.
  • 5. + Medimmune   1997: Medimmune forms with GlaxoSmithKline (formerly SmithKline Beecham) a worldwide human papillomavirus vaccine alliance.   1998: Receive FDA approval for Synagis   A monoclonal antibody produced by recombinant DNA technology used in the prevention of Respiratory Syncytial Virus ( RSV) infections.   Medimmune has three products in the market.   2000: David Mott becomes CEO
  • 6. + Medimmune   2003: FDA approves FluMist® (Influenza Virus Vaccine Live, Intranasal), the first influenza vaccine delivered as a nasal mist available in the United States for healthy people.   2004: MedImmune has 4 products on the market   Synagis is their biggest seller ( $1.06 billion in revenue in 2005)   2007: AstraZeneca acquires MedImmune drug development pipeline for $15.2 billion.   2008: David Mott leaves MedImmune and Becomes a General Partner in NEA.
  • 7. + MedImmune: Strengths & Weaknesses   Weaknesses:   Unproven CEO (????)   First four products failed   Strengths:   Good management team: David Mott   Founder did not wear so many hats   Clear technology focus   Very good at raising capital   Excellent project management
  • 8. + Panacea   Founded in 1999 by a father and a son.   Hossein A. Ghanbari, PhD Chairman, CEO & Chief Scientific Officer   Diagnostics and Therapeutics   Focused on targeting Cancer and CNS disorders.   2000: Series A financing   2002: Named Maryland Incubator Company of the Year   2002: Series B financing $3 Million   2002: Panacea Pharmaceuticals, Inc. and MedImmune Sign Collaboration and License Agreement to Discover, Develop, and Commercialize Cancer Therapeutics.   Exclusive, worldwide agreement covers development of drugs using Panacea's HAAH Oncology Technology
  • 9. + Panacea   2003:Signs License Agreement with Massachusetts General Hospital/Harvard University for SF-25 Oncology Program   2004:Collaboration with Walter Reed Army Institute of Research for Pre-Clinical Studies on Drug Candidates for Stroke and Other Neurodegenerative Conditions.   2005: Raises $7 Million in Series C Round of Financing   2006: New President & Chief Operating Officer ( Stephen Keith MD). Raises $8.9 Million in Series D Round of Financing.   2008: Panacea Pharmaceuticals Announces Issuance of a U.S. Patent Covering Anti-HAAH Antibodies
  • 10. + Panacea   2009:   COO & President resigns   Company is cash deficient   Sued for unpaid wages by former employees   In 10 years they have 3 products: All in pre-clinical!   Survival seems bleak   Ghanbari is in denial
  • 11. + Panacea: Strengths & Weaknesses   Weaknesses:   Inefficient Management Team: Founder was too involved, too many hats   Technology focus was to broad   Too many collaborations, no results   Not good at raising capital   All in-house technologies in pre-clinical for 10 yrs…questionable project management.   Strengths:   Rapid initial growth   Good at forging collaborations
  • 12. + Main Challenges For This Model   Securing IP   Important to have IP patented and “legally” licensed .   Monitoring to avoid infringements   Identifying your niche in the market   Choosing the right market and avoiding being too broad   Securing your capital   Capital requirements are high:   Seed: 1-5 million   Venture Capitals will demand high amount of equity to offset high risk.   Turning your company from science to a business.   Key Success Factor: Let a scientists do the science and a CEO do the business.
  • 13. + Summing-up   Average Cost of a therapeutic: $800-1 billion   40-60% of your pipeline will fail i.e. FDA approval   Very long regulatory process 9-12 yrs…and counting…   Why Invest in bio-therapeutics?   Pharma’s patents are running out. New Business Opportunities.   Average yearly revenue from a blockbuster therapeutic: $700million - $12 billion per year   David Mott made $150 million from Medimmune-AstraZeneca acquisition….if you are smart, you cash out.
  • 14. + Any questions???