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

        Discovery of therapeutics products that will treat, cure or
         prevent a...
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    MedImmune

        1988-89: Founded in by Wayne T. Hockmeyer as Molecular
         Vaccines Inc.
             Tech...
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    Medimmune

        1993: Acquired rights for distribution of CytoGam
         (Cytomegalovirus Immune Globulin Intr...
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    Medimmune

        1997: Medimmune forms with GlaxoSmithKline (formerly
         SmithKline Beecham) a worldwide hu...
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    Medimmune

        2003: FDA approves FluMist® (Influenza Virus Vaccine Live,
         Intranasal), the first influ...
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    MedImmune: Strengths & Weaknesses

        Weaknesses:
             Unproven CEO (????)
             First four p...
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    Panacea

        Founded in 1999 by a father and a son.
             Hossein A. Ghanbari, PhD
              Chairm...
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    Panacea

        2003:Signs License Agreement with Massachusetts General
         Hospital/Harvard University for S...
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    Panacea

        2009:
             COO & President resigns
             Company is cash deficient
             ...
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    Panacea: Strengths & Weaknesses

        Weaknesses:
             Inefficient Management Team: Founder was too inv...
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    Main Challenges For This Model

        Securing IP
             Important to have IP patented and “legally” licen...
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    Summing-up

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

        40-60% of your pipeline will fail i.e. ...
+
    Any questions???
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The Business Of Science

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An analysis of two companies with different business models

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The Business Of Science

  1. 1. + Human Therapeutic Product Discovery and Development Company Montserrat Capdevila
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 14. + Any questions???

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