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Annual

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Title: Annual


1
Annual Special Meeting of ShareholdersNovembe
r 7, 2006
2
Safe Harbour Statement
Except for historical data, the financial
information circulated during this presentation
contains statements that, by their very nature,
are forward-looking and, therefore, involve time
periods, risks and other factors, known or
unknown, which are beyond the Companys control.
Each of these factors may produce results or
performances that differ significantly
from expectations. No liability, present or
future, derived from this can be assumed by
Bioniche in any investment decision
made following this presentation.
1
3
Our Business Model
  • Late stage development of proprietary, large
    market human cancer therapies.
  • Supported by cash flow from globally marketed
    products in animal health.
  • Today revenues, Phase III product (Urocidin for
    bladder cancer).

2
4
Corporate Highlights
  • Phase III oncology product
  • UrocidinTM (MCC) - for non-muscle invasive
    bladder cancer in humans
  • - promising Phase II safety and efficacy
  • Most significant pipeline products
  • MCC for other human cancers
  • E. coli O157H7 cattle vaccine (in North
    American regulatory pathway)
  • High margin animal health business
  • Revenues of C25M in Fiscal 06
  • Contributes significant earnings before
    interest, taxes, depreciation and
  • amortization (EBITDA)

3
5
Corporate Structure
4
6
Sale of Non-Core Assets
5
7
Areas of Focus
  • Licensing of E. coli O157H7 cattle vaccine.
  • Signing of a marketing partnership agreement for
    Urocidin.
  • Successful completion of Phase III trials with
    Urocidin in the treatment of non-muscle invasive
    bladder cancer.
  • Liquidation of non-core assets to support
    strategic priorities.
  • Obtaining financing to complete priority projects.

6
8
Preferred Staging of Events
1
2
3
E. coli O157H7 vaccine license in Canada /or
U.S.
Signing of marketing partnership for Urocidin
Corporate financing
7
9
Development of the E. coli O157H7 Vaccine
  • Brett Finlay, PhD, Professor in the Michael
    Smith Laboratories, and the
  • Departments of Biochemistry and Molecular
    Biology, and Microbiology and
  • Immunology at the University of British Columbia
    (Canada)
  • Was conducting basic research in the laboratory
    in 1995 and
  • made two fundamental discoveries
  • 1. The E. coli O157H7 bacteria secrete
    attachment proteins
  • 2. When injected directly into a cell wall, one
    of these proteins
  • serves as a receptor, to which the bacteria
    adhere, allowing
  • them to colonize the intestine.
  • Realized that it might be possible to immunize
    against the
  • attachment proteins of the bacteria (initially
    thought useful in
  • childhood vaccines then realized that a
    cattle vaccine might be
  • the better opportunity to pursue)

8
10
Development of the E. coli O157H7 Vaccine
  • Dr. Finlay contacted Dr. Andy Potter at the
    Vaccine Infectious
  • Diseases Organization (VIDO - University of
    Saskatchewan, Canada)
  • and suggested they try and make secreted
    proteins to immunize
  • cows.
  • The pair demonstrated in a pilot study that the
    vaccine appeared
  • to reduce shedding of E. coli O157H7 in
    cattle manure.
  • VIDO and Dr. Finlay approached Bioniche, who has
    become the
  • global commercial partner responsible for the
    technology transfer,
  • development, scale-up, and commercial
    manufacture of the vaccine.
  • The Company has invested 13 million to date.

9
11
About E. coli O157H7
  • One of hundreds of strains of the bacterium
    Escherichia coli
  • Most strains are harmless live in intestines of
    healthy humans
  • and animals
  • O157H7 produces powerful toxin (Shiga/Vero
    toxin) and can cause severe
  • illness
  • O157H7 appears to be a mutant that was first
    seen in South America 20 years ago and has
    drifted north and internationally
  • This strain first recognized as a cause of
    illness in 1982 during
  • an outbreak of severe bloody diarrhea (traced
    to contaminated
  • hamburgers in the U.S.)
  • Until recently, most infections have come from
    eating undercooked ground beef (beef industry
    has spent hundreds of millions of dollars to
    improve production safety by implementing
    post-slaughter procedures FDA has implemented
    holding and testing of meat products prior to
    shipping)
  • (Centers for Disease Control - CDC)

10
12
The Latest E. coli O157H7 Outbreak
  • September, 2006 26 U.S. states
  • 199 people affected (at 10.06) 3 deaths 31
    with HUS
  • Linked to consumption of fresh spinach
  • Spinach likely contaminated with E. coli O157H7
    in irrigation
  • water downstream from large Californian dairy
    operations (three
  • counties) or with E. coli O157H7 in rinse
    water used prior to
  • packaging

Common denominator in all outbreaks the cow
11
13
What the Researchers are Saying
  • Vaccination has been efficacious as a pre-harvest
    intervention in phase II and phase III studies
    (gt25,000 doses)
  • Significantly reduced probability for shedding in
    feces
  • Significantly reduced colonization (terminal
    rectum mucosal scrapings)
  • Significantly reduced environmental detection/
    oral exposure (ROPES)
  • Herd-immunity / group-regional dynamics

Clinical Trials Process
Proof of concept
Safety, Immune response, Challenge studies
Safety, Dosage, Limited field studies
Does it really work? Large numbers
12
14
What the Researchers are Saying
The vaccine has been efficacious in field
trials, under conditions of natural exposure to
E. coli O157H7.  Pens of vaccinated cattle are
less likely to be colonized with E. coli O157H7,
shed the organism in feces, have environmental
exposure to the agent, or have E. coli O157H7
contaminated hides. David R. Smith, DVM, PhD,
DACVPM (Epidemiology) Department of Veterinary
and Biomedical Sciences University of
Nebraska-Lincoln
13
15
E. coli O157H7 Vaccine Status
  • Completed
  • proof of concept a
  • field studies a
  • adjuvant withdrawal trial a
  • pre-license serials a
  • field safety trials a
  • To complete
  • efficacy trials (ongoing)
  • human safety study (Canada)
  • USDA registration in progress.
  • Canadian dossier complete later in 2006 (for
    CFIA).

14
16
The Latest from the CFIA
Incoming documentation will be reviewed on a
high priority basis, in collaboration with our
colleagues at Health Canada The Veterinary
Biologics Section recently received a study
report on the lack of vaccine toxicity in
piglets. This study had been conducted to
investigate potential adverse effects, in the
event of accidental injection, using a piglet
model as a potential indicator of pathologic
effects in people exposed to the vaccine. We
will be working closely with Bioniches
manufacturing and quality assurance
representatives to establish manufacturing and
testing protocols to fulfill the Canadian
regulatory requirements, as well as conforming
with international standards where applicable, to
facilitate export certification for vaccine
manufactured in Canada. Glenn Gifford, DVM,
MSc National Manager, Veterinary Biologics
Section
15
17
Management Conclusions
  • Bioniche Life Sciences, with the University of
    Nebraska-Lincoln and
  • VIDO, has demonstrated that the vaccine is
    efficacious. There are no
  • other vaccine technologies demonstrating
    efficacy against O157H7.
  • The beef, dairy and vegetable industries cannot
    afford ongoing lawsuits
  • as a result of supplying adulterated food to
    consumers.
  • Lawsuits are currently being filed from Canada,
    in addition to the U.S.,
  • as a result of the spinach contamination.
  • Litigation will be the most effective sales
    tool.
  • Vaccination is clearly the logical solution to
    reducing the hazard of this
  • bacterium at the source.

16
18
Market Potential for Vaccine
17
19
Urocidin Marketing Partnership
  • A number of companies have expressed an interest
    in
  • working with Bioniche to market this
    technology.
  • Ferghana Partners has been retained as agent in
    this
  • partnering transaction.
  • The Bioniche Urocidin team includes
  • Dr. Nigel Phillips, Chief Scientific Officer
  • Dr. François Charette, Chief Medical Officer
  • Ms. Gail Garland, VP, Business Development
  • Ms. Cindy Benning, VP, Regulatory Affairs
  • Mr. Mohamed Elrafih, VP, Manufacturing

18
20
Mycobacterial Cell Wall-DNA Complexand
Bladder CancerDr. Nigel C. PhillipsChief
Scientific Officer
19
21
Bladder Cancer Treatment Issues
CARCINOMA IN SITU TCC
CIS/TCC OF THE BLADDER
MUTATIONAL STATUS AND INTRINSIC RESISTANCE TO
THERAPY
FIELD EFFECTS VS CLONALITY
RESIDENCE TIME IN THE BLADDER (1-3 HOURS)
PROGRESSION, METASTASIS AND DEATH
20
22
Bladder Cancer Pathways
Adapted in part from Knowles, M.A. Carcinogenesis
27361-373, 2006
21
23
Bladder Cancer and p53/p21/pRb
p53/p21/pRb status 5 year recurrence rate 5
year survival rate No alterations 23 70
Any one altered 32 58 Any two
altered 57 33 All three altered 93
8
Chatterjee, S.J. et al., J. Clin. Oncol.
151007-13 (2004). Combined effects of p53, p21
and pRb expression in the progression of bladder
transitional cell carcinoma.
22
24
Mycobacterial Cell Wall-DNA Complex
  • MCC is a mycobacterial cell wall composition
    containing DNA oligonucleotides
  • The DNA is associated with immune stimulant and
    anticancer activity
  • The cell wall functions as a biological drug
    delivery system (recognition by cell receptors
    such as TLR2, TLR9)
  • Commercial name Urocidin? (MCC suspension for
    bladder cancer)

23
25
Bladder Cancer Cell Lines
24
26
MCC Antiproliferative Activity
25
27
MCC Versus Chemotherapeutic Drugs
Inhibition of proliferation, 3 h assay
26
28
MCC -Cytokine/Chemokine Induction
  • MCC SUSPENSION INDUCES
  • IL-1?
  • IL-2
  • IL-6
  • IL-10
  • IL-12
  • IL-18
  • IFN-?
  • TNF-?
  • IL-8
  • MCP-1
  • RANTES
  • MCC SUSPENSION DOES NOT INDUCE
  • IL-4
  • IFN-?
  • In vitro
  • PRIMARY CELL TARGETS
  • Macrophages
  • Monocytes
  • Dendritic cells
  • Cancer cells

27
29
28
30
MCC Mechanism of Action
MCC
INDIRECT
DIRECT
Interaction and uptake
Inhibition of proliferation, cell cycle arrest
and apoptosis
Monocytes, Macrophages, Dendritic cells
Cancer cells
?
Activation

Cellular cytotoxicity
Monokine synthesis IL-6, IL-12, IL-18, TNF-?
NK-cell activation T-lymphocyte activation
Cytokine-mediated anticancer responses
?N.C. Phillips, 1997
29
31
The Phase III Bladder Cancer Clinical
Program Dr. François CharetteChief Medical
Officer
30
32
Bladder Cancer Facts
  • A frequent cancer
  • 4th in men
  • 8th in women
  • A difficult to treat cancer
  • 30-40 do not respond to therapy
  • Few are able to tolerate full dose treatment
  • An under-researched cancer
  • No new treatments for decades
  • Patients left with unmet needs

31
33
The Road to Market
  • Pre-clinical Scientific basis
  • Studies in the laboratory
  • Studies in cell lines
  • Studies in animals
  • Clinical Phase I-II Proof of concept trials
  • Is it safe?
  • Does it work?
  • Clinical Phase III Registration trials
  • Confirmation of safety
  • Confirmation of efficacy

32
34
First Registration Trial
  • Evaluation of the efficacy and safety of
    Urocidin in
  • patients who are refractory to BCG.
  • First patient today! (Victoria, B.C.)
  • We will recruit 105 patients within one year.
  • All patients will be followed for one year.
  • The data will be reviewed on a fast track basis
    by the
  • U.S. Food and Drug Administration (FDA).

33
35
Refractory Trial Sites
Centres -BCG Oncology (AZ) -Can-Med Clinical
Research Inc. (BC) -Center for Urologic Care
(NJ) -Centre for Advanced Urological Research
(ON) -Clinical Research Solutions (NV) -Columbia
Presbyterian Medical Center (NY) -Connecticut
Urological Research at Grove Hill (CT) -Dr.
Steinhoff Clinical Research (BC) -Hopital St. Luc
(QC) -La Clinique dUrologie Berger (QC) -McGill
University Health Centre (QC) -Memorial Sloan
Kettering Cancer Center (NY) -Johns Hopkins Brady
Urological Institute (MD) -London Health Sciences
Centre (ON) -Princess Margaret Hospital/University
Health Network (ON) -Sunnybrook Womens Health
Science Centre (ON) -The Male/Female Health
Centre (ON) -University of Miami (FL) -University
of Rochester (NY) -University of Texas MD
Anderson (TX) -Urology of Virginia at Devine
Tidewater Urology (VA) -Urology San Antonio
Center for Clinical Trials (TX) -Vanderbilt
University Medical Center (TN) -Winter Park
Urology Associates P.A. (FL)
34
36
Second Registration Trial
  • Evaluation of the efficacy and safety of
    Urocidin in
  • all patients who have bladder cancer at high
    risk
  • of recurrence or progression.
  • Comparing directly with BCG.
  • First patient next year.
  • We will recruit 700 patients worldwide.
  • All patients will be followed for two years.

35
37
Strong Clinical Team
  • Monique Champagne
  • Zvi Cohen
  • Sylvie Devost
  • Brigitte Robert
  • Poonam Tanwani
  • Jason Singh
  • Kevin Darbyson
  • Liz McGunnigle
  • Sylvia Filadelfi
  • Caterina Beddia

36
38
The Bladder Cancer Market Opportunity Ms. Gail
GarlandVP, Business Development
37
39
UrocidinTM
38
40
Bladder Cancer Market
39
41
Bladder Cancer Treatment



40
42
Market for Urocidin
41
43
Market for Urocidin
42
44
Financial Highlights for Fiscal 2006announced
September 28, 2006
  • Revenues remained flat at C26.7M
  • Gross margin constant at 57
  • Positive EBITDA before RD of C1.9M
  • Gross RD stable at C12.9M
  • Gains from sale non-core assets totalling C17.8M
  • Net loss for the year was of (C1.1M) or (C0.03)
    per share compares to (C 15.6M) or (C0.43) per
    share in 2005.

43
45
Strategic Corporate Financing
  • Completion of non-core asset sale (December,
    2006).
  • Pursuing financing options
  • Debt
  • Equity
  • Investment in Animal Health to grow revenues
  • Completion of Urocidin marketing partnership
    deal.

44
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Value Creating Events anticipated timing
subject to change
45
47
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Receptionin Trinity IV(this level, opposite)
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