Sydney, Australia and Bedminster, New Jersey – QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today that the United States Patent and Trademark Office (USPTO) issued the Company a new patent, U.S. Patent #7,923,453, which expires in 2029. This patent covers a proprietary dosing algorithm for converting patients from intravenous opioid administration to orally administered MoxDuo IR, thereby more effectively and safely managing acute pain following surgery.
“Patients often respond differently to opioids; this algorithm facilitates the personalised dosing of MoxDuo IR by the clinician, thereby improving efficacy and safety. This is the first of several patent applications filed by the Company to be approved which extend global exclusivity of the MoxDuo Dual Opioid® product line,” said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. “The issued patent describes a clinically derived dosing algorithm to be included in the MoxDuo IR product label to help patients and doctors maintain analgesic control of pain while minimising side effects,” Holaday added.
MoxDuo is a patented 3:2 ratio fixed dose combination of morphine and oxycodone that is being developed by QRxPharma in three presentations: oral immediate release (MoxDuo IR), intravenous (MoxDuo IV) and controlled release (MoxDuo CR). These three product candidates are staged to address the $12 billion global market for the treatment of moderate to severe pain. MoxDuo IR targets the acute pain market, a $2.5 billion segment of the $7 billion spent annually on prescription opioids in the US.
As the Company’s clinical studies consistently demonstrate, MoxDuo effectively treats acute pain while appreciably diminishing the intensity and frequency of moderate to severe opioid-related side effects when compared to frequently prescribed opioids. To date, the Company has successfully conducted twelve clinical trials, including three pivotal Phase 3 studies.
Based on QRxPharma’s recent pre-New Drug Application (NDA) meeting with the United States Food and Drug Administration (FDA), the Company believes it is on track to file an NDA in mid-2011for the use of MoxDuo IR in the management of moderate to severe acute pain.
For more information please contact:
John W Holaday, Ph.D.
Managing Director and Chief Executive Officer
Tel: +1 301 908 3086
Chris J Campbell
Chief Financial Officer and Company Secretary
Tel: +61 2 9492 8021
About QRxPharma Limited
QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) is a clinical-stage specialty pharmaceutical company focused on the development and commercialisation of new treatments for pain management and central nervous system (CNS) disorders. Based on a development strategy that focuses on enhancing and expanding the clinical utility of currently marketed compounds, the Company’s product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risk, abbreviated development paths, and improved patient outcomes. The Company intends to co-promote its products in the U.S. and seeks strategic partnerships for worldwide markets. QRxPharma’s lead product candidate, immediate release MoxDuo, has successfully completed pivotal Phase 3 studies and the Company expects to file its New Drug Application (NDA) with the US Food and Drug Administration (FDA) in mid-2011. The Company’s clinical pipeline includes an intravenous (IV) and continuous release (CR) formulation of MoxDuo, as well as other technologies in the fields of pain management, neurodegenerative disease and venomics. For more information, visit www.qrxpharma.com.
Forward Looking Statements
This release contains forward-looking statements. Forward-looking statements are statements that are not historical facts; they include statements about our beliefs and expectations. Any statement in this release that states our intentions, beliefs, expectations or predictions (and the assumptions underlying them) is a forward-looking statement. These statements are based on plans, estimates and projections, as they are currently available to the management of QRxPharma. Forward-looking statements therefore speak only as of the date they are made, and we undertake no obligation to update publicly any of them in light of new information or future events. By their very nature, forward-looking statements involve risks and uncertainties. A number of important factors could therefore cause actual results to differ materially from those contained in any forward-looking statement. Such factors include risks relating to the stage of products under development; uncertainties relating to clinical trials; dependence on third parties; future capital needs; and risks relating to the commercialisation of the Company’s proposed products.