morgans - eps 74.5c/share by fy2016!, page-15

Hello again frankshie,

It appears to me that your concern that Study 022 shows Moxduo IR only has a respiratory safety advantage over 16mg oxycodone and not 24mg morphine is, to some extent, unfounded as it is based on very old and outdated information.

The Biotech Daily article that you refer to was published on 28 February 2013, while its references to the results of Study 022 date from a previous Biotech Daily article that was published on 14 June 2011.

Here is the section of the Feb 2013 article that gives rise to your concerns:

"In 2011 QRX said the Study 022 trial showed that Moxduo had a mixed superior safety profile to equi-analgesic doses of either 24mg morphine alone or 16mg oxycodone alone (BD: Jun 14, 2011).
QRX said at that time that the Study 022 primary endpoint of respiratory depression, measured by oxygen desaturation, was less severe and of shorter duration in patients receiving Moxduo IR, but the difference was only significant against 16mg oxycodone and not 24mg morphine."

The key words here are: "In 2011 QRX said..." and "QRX said at that time..."

Looking back at the QRX timeline, their first NDA was filed between 18 July 2011 (preliminary filing) and 25 August 2011 (complete filing). At this point in time, Study 022 had not been properly analysed and was therefore not included in the filing.

Thus, in August 2012, when QRX outlined the results of their post-CRL (i.e. Complete Response Letter) meeting with the FDA, they noted that:

"Analysis of Study 022 was completed after the MOXDUO NDA filing in August 2011, although early safety data were included in the 120-day update filed last December. Accordingly, additional efficacy and safety information from this study was of significant interest to the FDA."

http://www.asx.com.au/asxpdf/20120820/pdf/4283m0dh210jfv.pdf

Given that QRX could only provide "early safety data" in their 120-day update to the FDA in December 2011, the references to the results of Study 022 in the Biotech Daily article from June 2011 must have been Preliminary with a capital "P".

In more recent references to Study 022 that are based on the fully analysed data, MoxDuo IR is claimed to have significant respiratory safety advantages over both 16mg Oxycodone and 24mg Morphine. However - and it is no doubt here that your concerns have some foundation - while these safety advantages are significant for all age groups in the MoxDuo Vs Oxycodone cohort, they are only significant for people aged 60 years and older in the MoxDuo Vs Morphine cohort. Thus, it is only in people under the age of 60 years that Moxduo IR shows no respiratory safety advantage over Morphine.

See slides 22-27 of the following QRX Investor Presentation from March 2013:
http://qrxpharma.com/download/file/cp/QRxPharma_Investor_Presentation_1_March_2013_Final.pdf

In conclusion, given the respiratory safety advantages of MoxDuo IR over Oxycodone (all ages) and Morphine (people aged over 59), IMHO I believe it is quite safe to say that it has a better chance at passing the FDA this time around.