Phosphagenics Initiates Clinical Program with Oxymorphone TPM® Patch Expansion of pain portfolio to include Oxycodone and Oxymorphone Oxymorphone Phase 1 trial to begin February 2013 Royal Adelaide Hospital
16 January 2013, Melbourne, Australia: Melbourne drug delivery technology company, Phosphagenics Limited (ASX: POH, OTCQX: PPGNY), will launch a Phase 1 study of a transdermal patch incorporating the powerful opioid oxymorphone in early February. The patch design incorporates the Company’s proprietary TPM® platform delivery technology to enable superior delivery of the potent compound, which is used to manage chronic pain. The study will be conducted at the Royal Adelaide Hospital with results expected to be announced in March. Oxymorphone is an opioid analgesic used for the relief of moderate-to-severe chronic pain. In an extended-release formulation it is used for patients requiring around-the- clock pain relief. The compound is ideally suited for use in a 72-hour patch. Oxymorphone is following a similar commercial path to oxycodone. Since the FDA approved oxymorphone in an extended release (twice a day) oral formulation in 2006, it has experienced meteoric sales growth in the USA, generating revenues of over $600 million in 2012. Prior to 2006, sales of the compound were negligible. Phosphagenics’ current pain portfolio includes both oxycodone and oxymorphone. The combined US market for these two compounds, which are currently administered orally, exceeds 70 per cent of the $5 billion extended-release opioid market. While oxycodone dominates the market, sales of oxymorphone grew by over 17 per cent in 2012 to become the third largest opioid in the category. Oxymorphone is a significantly more potent opioid than oxycodone. It is also less orally bioavailable. These factors mean oxymorphone presents Phosphagenics with another blockbuster opportunity. The Company is preparing to re-enter the clinic to conduct a multi-dose trial with its lead product, oxycodone patch. This product has been in development with global leaders in patch design and development over an extended period. The knowledge and experience gained by Phosphagenics during this process has enabled it to take oxymorphone from concept to clinic in approximately six months. This acquired capability, coupled with the superiority of the TPM® delivery platform, bodes well for the rapid expansion of the Company’s pain portfolio to include other opioids. Phosphagenics’ CEO, Dr Esra Ogru, said transdermal delivery of oxymorphone provided greater flexibility in terms of patch size and efficacy. Furthermore, transdermal delivery addresses the substantial food effect and low bioavailability associated with oral delivery of this compound. The Company has been in discussions with its US strategic commercial development partners, Neura Therapeutik, to define the main requirements for ongoing clinical and non-clinical development of the oxymorphone patch. This includes the preparation of a Target Product Profile, which the Company plans to research with potential patients and prescribers. Dr Ogru said: “We believe oxymorphone would be a suitable companion product to oxycodone in any transdermal pain management portfolio. Together, these products would be appropriate for tackling all levels of chronic pain indications from opioid naïve to opioid experienced patients.” She added: “We will build on the momentum generated by our development team in getting oxymorphone to the clinic so quickly and will aggressively pursue the clinical development program and the possibility of an early licensing deal.” Phosphagenics has started planning for the next stage of oxymorphone clinical trials. It is also on track to return its oxycodone patch to the clinic.
Phosphagenics oxymorphone pain patch close to clinic
Phase I trial planned for February
January 22, 2013 | By Suzanne Elvidge
Phosphagenics' ($PPGNY) 72-hour oxymorphone transdermal patch is set to enter the clinic next month, in a Phase I trial in Australia's Royal Adelaide Hospital. Results are expected as early as March.
Oxymorphone is a semisynthetic opioid for the management of chronic pain, but oral use is complicated by food effects and problems with bioavailability. The patch uses the Melbourne-based company's TPM (Targeted Penetration Matrix) delivery system to get around the issues of oral dosing, and has been developed to deliver round-the-clock pain control. Phosphagenics' TPM delivery system is designed to deliver small and large molecules as a patch, ointment, gel or oral liquid. Controlling the sizes of the vesicles carrying the drugs can modify the rate at which the active agent is delivered.
Phosphagenics has another TPM pain patch in its portfolio. Its lead oxycodone patch, in development in collaboration with 3M ($MMM), is expected to enter multidose trials this year, and may be the first sustained-release oxycodone patch to reach the market. The oxycodone patch went through some formulation and crystallization issues, but the learning from these has enabled the oxymorphone patch to be developed in just 6 months from concept to clinic.
"Together, these products would be appropriate for tackling all levels of chronic pain indications from opioid naïve to opioid experienced patients," says Phosphagenics' CEO, Esra Ogru.
The U.S. extended release opioid market is large, at around $5 billion, and is dominated by oxymorphone and oxycodone, suggesting a major sales opportunity for Phosphagenics and its U.S. commercial development partner Neura Therapeutik, should the patch products reach the market.
The partners have worked through crystallization issues and according to Phosphagenics, these have all been resolved and the formulation improved, to the point that a multidose clinical trial is planned for early next year.
Fast forward a month later and recent update highlights the speed at which development took place. I know I've mentioned this before, but this is a BIG selling point imo.
The oxycodone patch went through some formulation and crystallization issues, but the learning from these has enabled the oxymorphone patch to be developed in just 6 months from concept to clinic.
11 February 2013, Melbourne, Australia: Melbourne drug delivery technology company, Phosphagenics Limited (ASX: POH, OTCQX: PPGNY), is preparing to re-enter the clinic with its lead transdermal TPM® oxycodone patch technology by the end of Quarter 1. The patch has been successfully refined in collaboration with European development partner tesa Labtec GmbH – a company well regarded for its opioid patch development expertise. Extensive in-vitro testing indicates all crystallisation issues experienced with earlier designs have now all been resolved. Dr Ogru said this TPM® oxycodone patch and the company’s transdermal TPM® oxymorphone patch - also in clinical trial this quarter - would be vital components of a wider pain management portfolio. “Together these opioid candidates represent the implementation of the Company’s strategy to leverage the powerful TPM® platform delivery technology to develop a range of innovative transdermal products that are capable of managing all levels of chronic pain.” Phosphagenics is now actively planning all aspects of the clinical program to enable the Company to maximise the commercialisation potential of the patch portfolio.
ASX Limited Market Announcements Office Phosphagenics Further Expands Pain Portfolio Topical oxycodone opportunity Phosphagenics has achieved outstanding results from pre-clinical trial US$4 billion global topical pain market Topical oxycodone to join oxycodone and oxymorphone opioid patches in 2013 clinical trials 20 February 2013, Melbourne, Australia: Melbourne drug delivery technology company, Phosphagenics Limited (ASX: POH, OTCQX: PPGNY), has completed a pre-clinical study demonstrating that its oxycodone/TPM® technology can reduce local pain without the need to deliver oxycodone into the bloodstream. This discovery has significant commercial implications and the Company intends to commence clinical trials in Quarter 3 of 2013. These trials would be additional to the current oxymorphone and oxycodone patch trials referred to in recent announcements. This product represents a further extension to Phosphagenics’ pain product development program. The finding stems from TPM’s unique ability to deliver molecules in a targeted manner either into the skin or through the skin into the bloodstream, by modifying the formulation. Phosphagenics has formulated TPM® to deliver compounds into the skin for its many topical dermatological and personal care applications. In the pre-clinical study on oxycodone/TPM® for localised pain, TPM® was formulated to deliver oxycodone into the localised area of application, without spillage into the blood. This potential new application of oxycodone to local pain further broadens the Company’s pain franchise. The pre-clinical study in an appropriate pain model demonstrated a significant reduction in pain after topical application of the oxycodone/TPM® formulation, as compared to a control. The investigation also found the opioid worked rapidly and did not enter the bloodstream. A topical opioid able to act directly on inflamed tissue, without delivery into the systemic circulation, could eliminate all side effects associated with ingestion of the oral dosage form. It would therefore represent a much safer dosage form, and may be appropriate for localised pain indications that have traditionally proven very difficult to treat. These include both post-herpetic neuralgia/shingles and diabetic neuropathy. Phosphagenics’ CEO, Dr Esra Ogru, said the company was keen to expand its pain portfolio and progress further trials of topical TPM® oxycodone technology.
There is no topical opioid product on the market and sales of non-opioid pain drugs prescribed for localised pain exceed US$4 billion annually. Endo Pharmaceutical’s market leading topical pain product, LidodermTM, is used to treat neuropathic pain but belongs to a different class of non-opioid analgesic compounds. Dr Ogru said: “Delivering a powerful opioid like oxycodone topically has never been achieved commercially. It has been widely assumed that opioids can only treat pain by systemic delivery, that is, via the blood stream. Our study confirms more recent findings that opioid receptors are up-regulated in tissue in response to pain, particularly pain associated with inflammation.” Dr Ogru added: “There is no other company in the area of transdermal delivery of pain drugs progressing multiple products with multiple applications. This potential new application of oxycodone to local pain further broadens our pain franchise. We remain committed to our strategy of building a first class pain portfolio comprising a series of compounds with the ability to manage all levels of pain, with various application methods. Underpinning this entire platform is our TPM® delivery technology which we are continuously demonstrating enables superior delivery of many compounds.” Release of the conclusions from this pre-clinical investigation coincides with Phosphagenics’ two further clinical trials of its TPM® opioid pain patch technology for the systemic treatment and management of chronic pain using oxycodone and oxymorphone. The combined US market for these two compounds, currently administered orally, exceeds 70 per cent of the $5 billion extended-release opioid market. While oxycodone dominates the market, sales of oxymorphone grew by over 17 per cent in 2012 to become the third largest opioid in the category. Ends Enquiries: Dr Esra Ogru Chief Executive Officer Phosphagenics Limited +61 3 9565 1119 Rudi Michelson Monsoon Communications +61 3 9620 3333 About Phosphagenics David Segal Investor Relations Manager Phosphagenics Limited +61 3 9565 1103 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 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.comwww.elixia.com.au