__________________________________________________________________ Phosphagenics Limited ACN 056 482 403 ABN 32 056 482 403 11 Duerdin Street, Clayton Victoria 3168 Australia Telephone: +61 3 9565 1119 Facsimile: +61 3 9565 1151 Web : www.phosphagenics.com Email: [email protected]ASX Company Release ___________________________________________________________________ Annual General Meeting CEO Presentation ___________________________________________________________________ Date 17 May 2012 ___________________________________________________________________ Attached for release to the market is a copy of the power point presentation given at the Annual General Meeting of the shareholders of Phosphagenics Limited in Melbourne today by Chief Executive Officer, Dr Esra Ogru. -ENDS- For further information, please contact Dr Esra Ogru David Segal Chief Executive Officer Investor Relations Manager Phosphagenics Limited Phosphagenics Limited +61 3 9565 1119 +61 3 9565 1103 Rudi Michelson Monsoon Communications + 61 3 9620 3333 About Phosphagenics Phosphagenics Limited is commercialising drug delivery applications based on its novel transdermal (drugs administered via skin) TPM ® – Targeted Penetration Matrix technology. TPM ® is a patient friendly and cost effective system used to deliver proven pharmaceutical and nutraceutical products. The lead product advancing through clinical trials are an oxycodone and oxymorphone matrix system for the relief of chronic pain. Phosphagenics’ shares are listed on the Australian Securities Exchange (POH) and its ADR – Level 1 program in the US is with The Bank of New York Mellon (PPGNY). www.phosphagenics.com www.elixia.com.au For personal use only
ASX Company Release ___________________________________________________________________ Annual General Meeting CEO Presentation ___________________________________________________________________ Date 17 May 2012 ___________________________________________________________________ Attached for release to the market is a copy of the power point presentation given at the Annual General Meeting of the shareholders of Phosphagenics Limited in Melbourne today by Chief Executive Officer, Dr Esra Ogru.
-ENDS- For further information, please contact Dr Esra Ogru David Segal Chief Executive Officer Investor Relations Manager Phosphagenics Limited Phosphagenics Limited +61 3 9565 1119 +61 3 9565 1103 Rudi Michelson Monsoon Communications + 61 3 9620 3333 About Phosphagenics Phosphagenics Limited is commercialising drug delivery applications based on its novel transdermal (drugs administered via skin) TPM® – Targeted Penetration Matrix technology. TPM® is a patient friendly and cost effective system used to deliver proven pharmaceutical and nutraceutical products. The lead product advancing through clinical trials are an oxycodone and oxymorphone matrix system for the relief of chronic pain. Phosphagenics’ shares are listed on the Australian Securities Exchange (POH) and its ADR – Level 1 program in the US is with The Bank of New York Mellon (PPGNY). www.phosphagenics.com www.elixia.com.au
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TPM® : Development and Commercialisation
Annual General Meeting17 May 2013
Dr Esra OgruChief Executive Officer
PHOSPHAGENICS
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Disclaimer
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This presentation contains forward-looking statements based on current
expectations of future events. If underlying assumptions prove inaccurate or
unknown risks or uncertainties materialise, actual results could vary materially
from Phosphagenics' expectations and projections. Risks and uncertainties
include general industry conditions and competition; economic conditions,
such as interest rate and currency exchange rate fluctuations; technological
advances and patents attained by competitors; challenges inherent in new
product development, including obtaining regulatory approvals; domestic
and foreign health care reforms and governmental laws and regulations.
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PHOSPHAGENICS
PHOSPHAGENICS LIMITED IS A GLOBAL LEADER IN THE DEVELOPMENT OF TOPICAL AND TRANSDERMAL PRODUCTS FOR HUMAN AND ANIMAL HEALTH USING ITS PROPRIETARY DELIVERY SYSTEM - TPM® -TARGETED PENETRATION MATRIX TECHNOLOGY
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Overview
• Creating long term share holder value
• Creating low risk opportunities across multiple markets
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PAIN
INJECTABLES
ANIMAL HEALTHMASTITIS MANAGEMENT
PERSONAL CARE & DERMATOLOGY PEAU DE VIERGE
MASS MARKET
TPM® Delivery System Overview –Key Current Projects
TPM® as a delivery system
TPM® delivery system
Oxycodone (Labtec)
Mastitis - cattle (USDA)
Selenium - horses (Equine Nutrition Aus)
Elixia®/BioElixia® (own brand)
Le Métier de Beauté® (licensed brand)
Mass market - GNC
Injectable Solubilizer (Strides - now Mylan)
Diclofenac (Novartis; Themis; Nippon Zoki)
Oxymorphone (developed internally)
Anti-acne therapies
Intas INDIA - (licensed brand)
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COMMERCIALISATION UPDATE
Applications of TPM®
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Creating Value….Strong Partnerships
• Creating value and reducing risk by leveraging TPM® technology and products across diverse markets
• Create global strategic alliances in the field of pain, dermatology, animal health and skin care
• Our partners provide:– Credibility– Financial and technical support– Reduce risk through diversification– Commercialisation pathway
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TPM® Commercialisation Timetable
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Project Partner Status
Diclofenac prescription product
Themis (India)NOVARTIS (India)
Product launch Q3/2013Product launch Q3/2013
Injectable Antibiotic prescription
Strides (now Mylan) (Global)
Estimated launch date2015
PersonalCare/Dermatology/OTC
Intas (India) Product launch H2/2013
Selenium/HorseSupplements
Equine NutritionAustralia (ENA)(Global)
Commercialised – roll out to Asia
Diclofenac prescription product
Nippon Zoki (USA) Estimated launch2015F
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Project Partner Status
Personal Care/OTC GNC Launch Q2/2013
Personal Care/OTC Korea Launch Q3/2013
Personal Care/OTC Le Métier de Beauté (USA)
Commercialised
Personal Care/OTC Ashland (Global) Commercialised
TPM® Commercialisation Timetable
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TPM® Commercialisation Timetable
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Project Partner Status
Oxycodone patch TBD Licensing target date 2014
Oxymorphone patch TBD Licensing target date 2014
Oxycodone topical product
TBD Licensing target date 2014
Mastitis management for Dairy Cows
TBD Commercialisation target 2015
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OPIOID PATCH PROGRAMUPDATE
Pharmaceutical Applications of TPM®
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Opioid Development
• Patch development program
– Development of transdermal patches for the treatment of chronic pain
– Products incorporate TPM®
– Developed for the sustained delivery of opioids over 72 hours
Butrans* Doses above 20mcg/hr not recommended due to QTc prolongation limits upward titration to moderate-severe pain
* Irritation issues limit compliance and persistency
Duragesic*Not indicated in patients who are not opioid-tolerant
* 100 times more potent than morphine (iv)
Mild-to-Moderate Pain
Moderate Pain
Severe Pain
TPM® OxyC and OxyM well positioned formoderate-to-severe pain patients
Pain Management Environment
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About POH TPM® Patches
ü Patches are formulated as a drug-in-adhesive matrix patch• Phosphagenics
proprietary TPM® is the key excipient
ü Patent protected formulations
ü US 505(b)2 Development Pathway
ü Flexible dosing through multiple patch sizes
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The FDA has issued new “abuse-deterrence” labeling information for OxyContin and has blocked potential
generic versions of the original formulation that do not have abuse-deterrent properties
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About POH TPM® Patches
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Program H1/2013 Phase 1 H2/2013Phase 2 – Phase 3
TPM/oxycodonePatch
Phase 1New patch systemAssessment underway
Efficacy trials – smallEfficacy trials – large group
TPM/oxymorphonePatch
Phase 1 - completed Efficacy trials
TPM/oxycodone Topical
Efficacy trials
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DERMATOLOGY PROGRAMUPDATE
Applications of TPM®
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TPM® Dermatology Programs
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• TPM® is a multi-component, multi-functional delivery system
• TPM® is compromised of α-TP and α-T2P
• The ratios of the two entities can be altered to modulate the depth of delivery
• Unique properties enable TPM® to be used in dermatology to improve delivery of actives, improve efficacy and reduce side effects
• TPM/retinoic acid is currently in development for the treatment of mild –severe acne vulgaris For
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Human Study increased dermal absorption of tretinoin with TPM®
• Study Conditions:- Equivalent dose of Retin-A (Jannsen-Cilag) and TPM/tretinoin - N=16 tape strips taken at each time point. First strip discarded. Results pooled - N = 10 healthy volunteers, bars represent SEM
• Study Conclusion:- TPM/tretinoin lead to 4-fold increase in tretinoin absorption (p<0.05) and increased
penetration (p<0.02) compared to Retin-A with 22-fold increase in deepest layer
Depth of tretinoin penetration 1 hour after topical application
0 50 100 150 200 250 300 350
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5-7
8-11
12-16
Tape
str
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Average tretinoin per strip (ng)
TPM/RA
Retin-A
Total Absorption Penetration
Dermatology Application – TPM/Retinoic Acid
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TPM® Dermatology Programs
✔ Phase 2/3 Q3 2013
✔ Reduction of Irritation
✔ TPM differentiated products with superior delivery
✔ Significant advantage over commercialised products
✔ 505(b)2 development pathway
✔ Strong patent position
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CREATING VALUE
Applications of TPM®
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Long Term Growth
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10%
30%
50%
70%
90%
110%
130%
150%
08 May 12 12 Jun 12 17 Jul 12 21 Aug 12 25 Sep 12 30 Oct 12 04 Dec 12 11 Jan 13 18 Feb 13 25 Mar 13 02 May 13
POH.ASX ACR.ASX BNO.ASX GID.ASX MSB.ASX NAN.ASX
About 6 out of 10 peers had suffered similar large losses as ourselves over the last twelve months. The health index has gone up around 40%. This reflects huge rises in large cap companies who are heavily weighted in the index.
THIS REFLECTS A COMMON THEME IN THE MARKET AS A WHOLE where the All Ordinaries index has risen 20% and the resources index has fallen almost 10%. For
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Development & Execution
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• Strong news flow for 2013 onwards….
• Ongoing communication
• Regular updates
• Timelines
• Managed and de-risked programs
• Commercial execution
• Continue with commercialisation across multiple market segments
• Create multiple opportunities and multiple strategies
• Focused
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Strong News Flow
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Clinical development of TPM/oxycodone Q2/2013 ✔
Clinical development of TPM/oxymorphone Q2/2013 ✔
Expansion of TPM/diclofenac program with Nippon Zoki (Japan)
H2 /2013 ✔
Strategic partnership for TPM Mastitis Project - USDA Q2/2013 ✔
Novartis -Expansion of strategic partnership for TPM/diclofenac
