oxcodone progress/status

Here is an outline of the progress of the oxycodone patch project based on official releases by POH to the ASX. I hope that others might find it a useful aid in assessing the present status of the project.

Excerpts from formal ASX releases are in italic. Quotations are in italics and set off by quotation marks. All quotations are attributed.

Any comments of my own are in plain text.

I have not attempted to be totally comprehensive, but I have concentrated on three interrelated aspects of the program that I see as crucial to market valuation of both the program and the company:

• Regulatory - by this I mean to refer to aspects of the program designed to meet government regulatory requirements.

• Schedule - by this I mean to refer to the prospective timeline to commercialization as it has evolved over time.

• Commercial Potential - by this I mean to refer to statements by the company that provide insight into the future commercial prospects for the oxycodone patch.

REGULATORY

19 September 2011 Phosphagenics has appointed a prestigious steering committee to design and oversee the upcoming trials and to ensure that the strict regulatory requirements needed to obtain FDA approval are met. The four member committee consists of two clinical pain experts who are highly regarded internationally and two US based regulatory advisers.

Dr Ogru added, “The successful completion of the upcoming human trials will result in major commercial opportunities for the company and represents the culmination of many years of development.”

“Our TPM/oxycodone patch has ticked all the boxes with respect to clinical efficacy, safety, abuse profile and market potential. We look forward to our upcoming trials and anticipate a swift path to market.”

21 November 2011 Australian drug delivery technology company Phosphagenics Limited has been granted ethics approval to begin clinical trials on its leading pharmaceutical product, a TPM/oxycodone patch to manage chronic pain. The trials will start at the end of November 2011.

This pharmacokinetic study will examine the safety and tolerability of the patch, which has been optimised in collaboration with global company 3M, and builds on Phosphagenics’ proprietary transdermal TPM® platform delivery technology.

Sixty-five healthy subjects will participate in the trials at the CMAX facilities at the Royal Adelaide Hospital. The trials are designed to examine the oxycodone delivery profile of the newly developed patch. In the first stage of the trial subjects will be administered a single dose patch; the second stage will examine repeat dosing.

Dr Ogru said the trials were designed to capture the pivotal data that would form the basis of the IND regulatory submission to the FDA and to ensure the upcoming Phase 3 trials proceed as seamlessly as possible.

15 February 2012 “Clinically the new patch is of significant benefit from a safety and anti-abuse perspective in comparison to current oral dosage forms. Our patch with the sustained delivery profile will minimise the potential for overdose, reduce the rate at which drug tolerance develops and improve patient compliance.

“We believe that this result will be looked upon positively by both clinicians and the regulatory agencies.”

Phosphagenics’ top-level regulatory advisors have responded favourably to the trial results. Our senior advisor, Lee S Simon MD, a former Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products (DAAODP) at the FDA commented: “The delivery profile from this patch is extremely interesting and points to the need to engage with the FDA as soon as is practically possible. These results indicate that Phosphagenics is well on the way to creating a unique product.”

Prior to starting the Phase 3 program Phosphagenics will meet with the US FDA to get clinical study sign-off.

01 August 2012 “We are confident this partnership will ensure success at these crucial final stages. Together with our existing Pain Advisory Board, we believe the appointment of Neura will ensure the development of a commercially relevant product as we prepare a high quality package for the FDA.”

SCHEDULE

23 May 2011 Successful completion of this scale up stage will lead to commencement of Phase 2/3 clinical trials scheduled to start in Australia Q4/2011.

19 September 2011 Phosphagenics’ pivotal phase human trial program will begin in Australia in the next quarter and will be expanded next year into other countries including the United States. It is anticipated that Phase 3 will be completed by 2013.

21 November 2011 Results from this study will be used to design the upcoming Phase 3 trial scheduled to commence in the third quarter of 2012.

“We expect this trial will confirm the superior efficacy of the optimised commercial product and demonstrate a sustained drug delivery appropriate for the treatment of chronic pain. Our aim is to ensure Phase 3 trials are accelerated which will result in the swiftest path to market.”

23 May 2012 Once the Phase 3 clinical program commences, further changes cannot easily be made to the product. The company needs to optimise the commercial design of the patch prior to commencing the pivotal Phase 3 trial by Q1/2013. Based on current projections, this trial remains fully funded by the capital raising undertaken late last year.

05 June 2012 The Company remains on track to initiate the pivotal Phase 3 trial in Q1CY/2013.

01 August 2012 Dr Ogru said Phosphagenics’ expectation of returning to the clinic before the end of the year with an improved patch that has no crystallisation issues is on track, with patch development work progressing “according to plan”.

COMMERCIAL POTENTIAL

16 November 2010 Dr Ogru said, “The oxycodone patch is the company’s lead product and we are encouraged by the recent successful trials. 3M is a world leader in patch development and manufacturing. It is a company that commands respect around the world and we are thrilled to work with a company with depth and world market reach.”

23 May 2011 Phosphagenics’ CEO, Dr Esra Ogru, said the original patch prototype was very effective in human trials. But the technology has been boosted by an astounding 5 fold improvement in delivering the drug through human skin during in vitro studies, resulting from the collaboration with 3M. This should substantially improve the commercial prospects for the patch.

“Working with 3M with its expertise in patch technology and manufacturing has enabled us to refine and dramatically improve the delivery of oxycodone patch,” she said.

Dr Ogru said the oxycodone patch development program remains a primary focus.

“Oxycodone patch development is the core company pharmaceutical product and its commercialisation is the company’s number one imperative. It offers the best medium term value inflection potential for the company,” she said.

The global market for products to manage chronic pain is estimated at US$6 billion per annum. The oxycodone market is US$3.2 billion per annum with only oral forms of the powerful painkiller currently available.

19 September 2011 Oxycodone is one of the most prescribed pain drugs by physicians and the current market for oral forms of the drug is more than $3.5 billion.

21 November 2011 Dr Ogru noted: “This is a first-in-class product and a revolutionary way of transdermally delivering the powerful painkiller oxycodone which we believe will address many of the abuse issues related to this drug. According to a recently completed Physicians’ Survey projected demand for this product is expected to exceed $1 billion per annum.”

15 February 2012 Based on a previously announced Physician’s Survey, projected demand for the TPM/oxycodone patch is expected to exceed $1 billion per annum. The current global oxycodone market exceeds $3 billion per annum.

23 May 2012 In the meantime, the company is actively planning all aspects of the Phase 3 trial, including the commercial positioning of the product. An analysis of the oxycodone market, which exceeds $3 billion annually, indicates that with the competitive clinical benefits of the TPM/oxycodone patch the company expects to generate significant market share and revenue from this product.

The results of a previously announced survey commissioned by Phosphagenics indicated that projected revenues for the TPM/oxycodone should reach around $1 billion per annum.

01 August 2012 - With respect to the appointment of Neura Therapeutik, Phosphagenics CEO, Dr Esra Ogru, said the strategic partnership would assist with development, approval, partnering and marketing processes. The companies would collaborate to ensure all appropriate commercial parameters were considered in the design of the pivotal Phase 3 program.

“We remain committed and focused on the commercialisation of our TPM/oxycodone patch,” Dr Ogru said.

SUMMARY

It is very clear from the totality of evidence that the oxycodone patch is effective, will be supported by a comprehensive and persuasive regulatory submittal, and upon regulatory approval, is destined for ultimate commercial success.

The only questions that presently linger relate to the timetable and road map forward.

These issues are likely to be clarified soon. A week or so ago I asked David Segal about this and this was his reply:

“The timetable for lodgement of the IND is an item for discussion in a number of strategy meetings taking place over the next few weeks. We are due to release a newsletter next month and are likely to have a patch update relatively soon.

We will make sure that an expected timetable is part of the information that is released to the market.”