QRxPharma Inks Deal with Patheon for the Manufacture of MoxDuo(TM)CR Company on Track to Initiate Phase 1 Study by EOY 2009
SYDNEY and BEDMINSTER, N.J., Oct. 12 /PRNewswire-FirstCall/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today a contractual agreement with Patheon to manufacture clinical supplies of QRxPharma's controlled release Dual-Opioid(TM) formulation (MoxDuo(TM)CR). MoxDuo(TM)CR is designed to provide 12 hours of pain relief in patients suffering from moderate to severe chronic pain (including cancer, lower back, osteoarthritis and neuropathic).
"The Patheon relationship represents a major step forward for QRxPharma that rounds out our platform of MoxDuo(TM) products," said Dr. John Holaday, Managing Director and Chief Executive Officer. "Patheon is a well-known manufacturing organisation with proven ability to develop novel formulations of drugs that address global markets. Our goal is to provide physicians and patients with a variety of complementary Dual Opioids(TM) for managing moderate to severe pain. MoxDuo(TM)CR is expected to deliver clinical benefits similar to those clinically demonstrated with MoxDuo(TM)IR (immediate release formulation) - fewer side effects and superior pain relief."
The new formulation includes tamper resistant features and is designed to provide 12 hours of pain relief. "We are targeting a twice daily dosage with MoxDuo(TM) CR, and we anticipate our initial Phase 1 studies will begin this year to evaluate the pharmacokinetic profile of this patented formulation," said Holaday. "QRxPharma's most advanced product for treating acute pain, MoxDuo(TM)IR, is now in Phase 3 trials and scheduled for New Drug Application (NDA) filing with the US Food and Drug Administration in 2010. QRxPharma's formulation of MoxDuo(TM)CR is anticipated to complete clinical trials in 2012."
The Company's MoxDuo product portfolio includes immediate release, controlled release and intravenous formulations to address pain management in hospitals and at home. The goal is to significantly improve patient care, providing equal or better analgesia with fewer and/or less intense side effects than current standards of care.
"We are pleased to announce this manufacturing agreement with QRxPharma for MoxDuo(TM)CR; we are making significant progress with clinical formulations of this unique Dual-Opioid(TM) product," said Wes Wheeler, CEO of Patheon.
"With this agreement, the development of MoxDuo(TM)CR sets the stage to complete the MoxDuo(TM) product portfolio for managing moderate to severe pain in patients dealing with acute and chronic medical problems," Holaday said.
Forward Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of QRxPharma as of the date of this release. These forward-looking statements are not guarantees for future performance. Actual results could differ materially from those currently anticipated due to a number of factors including 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.
QRxPharma (ASX: QRX and OTCQX: QRXPY) is a clinical-stage specialty pharmaceutical company focused on the development and commercialisation of therapies for pain management and central nervous system (CNS) disorders. Based on a business strategy to expand the clinical utility and commercial value of marketed and/or existing compounds, QRxPharma's product portfolio includes both late and early stage clinical drug candidates with well-defined paths to regulatory approval and sales. The Company intends to directly commercialise its products in the US and seek strategic partnerships for worldwide markets. QRxPharma's lead compound, MoxDuo(TM)IR (Q8003IR), is in Phase 3 clinical development and has successfully completed multiple comparative studies evaluating its efficacy and safety against equianalgesic doses of morphine, oxycodone and Percocet® for the treatment of acute pain. Study results consistently demonstrate MoxDuo(TM)IR's greater overall tolerability, achieving better pain relief with substantially fewer incidences of moderate to severe side effects. The Company's preclinical and clinical pipeline includes other technologies in the fields of pain management, neurodegenerative disease and venomics. For more information: www.QRxPharma.com.
Patheon is a leading global provider of contract dosage form development and manufacturing services to the pharmaceutical and biotechnology industries. Employing more than 4,700 highly-skilled staff, Patheon's network of modern manufacturing facilities located in North America and Europe offer more than three million square feet (300,000 m2) of best in class capacity. With three facilities in the United States, three in Canada and four in Europe (including two in Italy, one in France and one in the United Kingdom) Patheon is able to meet the international requirements of its customers. Patheon's development and manufacturing capabilities cover prescription (Rx) products in solid, semi-solid and liquid dosage forms, as well as specialised capabilities in high-potency, cephalosporin, controlled/sustained release and sterile manufacturing, including aseptic filling and lyophilisation. Founded in 1974 and publicly traded since 1993 (TSX: PTI) Patheon has always been exclusively focused on outsourcing. Patheon proudly serves more than 270 customers including many of the world's leading pharmaceutical, biotechnology and specialty pharmaceutical companies. For more information: www.patheon.com
SOURCE QRxPharma Limited