PreSeed Biotech Forum

1
Pre-Seed Biotech Forum

• Medicine in Need
• Treating Tuberculosis in the Developing World
• May 3rd, 2002
• Harvard University

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Tuberculosis The Problem
Source World Health Organization http//www.who.i
nt/inf-fs/fact104.html
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Highest TB Incidence in Africa and Asia
Source WHO 2001 Report on Tuberculosis
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Current Treatment DOTS

• DOTS Directly Observed Therapy Short-course

• Only 7 treated effectively under DOTS

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MENDs Technology

• The LPNP technology
• Hybrid of two powerful technologies
• Large Porous Particles (proven)
• Nanoparticles (new)

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Available Anti-TB Drugs

• First line
• Isoniazid
• Rifampicin
• Pyrazinamide
• Ethambutol
• Streptomycin

• Second line
• Aminoglycosides
• Thiomides
• Fluoroquinolones
• Cycloserine
• Para-aminosalicylic acid (PAS)

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LPNP Dissolution

• Mechanism of LPNP dissolution 3 stages
• Cooperates with lines of defense in lung cilia
  and macrophages

Type I and II Cells
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Strategic Release of Drugs

• Rifampicin in matrix (quick release)
• PAS in NP (slow release)

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Therapeutic Advantages

• MENDs proposed technological advantages
• Time-release (long action)
• Higher bioavailability (direct to lungs)
• Consequently
• Fewer doses
• Shorter regimen
• Less oversight
• Avoids need for potable water

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Case Study Uganda

• Current DOTS regimen
• 32 drug expenses
• 398-509 DOTS implementation (2/visit, daily
  visits)
• 430-541 total (6-8 month regimen)
• MENDs regimen
• 25-35 (1/inhaler) x (1 inhaler/week) x
  (25-35 weeks)
• 50-70 (25-35 weeks) x (1 visit/week) x
  (2/visit)
• 75-105 Total
• Difference gt 325

Over 60 cost reduction
Source World Health Organization Treatment Of
Tuberculosis Guidelines For National
Programmes http//www.who.int/gtb/publications/tt
gnp/PDF/tb97_220.pdf
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MENDs Technology Space
Companies Pursuing Inhalation Delivery
Companies Utilizing Nanoparticle Technology
Companies Addressing Tuberculosis
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Year 1 Technology Development

• Initial fixed expenses to develop technology
  seeking 500K in grant/foundation funding

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MEND Business Model
MEND (Public Benefit Corporation)
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Interest in MEND

• A spray that could deliver four first-line
  drugswould revolutionize TB care.
• Dr. Jim Yong Kim, developer of DOTS-plus
• Safety, cost and ease of administration would be
  the primary features of an ideal Tuberculosis
  drug.
• Dr. Gail Cassell, Eli Lilly, VP of Infectious
  Diseases
• Interest expressed by Maria Freire, Jeffrey
  Sachs, Kofi Annan

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Acknowledgements

• David Edwards
• Howard Stone
• Paul Bottino
• Heather Gunter
• Willow Diluzio
• Andre Valente
• David Weitz
• Nicolas Tsapis
• Dave Bennett

• Tom Esselman
• Pierre Dreux
• Tony Hickey
• Jim Yong Kim
• Gail Cassell
• Jeffrey Sachs
• Cliff Barry
• Barry Bloom
• Bertrand Bodson

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Meet the Team
Nicolas Tsapis, David Bennett

• David Darst
• Denise Kim
• Nnamdi Okike
• Leif-Ann Reilly
• Dan Yamins

• Daniel Ang
• PJ Demarco
• Doug Wise
• Ian Wong
• Michelle Yu