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A biopharmaceutical company developing innovative therapeutics in the fields of oncology and infecti

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Life Science Analytics Medtrack Database. 7. PPL-100: Phase 1 ... With neat drug filled capsules, PPL-100 demonstrated a favorable PK profile ... – PowerPoint PPT presentation

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Title: A biopharmaceutical company developing innovative therapeutics in the fields of oncology and infecti


1
A biopharmaceutical company developing innovative
therapeutics in the fields of oncology and
infectious diseases (TSXAMB) 0
Corporate Presentation Last update April 24, 2007
2
This presentation contains forward-looking
statements that reflect the Companys current
expectation regarding future events. The
forward-looking statements involve risks and
uncertainties. Actual events could differ
materially from those projected herein and depend
on a number of factors including, but not limited
to, changing market conditions, successful and
timely completion of clinical studies,
uncertainties related to the regulatory approval
process, establishment of corporate alliances and
other risks detailed from time to time in the
Companys filings. Such statements are also based
on various assumptions, including the successful
and timely completion of clinical studies on
Ambrilias products demonstrating efficacy and
safety for human use, their successful
commercialization within the forecasted timelines
and the attainment of the forecasted milestone
payments and other revenues. While Ambrilia
anticipates that subsequent events and
developments may cause Ambrilias views to
change, Ambrilia specifically disclaims any
obligation to update these forward-looking
statements.
Ambrilias Forward-Looking Statements
3
Investment Highlights
  • Lead HIV/AIDS proprietary product licensed to
    top pharma, Merck Co. for US17 million
    upfront, potential US212 million in milestones,
    and royalties.
  • Near-term product revenue opportunities from two
    new formulations of existing drugs, Octreotide
    and Goserelin.
  • 2 leading pharma companies as licensees, TEVA
    and Mallinckrodt, of improved formulation of
    Octreotide.



4
Pipeline Overview
5
Ambrilia Merck Licensing Agreement
  • Terms
  • Merck receives exclusive worldwide rights to
    Ambrilias HIV PI Program, incl. lead compound
    PPL-100
  • Upfront licensing fee US 17M, additional
    potential milestones US 212M
  • Royalties on future product sales
  • Merck assumes all future development costs
  • Potential additional payments and royalties on
    development and commercialization of each related
    compound

6
PPL-100 Market potential
  • HIV/AIDS market(1) estimated to reach US 9
    billion at the projected
    time of launch of PPL-100 (2012)
  • PIs a healthy 1/3 of the HIV/AIDS treatment
    options - Todays Market
    leader Abbotts Kaletra US 1.0 B(2)
  • PPL-100 market share and revenues expected to be
    significant based on its competitive advantages
  • Excellent safety and tolerability
  • Favorable cross-resistance profile
  • High genetic barrier
  • Potential once or twice-a-day dosage, ritonavir
    free
  • Decision Resource 2004 HIV Infectious Diseases
    Study 68, Frost Sullivan 2004 Strategic
    Analysis World HIV Market, 2006 DataMonitor -
    Pipeline Insight HIV
  • Life Science Analytics Medtrack Database

7
PPL-100 Phase 1
  • Phase 1 single dose escalation study in healthy
    volunteers

8
PPL-100 Next Steps
  • Phase 1 repeat dosing study in healthy volunteers
    completed by Ambrilia
  • Good safety profile only mild (grade 1)
    adverse events and
  • no moderate or severe cardiovascular,
    lipidic or hepatic adverse
  • events observed
  • PK data support the potential for once or twice
    daily treatment,
  • without ritonavir boosting, for a
    significant proportion of
  • HIV/AIDS patients
  • Merck has initiated formulation development
  • Further development in patients will follow

9
Near-term product revenue opportunities from two
new formulations of existing drugs
10
Oncology Improved formulation of Octreotide
  • Therapeutic alternative to Novartis
    SandostatinLAR
  • (somatostatin analogue)
  • Indicated for acromegaly and some digestive
    tumors
  • 2006 Sandostatin sales(1) US 900M ( 4 ),
    over 70 for the LAR
  • Three dosages of LAR 10, 20 and 30 mg per unit
  • 30mg (over 50 of market) sells for US 2,830 per
    unit
  • 13 injections needed per year ( US 25,000 to gt
    US 36,000)
  • Ambrilias C2L Improved prolonged release (PR)
    formulation developed with patented technology
  • Less expensive and easier to use because more
    stable product
  • Less frequent injections (8 or 9 vs 13 per
    year)
  • Manufactured in-house, cGMP compliant
  • Novartis Annual Report 2006

11
Octreotide Development Program
  • Limited Phase 3 clinical studies
  • in Europe and in the U.S.
  • 3 months activity 3 months safety follow-up
  • Endpoints Surrogate marker (GH IGF-1 levels)
  • Upcoming milestones
  • Start of clinical studies in acromegaly patients
    ?
  • Filing in Europe. H1/08
  • Filing in the U.S. H2/08

12
Octreotide Marketing Strategy
  • Ambrilia manufactures and will sell the finished
    product to its licensees, at contractually
    fixed price
  • Licensing agreements concluded with leading
    companies worldwide
  • Agreements have been concluded for
    commercialization and have already generated
    milestone payments
  • Mallinckrodt (U.S.), TEVA (France, Germany,
    Benelux, Spain, Scandinavia), Archimedes Pharma
    (U.K.), Gerolymatos (Greece, Turkey, other
    countries), Kwidza Pharma (Austria), Pharmis
    (Portugal, Brazil)
  • C2L to be promoted as improved PR formulation,
    with 3 advantages less expensive, easier to use
    because more stable product, less frequent
    injections (8 or 9 instead of 13 per year)

13
Oncology New formulation of Goserelin
  • Potential first-to-market therapeutic alternative
    to Astra Zenecas Zoladex LP (LHRH
    analogue)
  • Indicated for hormone-sensitive prostate cancer
  • 3-month prolonged release formulation developed
    with patented technology
  • Zoladex 2005 sales(1) US 1.0 B (9),
    primarily in Europe (70 for the 3 month
    formulation)
  • Life Science Analytics Medtrack Database

14
Goserelin Development Plan
  • Upcoming Milestones
  • In house formulation optimization Ongoing
  • Start of phase 1/2 study in hormone-
  • sensitive prostate cancer patients 2007
  • Out-licensing 2008

15
Proprietary products in cancer and
infectious diseases
16
Oncology PCK3145
  • Therapeutic anti-cancer peptide
  • Indicated for hormone-resistant prostate cancer,
    a condition with very poor prognosis.
  • Studied in close to 50 patients
  • Safe, well-tolerated
  • Completed U.S. pilot study (Memorial Sloan
    Kettering Cancer Center, NYC)
  • Improved dosing
  • Study completed
  • Safety confirmed, and
  • Evidence suggesting clinical activity ( incl. PSA
    doubling time increased up to 5 fold in several
    patients)
  • Development partnership discussions ongoing

17
PSP94 Test Novel Biomarker Assay
  • A test to measure the plasma levels of PSP94, a
  • powerful new prostate cancer prognosticator
  • Confirmed diagnostic value in published study
    in patients with
  • prostate cancer
  • Confirmed prognostic value in patients with
    risk of recurrence
  • The PSP94 kit can help
  • Avoid biopsies in patients diagnosed with
    probable prostate cancer
  • Follow-up patients in observation before
    deciding to treat
  • Partnership negotiations ongoing

18
Oncology TVT (Tumor and tumor-vasculature
targeting) Platform
  • NGR peptides-based targeted drug delivery
    technology that
  • delivers anti-cancer drugs to the vasculature
    of solid tumors and
  • surrounding tumor cells
  • Technology consists of a carrier vesicle coated
    with a tumor homing peptide (NGR) which binds
    specifically to a receptor (CD13 isoform)
    exclusively expressed in newly formed tumor blood
    vessels as well as on the surface of some types
    of tumor cells
  • The carrier is then internalized and releases the
    anti-cancer drug which, in turn, specifically
    damages the tumor vasculature and kills the tumor
  • Targeted NGR peptide can be attached to the
    surface of
  • liposomes or other nanoparticles loaded with a
    single or
  • combination of anti-cancer agents
  • Proof-of-concept with Doxorubicin (Dox)
  • NGR targeted liposomal Dox with convincing
    results in animal solid tumors models

19
HIV Integrase Inhibitor Program
  • Integrase Inhibitor is a platform for the
    treatment of HIV/AIDS
  • Merck and Gilead have Integrase Inhibitor
    products in late-stage development for the
    treatment of HIV
  • Ambrilia to utilize Integrase Inhibitor Program
    to develop drugs to treat HIV/AIDS
  • Status Lead optimization
  • Novel structures with potentially a new mechanism
    of action
  • 12 months to a drug candidate

20
Financial Snapshot
21
Management Team
Stephen G. Sudovar Executive Chairman of the
Board and CEO Bonabes de Rougé, M.D. Senior
Executive Vice-President CSO Monique
Létourneau, M.Sc., CFA Executive Vice-President,
Finance CFO Chandra J. Panchal,
Ph.D. Executive V.-P., Business Development,
Licensing and IP Jinzi Wu, Ph.D. Vice-President.,
Preclinical Basic Research, Richard La Rue,
LL.L, D.D.N. Vice-President., Legal Affairs, HR
Corp. Secretary
22
Summary Upcoming Milestones
  • 2007
  • PPL-100 Out-licensing ?
  • Octreotide - Start of clinical trials ?
  • PCK 3145 - Clinical results (4 months
    exposure) ?
  • PSP94 Assay Licensing
  • Goserelin Start of clinical trials
  • 2008
  • Octreotide Regulatory filing worldwide
  • Goserelin Out-licensing
  • HIV Integrase Inhibitor Program Drug candidate

23
A biopharmaceutical company developing innovative
therapeutics in the fields of oncology and
infectious diseases (TSXAMB)
www.ambrilia.com
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