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Integrating Pharma Interests
-Why STI?
- Our Planning & Strategy
Presentation
May 2010
For personal use only
Forward Looking Statements
This presentation provides only an overview of Stirling Products Limited ABN 32 077 105 429
(ASX:STI) and its opportunities. The information may require further explanation and/or clarification.
Accordingly, this information should not be relied upon independently and should be considered in
conjunction with past and future public information and announcements that are made by STI.
Please contact STI and/or refer to the Company's website for further information.
The views expressed in this presentation may contain information derived from publicly available
sources that have not been independently verified. No representation or warranty is made as to the
accuracy, completeness or reliability of the information. Any forward looking statements in this
presentation have been prepared on a number of assumptions which may prove incorrect and the
current intentions, plans, expectations and beliefs about future events are subject to risks,
uncertainties and other factors, many of which are outside STI’s control. These factors could cause
actual results to differ materially from assumptions or expectations expressed or implied in this
presentation. Because actual results may differ materially to assumptions made and STI’s current
intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking
statements contained in this presentation with caution.
Nothing in this presentation should be construed as either an offer to sell or a solicitation of
an offer to buy or sell shares in any jurisdiction.
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About Stirling Products Limited
ASX:STI ....... Pharmaceutical & healthcare group
¾ building a fully integrated manufacturing and sales business
¾ bringing Advanced Drug Delivery Solutions to market
¾ targeting major pharma partnership opportunities
… operating through three key business units:
• Manufacturing – high-tech Cape Breton (Canada) plant
being commissioned - Q3, 2010
• Sales – commenced April, 2010
• Development of unique Blockbuster Opportunities ongoing
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WHY STI?
OPPORTUNITY? – Unprecedented!
• First-Class Proven Management – Building a worldclass management team. Each Business Unit managed
by industry recognised and proven professionals
• Sales – over $300k gross in first month (April) and will
grow progressively on monthly basis
• Assured Blockbusters – Inhalation Drug Delivery
Platform promises to be a Blockbuster ‘Re-Generator’
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Corporate – Our Board
Peter Boonen
Managing Director
Neil Covey
Director
Gulshan Jugroo
CFO/Director
Professor Glyn Tonge
Non Executive Director
GLOBAL OPERATIONS
• Corporate & operational headquarters - Sydney, Australia
• North American operations - Prince Edward Island, Canada
• Manufacturing - Cape Breton, Canada
• South African joint venture (Stanimate) – Johannesburg
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Our Management
•
Corporate
John Diasinos, Company Secretarial, Risk Management, Compliance and Corporate
Governance – ex Trust Company, looked after compliance and multi-billions in assets
for listed and unlisted clients
•
Sales
Neil Covey, Director, Australian & Global - ex Bayer Head Sales & Marketing
Mike Elliott, National Sales Manager - ex Pfizer and Innovex
Wayne Miller, Heads North American Sales – multi-awarded professional
•
Manufacturing
Alex Della Mora, Plant Manager – industry track record of increased performance,
sales and profits
•
Drug Delivery Platform
Vladimir Sheiman, Partner & Inventor
Ross Harricks, Commercialisation Consultant – Ex Group Marketing Executive,
Nucleus Group, ex director VentraCor, AtCor and ResMed
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Supported by Scientific Expertise
Prof Glyn Tonge, Non Executive - Extensive industry experience. Pharma,
corporate finance, funds manager, M&A, corporate and governance
Dr Allen Bain, Pharmacologist - co-developed a blockbuster anti-arrhythmia drug
now being commercialized by Merck
Dr Aldar Bourinbaiar, Trial Coordinator – specialist in viral disease, discovered an
AIDS treatment used globally
Dr Galyna Kutsyna, Lead Clinical Trials – researcher and specialist in AIDS and
viral disease
Dr Manuel Carpio, QA/QC Stirling Pharma - Doctor of Veterinary Medicine, viral
expert, commissioned and managed pharma plants
Dr Vladimir Sheiman, Scientific Lead and Inventor of Company’s JV drug delivery
platform – formerly head of Russia’s largest ultrasonic research centre and
inventor of numerous technologies in the ultrasonic and aerospace fields
Ross Harricks, Consultant – ex Group Marketing Executive of Nucleus Group, ex
director VentraCor, AtCor and ResMed
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Big Pharma Partner - Cipla
Cipla Limited is one of the world’s leading generics and OTC product
manufacturers exporting and distributing to over 180 countries
Stirling’s early relationship with Cipla the Company provides for:
•
A recognised quality manufacturer of our Stirling branded generic
and OTC products
•
A provider of generic versions of key branded respiratory drugs
available for use through our drug delivery platform* devices
•
A provider of ‘premium’ generic versions of key blockbuster
drugs for our patented devices*
•
A manufacturer and supplier of our R-salbutamol for our animal
products JV and for our obesity drug candidate ST-810
•
A future potential distribution partner
*Pending commercialisation and registration
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Manufacturing – StirlingPharma
4,310sq m Pharma Plant on 20,000 sq m land
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Manufacturing
With current fit-out and configuration the plant has an annual capacity
to manufacture and package over 550 million tablets, 5 million
bottles and blend up to 1.5 million kg of product
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Manufacturing – Plan & Options
¾Plant Manager, CFO, QA/QC and Sales& Marketing executives have
been appointed
¾Plant is being re-licensed through Canada Health – a 3-6 month process
¾Operations scheduled to commence late Q3, 2010
OPERATIONAL OPTIONS:
• Negotiations underway with Canadian authorities for a multimillion product development and manufacturing project
• Plant can be fully utilized producing product for Stirling Health in
Australia and for North American sales initiatives
• Contract manufacturing work is available
• Plant can also be fully utilized through arrangement with Cipla to
produce Canadian made generics
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Sales
Positioning our
Business Sales Units:
•
‘Stirling Health’ Australian
pharmacy brand and sales group
launched at APP in late March 2010
– major expansion underway
•
‘Nature’s Firewall’ launching in Q2,
2010 as a niche brand
•
‘Stirling Pharma’ to produce unique
product for distribution through
‘Stirling Health’ and throughout
North America
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Sales
Positioning our Products:
•
•
¾
World First – Pure Honibe™ Honey
Drops PLUS Stirling botanicals
‘Nature’s Firewall’ launching in North
America next month with:
Our ‘botanical’ Honibe™ drops
¾
And our ‘spray’ dietary supplements
coming soon
•
Multi-awarded platform – Honibe™
just awarded a best product 2010 and
best country (Canada) product at
prestigious SIAL D’or Awards in Paris
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Drug Delivery - Our Company-Maker
Stirling Advanced Drug Delivery Solutions
• Fully patented ‘platform’ technology has demonstrated improved
drug delivery through natural inhalation – Provides Stirling JV
the potential and opportunity of securing market share in a
range of blockbuster drugs as they come off patent
• Safer drug profile in that only around 10% of active product is
required to provide same benefit as 100% (oral delivery).
• Promises to be a blockbuster ‘re-generator’ providing unique
patent protection for better performing generic versions of the
industry’s biggest and best blockbusters
A GLOBALLY UNPRECEDENTED OPPORTUNITY
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Advanced Drug Delivery Solutions
A breakthrough ‘platform’ and ONLY devices in
the world that will offer ALL of the following:
•
Drug transport velocity - matched to natural breathing
•
Less deposition on drug delivery pathways
•
Up to 3 times the aerosol concentration of other ultrasonic
devices
•
Delivered drugs – sub 5 micron - have much better & faster
absorption - bioavailability
•
Active drug in unique disposable capsules – IP protection
•
Can potentially be used for administration of many drugs
TECHNOLOGY IS PROVEN, DEVELOPED AND PATENTED
Potential for major partnership
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Advanced Drug Delivery Solutions
•
Testing and earlier FDA 510K device approval have
supported its superiority and viability
•
Demonstrated that substantively LESS active drug (than
oral) is needed to provide the same benefit – potentially
less side-effects
•
This potential for increased safety provides a platform
that can transform ex-blockbuster drugs to exclusive
Stirling ‘premium’ generic product – In fact the platform
promises to be a generic blockbuster ‘re-generator’
•
Most of the world’s major blockbuster drugs (as at 2005)
will be off patent by end 2015 – Many are candidates that
Stirling can potentially adapt to its delivery device
DESIGN AND MANUFACTURE OF PRE-PRODUCTION
DEVICES UNDERWAY
StirlingProductsInhalationPlatformDeviceLayout
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Mouthpiece
Top module immersible
for thorough sterilisation
Nebulising Chamber
Stainless Tube
Top Housing
Drug Capsule
TransmissionMedium(water)
Easily replaceable sealed
drug container allows
accurate dosing
Userchangeabletransmission
fluid–– usecommontapwater
forsimplicity&convenience
Transducer
Switch
Bottom Housing
Sealed electronics
& battery
PCB
Li-Ion Battery
Base
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Company-Making Opportunities
As well as Stirling’s Advanced Drug Delivery Solutions opportunity the
Company also has:
•
•
•
ImmunoXel – as an immunomodulator for treatment of AIDS, TB and flu.
Currently in further clinical trials in the Ukraine (flu) and in Nigeria (AIDS & TB)
IMMUNOXEL IS PROVEN IN AIDS & TB TREATMENT
TRIALS
-
ST-810 – world’s only single enantiomer beta agonist patented for human obesity
– trial in beagle dogs demonstrated an approximate 2% per week weight loss
A successful obesity product has the potential to be the world’s biggest
blockbuster ever in a market estimated to be over US$75B
-
STIRLING OWNS A LEAD OBESITY CANDIDATE
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ImmunoXel …… A Lead Product
A Unique Immunomodulator
ImmunoXel has demonstrated in all its clinical trials that it:
• is a powerful immunomodulator and adjuvant
• substantively tunes the Immune System
• enhances efficacy of - antibiotics, viral therapies and
chemotherapies
• can substantially shorten drug and chemotherapy treatment duration
• can reduce and reverse treatment toxicity side-effects – esp. in liver
and kidneys
• is market ready for treatment of TB, TB/HIV, AIDS
• over 800 patients treated in clinical trials
– mainly TB, TB/HIV but also AIDS and influenza
• is a breakthrough blockbuster product candidate
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Proven in Tuberculosis
ImmunoXel
• Enhances efficacy of drugs 2-10 fold
• Shortens therapy duration 3-12 fold
• Reduces and reverses toxicity of
current TB drugs
• Is market ready for TB and TB/HIV
treatment
“…a drug effective against drug
resistant TB can earn US$300 million
a year…”
- Global TB Alliance
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Proven in AIDS Trials
ImmunoXel
Where ImmunoXel was used as an adjuvant to anti-retroviral (ART) chemotherapy in
the treatment of AIDS patients and compared to patients only on ART –
•
•
•
•
•
•
•
•
•
ImmunoXel:
Significantly increased CD3 T-lymphocytes
CD-4 T cell population almost doubled
The CD-4/CD-8 ratio increased 29.7%
CD-20 and B-lymphocytes declined to normal levels of around 333
CD-3, HLA-DR and T-cell population increased 216%
The CD3, CD16, CD56 and natural killer cells increased by 52.7%
95% of all patients had decrease in viral load burden
Reduced and reversed toxicity side effects of ART
Is market ready for use as an AIDS ART adjuvant treatment
Over 35 million people are living with HIV/AIDS today
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ST-810 for Obesity
ST- 810 is fully developed and has been safely used by humans for
respiratory disease for over 15 years in its purified form and 30 years in its
original formulation
Stirling is re-purposing this ‘old drug’ for a ‘new use’ – a well established
product development process within the pharmaceutical industry
ST- 810 is a ‘metabolic switch’ - turns off the body’s fat production
receptors and lets the body naturally adjust its weight – trial in Beagle dogs
showed approx 2% weight-loss per week
A successful obesity drug would most likely be the world’s biggest ever
blockbuster drug in a market estimated at well over US$75B
To commercialize ST- 810, partnering with a major
pharmaceutical group is targeted by 2011 year end.
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Major Opportunity
Obesity
In Australia - the total cost of obesity in 2008 was $58.2 billion
- Weighing it Up: Obesity in Australia May 2009 • House of Representatives Standing
Committee Report on Health and Ageing
In USA - “Nearly a third of U.S. adults are overweight, and another third
are technically obese, as defined by a BMI (body-mass index) of more
than 30. And Americans aren't happy about it.
Last year, they spent an estimated $46 Billion on diet products.”
- Forbes Magazine
A true and effective Obesity drug has an estimated market potential of well
over US$75 billion
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Stirling Growth Strategy
•‘Stirling Pharma’ to start manufacturing operations in Q3
•‘Stirling Health’ – sales to pharmacies commenced April
•‘Nature’s Firewall’ – niche product range – launch in June
•Licensing of products, in and out - ongoing
•Joint venturing of products and/or technologies - ongoing
•Relationship establishment with governments & agencies and
continued clinical trials in areas of unmet need such as TB and
HIV throughout Africa – ongoing
•Production of inhalation platform drug delivery devices –
current
•Potential major pharma partnering
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Our Future
Underpinned by Tangible Assets – Approx 1.6 cents per Share
• $20M+ replacement value - near new, freehold pharma plant
• Freehold offices – est. value $2M
…. positioned for:
• revenues from Sales & Manufacturing – commenced Q2
and to scale up progressively
• realization of unique blockbuster potential opportunities
- Advanced Drug Delivery Solutions Platform
- ImmunoXel as a treatment adjunct for AIDS and TB
- Obesity drug candidate
• continued aggressive growth
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Why STI? – Unprecedented!
Market Cap early 2009 - $500k
current
- $13M
Dec 2011 - $???
Thank you
Please visit: stirlingproducts.net