Company Announcement 31 May 2011 Phosphagenics Limited JUNE 2011 NEWSLETTER Attached for release to the market is a copy of the Company s June 2011 Newsletter to shareholders. In addition to receiving the printed Newsletter members and investors can view the Newsletter on the Company s website as noted below. ENDS Enquiries: Dr Esra Ogru Rudi Michelson Chief Executive Officer Monsoon Communications Phosphagenics Limited +61 3 9620 3333 +61 3 9565 1119 About Phosphagenics Phosphagenics 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 is an oxycodone 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 Page 1 of 1
PHOSPHAGENICS Newsletter June 2011 PHOSPHAGENICS LIMITED ABN: 32 056 482 403 Dear Shareholders, TPM/oxycodone patch, and two exciting dermatology It is an exciting time to update you again as three diverse Phosphagenics endeavors In our Nutraceutical division, pilot studies in dairy gather momentum towards commercial cattle have shown the benefit of using TPM technology reality. Our ELIXIA product line is expanding to deliver nutritional supplements to cattle, potentially and making a splash in the media through promotions on TVSN, Today Tonight and A Current Affair. Our farmers most significant problems improving the new e-commerce website is open for business and the ELIXIA projects have passed critical milestones. providing a natural product to meet one of dairy quality of milk supply. BodyShaper Cellulite Contour Crème has hit the shelves. We are thrilled with all the emerging opportunities for In the Pharmaceutical division, we continue to work with Phosphagenics. We thank you for your continued support and 3M who are adding expertise to our own, to the benefit of the we look forward to updating you regularly throughout 2011. IN THE PIPELINE Product Target Application Research and development Pre-clinical Phase 1 Phase 2 Phase 3 Drug Delivery Pharmaceutical Insulin Insulin Novartis Veterinary Oxycodone CSL Actives Lidocaine Diclofenac Diabetes Diabetes Drug Delivery Dermatology Retinoic Acid US Dermatology Company Global Dermatology Company Acne Dermatitis/Psoriasis Acne Product Target Application Product development Cosmetic ELIXIA ELIXIA high Performance Range ELIXIA AOP9604 Le Métier de Beauté Peau Vierge Active Delivery Oral Natural Anti-ageing Anti-ageing Body Sculpting Anti-ageing IND Granted Market development Commercial production Launch For personal use only Message from Dr Esra Ogru, Joint CEO, Phosphagenics Limited Nutritional Supplements Animal Feed Nutritional Supplements Dairy Cattle Antioxidants Antioxidants KEY Phosphagenics Project Collaborative Project for Commercial Partner
PHOSPHAGENICS Personal Care Division PERSONAL CARE UPDATE Phosphagenics Personal Care division has been working towards our goals for 2011, and there has been plenty of activity surrounding the new ELIXIA skincare launch, as well as our new BodyShaper Cellulite Contour Crème. Recent media activity surrounding our new ELIXIA BodyShaper Cellulite Crème has increased the spotlight on Phosphagenics and created exciting opportunities for the brand in Australia and in key export markets. Updated marketplace activity for ELIXIA in recent times include: RETAIL LAUNCHES TVSN mid-march 2011 ELIXIA skincare world launch. Sales expectations exceeded in three days on air (six live on air hours) TVSN mid-may 2011 featured ELIXIA BodyShaper Cellulite Crème. Dr Esra Ogru again in the spotlight launching ELIXIA BodyShaper Cellulite Crème to the Australian market ELIXIA launch into Myer department stores Discussions to sign new ELIXIA distributor in Hong Kong, with exclusive distribution to spa, salon and beauty school channels in Hong Kong and Macau Discussions regarding ELIXIA distribution in India ADVERTISING/MEDIA Today Tonight feature on Channel 7 (11 April 2011) BodyShaper Cellulite Contour Crème More than 1000 email enquiries at launch (12 April 2011) A Current Affair feature on Channel 9 (17 May 2011) focus on elixia, TPM and Myer Melbourne launch Body + Soul national print ad (10 April 2011) ELIXIA High Performance skincare launch, exclusive to TVSN Body + Soul national print ad (17 April 2011) free HC reader offer x 50 readers Body + Soul national print ad (1 May 2011) elixia High Performance skincare Available online at www.elixia.com.au Woman s Day (30 May 2011 issue) full page featuring ELIXIA BodyShaper, available online and at selected Myer stores The Australian Women s Weekly (June 2011 issue) full page featuring ELIXIA BodyShaper, available online ONLINE ACTIVITY Launched new e-commerce website (18 April 2011) Database members greater than 12,000 Website visits 17,099 (27 April 2011) Unique (new user) visits 12,088 (73% of total visits) Launched ELIXIA Facebook page (18 April 2011) SHAREHOLDERS ASX Press Release (AOD) BodyShaper eight week results and Myer launch (17 May 2011) ASX Press Release (AOD) BodyShaper four week clinical trial results (11 April 2011) Phosphagenics Shareholder VIP Card (Feb April 2011) Offer of 25% discount when purchasing online at www.elixia.com.au using VIP Shareholder code Phosphagenics Newsletter June 2011
Phosphagenics recently announced an ongoing collaboration with a major global dermatology company Pharmaceutical Division r & d update TPM enhances dermatology actives Phosphagenics is continuing to make significant inroads into the field of prescription dermatology, with two independent collaborative programs passing critical milestones. COMMERCIAL TPM/OXYCODONE PATCH MANUFACTURE in PARTNERSHIP WITH 3M The TPM/oxycodone patch remains the focus for Phosphagenics Pharmaceutical division, with the commercial development of the patch by 3M the next major milestone. In February, a senior 3M scientist from the Drug Delivery Systems division spent time at Phosphagenics in Melbourne, overseeing the transfer of the technology to the 3M manufacturing facility in Minnesota USA. This process is now complete and 3M are now adapting the Phosphagenics patch to their manufacturing lines to produce a product with superior efficacy, finish and reproducibility compared to the lab scale patches made at Phosphagenics. 3M s brief involvement thus far has already produced a five-fold improvement in patch delivery, dramatically improving the commercial acceptability of the patch, with further improvements expected before development is complete. The next phase of Phosphagenics clinical development for the TPM/oxycodone patch will involve Phase 2/3 human trials in an appropriate pain model. The optimal finished product manufactured by 3M will be used for these critical Phase 2/3 studies. Phosphagenics aims to commence its Phase 2/3 clinical study during the second half of 2011. Phosphagenics remains on track to be the world first to develop an effective and reliable patch system for the administration of oxycodone to pain sufferers in a safe and patient-friendly manner. In the first of these alliances, a US-based dermatology company approached Phosphagenics to determine whether TPM could increase the delivery of a potent topical steroid used for the treatment of a range of skin conditions, including eczema, dermatitis and psoriasis. A collaborative program was initiated, whereby TPM was found to significantly increase the delivery of the active into skin in vitro. The results were of sufficient magnitude to compel the US-based dermatology company to apply to the Food and Drug Administration (FDA) for an Investigational New Drug (IND) application, with the aim of conducting a human clinical trial to test the product in the US. As part of the IND submission, a detailed package was assembled documenting all aspects of the TPM technology, its safety and stability. The FDA granted the IND at the beginning of the year, marking the first time that the TPM technology has passed FDA scrutiny. The US-based dermatology company is currently planning the human study which is expected to begin mid-year. TPM/oxycodone Relief Patch Peel-off tab adhesive patch treatment area In relation to the second program, Phosphagenics recently announced an ongoing collaboration with a major global dermatology company to develop a novel anti-acne therapy using the TPM delivery system. Phosphagenics has undertaken extensive formulation development studies for the new product that combines Phosphagenics TPM platform delivery technology with a proprietary anti-acne drug. These formulations have been optimised to maximise drug delivery into the skin and are now in formal stability trials. Although the details of this collaboration must remain confidential, it is of high priority to Phosphagenics, with the potential for immediate access to a global market in partnership with a major player in the field of dermatology. Phosphagenics Newsletter June 2011
nutraceutical ELIXIA CHRISTMAS Division 2010 Animal Nutrition Phosphagenics has been actively seeking opportunities to improve human nutrition in recent years and now has an opportunity to apply this same expertise to animal nutrition. Optimal nutrition in animals is crucial for the prevention and management of a range of diseases and conditions. TPM delivery technology is being utilised to enhance the benefits of key vitamins and trace elements in a range of animals, including applications in production animals through to domesticated animals and pets. Dairy INDUSTRY Phosphagenics has partnered with dairy research company Mastitis Management Australia (MMA) to employ its TPM delivery technology to deliver an all-natural formula targeting the improvement in milk quality and therefore increased prices and production capacity. Recent trials of the natural formula have shown the somatic cell counts (SCC) in some cows has been reduced by up to 90% in four weeks. SCC levels are used as a measure of milk quality. The new technology will be sold as a dietary supplement aimed at improving the bioavailability of key nutrients (such as antioxidants), targeting susceptible cattle and providing a benefit as part of a natural holistic approach to control SCC within the herd. Key vitamins and minerals are integral components of the defence of tissues and cells, and influence a cow s resistance to infection. An improved resistance to infection may significantly lower the frequency and shorten the duration of illness, and potentially improve milk quality by reducing somatic cell counts. By employing the versatile TPM delivery technology, we aim to provide a superior benefit to farmers globally by reducing the down time, i.e. withholding periods for the milk produced by the animals treated with expensive drug treatments. mastitis management-australia.com elixia products available AT MYER, online and via TVSN www.elixia.com.au Phosphagenics Limited 11 Duerdin Street, Clayton VIC 3168 Australia PO Box 1415, Clayton South MDC VIC 3169 Ph: +61 3 9565 1119 Fax: + 61 3 9565 1151 Security Codes: ASX (POH) ; OTCQX (PPGNY) www.phosphagenics.com email: info@phosphagenics.com