QRx Pharma Ltd: Janette Dixon. Addressing the need for a better safer opioid product with MoxDuo-IR




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Video title: QRx Pharma Ltd: Janette Dixon. Addressing the need for a better safer opioid product with MoxDuo-IR
Released on: January 04, 2012. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, Fintan Walton talks to Janette Dixon, Vice President of Global Business Development at QRx Pharma Ltd.
Lead product MoxDuo:Technology and advantages
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at AusBiotech's convention, in Adelaide. On this show I have Janette Dixon, who is a Senior Vice President of a company called QRx which is an Australian company listed company with operations both here in Australia, but also substantially in New Jersey, USA. Welcome.
Janette Dixon:
Thanks very much Fintan, it's great to be here.
Fintan Walton:
So Janette, obviously QRx as I said is an Australian company, could you just tell us what is QRx? What is the focus of its products? How would you describe the company?
Janette Dixon:
Sure, so the Q in QRx comes from Queensland, so yes we are an Australian company and we have developing a technology that came out of the University of Queensland, it's a Dual-Opioid platform a combination of two different opioids together in the same product and we are developing that under the MoxDuo brand, we have several products in development our lead product is the immediate release formulation.
Fintan Walton:
Okay, so what is the advantage of MoxDuo-IR?
Janette Dixon:
Well as I said a combination of a two opioids together morphine and oxycodone in a 3:2 ratio it's the only opioid combination product in development anywhere in the world and the advantage of the product is that in clinical trials it is consistently showing a 50 to 75% reduction in the a clinically significant adverse events that are commonly seen with IPO drugs so that things like nausea, vomiting , dizziness that comes to patient.
Fintan Walton:
Right, so obviously someway's it might seem obvious to put two opioids together, what is it I mean obviously it's patented you are well protected we make that assumption, so why is that such an inventive step?
Janette Dixon:
Well in fact I said it's not that obvious to put two opioids together, in fact the World Health Organization actually teach against that, but Professor Maree Smith at University of Queensland challenged that document in here in early animal study she looked to see what happen when you put these two together in and surprising well and it still maintained a very good efficacy in terms of pain relief and the two different opioids interact to reduce the side effects of the two different drugs and that was very unexpected finding and that's why in fact we have patent protection for this combination product.
Clinical development programs and results
Fintan Walton:
Okay, so tell us a little bit about the clinical development program that you've got for that product, where are you? Where are your clinical trials and what's your expectation for future results?
Janette Dixon:
MoxDuo-IR the immediate release formulation it's been in development for four-years now and I am very pleased to say that we've reached the end of our Phase III program have in fact filed our NDA which we did that in July of this year, so completed the Phase II program in February with the completion of the total knee replacement study where we showed that MoxDuo had superior pain relief to a low dose active comparator, and then in June of this year we've released some other results from the Phase IIIb study that was the study where we compared the higher dose of MoxDuo the 12/8 milligram dose, that's 12 milligrams of morphine, 8 milligrams of oxycodone and with the morphine equivalent doses, so 24 milligrams of morphine, 16 milligrams of oxycodone so very high doses of opioids and in what we found in that trial is that the MoxDuo patients when they had a respiratory event an oxygen desaturation event it tended to be less severe and of shorter duration than the patient fit will have it on the morphine arm or the oxycodone arm where they had respiratory depression event, so sorry oxygen desaturation event, and so what we found there in this data MoxDuo does in fact have another feather in it's cap another attribute in terms of its safety profile so on top of the nausea, vomiting , dizziness it also has a respiratory advantage, so all together now the program is complete the NDA is filed.
Opportunities and positioning in market
Fintan Walton:
Fantastic, so the market where do you see yourselves positioned in the market, because obviously there are existing products out there, so what's your prediction there?
Janette Dixon:
Well without a doubt the biggest market opportunity for MoxDuo-IR is in the US and so we are targeting a 2 billion a year, dollar a year market opportunity it's a huge volume of scripts because it's a highly genera sized market at present, so there are 210 million scripts a year for opioids products for acute pain in the US and that's the market that we are targeting and you are right it is a competitive landscape there are lot of other opioid products out there, there are opioid combination products with the (indiscernable) and there are straight opioids products now other opioid products as I said, and there so our positioning in that market would be to address the need for a better safer opioid product and there has been little innovation in this market for decades so there are a many reformulations and there are few newer formulations with abuse deterrent or temporary system features, but none there offer a safer a better safe product.
Fintan Walton:
Because obviously the patients that need these products are themselves vulnerable anyway, so if you can reduce the adverse effects then obviously it's a true advantage?
Janette Dixon:
That's absolutely the case, because it is in fact the safety profile of IPO is that limit they use, I mean they are very effective for a moderate to severe pain that been in the market that we're targeting, but the use is limited by their nasty side effects a nausea, vomiting , dizziness that patients can't tolerate.
Product pipeline and partnership with Aoxing Pharmaceutical
Fintan Walton:
Okay, so let's just go back to QRx itself so that's your lead program, your lead product going forward, what about the remaining clinical development program? What else do you have in your pipeline?
Janette Dixon:
For the other products?
Fintan Walton:
Yes.
Janette Dixon:
Yes, so we have intravenous formulation in development and we've completed proof of concepts study for that, I think it was late last year it showed very similar side effect profile to the immediate release so again significant reductions in nausea, vomiting , dizziness and arterial desaturation and that is so attractive that we partnered with Aoxing Pharmaceutical a Chinese company [PharmaDeals ID = 35451], [PharmaDeals ID = 35452] for the Chinese rights and they helping us with the development of that product, we get to use the data from their development program outside the US, but the jewel in the crown is the controlled-release formulation that is in the Phase I trials at the moment.
Commercialisation and partnering strategy
Fintan Walton:
Okay, so going back to your lead product again, one question I have really is the you know what's your strategy there for commercialization are you going to go alone or you going to look for a partner, what's your strategy there?
Janette Dixon:
Well certainly that's where our attention is changing till now with the filing of the NDA and commercialization is very much on our mind and so what we are looking at is a dual strategy there where we are talking to various partners and what would be an ideal arrangement for us would be a co-promotion partnership were we together with the partner would attack at the US market outside the US we would definitely look to license, but at the same time we have the expertise in-house to take MoxDuo to market ourselves in the US if the right partner or the right associate teams that come along.
Fintan Walton:
Right, so obviously company like QRx which is an Australian company with a product that's filed in NDA must be a great success, congratulation.
Janette Dixon:
Yes, thank you very much.
Fintan Walton:
anette Dixon, thank you very much indeed for coming on the show.
Janette Dixon:
Thank you.
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).
Janette Dixon
Senior Vice President
At the time of recording this PTV interview Janette Dixon serves as Senior Vice President, Global Business Development at QRxPharma Ltd and CEO of Venomics Pty Ltd (a QRxPharma Ltd subsidiary). Formerly a medical scientist, Janette has extensive commercial experience at executive and director level in both start-up and corporate organizations in the fields of pharmaceuticals and clinical diagnostics. She has degrees in medical technology, marketing, finance and a Doctorate in Business and Administration wherein her research focused on the strategic management of biotech commercialization. Prior to joining QRxPharma , Janette held the role of Managing Director at Pacific Pharmaceuticals Ltd (now Mylan New Zealand Ltd) and led the restructuring of New Zealand's largest pharmaceutical manufacturing company, outsourcing production of 130 pharmaceutical products into six countries. Janette has spent 12 years living and working in Asia and has broad business development experience in the life sciences sector across Asia Pacific and more recently across the US and Europe. Janette founded and is a Director of Singapore based Synergy Pharmaceuticals Pte Ltd, a clinical stage company developing a drug for the eradication of Helicobacter pylori. She previously founded and successfully sold two diagnostics companies based in Singapore and Malaysia and has negotiated and implemented two joint ventures on behalf of QRxPharma with Chinese pharmaceutical companies.
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 (CNS) disorders . 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.