Human Therapeutic Product
Discovery and Development
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
Initial IP is usually spin-out from academic or federal
research. ( or other small biotech companies)
Or self developed ( rights of to the technology are given back to
1988-89: Founded in by Wayne T. Hockmeyer as Molecular
Technology spin-out from Walter Reed Army Institute of Research (?).
Main technology: Production of antibodies using DNA recombinant
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)
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.
1997: Medimmune forms with GlaxoSmithKline (formerly
SmithKline Beecham) a worldwide human papillomavirus
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
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
Unproven CEO (????)
First four products failed
Good management team: David Mott
Founder did not wear so many hats
Clear technology focus
Very good at raising capital
Excellent project management
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
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
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
Inefficient Management Team: Founder was too involved, too
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
Rapid initial growth
Good at forging collaborations
Main Challenges For This Model
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.
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.