James Thomsonafr 22/4/14The future of QRxPharma is under a cloud...

James Thomson
afr 22/4/14


The future of QRxPharma is under a cloud after the United States Food & Drug Administration effectively knocked back its pain management drug, Moxduo.

The company will face a meeting of the FDA’s advisory committee overnight on Tuesday, but briefing notes published prior to the meeting suggest that Moxduo, which combines morphine and oxycodone, is unlikely to get the regulator’s tick of approval.

“We have reviewed that response and the data and analyses in the application have not changed our conclusions,” the FDA said in the “background package” provided to members of the committee.

“While the applicant claims that they have a clear benefit in safety overall, and a specific benefit in the area of respiratory adverse events, the Agency review team has been unable to conclude that there is a safety benefit.”

Analyst Matthijs Smith from Canaccord, says the briefing notes are a blow for the company.

“I think there is a very, very low probability that they are going to get through this FDA hearing,” Mr Smith told The Australian Financial Review on Tuesday.

“Moxduo has effectively been knocked back twice, and this is the third time.”
Turbulent journey for Moxduo

The FDA asked for more data on the drug in June 2012, and then again in August 2013 as a result of a data mix up.

While both requests sent QRxPharma’s share price tumbling, neither was seen as a fatal to the company’s chances of getting Moxduo approved in the key US market, where consumers spend an estimated $2.9 billion a year on so-called acute pain management.

But the FDA’s latest verdict followed by a poor showing at the advisory committee would be a major blow.

“I think the challenge fro the company is that most of their drug development pipeline is based on permutations of this drug,” Mr Smith said.

“[A rejection] is going to call into question the merit of pursing other versions of the same products.”

QRxPharma declined to comment ahead of the meeting, but will hold a conference call for investors on Wednesday.

Mr Smith said that the company’s key claim was that it helped reduce the risk of respiratory depression (breathing difficulties) which have been associated with other pain management drugs.
No major benefit

But the FDA studies – the agency conducts its own trials as well as relying on those run by drug companies – didn’t support this.

“The company’s interpretation of their data and the FDA’s interpretation was quite different. When they looked across all of the studies, the FDA’s view was there really wasn’t a major benefit in terms of respiratory depression,” Mr Smith said.

He also said growing concerns in the US about opioid drugs meant that Moxduo faced a “slightly higher hurdle” than other drugs.

All may not be lost if the advisory committee meeting does not go QRxPharma’s way, Mr Smith said.

“A lot will depend on how strong the advisory committee comes out. To what extent it is a complete shutdown of this program? Or what are the opportunities that come out of this?”

However, he said Australian biotech companies had a poor record of pushing on with the development of drugs that have been rejected by regulators, often a high cost to investors.

Shares in QRxPharma, which has a market capitalisation of $143 million, were in a trading halt pending the results of the meeting. In the last 12 months, the company’s shares have fallen from a high of $1.34 to 70¢.