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1 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. For further information, please contact -ENDS- Dr Esra Ogru David Segal Chief Executive Officer Investor Relations Manager Phosphagenics Limited Phosphagenics Limited Rudi Michelson Monsoon Communications 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). Phosphagenics Limited ACN ABN Duerdin Street, Clayton Victoria 3168 Australia Telephone: Facsimile: Web : info@phosphagenics.com
2 TPM : Development and Commercialisation Annual General Meeting 17 May 2013 Dr Esra Ogru Chief Executive Officer
3 Disclaimer 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. 2
4 Overview 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 Creating long term share holder value Creating low risk opportunities across multiple markets 3
5 TPM Delivery System Overview Key Current Projects Oxycodone (Labtec) PAIN Oxymorphone (developed internally) Diclofenac (Novartis; Themis; Nippon Zoki) INJECTABLES Injectable Solubilizer (Strides - now Mylan) TPM delivery as a delivery system system ANIMAL HEALTH Mastitis - cattle (USDA) Selenium MASTITIS - horses MANAGEMENT (Equine Nutrition Aus) PERSONAL CARE & DERMATOLOGY Elixia /BioElixia (own brand) Le Métier de Beauté (licensed brand) PEAU Mass DE market VIERGE - GNC MASS MARKET Intas INDIA - (licensed brand) Anti-acne therapies 4
6 Applications of TPM COMMERCIALISATION UPDATE 5
7 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 6
8 TPM Commercialisation Timetable Project Partner Status Diclofenac prescription product Themis (India) NOVARTIS (India) Product launch Q3/2013 Product launch Q3/2013 Injectable Antibiotic prescription Strides (now Mylan) (Global) Estimated launch date 2015 Personal Care/Dermatology/OTC Intas (India) Product launch H2/2013 Selenium/Horse Supplements Equine Nutrition Australia (ENA) (Global) Commercialised roll out to Asia Diclofenac prescription product Nippon Zoki (USA) Estimated launch
9 TPM Commercialisation Timetable 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 8
10 TPM Commercialisation Timetable 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
11 Pharmaceutical Applications of TPM OPIOID PATCH PROGRAM UPDATE 10
12 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 Two products in development: Oxycodone - systemic/topical Oxymorphone - systemic 11
13 Pain Management Environment TPM OxyC and OxyM well positioned for moderate-to-severe pain patients Severe Pain Mild-to- Moderate Pain Butrans Moderate Pain * 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) 12
14 About POH TPM Patches Patches are formulated as a drug-in-adhesive matrix patch Phosphagenics proprietary TPM is the key excipient Patent protected formulations US 505(b)2 Development Pathway Flexible dosing through multiple patch sizes 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 13
15 About POH TPM Patches Program H1/2013 Phase 1 H2/2013 Phase 2 Phase 3 TPM/oxycodone Patch Phase 1 New patch system Assessment underway Efficacy trials small Efficacy trials large group TPM/oxymorphone Patch TPM/oxycodone Topical Phase 1 - completed Efficacy trials Efficacy trials 14
16 Applications of TPM DERMATOLOGY PROGRAM UPDATE 15
17 TPM Dermatology Programs TPM is a multi-component, multi-functional delivery system TPM is compromised of α-tp and α-t 2 P 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 16
18 Human Study increased dermal absorption of tretinoin with TPM Study Conditions: - Equivalent dose of Retin-A (Jannsen-Cilag) and TPM/tretinoin For personal use only Dermatology Application TPM/Retinoic Acid - N=16 tape strips taken at each time point. First strip discarded. Results pooled - N = 10 healthy volunteers, bars represent SEM Total Absorption Penetration Depth of tretinoin penetration 1 hour after topical application TPM/RA Retin-A Tape strips Average tretinoin per strip (ng) 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 17
19 TPM Dermatology Programs Phase 2/3 Q Reduction of Irritation TPM differentiated products with superior delivery Significant advantage over commercialised products 505(b)2 development pathway Strong patent position 18
20 Applications of TPM CREATING VALUE 19
21 Long Term Growth POH.ASX ACR.ASX BNO.ASX GID.ASX MSB.ASX NAN.ASX 150% 130% 110% 90% 70% 50% 30% 10% 08 May Jun Jul Aug Sep Oct Dec Jan Feb Mar May 13 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%. 20
22 Development & Execution 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 21
23 Strong News Flow Clinical development of TPM/oxycodone Clinical development of TPM/oxymorphone Expansion of TPM/diclofenac program with Nippon Zoki (Japan) Strategic partnership for TPM Mastitis Project - USDA Novartis -Expansion of strategic partnership for TPM/diclofenac Q2/2013 Q2/2013 H2 /2013 Q2/2013 Q2/2013 Phase 2 TPM/retinoic acid (dermatology) Q3/2013 Phase 2 TPM/ketocanozole (dermatology) Q4/2013 Phase 2 TPM/oxycodone topical assessment Q3/
24
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