Advitech: A new concept in milk peptides and natural growth factors

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Advitech A new concept in milk peptides and
natural growth factors  

• Renaud Beauchesne MBAPresident and Chief
  Executive OfficerAdvitech inc.Québec,
  Canadawww.advitech.com

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Agenda

• Corporate Profile
• XP-828L Platform
• Market Opportunity
• Clinical Study
• Business Strategy
• Product Pipeline
• Conclusion

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Corporate Profile

• Founded in 1996 by CEO and 3 researchers from
  Laval University
• Associate Researchers from Laval University
• Dr Sylvie Gauthier, Ph.D.
• Dr Yves Pouliot, Ph.D.
• Expertise in bioactive ingredients derived from
  milk proteins
• Partnerships with 3 large ingredient
  manufacturers
• 14 employees, 8 in RD (2 Ph.D.)

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Board of Directors Scientific Board

• Board of Directors
• CEO Chairman 7 directors, including 2 former
  investment bankers, former COO of National
  Financial Bank, Dr Fernand Labrie and others
• Scientific Board
• Dr Georges M. Halpern, MD, PhD, Distinguished
  Professor of Pharmaceutical Sciences, Hong Kong
  Polytechnic University
• Dr Jean-Paul Marty, PhD, professor of
  dermopharmacology and cosmetology at the
  University of Paris-Sud, School of Pharmacy
• Dr Patrice E. Poubelle, MD DSc, professor at the
  Faculty of Medicine, Université Laval. Member of
  the rheumatology and immunology research unit
• Mr Robert Beland, Senior VP Pre-clinical
  Research, MDS Pharma, USA

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Revenue stream Lactium

• Clinically tested protein fraction with
  anxyolitic properties
• Originally developed by Ingredia, World Wide
  Patent
• Marketed as a nutraceutical ingredient for the
  anti-stress market (350 M US end-market,
  Nutrition Business Journal 2002 Study).
• Worldwide Distribution
• Advitech has exclusive rights for North/South
  America
• IngrediA for other markets
• Asia through an agent network
• China Mrs Janet Dong
• Distribution network Retail and Health
  Professionnals under private label

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XP-828L Platform

• Growth Factors
• Whey Proteins
• Immune System Disorders

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Growth Factors

• A specific category of molecules of the immune
  system
• Play key roles in the development of the human
  body
• Promote and regulate cell growth and
  differentiation
• Suppressive effect for certain types of cells
  (e.g. lymphocytes, epidermal and epithelial
  cells)
• Growth Factors are also present in Bovine Milk
• Growth Factors can be extracted and concentrated
  from Milk using specialized processes and
  techniques

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Market Opportunity Immune System Disorders
The Psoriasis Opportunity
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Psoriasis

• A global health problem 23 of the global
  population
• A significant market (number of individuals)
• Canada 1 million
• USA 5 million
• Europe 14 million
• Asia 75 million
• USA Market in US 1B in 2005
• U.S estimated sales forecasts for psoriasis
  treatments in 2005 Source Script Report, March
  2003 Skin Disorders, New Horizons for Psoriasis
  Management)

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Existing treatments Unmet demand
BIOLOGICAL DRUGS
Effective, but high cost (25,0K ), injection
based and uncertain safety profile
ORAL IMMUNOSUP- PRESSIVE DRUGS
Effective oral, but significant toxicity
problem and very poor safety profile
UVB RAYS ACTIVATOR  
Somewhat effective, time-consuming Toxicity
problem (activator) Short-term solution
CORTICOSTEROID CREAMS
Limited effectiveness Inconvenient Long-term
impact on skin Can not be used on large skin
surface
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Market opportunity
Mild to moderate psoriasis 83 of total market
Target Market represents 4 Million mild to
moderate patients in the USA alone
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What patients are asking for ?
BIOLOGICAL DRUGS
BIOLOGICAL DRUGS
ORAL IMMUNOSUP- PRESSIVE DRUGS
EFFECTIVE ORAL SAFE
UVB RAYS ACTIVATOR  
UNMET DEMAND FOR AN ORAL, SAFE, 1ST LINE
TREATMENT FOR MILD-TO-MODERATE PSORIASIS
CORTICOSTEROID CREAMS
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Safety What the patient says ?

• 78 of patients with moderate-to-severe psoriasis
  do not use more aggressive therapies because of
  side effects
• In psoriasis, our competitor is no treatment
• Robert Hamilton, Biogen-Idec Canada

Source US National Psoriasis Foundation
Inquiry in 2001-2002 on behalf of 1,932 people
suffering from psoriasis
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XP-828L Platform and Growth Factors

• Growth Factors such as TGFs have a modulating
  effect on Th1 pro-inflammatory cytokines
• TGFs are naturally presents in Whey proteins

Whey Proteins Isolate (WPI)
XP-828L Process
PATENTED (PENDING) FRACTIONATION AND PURIFICATION
PROCESS
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XP-828LGrowth Factors Composition
PATENTED (PENDING) COMPOSITION AND APPLICATIONS
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• IGF, TGF-ß1, TGF-ß2

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XP-828L and the Immune System
T-cell Proliferation and Differentiation
XP-828L
Hyperproliferation
Pro-inflammatory Th1 cytokines
Cell inflammation
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XP-828L inhibits Lymphocytes proliferation in
vitro
?20 plt0.01

Figure 1 Proliferation of ConA-stimulated
splenocytes in the presence of RPMI medium, BSA
(control), and XP-828L (1000 µg/mL). Values are
means standard deviations of five mice.
Plt0.01. Immunology 12th International
Congress of Immunology and 4th Annual conference
of FOCIS. Montreal, Canada, July 18-23. 2004
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XP-828L inhibits Cytokines expression in vitro
Figure 2 IL-2, IFN-g, IL-4 and IL-10 production
in ConA-stimulated splenocytes in the presence of
the RPMI medium, BSA (control), and XP-828L (1000
µg/mL). Values are the means standard deviation
of five mice. Plt0.05. Immunology 12th
International Congress of Immunology and 4th
Annual conference of FOCIS. Montreal, Canada,
July 18-23. 2004
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What Patients are Looking for ?

• An Effective Treatment
• Convenient (Oral)
• Safe

Recently approved products (Amevive, Enbrel,
Remicade) are injection-based, cost ten of
thousands per year and require continuous
medical supervision
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XP-828L Clinical Studies
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Open Clinical Study

• March June, 2004
• Lead Investigator Dr. Yves Poulin, Participated
  in more than 65 clinical studies
• Patients 11 patients light-to-moderate
  psoriasis
• Duration 56 days. Extension study (up to 112
  days) for 7 patients.
• End-Point PASI score (Psoriasis Area and
  Severity Index)
• Wash out 2 weeks, topical treatment, 4 weeks
  systemic treatments

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Open Study Results

• After 56 days (initial phase 11 patients)
• 7 patients out of 11 achieved a reduction in PASI
  scores ranging from 9.5 to 81.3
• After 112 days (extension phase 7 patients)
• 5 patients out of 7 showed a reduction in PASI
  scores ranging from 6.7 to 78.4
• 2 patients achieved PASI-75, reduction of 75 of
  PASI score, a key benchmark in the treatment of
  psoriasis
• Safety controls No adverse reactions
• Comments from Patients they like the product
  (taste)

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Probing Examples
Patient 9 Reduction of PASI score from 17.4 to
7.4 (57.5) in 56 days Source Dr
Yves Poulin
Day 56
Day 28
Day 1
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Probing Examples
Patient 4 Reduction of PASI score from 10.8 to
2.4 (77.7) in 84 days Source Dr
Yves Poulin
Day 1
Day 56
Day 84
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On-Going Clinical Study

• Placebo-controlled, double-blind, Multicentre
• 84 patients, 112 days. Single dose, double-dose,
  placebo groups
• Lead Investigators Dr Yves Poulin, Dr Robert
  Bissonnette
• Authorization from Health Canada
• Enrolment to be completed before end of 2004
• Final Results during Q2-2005

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Business Strategy

• Target Market
• Mild to moderate psorasis patients (92 of total
  market)
• Product Positioning
• Effective, convenient (oral) and safe product
• Regulations
• Positioned as a  Medical Food or Dietary
  supplement  under FDA regulations
• Distribution
• Strategic partnerships. Companies in dermatology

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Product Pipeline

• XP-828L Platform
• Other immune system disorders such as Crohns
  disease and
• Irritable Bowel Disease (IBD)
• To be investigated in 2005 ( First results June
  2005), Clinical study in 2006
• Prevention of Influenza
• Protein fraction with anti-viral properties to
  prevent influenza
• Partnership with DMV, Netherlands, a global
  company with a 6B in revenues
• Lead investigator Dr Guy Boivin, CHUQ research
  center
• In vivo tests during fall 2004