Broker Presentation For personal use...
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Broker Presentation April 2015 ASX: PAA ACN 094 006 023 For personal use only
Transcript of Broker Presentation For personal use...
BrokerPresentation
April 2015
ASX: PAAACN 094 006 023
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DISCLAIMER
• This presentation does not constitute investment advice. Neither this presentation nor the
information contained in it constitutes an offer, invitation, solicitation or recommendation in
relation to the purchase or sale of shares.
• Shareholders should not rely on this presentation. This presentation does not take into
account any persons particular investment objectives, financial resources or other relevant
circumstances and the opinions and recommendations in this presentation are not intended
to represent recommendations of particular investments to particular persons.
• The information set out in this presentation does not purport to be all inclusive or
to contain all the information which its recipients may require to make an informed
assessment of the proposed transaction.
You should conduct your own
investigations and perform your own
analysis in order to satisfy yourself as to
the accuracy and completeness of the
information, statements and opinions
contained in this presentation.Fo
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PHARMAUST LIMITED
…Fast tracking leading edge technology in cancer therapy…
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PharmAust Cancer
Programs
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PHARMAUST LIMITED ASX:PAA
100% 100%
Sydney-‐Based Perth-‐Based
PHARMAUST LIMITED
CORPORATE STRUCTURE
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PharmAust - > Challenging
Limitations in Cancer Therapy
• Drug Toxicity
• Drug Resistance
• Cancer Recurrence
• Poor Tumour Targeting
• Poor Diagnosis ‐> Patients Progressed at Treatment
• Optimising Treatment
• Survival vs Quality of Life
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PHARMAUST STRATEGY
• Targeting oncology applications of well established drugs and piggy-
backing” on substantive programmes of major pharmaceutical companies
• Engaging a leading clinical oncology units (St George Hospital, Sydney)
and The Royal Adelaide Hospital
• Granted patents or patent filings (either owned outright or jointly with
partner)
• Relationships with major
global corporations
• Use of CROs and external
R&D suppliers
Oncology Focus
Leading New
Drug for Cancer
Management
Phase II Clinical
Stage
Strategic
Partnerships
with two Global
Corporations
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Recent Examples of New Targeted Therapies
DRUG TARGET PEAK ANNUAL SALES
PATIENT COST
COMPANY
HERCEPTIN + PACLITAXEL
BREAST CANCER (HER2-‐NEU)
$6.5Bln $60,000/ANNUM
GENENTECH/ROCHE
GLEEVEC MULTIPLE CANCERS TYROSINE KINASE
$4.7Bln $92,000/ANNUM
NOVARTIS
AVASTIN + 5FU
COLON, RENAL, OVARIAN CANCER VEGF INHIBITOR
$2.6Bln $100,000/ANNUM
(US)
GENENTECH
ABRAXANE + GEMCITABINE
PANCREATIC CANCER
$800M $60,000/ANNUM
CELGENE
Targeted Therapies
for Cancer
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NEW SOUTH WALES
INNOVATIONS
NOVARTIS ANIMAL HEALTH
Strategic Alliances
IP -‐ Granted and Pending Patents
UNIVERSITY OF CAMBRIDGE
Listed Japanese Group
Royal Adelaide Hospital
CMAX & CPR
THE ST. GEORGE HOSPITAL S
Pharmaust Limited Foundations, Relationships and Commercial
Cornerstones
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St George Hospital Department of Surgery/OncologyFo
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MONEPANTEL
(MPL or PPL-1)
1. MPL is a new class of anticancer drug
2. MPL can act alone or in combination with standard of care
chemotherapy for treatment of cancer
3. Pharmaust has the IP for MPL
assigned from the University of NSW
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MONEPANTEL’S
UNIQUE PROPERTIES
v Unlike most cancer drugs, MPL has virtually little or no toxicity based
on the toxicology undertaken by Novartis Animal Health
v MPL has shown a high degree of selectivity in killing cancer cells over
normal cells in culture
v Studies in animal models show potent tumour regression without
toxicity as measured by weight loss
v MPL demonstrates a potent synergistic
action with many cytotoxic drugs used
in “Standard of Care”
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Control Group VEHICLE Low dose Group
MPL (25 mg/kg)
DRUG
High dose group
MPL (50 mg/kg)
DRUG
EFFECT OF MPL ON
TUMOUR-BEARING MICE
Dose-finding study of IP administered Drug in nude mice bearing Subcutaneous ovarian
tumours (OVCAR-3), SC / IP
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Monepantel Kills Drug
Resistant Cancer Cells
• Temozolamide resistant cancer cells are effectively killed by MPL
• MPL has little toxicity on “Normal” Human Embryonic Kidney Cells
• MPL offers Treatment Optins either singularly or with “Standard of Care”
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0
25
50
75
100
[MPL] (µM)
Ce
ll P
roli
fera
tio
n (
% o
f C
on
tro
l)
0 5 10 25 50
TEMOZOLAMIDE RESISTANT GLIOMA U251
HEK [Human Embyonic Kidney cells]
0
25
50
75
100
0 10 25 50
Monepantel [µM]
Via
bil
ity
(%)
NORMAL CELLS
TEMOZOLAMIDE RESISTANT GLIOMA U251
EFFECT OF MPL ON
CANCER CELLS
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SYNERGY BETWEEN
AMINOACETONITRILES AND
CYTOTOXIC DRUGS
• Selective Synergy between MPL and cytotoxic drugs on “cancer” cells
• Little synergy between MPL and cytotoxic drugs on “normal” cells
• Opportunity for “New Class” of drug for cancer
• Therapy in conjunction with standard clinical practice
• Optimization of Synergy
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0
1 0 0
2 0 0
D a y s a fte r tu m o r in o c u la t io n
Tu
mo
r v
olu
me
(m
m3)
C o n tro l
T a x o l 2 .5 m g /k g + M P L 2 5 m g /k g
T a x o l 2 .5 m g /k g + M P L 5 0 m g /k g
T a x o l 5 m g /kg
T a x o l 5 m g /k g + M P L 2 5 m g /k g
T a x o l 5 m g /k g + M P L 5 0 m g /k g
M P L 2 5 m g /k g
10 13 15 17 20
M P L 5 0 m g /k g
T a x o l 2 .5 m g /kg
Comparison of tumour volume V.s. treatment ,me in mice treated with MPL/Taxol alone or in combina,on (aoer 5 doses).
Synergy with Taxol
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B o d y W e ig h t
D a y s p o s t c e ll in o c u la t io n
An
ima
l w
eig
ht
(g)
9 1 1 1 4 1 6 1 8 2 1 2 3 2 5 2 8 3 0 3 2 3 51 5
1 6
1 7
1 8
1 9
2 0
2 1
2 m g /k g G e m
2 m g / k g G e m + 2 5 m g /k g M P L
5 m g / k g G e m + 2 5 m g /k g M P L
5 m g /k g G e m
2 m g /k g G e m + 5 0 m g /k g M P L
5 m g /k g G e m + 5 0 m g /k g M P L
2 5 m g /k g M P L
5 0 m g /k g M P L
C o n tro l
OVCAR 3 S.C tumour; i.p. injection
Lack of PPL- 1 Toxicity as
Measured by Weight Loss
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Successful Demonstration of Safety and Indication of
Clinical Value by Suppression of Key Cancer Marker
Human Safety Trial - Monepantel
ACCELERATED ENTRY INTO MAN DUE TO EXTENSIVE TOXICOLOGY BY GLOBAL MAJOR
- Patient #1 ‐> Discontinued after 3 days (drug-unrelated death)
- Patient #2 ‐> Completed 28 days
- Patient #3 ‐> Discontinued after 13 days (urinary tract infection)
- Patient #4 ‐> Discontinued after 4 days (did not wish to continue)
- Patient #5 ‐> Completed 28 days
- Patient #6 ‐> Completed 28 days
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p70S6K
0
50
100
150
200
250
300
350
0 7 14 21 28
Plasma ConcentraTon (ng/mL)
Study Day
MPLS, R101
MPLS, R02
MPLS. Average
R 0 1 R 1 0 1 R 0 2 R 1 0 2 R 2 0 2 R 0 3
0
5 0
1 0 0
D e te r m in a tio n o f p -P 7 0 S 6 K in P B M C o f p a tie n ts t re a te d w ith M P L
p-P
70
S6
K
(% c
on
tro
l)
D a y 1 b e fo re tre a tm e n t
D a y 3
D a y 7
Significance at Day 3 p<0.0005
PK – BLOOD LEVELS
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Target Markets
Monepantel offers a new therapeutic regimen with
or without standard Chemotherapy. The current
Chemotherapy market is US$42 billion/annum.
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Canine Trial
No Adverse Events Noted
• Four Dogs Received MPL (25mg/kg) compassionately
• Three Dogs treated with the lowest dose of MPL (25mg/kg) as part of trial
Tasteless Formulation of MPL in Soft ‐ Gel CapsulesF
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Albendazole for the
Treatment of Ascites
Two Clinical Trials Completed Showing:
1. Maximum tolerated dose
2. Benefits in Localised Therapy in the abdomen
3. Significant Inhibition of VEGF
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Albendazole Ascites I
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Tumour Growing in the Abdomen and producing large quantities of
Ascites fluid which distends the abdomen and reduces life expectancy
0
0.2
0.4
0.6
0.8
1
1.2
0 0.25 1 2 4 8 12 16 24 30 48 72 120
Time a'er drug administra/on (h) Albe
ndazole concen
ra/o
n (m
g/ml)
i.p
Oral
Reten7on of Albendazole in the Abdomen
Ascites in Man
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Mucin Dissolution
Efficacy of a Novel Mucolytic
Agent on Pseudomyxoma
Peritonei Mucin with Potential
for Treatment through Peritoneal
Catheters.
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EPICHEM
Epichem is a profitable wholly owned subsidiary of PharmAust
which provides services in synthetic and medicinal chemistry to the
drug discovery and pharmaceutical industries. Epichem turnover
is $2.0M/annum. With two state-of-the-art laboratories in Perth
and Melbourne, Epichem serves an international clientele ranging
from small operations to large multinational pharmaceutical
companies. Epichem’s ability to excel in a highly competitive
global marketplace was recently recognized when in 2010 it won
an Australian Export Award. It has achieved this by combining a
world-class team (12 Ph.Ds) of highly innovative chemists and a
management committed to customer service.
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Contact Details
DR ROGER ASTONExecutive Chairman
PharmAust Limited
Email: [email protected]
Phone: 61 (0) 402 762 204
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