BIO 2010: QRxPharma begins end run

This feature appeared in the March/April 2010 issue of Australian Life Scientist. To subscribe to the magazine, go here.

Sometimes the whole is greater than the sum of its parts. That’s certainly the case with Australian-based pharmaceutical company, QRxPharma. Not only does its lead product, MoxDuo, combine two existing drugs to give a superior effect with fewer side effects than current products, but the company has combined a strong background in science with a prudent approach to clinical trials to build a robust biotechnology company with global aspirations.

The story of QRxPharma begins with a discovery made by Professor Maree Smith and her colleagues at the University of Queensland that not all opioids are created equal. In fact, they found that oxycodone – an opioid pain killer developed nearly 100 years ago – has a different mechanism of action compared to the ubiquitous morphine, acting via a different set of receptors. This raised an intriguing possibility with dramatic therapeutic consequences that QRxPharma hopes to capitalise on.

Two opioids are better than one
Pain killers are big business. In the US, the market value of prescription opioid sales alone was more than $7 billion in 2007, and the opioid market continues to grow year-on-year. Yet opioids, despite their potent pain relief effects, are beset by well-known issues, including side effects such as drowsiness, nausea and constipation amongst others, plus the threat of tolerance and withdrawals when medication is discontinued.

Thus the ideal opioid would deliver the same analgesic properties while having fewer side effects and requiring a lower dosage. However, after many decades of research, new opioids have provided only incremental improvements on their predecessors. This is where MoxDuo and its dual opioid action comes into play.

“What we’ve shown is, by virtue of certain chemical interactions between morphine plus oxycodone when given together, we’ve significantly reduced the side effects by 50 to 75 per cent for the same amount of pain relief,” says QRxPharma CEO, Dr John Holaday. “So this is a paradigm shifting opioid.”

QRxPharma is working on three formulations of MoxDuo, which, together, will cater for the full spectrum of moderate-to-severe pain applications. “What we would like to be able to do is give a toolbox full of tools to the pain practitioner,” says Holaday. The first, and most advanced in clinical trials, is MoxDuo IR, the immediate release formulation. The second is MoxDuo IV, the intravenous product. The final one is MoxDuo CR, or controlled release, which is the earliest in the trial process. With all three, QRxPharma has covered post-surgical pain relief with MoxDuo IV product; the recovery and physical therapy stage with MoxDuo IR; and chronic pain market with MoxDuo CR.

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“The largest market is in the controlled release space, which is dominated by oxycontin, a $2.2 billion a year product. However, that goes off patent in 2013, and that’s about when we think we’ll be ready to launch, maybe 2014, in to that large marketplace. The immediate release market is dominated by generic drugs but there are also some well known proprietary products in that space as well. The intravenous market is the smallest of the three but is one where we think we can make headway,” says Holaday.

That’s not to say QRxPharma is a one trick pony. While MoxDuo is its vanguard product, the company is also exploring therapeutics for central nervous system disorders such as Parkinson’s disease, Huntington’s and Alzheimer’s. Like its approach with MoxDuo, it’s also investigating known drugs, although these ones prevent protein misfolding, thus potentially treating the underlying causes of these neurodegenerative diseases. Currently the early research is being undertaken at the University of Alabama, supported by funding from the Michael J. Fox Foundation for Parkinson’s Research.

Trials and successes
2009 was a tough year for many biotechs, especially ones like QRxPharma that are in the thick of conducting expensive clinical trials. “2009 was not pleasant,” says Holaday. “But we had planned appropriately, guarded our resources, added value to the company and are now coming out with the rest of the industry, but perhaps in a little stronger spot because we’ve added a lot of value to our products.”

QRxPharma was fortunate – or clever – enough to place itself in a strong financial position in 2008, having raised $50 million through its IPO in May 2007, which was enough to fund its late stage trials. During the economic downturn it also cut back on its expenditure and delayed a couple of pivotal studies in favour of marketing studies that were less expensive and provided data to reinforce its argument that MoxDuo is a viable product.

MoxDuo IR is currently in the thick of two phase III studies, with results to be reported before the middle of the year. If all goes well, QRxPharma hopes to file for NDA with the US Food and Drug Administration (FDA) before the end of 2010. Clinical work progresses in Germany on the comparative proof-of-concept study to evaluate the efficacy and safety of MoxDuo IV versus IV morphine alone . The controlled release formula, MoxDuo CR, will begin phase I studies in the second quarter of this year.

QRxPharma has had a relatively smooth run to date in clinical trials, aided by the fact that its product is an amalgam of existing products with a long history and well known effects. As a result, all QRxPharma essentially had to demonstrate is that its product had the same or superior performance with fewer side effects – something it has successfully achieved in all studies published to date.

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Road to market
Assuming the trials progress without any hiccups, Holaday expects QRxPharma to begin shifting emphasis in 2011 to work on the end run to marketing and distributing MoxDuo IR, a task it hopes to tackle itself with the help from some partners.

Given the usual caveats about forward looking statements, says Holaday, “in 12 months times, we will have completed our pivotal studies, we will have our NDA filed with the FDA and we will be engaged in further marketing studies that distinguish us from existing products in a way that will allow our sales reps and our partners to get the benefit of drugs for moderate to severe pain that don’t make you nauseated, vomit, get constipated, get dizzy and all these other things which are the severe side effect limiting parts of these products.”

QRxPharma will also be looking at forming strategic partnerships for the sale and distribution of MoxDuo. “We will also have a strategic relationship, and we’re building our US presence. We’re doing so in a way that allows us to openly market and sell. We’ve not built QRxPharma to be sold, we’ve built QRxPharma to sell products.”

This is because of a firm belief in driving QRxPharma under its own steam for as far as it can and only partnering for the later stages of marketing and sales. “We could have partnered earlier and had our partners pay for the pivotal studies necessary for registration. But when you look at value inflections when companies pay for themselves and get through the phase III trials and register their own products, on the average, according to US sources, deal structures are north of $US1 billion, but less than half that if you have your partners pay and take the risk. For that reason we’re very interested in, and are proceeding with, our plans to add that value ourselves.”

If QRxPharma is able to bring its suite of MoxDuo products into the multi-billion dollar pain management market, it will demonstrate once again that innovative Australian research can be effectively be commercialised by innovative Australian biotechnology companies. The two combine to make something even greater than the sum of their parts.

This feature appeared in the March/April 2010 issue of Australian Life Scientist. To subscribe to the magazine, go here.