QRX Pharma: Finding ‘the holy grail of opioid pharmacology’




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Video title: QRX Pharma: Finding ‘the holy grail of opioid pharmacology’
Released on: December 13, 2010. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, Fintan Walton talks to Dr John W Holaday, Managing Director and CEO at QRX Pharma Ltd.
Origins and growth of QRxPharma
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at AusBiotech in Melbourne, in Australia. On this show I have got John Holaday , who is CEO and Managing Director of a company called QRxPharma based in Queensland, welcome to the show.
John Holaday:
Thank you very much, good to be here.
Fintan Walton:
John Holaday , your company focuses in the area of pain, tell us the story about QRx how was founded and when you got involved?
John Holaday:
Actually the story of QRx from the point of view of the pain product goes back over 200 years when Morphine was first isolated and purified from the opium poppy and since then chemist have looked for a better form of Morphine for treating moderate to severe pain and all the chemicals that they have invented the fentanyls, the oxycodone et cetera, in clinical practice showed the same side effects which severely limit the utility of these drugs for treating moderate to severe painnausea and vomiting, constipation, drowsiness, sedation, euphoria, respiratory depression et cetera. So what we have done is to show that the combination of Morphine and oxycodone when given together they violate each other's side effect profiles let the pain relief come through, so it's a way of getting pain relief without the side effect in many ways the holy grail of opioid pharmacology and this was recognized in Queensland at the University of Queensland by Professor Maree Smith, did the early research with the rats and the white goats and showed synergy and pain relief with fewer side effects and then that was slowly built from a private founding and early venture money here in Australia into a company that we took public in May of '08, excuse me May of '07 time flies and in that process build up some really value with the number of clinical trials showing that in people as in rats and mice you get better pain relief with a 50 to 75% reduction in side effects.
Fintan Walton:
And now let's go back when did you actually joined the company?
John Holaday:
In May of '07 when we took it public, I took the reigns from its prior founder Gary Pace and in that process with Garry still remains very active with us, but in that process got the value that we now have added through the course of clinic trials to include two pivotal studies one of which is nearing completion and other which was completed three months ago allowing us to file an NDA within the next few months.
Fintan Walton:
Okay, lets go back to 2007 still, because it was important because obviously with that IPO there is a significant amount of money had been raised at that time, can you talk about that?
John Holaday:
Indeed, JP Morgan underwrote the $50 million transaction on the ASX taking us public, which then and I think still is the largest life sciences transaction.
Fintan Walton:
Here in Australia?
John Holaday:
In Australia indeed, we took those money's put them to good use and did the clinical trial program that has now enabled us to be on the cost profiling our new drug application.
The challenges in taking combination product through regulatory process
Fintan Walton:
Right, and now clearly it's a combination product taking that through the regulatory process what was is it like, was that difficult?
John Holaday:
Well interestingly enough.
Fintan Walton:
What challenges did you have?
John Holaday:
The beauty of this is the fact that we have a composition of matter patent, because it was preached against by the authorities like the World Health Organization who said never combined two powerful opioids and the scientist often do Maree Smith combined them and show these wonderful facts, so by virtue of that we were able to get composition of matter patent but because these are old drugs they were teaching new tricks, we have a regulatory status that the FDA call 505(b)(2) which means we've seen these before and these are old drugs 200-years old for Morphine, 50 for oxycodone but putting them together is unique, but it is also expected that these have known side effect profiles and anything you do to reduce those there is something the FDA wants to see, so we've had very good interactions with the Food and Drug Administration as we have tailored our programs to do the pivotal studies necessary for approval.
Fintan Walton:
So you've got operations in the US as well as here in Australia, so what is your strategy for taking this through to market?
John Holaday:
We have an exceptional group of people in Bedminster, New Jersey which is our US operations. We are three people in Sydney and then the rest of us are in New Jersey a team of totally 14 people in all and through that team we are very focused on late stages of clinical development and commercialization which we've been able to do because of these successful clinical trials. Today we've performed approximately a 1000 bunionectomies, bunionectomy is a very serious form of pain and shown MoxDuo effects in that also hip replacement, knee replacement studies, we've taken these data and we are ready to file in with the US FDA and also we've had meetings with the European agencies like wise, so that will be so hopefully filing our regulatory process in Europe probably through Germany right after we file in the US.
Formulations in development and range of applications
Fintan Walton:
Now you've also got several formulations, because obviously each of these, it's got a broad range of applications you tell us a little bit about how you've approached that?
John Holaday:
The farthest in development is an immediate release formulation for the treatment of acute pain that's the product that we will putting a new drug application in within the next several months, right behind there is an intravenous formulation which is useful for hospital based clinic as you may know patients were often given a buttoned push where they get intravenous injections of Morphine what we just completed some studies in Germany showing that for the same analgesic dose it takes less drug and also the side effects are reduced by that 50 to 75% and then the farthest backend development is a continuous release for the CR formulation and that will allow 14-12 to 14 hours of pain relief and that will have temper and abuse resistance features in that as well that's the largest market as you may know. Oxycontin sells $2.9 billion worth of drugs annually and globally around almost $6 billion worth of CR drugs in the marketplace and that's the global market of about 12 billion. So it's one that's looking for something new, looking for something different as witnessed by the recent acquisition of King Pharma by Pfizer [PharmaDeals ID = 37764] that made that purchase of 3.6 billion for their pain space.
Partnering strategy,funding and opportunities
Fintan Walton:
Sure, right. So when we we've talked about the clinical strategy, what about your partnering strategy, what do you how you gonna take this now to the next commercial stage, because you are know as you said on the cusp of moving into that stage?
John Holaday:
It's been great for us that as these data have come in showing the positive results in a very consistent way with all different forms of pain and different rounds of administration that the partners are been knocking on our door. We are in the process right now of engaging in some various serious discussions with some leading pharma companies that are interested in what we are doing, they see the market opportunity, they like the way we brought it through to this point in time showing better pain relief and fewer side effects. So the result of that has given us the opportunity to co-promote ultimately into the market that brings back I think a different form of value to our shareholders, but the same time license with these partners they can help us pay the costs of in stages development, stages for the compounds like there, continuous release et cetera, which is farther back in the pipeline.
Fintan Walton:
Sure, and you said you've got, you are in discussions what's your aim when you would like to get some sort of deal out and completed?
John Holaday:
We anticipate getting our new drug application filed at the end of the first quarter of next calendar year, we may well have something before then to take to the Board of Directors for consideration with the number of different companies with whom we are speaking. So I would say that within certainly the next year we will have a partner in relationship that will allow us to then expand globally and also get into to these marketplaces with a little more muscle than we could on our own.
Fintan Walton:
And currently you are also just doing another round of funding is that correct?
John Holaday:
Yes, we just completed a transaction that's actually work in progress allowing us to raise through a placement here in Australia $14 million with an additional program that allows existing shareholders to purchase further shares all of which would be concluded in the second week of November bringing in estimated totally around $18 million for us.
Fintan Walton:
And that's to provide continuum of momentum to your clinical program and also your partnering program?
John Holaday:
It does, perfect and one other study that we are very interested in completing is a marketing study showing that we are better than Morphine, we are better than oxycodone because of the fewer side effects and with those claims from this additional study we hope to get labels that will allow us to make those claim instead of just making them through advertisements.
Fintan Walton:
Sure, and just to make clear that allows to reduce in side effects mean that you can administer at little higher levels of dose?
John Holaday:
Great point Fintan Walton, one can do two things, one can either give higher levels of Morphine or MoxDuo for a opioid pain relief with the same side effects or on the other side of the coin give the usual traditional amount of pain relief with a 50 to 75% reduction in side effects that's the key though, and if you can show reduces side effects a better safety profile you now might benefit the patients but the doctors they won't get the calls in the middle of the night to come in and fix the respiratory depression the reimburses like it, they'll get out of the hospital faster, they'll get on the bicycles faster and recover earlier, so it's really a combination of advance that by virtue to sude effect benefit allow us to open market opportunities.
Fintan Walton:
John Holaday , thank you very much for coming on the show.
John Holaday:
Thank you very much.
Fintan Walton
Dr Fintan Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).
John W Holaday
Chief Executive Officer
John W Holaday joined QRxPharma in 2007 as Managing Director and Chief Executive Officer, and is also President of QRxPharma's US operations. Dr. Holaday brings 39 years of experience as a scientist, executive manager of biotechnology and biopharmaceutical companies, and as a banker. Dr. John W Holaday has extensive experience building specialty pharmaceutical companies. A veteran life-science entrepreneur, Dr. Holaday has built five biopharmaceutical companies over the past 19 years, raising more than $400M in public and private financing. Dr. Holaday founded EntreMed, (ENMD, NASDAQ) in 1992 and served as its Chairman, President and CEO until his retirement in 2003 and was the co-founder, director, Scientific Director and SVP of Medicis Pharmaceutical Corporation (MRX, NYSE). He also founded MaxCyte Inc., co-founded HarVest Bank of Maryland, and is a member of the Board of Directors of Qbit, CytImmune Sciences and Accelovance. From 1968 to 1989, Dr. John W Holaday served as a Captain in the US Army and subsequently as a senior civilian employee at the Walter Reed Army Institute of Research, where he founded the Neuropharmacology Branch in 1980. Dr. John W Holaday currently serves as an officer and Fellow in several biomedical societies and has authored and edited over 200 scientific articles in journals and books. He holds over 30 patents. He served as Chairman of the Maryland BioAlliance, is a Judge for the Ernst and Young Entrepreneur of the Year Award (2003 to present) and was named to the Ernst and Young Entrepreneur of the Year Hall of Fame in 2006. Dr. Holaday is an Associate Professor of Anesthesiology and Critical Care Medicine and Senior Lecturer in Medicine at The Johns Hopkins University of Medicine and Adjunct Professor of Psychiatry at the Uniformed Services University School of Medicine, Bethesda, Maryland. Dr. John W Holaday obtained his Doctorate in Pharmacology at the University of California San Francisco in 1977.
PharmaVentures
PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialisation.
QRxPharma Ltd
QRxPharma Ltd (ASX: QRX) is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of new treatments for pain management and central nervous system disorders(CNS). On May 25, 2007, QRxPharma completed an underwritten initial public offering under the symbol "QRX" on the Australian Securities Exchange (ASX). QRxPharma's strategy is to commercialize late-stage development products obtained through sponsored research and in-licensing of clinical-stage compounds. The Company's Dual-Opioid products target moderate to severe pain, a US$12 billion global opioid prescription market. The goal is to provide greater patient tolerability and a broader selection of analgesic options to pain specialists. QRxPharma remains open and committed to finding the best possible business relationships to expand its US and overseas markets, accelerate revenues, and maximize the value of its product portfolio while providing significant financial return to its shareholders. QRxPharma will initially focus its commercialization efforts in North America and seeks strategic partners for Europe and Asia.